Alli - reseptfritt legemiddel mot fedme (legemiddelverket.no 10.11.2008)

Ønsker forbud En amerikansk forbrukergruppe ber myndighetene om å trekke fedmemedisinen Xenical fra markedet. (tv2.no 11.4.2006)

Public Citizen anmoder FDA om å forby Xenical (orlistat) ("Alli") (citizen.org 10.4.2006)

"Neppe farlig" (vg.no 27.10.2008 (Av Mari Rian Hanger (Dagens Medisin))

So why all the hype about an 8 year old drug? (themorbidme.com 22.6.2007)

Preparatomtale Alli (Xenical (orlistat)) (fda.gov) (fda.gov) (dailymed.nlm.nih.gov) (Felleskatalogen.no) (SLV)

GlaxoSmithKline Håper på en blockbuster (nytimes.com 26.4.2006)

- Slutsålt för Alli

Slutsålt för Alli
lakemedelsvarlden.se 3.10.2012
Det receptfria bantningspreparatet som förutspåddes en lysande framtid finns snart inte på svenska marknaden längre. (...)

Det var 2009 som den europeiska läkemedelsmyndigheten EMA tog beslut om att det viktreducerande läkemedlet Alli skulle få säljas utan recept inom hela EU. Den verksamma substansen, lipashämmaren orlistat, fanns sedan tidigare i det receptbelagda Xenical men i en högre styrka. (...)

Biverkningarna i form av mag-tarmproblem som yttrat sig ibland annat läckande diarréer har lett till att många patienter avbryter sin behandling. Dessutom ledde rapporter om leverbiverkningar att EMA:s vetenskapliga kommitté CHMP gjorde en utredning hösten 2011 av produkter innehållande orslistat. Slutsatsen var att nyttan överväger riskerna men nu finns alltså bara den receptbelagda varianten kvar i Sverige. (...)

(Anm: Drug companies in US spent millions pushing for weight loss drug approvals, investigative report finds. BMJ 2015;350:h2138 (Published 22 April 2015).)

(Anm: Drug maker must restart obesity drug study after releasing early data. A major US study of a newly approved antiobesity drug that was designed to measure adverse cardiovascular effects has been stopped by its steering committee after the manufacturer revealed first quarter data in a patent application. BMJ 2015;350:h2844  (Published 22 May 2015).)

(Anm: CardioBreak: Obesity Drug Safety, HF Device Flop, $$ for Heart Docs. Recent developments of interest in cardiovascular medicine. (…) Obesity drugs were deemed "pretty safe" in an analysis of the postmarketing data by AdverseEvents, but some reports of serious cardiovascular and neuropsychiatric side effects were also deemed worth watching. (medpagetoday.com 27.7.2015).)

(Anm: New obesity meds 'pretty safe,' but some side effects bear watching: AdverseEvents (fiercepharma.com July 22, 2015).)

- Spesialrapport på uheldige bivirkninger for fedmelegemidler (fedmemedisiner)

Special Report Download
Comparative Analysis of the Newly Approved Obesity Drug: Contrave

adverseevents.com 28.7.2015
ObesityContraveOn September 10th, the FDA granted approval of a new chronic weight-loss drug, Contrave (naltrexone and bupropion extended-release). Contrave is formulated as a combination product consisting of an opioid antagonist (naltrexone) and an antidepressant (bupropion), both of which are FDA-approved drugs indicated for treating different conditions as individual agents. Several issues pertaining to Contrave’s safety profile raise significant concerns.

This report serves to highlight some of the safety considerations for currently approved obesity treatments as well as compare the safety profiles of Contrave and Qsymia. (…)

(Anm: Endnu et dødsfald efter fedmestudie. Et amerikanske selskab, der er en af Novo Nordisks mulige konkurrenter på markedet for medicinsk behandling af fedme, har oplevet endnu et dødsfald efter et klinisk studie med selskabets hovedaktiv. (medwatch.dk 2.12.2015).)

(Anm: Zafgen - Dedicated to the Treatment of Obesity. (Zafgen.com).)

(Anm: Beloranib is an experimental injectable[1] drug candidate for the treatment of obesity. It was discovered by CKD Pharmaceuticals and is currently being developed by Zafgen.[ (en.wikipedia.org).)

(Anm: Zafgen Says a Second Patient Died in Beloranib Study. FDA had placed beloranib on partial clinical hold in October following first patient’s death. (...) “Our thoughts are with the patient and their family at this time,” he said. “Patient safety remains our top priority, and we are investigating the circumstances around this event.” (wsj.com 3.12.2015).)

(Anm: UPDATED: Beleaguered Zafgen crushed after FDA demands force it to dump lead drug. Stymied at the FDA with a lingering clinical hold on its lead obesity drug, Zafgen is dumping the therapy and retreating to a preclinical program in the pipeline. The biotech announced after the market closed on Tuesday that it will now circle the wagons around ZGN-1061 after beloranib was linked with the death of two patients in a pivotal study. (endpts.com 19.2016.)

- GSK vill sälja Alli

GSK vill sälja Alli
lakemedelsvarlden.se 20.4.2011
Glaxosmithkline kommer att göra sig av med delar av sitt receptfria sortiment. Bantningspreparatet Alli är en av de produkter som företaget vill sälja innan årets slut.

Företaget meddelar att den planerade försäljningen är en del i at strömlinjeforma verksamheten och att fokusera på områden som tillväxtmarknader. Planen för Glaxosmithkline, GSK, är att göra sig av med delar av det receptfria sortimentet som säljs främst i Europa och USA.

Bland produkterna som de nu letar köpare till finns viktminskningspreparatet Alli (orlistat), Zantac (ranitidin) mor halsbränna och en serie vitaminer och kosttillskott. Flera av produkterna är storsäljare med enligt Pharma Times anser GSK trots det att verksamheten kommer att må bättre av att dra ner på sin produktportfölj.

Ungefär samtidigt som GSK meddelade sina planer har den inflytelserika amerikanska medborgarorganisationen, Public Citizen, vänt sig till FDA och krävt att både Alli och den receptbelagda varianten Xenical, dras in. Anledningen är rapporter om njur- och leverskador i samband med behandling.

Företaget uppger att de kommer att börja leta efter intresserade köpare den närmaste tiden och att försäljningen kommer att vara klar vid slutet av 2011. (...)

Highlights in this report include:

  • Drug comparison listing of Outcomes including Death, Hospitalization and Disability
  • RxScore comparisons –highest and lowest safety profiles
  • Comparison of on-label Contrave adverse events to reported adverse events for Belviq and Qsymia
  • Off-label adverse events that may trigger future pharmacovigilance action for Qsymia
     
    Drugs included in this report include:
  • Alli (orlistat), GlaxoSmithKline
  • Belviq (lorcaserin hydrochloride), Eisai, Arena Pharmaceuticals
  • Contrave (bupropion hydrochloride; naltrexone hydrochloride), Orexigen Therapeutics
    Phentermine (phentermine)
  • Qsymia (phentermine hydrochloride; topiramate), Vivus
  • Xenical (orlistat), Roche (...)

(Anm: Drug interventions for the treatment of obesity in children and adolescents. OBJECTIVES: To assess the efficacy of drug interventions for the treatment of obesity in children and adolescents. (…) AUTHORS' CONCLUSIONS: This systematic review is part of a series of associated Cochrane reviews on interventions for obese children and adolescents and has shown that pharmacological interventions (metformin, sibutramine, orlistat and fluoxetine) may have small effects in reduction in BMI and bodyweight in obese children and adolescents. However, many of these drugs are not licensed for the treatment of obesity in children and adolescents, or have been withdrawn. Trials were generally of low quality with many having a short or no post-intervention follow-up period and high dropout rates (overall dropout of 25%). Future research should focus on conducting trials with sufficient power and long-term follow-up, to ensure the long-term effects of any pharmacological intervention are comprehensively assessed. Adverse events should be reported in a more standardised manner specifying amongst other things the number of participants experiencing at least one adverse event. The requirement of regulatory authorities (US Food and Drug Administration and European Medicines Agency) for trials of all new medications to be used in children and adolescents should drive an increase in the number of high quality trials. Cochrane Database Syst Rev. 2016 Nov 29;11:CD012436.)

