MinTankesmie

PPI og risiko for hoftefraktur hos kvindelige rygere
irf.dk 30.4.2012 (Institut for Rationel Farmakoterapi (IRF)
Kort om studiet
Prospektiv kohorteundersøgelse af 79.899 postmenopausale sygeplejersker i alderen 30-55 år, som i gennemsnit er fulgt i godt 7 år (1).

Den absolutte risiko for hoftefraktur var 2,02 tilfælde per 1.000 personnår (149 tilfælde/5.341 personer) i gruppen, der regelmæssigt havde taget protonpumpehæmmere (PPI) sammenlignet med 1,51 tilfælde per 1.000 personår (744 tilfælde/75.558 personer) hos dem, der ikke havde taget PPI.
Aldersjusteret hazard ratio (HR) var 1,35 (95 % sikkerhedsgrænser (CI) var 1,31 til 1,62).

Langvarig brug af PPI og rygning var associeret med øget risiko.

Blandt nuværende og tidligere rygere var brug af PPI associeret med mere end 50 % øget risiko for fraktur, HR 1,51 (CI 1,20 til 1,91).

Blandt kvinder, der aldrig havde røget var der ingen signifikant association, HR 1,06 (CI 0,77 til 1,46). (...)

Proton Pump Inhibitors (PPIs) - Drug Safety Communication: Clostridum Difficile-Associated Diarrhea (CDAD) Can be Associated With Stomach Acid Drugs
fda.gov 8.2.2012
• AcipHex (rabeprazole sodium)
• Dexilant (dexlansoprazole)
• Nexium (esomeprazole magnesium)
• Omeprazole (omeprazole) Over-the-Counter (OTC)
• Prevacid (lansoprazole) and OTC Prevacid 24hr
• Prilosec (omeprazole) and OTC
• Protonix (pantoprazole sodium)
• Vimovo (esomeprazole magnesium and naproxen)
• Zegerid (omeprazole and Sodium bicarbonate) and OTC (...)

ISSUE: FDA notified the public that the use of stomach acid drugs known as proton pump inhibitors (PPIs) may be associated with an increased risk of Clostridium difficile–associated diarrhea (CDAD). A diagnosis of CDAD should be considered for patients taking PPIs who develop diarrhea that does not improve. The FDA is working with manufacturers to include information about the increased risk of CDAD with use of PPIs in the drug labels.

FDA is also reviewing the risk of CDAD in users of histamine H2 receptor blockers. H2 receptor blockers are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and heartburn. (...)

PPIs raise fracture risk by 35%
pulsetoday.co.uk 1.2.2012
Regular use of proton pump inhibitors is associated with an increased hip fracture risk - particularly in smokers - concludes a large US study.

The prospective cohort study looked at data from 79,899 postmenopausal women on their use of PPIs between 2000 and 2008, and found those who regularly used PPIs for at least two years the risk was 35% higher than non-users, even when adjusted for age.

The absolute risk of hip fracture was 2.02 events per 1000 person years in regular PPI users, compared with 1.51 events in non-users. PPI use in current or former smokers was associated with a 51% increase in fracture risk, while there was no association between PPI use and fracture risk in women who had never smoked. (...)

Proton Pump Inhibitors Raise Hip Fracture Risk Over Time
medscape.com 31.1.2012
January 31, 2012 — A new study strengthens the association of long-term use of proton pump inhibitors (PPIs) with increased risk for hip fracture in postmenopausal women, particularly those who smoke.

PPIs can affect fracture risk by increasing secretion of gastrin, inhibiting calcium absorption, and altering osteoclast function. Use of these drugs to treat indigestion increased when they became available over the counter in the United States in 2003. In May 2010, the US Food and Drug Administration issued a warning about the possible link between extended PPI use and hip fracture and requested further information. (...)

Use of proton pump inhibitors and risk of hip fracture in relation to dietary and lifestyle factors: a prospective cohort study
BMJ 2012;344:e372 (31 January)
Objective To examine the association between chronic use of proton pump inhibitors (PPIs) and risk of hip fracture. (...)