- Håper på en blockbuster (- Legemiddel med årlig salg over 1 milliard dollar)

Hoping for a Blockbuster (Håper på en blockbuster)
nytimes.com 26.4.2006
When GlaxoSmithKline began talking to Roche three years ago about commercializing the prescription diet drug Xenical, the timing could not have been better for Steven L. Burton. (...)

Now Mr. Burton, 47, has the job of motivator in chief as Glaxo prepares to market an over-the-counter version of Xenical. During the last three years, while ramping up the marketing plans, he has been using the drug himself. And while he does not envision himself posing for the before and after shots in a diet ad, he can offer personal testimony to the drug's potential benefits. In his three years on Xenical, Mr. Burton said he has dropped to 210 pounds from 270, and kept it off. (...)

Xenical, sold by Roche in the United States since 1999, has had only moderate success as a prescription drug in this country. (...)

Xenical has a generally clean safety record. But the consumer watchdog group Public Citizen recently called for its withdrawal, citing research that some scientists say links the drug to colon changes that can be precursors to formation of polyps and colon cancer.

A Glaxo company spokeswoman, Malesia A. Dunn, said long-term testing in humans had demonstrated no increased risk of colon cancer in the drug's users. (...)

(Anm: blockbuster; legemiddel med årlig salg over 1 milliard dollar.)

Glaxo to Shed Its OTC Diet Drug, Alli
Online.wsj.com 15.4.2011
Four years after launching the nonprescription diet pill Alli with much fanfare and a heavy marketing budget, U.K. drug maker GlaxoSmithKline PLC on Thursday said that it plans to sell off the drug along with a clutch of other over-the-counter brands.

Glaxo once tipped Alli as a possible blockbuster, but sales never took off, and the drug was hurt last year by reports that a small number of people taking it experienced liver damage. (...)

(Anm: Chronic liver damage worsened by alcohol-fueled gut bacteria (medicalnewstoday.com 9.2.2016).)

- Advarer mot nyre- og leverskader, og akutt pankreatitt

Orlistat and the risk of acute liver injury: self controlled case series study in UK Clinical Practice Research Datalink
BMJ 2013;346:f1936 (12 April 2013)
(...) Objective To measure the association between orlistat and acute liver injury. (...)

Participants 94 695 patients receiving orlistat and registered in the UK Clinical Practice Research Datalink and linked with Hospital Episode Statistics data between 1999 and 2011.

Main outcome measure Relative incidence of acute liver injury comparing periods when patients were receiving orlistat with periods of non-usage.
Results Among 94 695 patients who received orlistat, 988 cases of acute liver injury were identified, with 335 confirmed as definite cases and 653 as probable cases. For all cases an increased incidence of liver injury was detected during the 90 day period before orlistat was first started, with an incidence rate ratio of 1.50 (95% confidence interval 1.10 to 2.06). The incidence remained raised during the first 30 days of treatment (2.21, 1.43 to 3.42), before returning to baseline levels with prolonged treatment. When the risk during the first 90 days of treatment was compared with the 90 days preceding first treatment, the incidence of liver injury was not increased (1.02, 0.67 to 1.56). An analysis restricted to definite cases showed no evidence of an increased risk of liver injury during treatment.

Conclusion The incidence of acute liver injury was higher in the periods both immediately before and immediately after the start of orlistat treatment. This suggests that the observed increased risks of liver injury linked to the start of treatment may reflect changes in health status associated with the decision to begin treatment rather than any causal effect of the drug. (...)

Forskere advarer mot slankepiller
vg.no 17.12.2012
Amerikanske forskere mener slankepiller som selges over disk i Norge kan føre til at organer svikter og kreftmedisin fungerer dårligere. Norske myndigheter er ikke bekymret.

Forskerne bak studien er bekymret nok for funnene til at de har meldt fra om dem til det amerikanske legemiddelverket U.S. Food and Drugs Administration (FDA).

Hovedforsker Bingfang Yan ved University of Rhode Island og kollegene har undersøkt legemiddelet orlistat, som stopper opptak av fettsyrer i tarmen. Det brukes derfor som slankemedisin.

Reseptfritt
Orlistat selges reseptfritt i Norge som slankepillen Alli. I tillegg kan man få resept på piller med større doser, da under navnet Xenical. (...)

Ifølge Yan blir et viktig enzym som brukes til å rense indre organer hemmet av legemiddelet. I verste fall kan det føre til at leveren, nyrer eller bukspyttkjertelen slutter å fungere.
Yan har sjekket hvordan orlistat påvirker enzymet karboxylesterase-2, som finnes i forskjellige varianter i mus, rotter og mennesker. Forskerne har testet orlistats påvirkning på alle de tre enzymvariantene.

Karboxylesterase-2 har som jobb å rense ut avfallsstoffer i nyrer, lever og bukspyttkjertel.

Organsvikt
Om enzymet ikke lenger fungerer, kan det fort hope seg opp giftstoffer i disse viktige organene. Det kan føre til betennelser, og i verste fall full organsvikt.

Ifølge Yan og fem andre kolleger er det nettopp dét som kan skje om man bruker Alli eller Xenical:

De skriver i tidsskriftet Biochemical Pharmacology at selv lave doser orlistat kan hemme enzymet. (...)

Tidligere i år kom Statens legemiddelverk med en oppdatert uttalelse om orlistat. Der skriver de at nytten for overvektige pasienter fortsatt er større enn risikoen. (...)

Slankemidlene Xenical og Alli og leverpåvirkning
legemiddelverket.no 27.9.2011
Det europeiske legemiddelkontoret (EMA) har startet en ny gjennomgang av sikkerheten ved bruk av slankemidler som inneholder orlistat (Xenical og Alli). Bakgrunnen er rapporter om svært sjeldne, men alvorlige leverbivirkninger.

Det er kjent at behandling med orlistat kan gi leverbivirkninger i svært sjeldne tilfeller, og dette er beskrevet i produktinformasjonen. De fleste meldingene om leverbivirkninger som mistenkes å være forårsaket av orlistat er ikke alvorlige, mens alvorlige leverbivirkninger er svært sjeldne. Det er rapportert fire alvorlige tilfeller av leverbivirkninger i verden det siste halvannet året. Den nye gjennomgang skal forsøke å klargjøre om de alvorlige leverbivirkningene er forårsaket av orlistatbruk, og om balansen mellom nytte og risiko er endret.

Inntil resultatet av gjennomgangen foreligger er det ikke grunn til å endre bruken av orlistat. (...)

(Anm: European Medicines Agency starts review of orlistat-containing medicines (ema.europa.eu).)

Viktminskningspreparat som innehåller orlistat (Alli och Xenical) utreds efter rapporter om leverpåverkan
lakemedelsverket.se 23.9.2011
De europeiska läkemedelsmyndigheterna har inlett en utredning av läkemedel som innehåller orlistat efter ett mindre antal rapporter om allvarliga leverbiverkningar. (...)

Orlistat og akutt nyreskade
relis.no 15.4.2011
Tidligere har det vært rapportert enkelttilfeller av nyreskade ved bruk av orlistat, og i den godkjente norske preparatomtalen er oksalatnefropati angitt som en mulig bivirkning med ukjent frekvens (1).

Det nye er at kanadiske forskere har gjennomgått et materiale med ca 950 pasienter. Der fant de at 18 pasienter (2%) hadde fått nyresten i løpet av det første året de ble behandlet med orlistat, mens bare fem pasienter hadde hatt nyresten i løpet av det siste året før de begynte å bruke orlistat. Forskerne mener disse funnene støtter tidligere rapporterte enkelttilfeller, og at bruk av orlistat kan være en mulig årsak til akutt nyreskade (2).

Det skal også finnes rapporter om akutt pankreatitt og nyresten i amerikanske legemiddelmyndigheters (FDA) bivirkningsdata (3). (...)

Roche's diet drug tied to kidney damage
reuters.com 12.4.2011
(Reuters Health) - In another blow to diet drugs, Canadian researchers are reporting a link between Roche's Xenical and an increase in kidney injuries.
Tapping into healthcare databases from the province of Ontario, they found that 0.5 percent of new orlistat users were hospitalized for kidney problems in the year before starting on the drug. Over the next year, that number jumped to 2 percent.

Dr. Matthew Weir, who worked on the study, said a few earlier case reports had found kidney problems in people on Xenical, but that it wasn't listed among the drug's side effects.

"I'd just like to add that this study should be interpreted cautiously," he noted in an email to Reuters Health. "It is observational and cannot prove causality."
Last year, U.S. health officials warned about rare cases of liver damage in patients on Xenical or GlaxoSmithKline's Alli. The active ingredient of both drugs -- called orlistat -- inhibits the absorption of fat in the gut.

Alli's global sales totaled about $317 million in 2009. Worldwide sales of Xenical in 2009 hit about 400 million Swiss francs ($345 million).

Roche did not return calls for comments in time for this article.

The new study is based on 953 new users of orlistat and is published in the Archives of Internal Medicine. (...)

FDA puts liver damage warning on weight loss pill (PDA advarer mot leverskade for slankepille)
forbes.com 26.5.2010
WASHINGTON -- Federal health officials are warning consumers that the weight loss pill alli may cause severe liver damage in rare cases.

The Food and Drug Administration says it has added a warning about the risk to the label of the drug, which is sold over-the-counter by GlaxoSmithKline (GSK - news - people). A prescription version called Xenical is marketed by Roche (RHHBY.PK - news - people). (...)

(Anm: Orlistat (marketed as Alli and Xenical): Labeling Change (fda.gov (Posted 05/26/2010).)

(Anm: FDA Drug Safety Communication: Completed safety review of Xenical/Alli (orlistat) and severe liver injury. (fda.gov (Posted 05/26/2010).)

Slankemidlene Xenical og Alli og leverpåvirkning
legemiddelverket.no 27.10.2009
Det er ikke dokumentert at slankemidler som inneholder orlistat (Xenical og Alli) fører til mer alvorlige leverproblemer enn det som allerede er beskrevet i preparatomtale og pakningsvedlegg. Dette er konklusjonen etter at Europeiske legemiddelmyndigheter (EMEA) har fullført sin sikkerhetsgjennomgang.

Det er derfor ikke grunnlag for å gi nye anbefalinger om bruk av disse legemidlene. (...)

Amerikanske legemiddelmyndigheter (FDA) undersøker slankemidlene Xenical og Alli
legemiddelverket.no 27.8.2009
FDA har varslet* gjennomgang av rapporter om leverbivirkninger ved bruk av Xenical (reseptpliktig) og Alli (reseptfritt). Begge inneholder virkestoffet orlistat. Europeiske legemiddelmyndigheter (EMEA) gjør en tilsvarende gjennomgang.

Food and Drug Administration (FDA) har fått 32 rapporter om alvorlig leverskade, inkludert 6 tilfeller av leversvikt hos pasienter som har brukt orlistat. 30 av rapportene gjelder tilfeller som er oppstått utenfor USA. (...)

I Norge er det rapportert ett tilfelle av leversvikt og ett tilfelle av leverbetennelse i forbindelse med bruk av orlistat etter at det kom på markedet i 1999. Selv om disse pasientene brukte orlistat, kan vi ikke konkludere med at legemiddelet er årsak til leverskadene. (...)

Orlistat (marketed as Alli and Xenical): Early Communication about an Ongoing Safety Review
fda.gov/Safety/MedWatch 24.8.2009
Audience: Endocrinological healthcare professionals, patients
FDA notified healthcare professionals and patients that it is reviewing new safety information regarding reports of liver-related adverse events in patients taking orlistat. Orlistat is marketed in the United States as a prescription product, Xenical, and as an over-the-counter (OTC) product, Alli. Between 1999 and October 2008, 32 reports of serious liver injury, including 6 cases of liver failure, in patients using orlistat were submitted to FDA’s Adverse Event Reporting System. The most commonly reported adverse events described in the 32 reports of serious liver injury were jaundice, weakness, and abdominal pain. (...)

FDA urges both healthcare professionals and consumers to report side effects from the use of orlistat (Alli and Xenical) to FDA's MedWatch Adverse Event Reporting program.

[08/24/2009 - Early Communication About an Ongoing Safety Review - FDA]

[08/24/2009 - News Release - FDA] (...)

- Fedmemedisin kan gi kreft

ADVARER:
Fedmemedisin kan gi kreft

tv2.no 11.4.2006
En amerikansk forbrukergruppe ber myndighetene om å trekke fedmemedisinen Xenical fra markedet.

Grunnen er at de mener medisinen kan gi kreft, og at dette er påvist i studier gjort med dyr, melder Reuters.

Studien den amerikanske forbrukergruppen refererer til er publisert i The journal Cancer Letters.

Medisinen produseres av selskapet Roche Holding og det amerikanske selskapet GlaxoSmithKline Plc. har fått grønt lys av den «American food and drug administration» til å selge medisinen uten resept, men bare dersom medisinen møter diverse hemmelige kriterier først. (...)

- Forsker ser potentiel kræftrisiko ved Novos fedmemiddel

Forsker ser potentiel kræftrisiko ved Novos fedmemiddel
medwatch.dk 11.3.2015
En internationalt anerkendt forsker ser ifølge Berlingske en potentiel risiko for, at tarmhormonet GLP-1, som blandt andet indgår i fedmemidlet Saxenda og diabetesmidlet Victoza, kan øge risikoen for at udvikle tarmkræft.

Ny canadisk forskning med mus viser, at tarmhormonet GLP-1 kan føre til øget forekomst af tumorer i form af små polypper hos musene. Netop tarmpolypper kan udvikle sig til tarmkræft. Novo Nordisk hæfter sig ved, at der ikke er noget, der tyder på, at det fører til øget risiko for tarmkræft hos mennesker, skriver Berlingske.

"Vi har ingen beviser på, at det er tilfældet, men vores artikel rejser muligheden for, at GLP-1 er en vækstfaktor i tarmen. Ingen studier har til dato linket langtidsbrug af GLP-1 til øgede rater af cancer, men vi mener, at patienter med en tidligere historie om, eller øget risiko for, tarmkræft måske ikke er velegnede til behandling med disse lægemidler," siger Daniel J. Drucker, forskeren bag de de nye studier, ifølge Berlingske.

Novo Nordisk holder ører og øjne åbne. (...)

Avisen hæfter sig ved, Daniel J. Drucker har modtaget international hæder for sin forskning, og at forskeren har modtaget penge fra Novo Nordisk. Novo Nordisk selv kalder over for Berlingske forskeren for en af de absolut fremmeste inden for det her felt. (…)

- Ny slankemedisin: Ny medisin skal slanke overvektige. (…) men bivirkningene kan være alvorlige. (- Både Mysimba og Saxenda er medisiner som virker på hjernen, og som skal hjelpe deg ned i vekt ved å dempe appetitten og øke følelsen av metthet. Mysimba er basert på stoffer som allerede er i bruk i andre medisiner, som blant annet brukes ved depresjoner og i forbindelse med røykavvenning.)