Results During 565 786 person years of follow-up, we documented 893 incident hip fractures. The absolute risk of hip fracture among regular users of PPIs was 2.02 events per 1000 person years, compared with 1.51 events per 1000 person years among non-users. Compared with non-users, the risk of hip fracture among women who regularly used PPIs for at least two years was 35% higher (age adjusted hazard ratio 1.35 (95% confidence interval 1.13 to 1.62)), with longer use associated with increasing risk (Ptrend<0.01). Adjustment for risk factors, including body mass index, physical activity, and intake of calcium did not materially alter this association (hazard ratio 1.36 (1.13 to 1.63)). These associations were also not changed after accounting for reasons for PPI use. The relation between PPI use and fracture differed by smoking history (Pinteraction=0.03). Among current and former smokers, PPI use was associated with greater than 50% increase in risk of fracture, with a multivariate hazard ratio for fracture of 1.51 (1.20 to 1.91). In contrast, among women who never smoked there was no association (multivariate hazard ratio 1.06 (0.77 to 1.46)). In a meta-analysis of these results with 10 prior studies, the pooled odds ratio of hip fracture associated with PPI use was 1.30 (1.25 to 1.36).

Conclusion Chronic use of PPIs is associated with increased risk of hip fracture, particularly among women with a history of smoking. (...)

Children, Asthma, and Proton Pump Inhibitors
Editorial
JAMA. 2012;307(4):406-407 (January 25)
(...) In conclusion, the study by Holbrook et al in this issue of JAMA indicates that chronic use of PPIs does not improve symptom control in children with asthma. Moreover, the observation that such use might be associated with serious adverse effects should suggest great caution in prescribing PPIs in general pediatric practice. (...)

Proton pump inhibitors and risk of fractures: a meta-analysis of 11 international studies
Am J Med. 2011 Jun;124(6):519-26.
BACKGROUND: Concerns have been raised about the risk of fractures with acid-suppressive medications, such as proton pump inhibitors and histamine(2)-receptor antagonists. (...)

CONCLUSION: In this meta-analysis of observational studies, proton pump inhibitors modestly increased the risk of hip, spine, and any-site fractures, whereas histamine(2)-receptor antagonists were not associated with fracture risk. The possibility of residual confounding cannot be excluded. Further skeletal evaluation should be considered for patients who are taking proton pump inhibitors and also at risk for osteoporotic fracture. (...)

Proton pump inhibitor use and risk of adverse cardiovascular events in aspirin treated patients with first time myocardial infarction: nationwide propensity score matched study
BMJ 2011; 342:d2690 (11 May)
Objective To examine the effect of proton pump inhibitors on adverse cardiovascular events in aspirin treated patients with first time myocardial infarction. (...)

Conclusion In aspirin treated patients with first time myocardial infarction, treatment with proton pump inhibitors was associated with an increased risk of adverse cardiovascular events. (...)

Study questions heartburn drugs for kids
reuters.com 5.4.2011
NEW YORK (Reuters Health) - Acid-suppressing drugs like Prilosec and Prevacid may not be much help for infants with troublesome acid reflux, and there's too little evidence that they help older children and teenagers, a new research review concludes.

The findings, reported in the journal Pediatrics, question the usefulness of so-called proton-pump inhibitors in children with gastroesophageal reflux disease, or GERD.
The drugs, which suppress stomach-acid production, have names like omeprazole (Prilosec), lansoprazole (Prevacid) and esomeprazole (Nexium). Prilosec and Prevacid are both available over the counter, and typically cost about 50 cents per pill. Nexium is still only available by prescription, and is more expensive.

In the new study, the researchers reviewed 12 clinical trials that tested the medications for treating GERD in infants, children or teenagers.
They found no good evidence that the drugs eased acid-reflux symptoms in infants -- such as crying and "fussing" after being fed. (...)

Proton Pump Inhibitor drugs (PPIs): Drug Safety Communication - Low Magnesium Levels Can Be Associated With Long-Term Use
fda.gov 2.3.2011
Prescription PPIs include Nexium (esomeprazole magnesium), Dexilant (dexlansoprazole), Prilosec (omeprazole), Zegerid (omeprazole and sodium bicarbonate), Prevacid (lansoprazole), Protonix (pantoprazole sodium), AcipHex (rabeprazole sodium), and Vimovo (a prescription combination drug product that contains a PPI (esomeprazole magnesium and naproxen).