(Anm: Ny slankemedisin: Ny medisin skal slanke overvektige. Noen tabletter om dagen skal hjelpe overvektige ned i vekt, men bivirkningene kan være alvorlige. (…) Koster 12 000 kr i året - Slankemedisinen Mysimba har nå fått markedsføringstillatelse og fått fastsatt pris, det betyr at den er klar for å tas i bruk, sier Steinar Madsen, medisinsk fagdirektør i Statens legemiddelverk til KK. (…) Langtidseffektene og langtidsbivirkningene vet man lite om. Medisinen er kun testet på pasienter i ett år. Man vet også lite om hva som skjer med vekten idet du slutter å ta medisinen. - Det er det store ukjente spørsmålet. Dette er ikke noen vidundermedisin, du vil ikke gå fra å være svært overvektig til sylslank, sier Madsen. (…) Den andre slankemedisinen, som Statens legemiddelverk nå jobber med å gjøre klar for det norske markedet, heter Saxenda. Også den vil være reseptbelagt og ment for samme pasientgruppe som Mysimba. Det er imidlertid en medisin som settes med daglige sprøyter. (…) Både Mysimba og Saxenda er medisiner som virker på hjernen, og som skal hjelpe deg ned i vekt ved å dempe appetitten og øke følelsen av metthet. Mysimba er basert på stoffer som allerede er i bruk i andre medisiner, som blant annet brukes ved depresjoner og i forbindelse med røykavvenning. Til nå har det kun eksistert én slankemedisin i Norge, den reseptbelagte pillen Xenical. Det har tidligere vært flere andre medisiner på markedet, som blant annet har blitt trukket på grunn av alvorlige bivirkninger. (kk.no 20.10.2017).)

(Anm: Mysimba (Orexigen) Sentraltvirkende middel mot fedme. ATC-nr.: A08A A62 (…) Forsiktighetsregler Sikkerhet og tolerabilitet bør vurderes med jevne mellomrom, og behandlingen bør avbrytes ved bekymring vedrørende sikkerhet eller tolerabilitet, inkl. bekymring for økt blodtrykk. Selvmord eller selvmordsrelatert atferd: Bupropion er indisert for behandling av depresjon. Det er vist at antidepressiver gir økt risiko for selvmordsrelatert atferd hos voksne med psykiatriske lidelser. Nøye overvåkning, særlig av de med høy risiko, spesielt tidlig i behandlingen og ved doseforandringer. (…) (felleskatalogen.no).)

(Anm: Zyban (bupropion hydrochloride) (...) Bupropion hydrochloride (marketed as Wellbutrin, Zyban, and generics) Information (fda.gov).)

(Anm: Substansregister Substans: Bupropion ATC-koder: A08A A62, N06A X12 Preparater som inneholder denne substansen: Mysimba «Orexigen» depottabl. Wellbutrin Retard «Farmagon» tabl.
Wellbutrin Retard «GlaxoSmithKline» tabl. Zyban «2care4» depottabl. Zyban «GlaxoSmithKline» depottabl. (felleskatalogen.no).)

(Anm: Forskere opdager mulig kræftrisiko ved Novos fedmemiddel (berlingske.dk 11.3.2015).)

(Anm: Saxenda (liraglutide) contains liraglutide, the same active ingredient contained in the type 2 diabetes medicine Victoza. (drugs.com 23.12.2014).)

(Anm: Professor vil ha slankemedisiner til Norge - og ber det offentlige betale. – Disse er effektive og har dokumentert god virkning, sier Jøran Hjelmesæth. Minst halvparten av voksne nordmenn er overvektige eller har fedme, viser rapport. Samtidig vet vi at fedme blant annet øker risikoen for hjerte- og karsykdom, hjerneslag, høyt blodtrykk, type 2 diabetes og flere kreftformer.  (…) Han oppfordrer derfor legemiddelfirmaene til å begynne å markedsføre de to slankemedisinene som er godkjent i Norge: Saxenda og Mysimba. (…) Hjelmesæth har selv ledet den norske delen av en internasjonal studie på Saxenda , der senteret han leder ble kompensert for utgifter til drift av studien. Men professoren avviser at han har egeninteresser av å fremme slankemedisinene. (adressa.no 30.1.2017).)

(Anm: Novo Nordisks fedmekonkurrent møder modstand i EU. To nye fedmemidler er på vej til at blive godkendt i EU i løbet af kort tid – Novo Nordisks Saxenda og det konkurrerende middel Mysimba. Men Novo Nordisk-konkurrenten er løbet ind i modstand. (b.dk 26.2.2015).)

(Anm: Association of Bile Duct and Gallbladder Diseases With the Use of Incretin-Based Drugs in Patients With Type 2 Diabetes Mellitus. (…) Conclusions and Relevance: The use of GLP-1 analogues was associated with an increased risk of bile duct and gallbladder disease. Physicians should be aware of this potential adverse event when prescribing these drugs.JAMA Intern Med. 2016 Aug 1. [Epub ahead of print].)

- Forskere opdager mulig kræftrisiko ved Novos fedmemiddel

Forskere opdager mulig kræftrisiko ved Novos fedmemiddel
berlingske.dk 11.3.2015
Internationalt anerkendt forsker advarer mod at bruge midler som Novo Nordisks fedmemiddel til patienter med øget risiko for tarmkræft. Novo Nordisk afviser sammenhæng. (…)

Netop som Novo Nordisk står foran at skulle lancere selskabets nye fedmemiddel Saxenda i USA og afventer den endelige godkendelse i Europa, sætter en gruppe af canadiske forskere spørgsmålstegn ved sikkerheden af lægemidlet.

Forsøg med mus viser nemlig, at tarmhormonet GLP-1, som blandt andet indgår i Saxenda og i det populære diabetesmiddel Victoza, ikke kun har positive effekter på tarmen, men også kan føre til øget forekomst af tumorer i form af små polypper hos musene.

Læs også: Novo: »Intet tyder på, at det gælder mennesker«

Omvendt er musene mindre tilbøjelige til at få polypperne, hvis man fjerner påvirkningen fra GLP-1-lægemidler. Tarmpolypper kan udvikle sig til tarmkræft. (...)

- Public Citizen anmoder FDA om å forby Xenical (orlistat) ("Alli")

Public Citizen Petitions FDA to Ban Xenical (orlistat) (Public Citizen anmoder FDA om å forby Xenical (orlistat))
citizen.org 10.4.2006
Prescription Obesity Drug Linked to Colon Cancer; Petition Filed Today with FDA
WASHINGTON, D.C. – Public Citizen today petitioned the U.S. Food and Drug Administration (FDA) to immediately remove from the market the prescription version of Xenical (orlistat, made by Roche Pharmaceuticals) because the obesity treatment has been known to cause a significant increase in aberrant crypt foci (ACF), which are widely believed to be a precursor to colon cancer. Last week, the FDA sent an “approvable” letter concerning the over-the-counter (OTC) version of orlistat to GlaxoSmithKline, which has applied to market this version. Despite safety concerns, if GlaxoSmithKline meets the conditions set by the FDA – conditions that have not been made public – this would make the drug eligible for final approval for OTC sales.

Public Citizen’s petition is based on findings from the pharmacology review of Roche’s own data and a recent independent confirmation that orlistat causes ACF in the colon of rats. There is a large amount of scientific literature that acknowledges the importance of ACF as the earliest identifiable neoplastic colonic lesion and a putative precursor of colon cancer. The FDA’s own 1997 review of orlistat indicated a concern with colonic cell proliferation, and the drug was not initially approved by the FDA because of clinical trials that found a four- to seven-fold increased risk of getting breast cancer while taking orlistat.
In addition to cancer concerns, adverse events for patients taking orlistat include a cluster of gastrointestinal symptoms and a loss of fat-soluble vitamins, including beta-carotene and vitamins A, D, E and K. Orlistat’s efficacy has also been called into question because of two recently published clinical trials that showed only a 2.8 percent difference in weight loss after four years between patients taking orlistat and those on placebo.

“The failure to ban the prescription version of this drug or, worse, to make it much more widely available by allowing OTC sales, is a decision that is likely to increase cancer incidence,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. Public Citizen is joined in the petition by two professors of pathology at Case Western Reserve School of Medicine, Dr. Theresa Pretlow and Dr. Thomas Pretlow, who are both experts on ACF’s link to colorectal cancer. Their work on this topic has been largely funded by the National Cancer Institute, whose director is now acting FDA commissioner.

“The FDA should not allow a drug … to remain on the market for the long-term treatment of a non-lethal condition when it combines so little efficacy coupled with a still unresolved potential to cause breast and colon cancer,” says the 12-page petition. “[The] FDA is now considering increasing the number of people exposed to the drug by allowing OTC use. There is no scientific justification for this decision.”

Public Citizen has a strong track record of identifying dangerous drugs well before federal regulators take action to ban or put warnings on these drugs. For example, Public Citizen warned consumers about the dangers of Vioxx, ephedra, Bextra, Rezulin, Baycol, Propulsid and many other drugs years before the drugs were pulled from the market.

The petition can be viewed at www.WorstPills.org. (...)

- Neppe farlig

Slankemiddel kan bli reseptfritt
dagensmedisin.no 27.10.2008
Et legemiddel mot overvekt og fedme kan bli godkjent for salg på apotek - uten resept. (...)

Slankemiddel kan bli reseptfritt
vg.no 27.10.2008
Av Mari Rian Hanger (Dagens Medisin)
Et legemiddel mot overvekt og fedme kan bli godkjent for salg på apotek - uten resept.

Dette vil bli det første godkjente legemiddelet mot fedme som kan selges reseptfritt i Europa, så fremt EU-kommisjonen følger anbefalingen fra Den europeiske komiteen for legemidler til mennesker.

GSK står bak legemidlet alli, som består av 60 mg orlistat. Dette er halvparten av virkestoffet i Senecal, som markedsføres av Roche. (...)

Neppe farlig
Det er nødvendig å bruke medisinen sammen med en diett, og over en periode for å få effekt.

Heggen mener imidlertid ikke det er særlige farer forbundet med at slankemiddelet blir reseptfritt.

- Det kan være noen ubehagelige bivirkninger, som diaré. I tillegg kan det være fornuftig å ta D-vitamintilskudd. Men farlig er det nok ikke, sier Heggen. (...)

- PBS-ombudsmann kritiserer sponsing fra legemiddelfirma

PBS obesity program under fire
edrugsearch.com 26.2.2007
On April 11, PBS plans to broadcast “Fat: What No One is Telling You” — a program sponsored by GlaxoSmithKline.

Jeff Chester, executive director of the Center for Digital Democracy, comments: (...)

PBS Ombudsman Criticizes Drug Company Sponsorship (PBS-ombudsmann kritiserer sponsing fra legemiddelfirma)
broadcastingcable.com 19.2.2007
PBS ombudsman Michael Getler says he doesn't think PBS should have accepted a sponsorship from drug compnay GlaxoSmithKline for an obesity special airing next month.

Glaxo just got FDA approval for a new diet drug and the Center for Digital Democracy's Jeff Chester, who wrote to complain, is concerned the entire show could be seen as a plug for the company. (...)

PBS Obesity Series Tainted By Diet Drug Sponsor
livinlavidalocarb.blogspot.com 15.2.2007
What's GlaxoSmithKline doing sponsoring a new obesity series on PBS?

Something fishy is going on with an upcoming program about obesity on your friendly public television station and this Broadcasting & Cable story provides all the sordid details about what is going on.

It seems there is a new set of programs coming out on PBS in April called "Fat: What No One Is Telling You" as part of the "Take One Step" series of shows. Learn more about this documentary and even meet the producers as well as an interview with them. (...)

Diverse artikler

USA godkjenner første slankepille på 13 år
nrk.no 28.6.2012
Lorcaserin, eller Belviq slik den heter i USA, er den første slankepillen FDA har godkjent på 13 år.

USAs helsemyndigheter (FDA) godkjente onsdag den første slankepillen på 13 år. Lorcaserin, som pillen heter, skal regulere appetitten til de som tar den. (...)

FDA Panel Gives Nod to New Diet Drug
medpagetoday.com 11.5.2012
SILVER SPRING, Md. -- An FDA advisory committee has voted 18-4, with one abstention, in favor of approving lorcaserin hydrochloride (Lorqess) as the first new weight-loss drug in more than a decade.

The FDA's Endocrinologic and Metabolic Drugs Advisory Committee on Thursday afternoon voted that the benefits of lorcaserin outweigh its risks, despite the modest weight loss provided by the drug and a lack of data to rule out heart valve issues. If approved, lorcaserin would be an option for those with a BMI of 30 or more, or a BMI of 27 with comorbidities related to obesity.

The panelists agreed that lorcaserin caused a statistically significant greater number of patients (more than double) to lose at least 5% of their total weight compared with placebo, which is one of the FDA's requirements for approving weight-loss drugs.

But the difference in weight loss between the lorcaserin group and the placebo group was small -- just a 3.3% difference. The placebo group in the company's clinical trials also had diet and exercise counseling, so the difference in between the two groups may have been smaller than what it would be in the real world, some panelists pointed out. (...)

Lorcaserin is one of three weight-loss drugs vying to be the first new diet drug approved in a decade.

The FDA is expected to make a decision on Qnexa -- a low-dose combination of phentermine and topiramate -- in July. Like lorcaserin, Qnexa was at first rejected by the FDA, but Vivus, the manufacturer of Qnexa, submitted new data on the drug's psychiatric and cardiovascular side effects and an FDA advisory committee endorsed approval by a 20-2 vote in February. (...)

(Anm: Altered microbiome burns fewer calories. The link between the gut microbiome and obesity seems clear, but just how changes to gut bacteria can cause weight gain is not. (medicalnewstoday.com 15.12.2015).)

Panel Recommends More Testing for Obesity Drugs
nytimes.com 29.3.2012
Obesity drugs should undergo clinical trials to ensure that they do not cause heart attacks, federal advisers said Thursday, a requirement that could make it harder for such drugs to gain approval.

An advisory committee to the Food and Drug Administration voted 17 to 6 to require such studies, even if there were no apparent signs that a drug increased cardiovascular risk.

“Given the checkered history of weight-loss drugs, I think it is better to be prudent and err on the side of caution,” Dr. Sanjay Kaul, a cardiologist at Cedars-Sinai Medical Center in Los Angeles, said at the end of the two-day meeting in Silver Spring, Md.

But some committee members warned that such a requirement would increase the time and cost of developing weight-loss drugs, discouraging pharmaceutical companies. (...)

It was not immediately clear how, if at all, the committee vote would affect the fates of two obesity drugs awaiting approval from the F.D.A. — Qnexa from Vivus and Lorqess from Arena pharmaceuticals. (...)

Nyttan överväger riskerna för läkemedel som innehåller orlistat (Alli och Xenical)
lakemedelsvarlden.se 20.2.2012
Nyttan överväger riskerna för viktminskningspreparat som innehåller orlistat vid behandling av patienter med ett BMI på 28 kg/m2 eller mer. Det visar utredningen som den europeiska läkemedelsmyndighetens vetenskapliga kommitté (CHMP) nu avslutat. Utredningen inleddes med anledning av ett mindre antal rapporter om allvarliga leverbiverkningar.

Utredningen av läkemedel som innehåller orlistat inleddes i augusti 2011 med anledning av rapporter om allvarliga leverbiverkningar. CHMP har gått igenom alla tillgängliga data gällande såväl leverbiverkningar som övriga biverkningar. (...)

I utredningen ingick Xenical och Alli, samt andra läkemedel som innehåller orlistat och är nationellt godkända i vissa länder. (...)

Year in Review: No Cardiovascular Benefit Found for Rimonabant
medpagetoday.com 29.12.2010
Our Year in Review series highlights the major medical news stories of 2010. The failure of yet another diet drug, rimonabant, was one of the compelling topics that made headlines during the year and here, again, is the original article first published on Aug. 12, 2010. In a companion article, you'll find out what's happened since.

The early promise of an anti-obesity drug may never be fulfilled following the discontinuation of a randomized trial for safety reasons and a subsequent data analysis showing no evidence of efficacy for the study's primary endpoint of reduced cardiovascular risk.

In a multicenter trial of rimonabant that included almost 19,000 patients, the hazard ratio for the composite endpoint of cardiovascular death, myocardial infarction, and stroke was 0.97 (95% CI 0.84 to 1.12, P=0.68), according to Eric J. Topol, MD, of the Scripps Translational Science Institute in La Jolla, Calif., and colleagues.

The trial, known as CRESCENDO, had been terminated in November 2008 following reports of four suicides in the active treatment arm compared with one in the placebo arm, the investigators reported in the Aug. 14 issue of The Lancet. (...)