Over-the-counter (OTC) PPIs include Prilosec OTC (omeprazole), Zegerid OTC (omeprazole and sodium bicarbonate), and Prevacid 24HR (lansoprazole). (...)

ISSUE: FDA notified healthcare professionals and the public that prescription proton pump inhibitor (PPI) drugs may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (in most cases, longer than one year). Low serum magnesium levels can result in serious adverse events including muscle spasm (tetany), irregular heartbeat (arrhythmias), and convulsions (seizures); however, patients do not always have these symptoms. Treatment of hypomagnesemia generally requires magnesium supplements. In approximately one-quarter of the cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels and the PPI had to be discontinued.

BACKGROUND: PPIs work by reducing the amount of acid in the stomach and are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus. (...)

Protonpumpshämmare minskar skyddet mot fraktur
lakemedelsvarlden.se 23.2.2011
Vanliga protopumpshämmare som omeprazol försämrar behandlingen mot benskörhet. Det visar en dansk studie.

Studien visar att patienter som behandlas med alendronat för osteoporos och som samtidigt använder protonpumpshämmare, som omeprazol och ezomeprazol har större risk för höftfrakurer än patienter som inte använder protonpumpshämmarna. (...)

Opportunities to Decrease Inappropriate Uses of Proton Pump Inhibitors (Muligheter for å redusere uhensiktsmessig bruk av protonpumpehemmere)
Arch Intern Med. 2011 (Published online February 14)
The May 2010 issue of the Archives included 3 articles on the harms of PPIs: Gray et al¹ showed that PPI were associated with an increase in the rate of spine, lower arm, and total fractures; Howell et al² showed that PPI increased the risk of Clostridium difficile infection; and Linsky et al³ showed that PPI also increased the recurrence of C difficile infection. We deliberately grouped these articles together because we wanted to draw attention to the adverse effects of these drugs given data showing that 53% to 69% of PPI prescriptions are for inappropriate indications.^4-6 (...)

Use of acid-suppressive drugs and risk of pneumonia: systematic review and meta-analysis
CMAJ 2010 8 (Published online ahead of print December 20)
Background: Observational studies and randomized controlled trials have yielded inconsistent findings about the association between the use of acid-suppressive drugs and the risk of pneumonia. We performed a systematic review and meta-analysis to summarize this association. (...)

Interpretation: Use of a proton pump inhibitor or histamine2 receptor antagonist may be associated with an increased risk of both community- and hospital-acquired pneumonia. Given these potential adverse effects, clinicians should use caution in prescribing acid-suppressive drugs for patients at risk. (...)

(Anm: pneumoni; det samme som lungebetennelse. Kilde: Store norske leksikon.)

(Anm: pneumoni; pnevmoni; pneumonia, infeksjon der lungealveolane blir fylte med betennelseseksudat som blir til fortetning (konsolidasjon, jf hepatisasjon) slik som ved kruppøs pneumoni, eller infeksjon som også sit i luftvegsgreinene slik som ved bronkopneumoni eller som helst er i sjølve lungevevet (interstitielt); jf andre oppslag på pneumonia; dessutan: aspirasjonspneumoni, kjempecellepneumoni (Hechts pneumoni), Løfflers pneumoni, hypostatisk pneumoni, influensaviruspneumoni, interstitiell pneumoni, organiserande pneumoni; sjå også Klebsiella pneumoniae; e.n. lungebrune, lungebrann, lungekolda EN pneumoni ET [gr pneumonia]. Kilde: Norsk medisinsk ordbok.)

Proton-pump inhibitors are associated with increased cardiovascular risk independent of clopidogrel use: a nationwide cohort study.
Ann Intern Med. 2010 Sep 21;153(6):378-86.
BACKGROUND: Controversy remains on whether the dual use of clopidogrel and proton-pump inhibitors (PPIs) (...)