Website review: www.myalli.com/global - GSK-sponsored site about its pharmacy-only weight loss aid, alli
Emma D’ArcyPharma Expert Contributor
social.eyeforpharma.com 29.10.2010
Welcome to the first in eyeforpharma’s series of pharma website reviews. Each month, Emma D’Arcy will look at a different online patient forum to explore how pharma engages with patients and how the patient-physician-pharma relationship can be improved through branded websites. First up: www.myalli.com/global, GSK’s sponsored site about its pharmacy-only weight loss aid, alli (...)

F.D.A. Rejects Qnexa, a Third Weight-Loss Drug
nytimes.com 28.10.2010
The Food and Drug Administration rejected another new diet pill on Thursday, the latest setback in the quest to develop treatments for overweight Americans amid the nation’s obesity epidemic.

The rejected drug, called Qnexa, is the third weight loss medicine to run into trouble this month because of concerns about safety. Last week, the F.D.A. declined to approve another new drug, lorcaserin, because it caused tumors in rats. And earlier in the month it forced the withdrawal of Meridia from the market after 13 years, citing the risk of heart attacks and strokes for certain patients. (...)

Meridia Recall Shows How FDA Has Changed
blogs.forbes.com 8.10.2010
The FDA finally recalled Abbott Laboratories’ obesity drug Meridia today. The nail-in-the-coffin was a big new study showing that the drug can increase heart attacks and strokes in high-risk patients. (For more details, read Matt Herper’s post here.)

But the potential for harm was obvious from day one. From the beginning it was clear the drug raised blood pressure and heart rate. Given this effect, it was always hard to imagine how the drug would have a net benefit to patients. Way back in 1996, an advisory panel agreed that the blood pressure rise produced by the drug was clinically important. Public Citizen has been petitioning to get the drug off the market since 2002 based on the potential for heart harm. (...)

(Anm: Meridia (sibutramine): Market Withdrawal Due to Risk of Serious Cardiovascular Events (fda.gov 8.10.2010).)

F.D.A. Panel Rejects Diet Pill
prescriptions.blogs.nytimes.com 16.9.2010
A federal advisory committee Thursday voted against recommending approval of a new weight loss drug developed by Arena Pharmaceuticals.

In their 9-to-5 vote, the advisers said there were some uncertainties about the safety of the drug, called lorcaserin, particularly findings of tumors in rats.

While some said the drug was not clearly unsafe, even the possibility that it might cause harm seemed enough to outweigh what some panel members characterized as the drug’s minimal effectiveness in causing weight loss. (...)

On Wednesday the advisory panel split 8 to 8 on whether the diet drug Meridia should be removed from the market. A study showed that it increased the risk of cardiovascular problems. The drug has already been removed from the market in Europe.

Abbott Laboratories, which makes Meridia, said the patients in the clinical trial already had cardiovascular risks and should not be given the drug but that the product was useful for other people. (...)

Diet Drug Implicated In Depression And Suicidality
medicalnewstoday.com 12.2.2010
A group of claimants who were prescribed the diet drug Acomplia (Rimonabant) are bringing proceedings against the manufacturer, Sanofi Aventis, for compensation for depression and suicidal ideation suffered as a result of taking the drug.

Acomplia was withdrawn from the European market in December 2008, following findings that the drug doubled the risk of patients suffering from depression and other psychiatric disorders compared with patients taking a placebo. (...)

Withdrawal of sibutramine leaves European doctors with just one obesity drug (Tilbaketrekking av sibutramine gjør at europeiske leger sitter igjen med bare ett fedmelegemiddel)
BMJ 2010;340:c477 (25 January)
European regulators have suspended the marketing authorisation for the weight loss drug sibutramine, and the US Food and Drug Administration has restricted its licence, amid concerns about a raised risk of heart attacks and strokes.

The European Medicines Agency recommended on Thursday 21 January that doctors stop using the drug because the risks outweigh the benefits. Its recommendation came after the agency’s committee for medicinal products for human use finalised a safety review, prompted by unpublished data from the sibutramine cardiovascular outcomes trial (SCOUT). This six year trial of 10 000 mostly European patients, which began in December 2002, showed a 16% rise in the risk of non-fatal myocardial infarction or stroke in people taking sibutramine, the agency said. (...)

Sibutramine’s manufacturer, Abbott, defended the drug’s risk-benefit profile.
Eugene Sun, vice president of global pharmaceutical research and development at Abbott, said, "We believe there are many patients who benefit from sibutramine and respectfully disagree with the committee’s opinion and the recommendation to suspend the medicine. However, we will act promptly to comply with the committee’s recommendation." (...)

The US licence will now list a history of cardiovascular disease as a contraindication, including uncontrolled hypertension. (...)

The appetite suppressant rimonabant was taken off the market in October 2008. That leaves European doctors with just one weight loss drug to prescribe to obese patients, the lipase inhibitor orlistat. (...)

Diet Drug Maker Glaxo to Pay for a Film on Eating
nytimes.com 6.1.2010
LOS ANGELES — GlaxoSmithKline is getting into the movie business, pursuing an unusual and most likely controversial strategy to increase interest in a weight-loss drug.

Glaxo, the pharmaceutical giant behind Alli, an over-the-counter weight-loss product, has decided that a good way to educate Americans about obesity — and increase sales of Alli — is to finance a “hard-hitting” documentary about eating.

Although a budget has not been set, an Academy Award-winning director will be named on Jan. 25 at the Sundance Film Festival, a spokesman for Glaxo said. (...)

Slankepiller - ingen snarvei
Mange bivirkninger, liten effekt

vg.no 27.12.2009
Mange slankemidler lover at kiloene raser av. (...)

Tre tillatt: Reductil, Xenical og Alli

Dette er de vektreduserende medikamentene som er godkjent i Norge. De to førstnevnte fås på resept, mens Alli har vært reseptfritt siden mai i år.

Den første måneden solgte Alli nesten 20 000 pakninger. Siden har salget stupt til 5 000 i november.

- Dette er ikke noe tryllemiddel. Folk har kanskje ikke fått den effekten de trodde, sier fagdirektør Anne Elisabeth Smedstad i Apotekforeningen.

Reductil og Xenical har derimot økt jevnt fra 46 000 i 2007 til 51 000 i 2008. Hittil i år er det solgt 53 000 døgndoser. Enkelt fortalt virker Reductil ved å dempe appetitten, mens Xenical reduserer opptaket av fett i tarmen. Astrid Danielsen har prøvd begge.

- Med Reductil ble jeg mindre sulten og gikk ned noen kilo. Men for min del var bivirkningene så store at det ikke var verdt det. Det gikk ut over psyken, alt ble forferdelig mørkt og trist og tungt. (...)

Preparatinformasjonen om Alli harmoniseres med Xenical
legemiddelverket.no 7.12.2009
Preparatomtale og pakningsvedlegg for den reseptfrie slankemedisinen Alli (60 mg orlistat) oppdateres med ny sikkerhetsinformasjon. Denne informasjonen finnes allerede i preparatinformasjonen for reseptpliktige Xenical (120 mg orlistat).

Oppdateringen inneholder ny advarsel om oksalatnefropati og informasjon om interaksjoner med levotyroksin og antiepileptika. Pankreatitt (betennelse i bukspyttkjertelen) og oksalatnefropati (nyreskade som skyldes salter av oksalsyre) er lagt til som bivirkning. (...)

Fikk slankepiller mot svulst i magen
nrk.no 2.11.2009
Den svenske kvinnen hadde en svulst på seks kilo i magen, men legen hennes skrev ut resept på slankepiller. (...)

Det tynnes blant Alli-kjøperne
apotek.no 14.9.2009
Det har vært en klar tilbakegang i salget av det reseptfrie slankemiddelet Alli. Antallet kjøpere er nær halvert på fire måneder.

Det reseptfrie slankemiddelet Alli kom i salg i mai 2009. Omsetning første måned var stor, med over 18 000 solgte pakninger. Også i juni og juli var omsetningen relativt høy. I august ser man en klar tilbakegang av salget, med så vidt over 10 000 solgte pakninger. (...)