(...) CONCLUSION: Proton-pump inhibitors seem to be associated with increased risk for adverse cardiovascular outcomes after discharge, regardless of clopidogrel use for myocardial infarction. Dual PPI and clopidogrel use was not associated with any additional risk for adverse cardiovascular events over that observed for patients prescribed a PPI alone. Primary Funding Source: The Danish Medical Research Council and the Danish Heart Foundation. (...)

Proton Pump Inhibitors (PPIs)
fda.gov 9.8.2010
The FDA is revising the prescription and over-the-counter (OTC) labels for proton pump inhibitors to include new safety information about a possible increased risk of fractures of the hip, wrist, and spine with the use of these medications.

The new safety information is based on FDA's review of several epidemiological studies. Some studies found that those at greatest risk for these fractures received high doses of proton pump inhibitors or used them for one year or more. The majority of the studies evaluated individuals 50 years of age or older and the increased risk of fracture primarily was observed in this age group. As a precaution, the "Drug Facts" label on the OTC proton pump inhibitors (indicated for 14 days of continuous use) also is being revised to include information about this risk. (...)

FDA revises labels on stomach drugs over bone break risks (FDA reviderer preparatomaler for legemidler som nedsetter syresekresjon grunnet risiko for benbrudd)
pharmatimes.com 26.5.2010
(...) The US Food and Drug Administration has changed the labels on PPIs, to include the possible increased risk of fractures of the hip, wrist and spine with high doses or long-term use of the drugs. They are used to treat gastroesophageal reflux disease, stomach and small intestine ulcers, and inflammation of the esophagus, as well as over-the-counter treatments for frequent heartburn

The FDA noted that drugs which will be affected by the label change include Protonix (pantoprazole), Nexium (esomeprazole) and AstraZeneca’s older treatment Prilosec (omeprazole), as well as Takeda’s Dexilant (dexlansoprazole) and Prevacid (lansoprazole), plus Johnson & Johnson’s Aciphex (rabeprazole). (...)

Behandling med PPI kan öka frakturrisk varnar FDA
lakemedelsvarlden.se 26.5.2010
Den amerikanska läkemedelsmyndigheten FDA har gått ut med en varning där man vill uppmärksamma på sambandet mellan långvarig användning av protonpumpshämmare och en ökad frakturrisk.

På tisdagen publicerade FDA ett meddelande på sin hemsida om att den kan finnas en risk för frakturer för patienter som behandlas en längre tid med protonpumpshämmare, PPI. (...)

Protonpumpehemmere uten resept
H L Waldum
Tidsskr Nor Legeforen 2010; 130:1014 (20.5.2010)
Jeg leste med undring Hatlebakk og medarbeideres emosjonelle kommentar i Tidsskriftet nr. 6/10 (1) til mitt innlegg om protonpumpehemmere solgt uten resept (2). Det kan synes som om de overhodet ikke kjenner til den danske studien som viste at friske, symptomfrie medisinstudenter får dyspepsi etter bruk av protonpumpehemmere (3) på grunn av økt syresekresjon (4). Allikevel hevder de at den kliniske betydning av tilbakefall med hypersekresjon av syre (acid rebound) ikke er vist (1). Hvorfor skulle ikke den økte syresekresjonen forverre reflukssykdommen der det på forhånd er en funksjonell defekt i ventilfunksjonen i cardia når den gir reflukssymptomer hos friske? Er ikke tilbakefall med hypersekresjon av syre den mest sannsynlige årsaken til den påfallende økningen i reflukssykdom man har sett de siste tiåene? (...)

Overuse of heartburn drugs is risky: study (Overforbruk av legemidler mot halsbrann er risikabelt ifølge studie)
reuters.com 10.5.2010
(Reuters) - Although they are sometimes used to make spicy meals go down easier, common heartburn drugs can cause serious side effects and should be used with caution, a series of studies released on Monday suggests.

Well-known brands of the drugs -- called proton pump inhibitors or PPIs -- include AstraZeneca's Nexium and Prilosec. Formerly AstraZeneca's biggest seller, Prilosec is available generically as omeprazole and is also sold over the counter by Procter & Gamble Co.

While the drugs are a great help to the right patients, they can raise the risk of fractures in post-menopausal women and cause bacterial infections in many patients, according to a special report in the Archives of Internal Medicine. (...)