ALLI UNDER LUPEN:
Alli kan gi leverskade

klikk.no 25.8.2009
Slankemiddelet Alli ble svært godt mottatt i Norge da det 4. mai i år ble gjort tilgjengelig på apoteket uten resept.

– Ingen grunn til bekymring
Nå melder VG Nett derimot at det populære slankemiddelet granskes av legemyndigheter i USA, etter mistanke om at det kan gi leverskade. (...)

– Det er foreløpig ikke påvist en sammenheng mellom stoffet Orlistat og leverskader. Og det er overhodet ingen grunn til å slutte å bruke Alli, sier medisinsk sjef hos GlaxoSmithKline Norge Erik Hjelvin til Klikk.no. (...)

"Pasienter bør kontakte lege dersom de opplever symptomer på leverskade. Symptomer kan være feber, oppkast, kvalme og utslitthet", skriver FDA og oppfordrer dermed ikke pasienter til å slutte med medisinen omgående. (...)

U.S. probes Roche, Glaxo diet drug over liver injury
reuters.com 24.8.2009
WASHINGTON (Reuters) - U.S. health officials are reviewing reports of liver injury in people who took Roche Holding AG's weight loss drug Xenical or the over-the-counter version sold by GlaxoSmithKline.

The Food and Drug Administration said on Monday it had received 32 reports between 1999 and 2008 of serious liver injury in patients taking the drug, which is known generically as orlistat. All but two involved prescription Xenical and occurred outside the United States. (...)

"The FDA's analysis of these data is ongoing, and no definite association between liver injury and orlistat has been established at this time," the agency said. (...)

Reports of Liver Injury Prompt FDA Review of Diet Drug
medpagetoday.com 24.8.2009
(...) Orlistat 120 mg (Xenical) was approved in 1999 for weight loss in conjunction with a reduced caloric diet and for prevention of rebound weight gain after weight loss. The OTC version, orlistat 60 mg, was approved in 2007 for use by overweight adults ages 18 and older.

The FDA said the drug is currently approved for marketing in 100 countries worldwide. (...)

Reports of Liver Injury Prompt FDA Review of Diet Drug (Rapport om leverskader medfører at FDA gjennomgår diettlegemiddel)
medpagetoday.com 24.8.2009
WASHINGTON -- The FDA said it has received 32 reports of serious liver injury -- including six cases of liver failure -- among users of diet drug orlistat, which is sold as a prescription drug under the trade name Xenical and as an over-the-counter diet aid under the name Alli.

As a result of those reports, the FDA said it had initiated a safety review of the product, which works by blocking the absorption of ingested dietary fats.

Orlistat 120 mg (Xenical) was approved in 1999 for weight loss in conjunction with a reduced caloric diet and for prevention of rebound weight gain after weight loss. The OTC version, orlistat 60 mg, was approved in 2007 for use by overweight adults ages 18 and older. (...)

FDA releases list of potential drug risks
reuters.com 4.6.2009
WASHINGTON (Reuters) - U.S. regulators on Thursday listed two dozen drugs, including weight-loss medicines and sleep disorder pills, that it is at an early stage of reviewing for potential safety problems.

Many of the issues have been previously disclosed, but remain under review by the Food and Drug Administration.

The FDA said it was checking Pfizer Inc's smoking cessation drug Chantix for possible risk of accidental injury, vision impairment and other issues, and Cephalon Inc's sleep disorder drugs Nuvigil and Provigil for a potential of serious skin reactions.

Other drugs listed included orlistat, a weight-loss drug sold by Roche Inc as the prescription product Xenical and by GlaxoSmithKline Plc as the over-the-counter drug Alli. The FDA said it was continuing to evaluate liver toxicity reports for orlistat.

The FDA also said Pfizer's overactive bladder drug Detrol was under investigation for reports of Stevens-Johnson syndrome, a serious skin reaction. (...)

(Anm: FDA warn Chantix could affect patients' alcohol tolerance (medicalnewstoday.com 10.3.2015).)

SLANKEPILLEN ALLI
- Alli er ingen vidunderpille

klikk.no 19.5.2009
Etter ett år i salg i USA var slankepillen Alli mer kjent for stinkende effekter, enn sine slankende egenskaper.

Da Alli ble introdusert på det amerikanske markedet sommeren 2007, var kundene mange. Enkelte apoteker rapporterte om salg for en hel måneds forbuk til flere personer.

Ett år senere, i juni 2008, kom mediene med nyheten om at salget var i ferd med å dale, og meldingene kom fra folk som ikke var fornøyde med bivirkningene slankeproduktet førte til. (...)

Alli (orlistat 60 mg)
medicinmedfornuft.dk 7.5.2009 (Institut for Rationel Farmakoterapi)
Hvad er alli?
alli (orlistat 60 mg) er en medicin i håndkøb til overvægtige, der gerne vil tabe sig. Alli indeholder det samme virksomme stof som Xenical, som er en medicin på recept med den dobbelte dosis. Alli tages til dagens 3 større måltider og er godkendt til anvendelse i maks. 6 måneder. (...)

Læs mere om alli i indlægssedlen her: http://xnet.dkma.dk/indlaegsseddel/PdfFileServlet?fileid=5259&lang=da
og hos Lægemiddelstyrelsen her. (...)

alli (orlistat) 60 mg i håndkøb
irf.dk 12.5.2009
Konklusion
alli (orlistat 60 mg) er et slankemiddel, der virker ved at hæmme optagelsen af triglycerid fra tarmen.

Orlistat 60 mg 3 gange daglig sammen med hypokalorisk diæt hos personer med BMI ≥ 28-43 medførte et absolut vægttab på 2,2 kg efter ½ års behandling. Efter 1 år havde deltagerne tabt sig cirka 3 – 3,6 kg. I studierne, der førte til godkendelse af orlistat, opnåede halvdelen af deltagerne et vægttab på ≥ 5 % af kropsvægten, og dette har en positiv effekt på følgesygdomme som hypertension, diabetes og hyperkolesterolæmi. (...)

SLANKEMIDDELET ALLI
Alle får Alli

klikk.no 8.5.2009
Apoteket nekter ingen å kjøpe det reseptfrie slankemiddelet Alli. De bare fraråder det.

Ifølge Apotekforeningen er det produsenten selv, Glaxosmithklein, som har innført restriksjoner for kjøp av Alli, et nytt, omstridt slankemiddel som skal hemme fettopptaket. (...)

– Utsolgt flere steder
– Hvordan har etterspørselen vært den første uka Alli har vært på markedet?

– Salget har gått strykende. Vi har ingen konkrete tall fra apotekene ennå, men vi har sendt ut 26.000 pakker til grossistene hittil, og mange apotek er allerede tomme. Neste uke sender vi ut 18.000 pakker til, det er alt vi har klart å oppdrive. Men vi skaffer mer snart, lover Kristin Henriksen. (...)

Misbrug af ny slankepille
ekstrabladet.dk 7.5.2009
Slanke unge danskere står i kø for at få den nye 'vidunderpille' mod fedme

Også slanke danskere vil have fat i den nye slankepille 'Alli'.

- Det er selvfølgelig uheldigt, og tale om et misbrug, hvis hver 10. køber af de nye slankepiller 'Alli' er slanke unge danskere. Men der bliver ikke af den grund tale om forbud, og receptpligt. Jeg kan dog sige, at vi nøje følger udviklingen.

Pressechef Christian Howard-Jessen, Lægemiddelstyrelsen, siger i dag til Ekstra Bladet, at det er sket før, at Lægemiddelstyrelsen har tilbagekaldt receptfriheden for medicin, der tidligere krævede recept.

Men lad os nu se, hvad der sker på lidt længere sigt. (...)

Nå får du slankemedisin uten resept
abcnyheter.no 4.5.2009
Nå selges slankemedisin reseptfritt i Norge for første gang. Lege advarer mot ekkel bivirkning ved misbruk.

Medisinen Alli, til bruk mot fedme, er godkjent som reseptfritt legemiddel i hele EU/EØS. Dette er første gangen et reseptfritt legemiddel får felles europeisk godkjennelse.

Bivirkninger
Det er ikke rapportert alvorlige bivirkninger ved bruk av Alli i kliniske studier. De vanligste bivirkningene er hodepine, diaré og magesmerter. (...)

Reagerer kraftig
Professor ved Norges Idretthøyskole Jorunn Sundgot-Borgen reagerer derimot kraftig på at slankemedisin nå blir tilgjengelig reseptfritt på apoteket.

- Mange av de som kjøper det er personer som allerede har et problematisk forhold til kropp, vekt og mat. De gir blaffen i eventuelle bivirkninger, sier hun til TV 2 Nyhetene.

Professoren mener at om et slikt medikament skal fungere, må det stilles krav til hvem som kan bruke det. I tillegg må disse følges opp av helsepersonell, slik at de også får gjort livsstilsendringer som gir effekt på lang sikt, sier hun.

Også Eli Heggen, lege ved Klinikk for forebyggende medisin ved Ullevål universitetssykehus, mener man vil få lite nytte av Alli uten legeoppfølging.

- Det er svært viktig å få medisinsk oppfølging. Mange har også falske forhåpninger om å gå ned mye i vekt raskt. Når dette ikke skjer, vil man gi opp og slutte med medisinen, sa hun da det ble klart at legemiddelet kunne bli tilgjengelig uten resept. (...)

Novo Nordisk: EU frigiver fedmemedicin uden recept
finansnyheder.dk 21.1.2009
Glaxosmithklines antifedmeprodukt Alli (orlistat) får nu grønt lys fra EU-kommissionen til at kunne købes i håndkøb femfor som nu kun at udskrives som receptpligtig medicin. Det skriver nyhedsbureauet Reuters.

Det er første gang, at myndighederne taget skridt til at frigive receptpligtig medicin i EU.

Godkendelsen har været ventet, efter at de europæiske medicinalmyndigheder European Medicines Agency - EMEA -i oktober sidste år anbefalede, at midlet blev givet frit. EMEA fandt nemlig fordelene ved Alli større end risikoen for komplikationer og pointerede, at såvel indlægsseddel som pakning giver instruktion om brugen af midlet.

Også Novo Nordisk er på vej med fedmemedicin. Det er medicinalkoncernens ny GLP-1 variant liraglutide, som for tiden er i klinisk forsøg mod netop fedme. (...)

Alli - reseptfritt legemiddel mot fedme
legemiddelverket.no 10.11.2008
Medisinen Alli, som brukes mot fedme, er nå godkjent som reseptfritt legemiddel i hele Europa. Dette er første gang et legemiddel får felles europeisk godkjennelse som reseptfritt legemiddel.

Alli inneholder virkestoffet orlistat. Orlistat er samme virkestoff som finnes i det reseptbelagte legemidlet Xenical. Alli inneholder 60 mg orlistat, mens Xenical inneholder 120 mg. Alli inneholder altså mindre dose av virkestoffet orlistat enn Xenical. (...)

Alli kan brukes til behandling av overvektige voksne pasienter med ”body mass index” (BMI) større eller lik 28 kg/m2, og skal kombineres med kaloriredusert diett med lavt fettinnhold. (...)

Bivirkninger
Det er ikke rapportert alvorlige bivirkninger ved bruk av Alli. De vanligste bivirkningene er hodepine og mage- tarmproblemer. (...)

Roche is suspended from ABPI for "actions likely to bring discredit" on the industry
BMJ 2008;337:a835 (16 July)
Roche has been suspended from membership of the Association of the British Pharmaceutical Industry (ABPI) for a minimum of six months over serious breaches of the association’s code of practice.

In particular, the company was held to be in breach of clause 2, which deals with actions likely to bring discredit on, or reduce confidence in, the drug industry.

The action followed a complaint made by a former Roche employee, Ryta Kuzel, who referred to an article in the Financial Times (www.ft.com, 12 Feb, "Diet pills case sheds light on Roche practice") that alleged the company had sold large quantities of orlistat (Xenical), a prescription only drug for the treatment of obesity, to the operator of a group of private diet clinics. The article also alleged that Roche had agreed to provide £55 000 (€70 000; $110 000) for the operator to purchase another clinic. (...)

Alli the new Weight Loss Orlistat Marketing Drug
themorbidme.com 22.6.2007
With the FDA banning last week the Rimonabant Obesity Drug, all eyes (and mouths) are now focused on the new drug Alli, that coincidentally was launched last week. (...)

So why all the hype about an 8 year old drug? Well, the answer is simple: Marketing! Yes, we are in America, and we will do whatever it takes to sell whatever we want to whoever is American enough to buy it.

Alli is all about marketing and hype, and soon you will see GlaxoSmithKline’s executives (the makers of this drug) showing off their new Bentleys all over the country. (Wait, a Bentley is a car for old fat rich people, since they sure are not fat, let’s change it for a slick Ferrari)

The over-the-counter dose of Alli is just half of the prescription one Xenical. Also, Orlistat as such, has a few side effects that Alli calls “Treatment Effects”. Wow, this is marketing! Have you ever heard a doctor tell you: “This medicine, has NO side effects, it has Treatment Effects!” (...)

Alli Side-Effects May Outweigh Benefits
montgomery.injuryboard.com 18.6.2007
A new diet drug has hit the shelves with the FDA's approval, but users may want to be wary of the side effects. Alli, manufactured by GlaxoSmithKline, is supposed to help people lose 50% more weight than other dietary supplements.

Alli blocks enzymes that digest fat, preventing the body from absorbing about a quarter of the fat eaten. The undigested fat is then excreted. One study of Alli showed that dieters who took the drug along with diet and exercise over a year lost about three pounds more than people who only dieted and exercised.

This drug is a low-dose version of the prescription-only drug Xenical which has been on the market since 1999.

Doctors say that the drug will help people lose weight, but if users eat foods high in fat they will definitely feel the side effects.

Side effects include oily discharge, diarrhea, and uncontrollable bowel movements. Many patients who took Xenical did not end up refilling their prescriptions because they could not handle the side effects. (...)

There have also been claims by the non-profit group Public Citizen, that the drug may increase the risk of colon cancer. The drug has been shown in studies to cause precancerous lesions in the colons of mice.

The FDA responded to the group by saying that there is not enough evidence linking Alli to colon cancer to not approve the drug. (...)

Weight-Loss Drug Approved Despite Cancer Concerns
americanchronicle.com 21.2.2007
(...) The Food and Drug administration has a plan to fight obesity. According to the FDA, this strategy includes “revising FDA guidance for developing drugs to treat obesity.” That could be part of the reason why in early February the FDA approved orlistat capsules as an over-the-counter (OTC) weight loss drug. (...)

FDA drug rush is ill-advised
Today's Topic: FDA thorough enough on drugs?
tennessean.com 16.2.2007
With a lot of fanfare, the Food and Drug Administration last week announced a first — its approval of a diet pill that can be bought without a prescription. (...)

And there is another problem: The watchdog group Public Citizen reports the drug can cause precancerous lesions of the colon.

GlaxoSmithKline denies that is the case, and points to its clinical trials of 30,000 patients as proof of the drug's safety. But Dr. Sidney Wolfe, Public Citizen's director of health research, called the FDA approval "a dangerous mistake in light of its marginal benefits, frequent coexistence of other diseases, common, bothersome adverse reactions, and significant inhibition of absorption of fat-soluble vitamins." (...)

Anti-obesity drug is hard pill to swallow
timesofindia.indiatimes.com 10.2.2007
WASHINGTON: A health research advocate has called the government's decision to approve an over-the-counter version of a diet pill the "height of recklessness".

Sidney Wolfe says studies have linked the prescription version of the drug, called Xenical, with pre-cancerous lesions of the colon.

The director of Public Citizen's Health Research Group says the plans to market a non-prescription version are a "dangerous mistake" in light of what he calls the product's "marginal benefits." He also says the diet pill can have "bothersome adverse reactions."

The FDA said on Wednesday it had approved sales of a lower-dose version of Xenical. The non-prescription version is called "alli." (...)

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