(Anm: Benefits of Proton Pump Inhibitors May Not Justify the Risks for Many Users. Arch Intern Med. 2010;170(9):747-748 (May 10).)

How Safe Are Popular Reflux Drugs? (Hvor sikre er populære legemidler mot reflukssykdom?)
medicinenet.com 4.11.2009
(HealthDay News) -- Millions of Americans take drugs like Nexium, Prevacid and Prilosec to ease the erosive effects of acid reflux, but do these medicines put patients at risk for other health problems?

Experts remain divided on the potential dangers these common prescription medications might pose.

The drugs belong to a class of pharmaceuticals called "proton pump inhibitors," or PPIs, which are generally considered safe and effective. But lately these acid-reducing medications have been the subject of studies linking their use to a number of health risks, from an increased rate of hip fracture to a greater likelihood of diarrhea and community-acquired pneumonia.

Dr. Kenneth W. Altman, an associate professor of otolaryngology at Mount Sinai School of Medicine in New York City, draws attention to some of the potential consequences of PPI use in a commentary published in the November issue of Otolaryngology -- Head and Neck Surgery. (...)

(Anm: Unexpected consequences of proton pump inhibitor use. Otolaryngology - Head and Neck Surgery 2009;141(5):564-566 (November).)

Protonpumpehemmere kan redusere effekten av klopidogrel
legemiddelverket.no 5.6.2009
Ved samtidig bruk av visse protonpumpehemmere og klopidogrel, kan effekten av klopidogrel reduseres. Dette kan føre til økt risiko for tromboser, inkludert hjerteinfarkt eller hjerneslag. (...)

Klopidogrel hemmer blodplateaggregasjonen og benyttes forebyggende ved ulike aterotrombotiske hendelser, som hjerteinfarkt og hjerneslag. I EU er det markedsført flere klopidogrelholdige legemidler. I Norge er det foreløpig bare ett legemiddel på markedet, Plavix (Sanofi Pharma Bristol-Myers Squibb). Som bivirkning kan klopidogrel selv forårsake halsbrann og magesår. Derfor bruker mange pasienter samtidig protonpumpehemmere (“proton pump inhibitor”, PPI) for å unngå eller redusere slike symptomer. (...)

Myndighet varnar för Plavix och protonpumpshämmare
dagensmedicin.se 3.6.2009
Det tromboshämmande läkemedlet Plavix och protonpumpshämmare som Losec och Lanzo bör inte användas samtidigt, varnar Läkemedelsverket.

Läs även: Plavix och magsyrahämmare ökade risken för hjärtdöd

Att både ta klopidogrel och protonpumpshämmare ökar risken för att dö eller få hjärtinfarkt. Protonpumpshämmarna, som används mot bland annat magsår och sura uppstötningar, tycks motverka den effekt som klopidogrel har. (...)

Common Drugs Boost Pneumonia Risk at Hospitals (Vanlige legemidler øker risiko for pneumoni på sykehus)
Ivanhoe.com 1.6.2009
(Ivanhoe Newswire) – Hospitalized patients who are given acid-suppressive medications are 30 percent more likely to develop pneumonia during their hospital stay, a new study found. (...)

Fifty-two percent of the patients were given acid-suppressive medications, which included any order for a proton-pump inhibitor or histamine2 receptor antagonist. Of that group, 83 percent received proton-pump inhibitors, 23 percent received histamine2 receptor antagonist and some received both. (...)

(Anm: Acid-Suppressive Medication Use and the Risk for Hospital-Acquired Pneumonia. JAMA. 2009;301(20):2120-2128 (May 27).)

(Anm: pneumonia; pneumoni; (SML-artikkel) det samme som lungebetennelse. Kilde: Store norske leksikon.)

Long term use of proton pump inhibitors raises risk of osteoporosis (Langtidsbruk av protonpumpehemmere øker risko for benskjørhet)
BMJ 2008;337:a1272 (13 August 2008)
Patients who use proton pump inhibitors for seven or more years to treat reflux, peptic ulcers, and other conditions are at more risk of fractures related to osteoporosis, a large Canadian study has found (CMAJ 2008;179:319-26, doi: 10.1503/cmaj.071330). (...)

Proton Pump Inhibitors Over Years Increase Osteoporotic Fracture Risks
medpagetoday.com 12.8.2008
WINNIPEG, Manitoba, Aug. 12 -- Chronic use of proton pump inhibitors over years for gastroesophageal acid reflux is associated with osteoporotic fractures but short-term use seems to be safe, researchers here found. (...)

Proton pump inhibitors may be linked to rise in C difficile associated diarrhoea
BMJ 2008;337:a823 (15 July)
Proton pump inhibitors may be linked to rise in C difficile associated diarrhoea: Restricting the use of proton pump inhibitors may be a way to control Clostridium difficile associated diarrhoea, say researchers, who note that its prevalence has grown in tandem with an increase in use of the drugs, much of which, they say, is inappropriate (Journal of Hospital Infection doi: 10.1016/j.jhin.2008.04.023). (...)

Dobling av unge som bruker magesårmedisin
apotek.no 31.3.2008
Apotekforeningens månedsstatistikk mars 2008

Forbruket av legemidler mot magesår og andre syrerelaterte lidelser er doblet fra 2003 til 2007 blant ungdom i aldersgruppen 10-19 år. Økningen fortsetter i 2008, og forbruket de to første månedene i år er 27 prosent høyere enn samme periode i fjor. Fra 2006 til 2007 økte bruken med 21 prosent. (...)

(De mest kjente legemidlene i denne gruppen er Losec (omeprazol) og Zantac (rantidin).) (...)

An old problem
BMJ 2008;336:109 (19 January)
Overprescribing PPIs
Forgacs and Loganayagam described the problem of overprescribing proton pump inhibitors (PPIs).¹ In June 2002 we wrote to many journals—and were ignored—about long term side effects being identified in general practice and surgery patients, with the then extensive, long term use of PPIs. At the time we shared an increasing number of patients with dependence on PPIs who experienced acute, severe gastritis and gastro-oesophageal reflux if they suddenly stopped or missed their PPIs; some showed refractory gastroparesis and severely delayed jejuno-ileal and colonic peristalsis when trying to reduce or stop their treatment after taking the PPI for extended periods (>3-60 months). (...)

Overprescribing proton pump inhibitors
Editorials
BMJ 2008;336:2-3 (5 January)
Is expensive and not evidence based (...)

FDA Reviews Two Major Heartburn Drugs
forbes.com 10.12.2007
WASHINGTON - Patients who suffer from heartburn are not at increased risk for heart problems as a result of taking Prilosec or Nexium, according to a review released Monday by the Food and Drug Administration. (...)

Syrehemmere gir økt risiko for pneumoni
Tidsskr Nor Lægeforen 2007; 127: 1919
Behandling med protonpumpehemmere er forbundet med økt risiko for utvikling av pneumoni. (...)

(Anm: pneumoni; pnevmoni; pneumonia, infeksjon der lungealveolane blir fylte med betennelseseksudat som blir til fortetning (konsolidasjon, jf hepatisasjon) slik som ved kruppøs pneumoni, eller infeksjon som også sit i luftvegsgreinene slik som ved bronkopneumoni eller som helst er i sjølve lungevevet (interstitielt); jf andre oppslag på pneumonia; dessutan: aspirasjonspneumoni, kjempecellepneumoni (Hechts pneumoni), Løfflers pneumoni, hypostatisk pneumoni, influensaviruspneumoni, interstitiell pneumoni, organiserande pneumoni; sjå også Klebsiella pneumoniae; e.n. lungebrune, lungebrann, lungekolda EN pneumoni ET [gr pneumonia]. Kilde: Norsk medisinsk ordbok.)

F.D.A. Is Reviewing Heartburn Drugs After Studies Find Possible Heart Risk
nytimes.com 10.8.2007
WASHINGTON, Aug. 9 — Two small studies of the popular heartburn drugs Prilosec and Nexium found that patients who took the medicines over many years had an increased risk of sometimes fatal heart attacks and heart failure.

But officials at the Food and Drug Administration played down the heart worries, saying that other studies suggested no such risks. The F.D.A. will need another three months to complete a thorough analysis of the drugs’ safety, the officials said in an announcement on Thursday. (...)

FDA safety review on Nexium and Prilosec hits AstraZeneca stock
pharmatimes.com 10.8.2007
AstraZeneca shares have taken a tumble after health regulators in the USA and in Canada revealed that they are conducting safety reviews of the blockbuster antiulcerants Nexium and Prilosec, even though findings thus far suggest that the drugs do not increase the risk of heart trouble.

The process began at the end of May when AstraZeneca sent the US Food and Drug Administration, and other regulatory authorities worldwide, a preliminary review of new data from two small long-term clinical studies of Nexium (esomeprazole) and Prilosec (omeprazole) in patients with severe gastroesophageal reflux disease (GERD). Patients were randomised to receive either drug or to have surgery to control their GERD and the results from the 14-year study of Prilosec and five-year analyses from an ongoing study of Nexium “raised concerns that long-term use” of both drugs “may have increased the risk of heart attacks, heart failure, and heart-related sudden death...compared to patients who received surgery”, the FDA stated. (...)

Stomach drugs 'may weaken bones'
bbc.co.uk 27.12.2006
Hip fractures are more common among the elderly
Long-term use of some of the most common drugs prescribed to tackle stomach acid problems may be weakening people's bones. (...)

Study Links Heartburn Drugs, Broken Hip
forbes.com 26.12.2006
Taking such popular heartburn drugs as Nexium, Prevacid or Prilosec for a year or more can raise the risk of a broken hip markedly in people over 50, a large study in Britain found.

The study raises questions about the safety of some of the most widely used and heavily promoted prescription drugs on the market, taken by millions of people.

The researchers speculated that when the drugs reduce acid in the stomach, they also make it more difficult for the body to absorb bone-building calcium. That can lead to weaker bones and fractures.

Hip fractures in the elderly often lead to life-threatening complications. As a result, doctors should make sure patients have good reason to stay on heartburn drugs long term, said study co-author Dr. Yu-Xiao Yang of the University of Pennsylvania School of Medicine.

"The general perception is they are relatively harmless," Yang said. "They often are used without a clear or justified indication for the treatment." (...)

Long-term Proton Pump Inhibitor Therapy and Risk of Hip Fracture
JAMA 2006;296:2947-2953 (December 27)
(...) Conclusion Long-term PPI therapy, particularly at high doses, is associated with an increased risk of hip fracture. (...)

Proton-Pump Inhibitors and Hypomagnesemic Hypoparathyroidism
N Engl J Med 2006; 355:1834-1836 (October 26)
To the Editor: We report two cases of hypomagnesemic hypoparathyroidism associated with the use of proton-pump inhibitors, in which patients presented with carpopedal spasm in association with severe hypomagnesemia and hypocalcemia without an appropriate increase in the level of parathyroid hormone.

Patient 1 was a 51-year-old premenopausal woman who had been taking omeprazole for more than a year (at a dose of 20 mg twice daily) and who presented with carpopedal and truncal spasm. She began receiving 2.4 g of elemental calcium per day and, later, high-dose magnesium (Figure 1A). Fourteen months later, omeprazole was discontinued, and ranitidine . . . [Full Text of this Article] (...)

(Anm: hypoparatyreoidisme; nedsett funksjon i biskjoldkjertlane, d e skort på paratyreoideahormonet (PTH); fører til fall i kalsiuminnhaldet i blod; dette kan føra til muskelkrampar (tetani (s d)), grå stær, beinvevsforandringar m v; årsak har ofte vore tilfeldig fjerning av paratyreoidkjertlane ved strumaoperasjon men genetiske feil med hormonet eller hormonet sin reseptor, ev med den kalsiumsansande reseptoren e a kan gi ulike former for hypoparatyreoidisme; jf de Georges syndrom og automuun-polyendokrinopati-candidiasis-ectodermal dystrofi, pseudohypoparatyreoidisme EN hypoparathyroidism Kilde: Norsk medisinsk ordbok.)

Heart-burn cure may be worse than cause
seattletimes.nwsource.com 20.12.2005
CHICAGO — Holiday revelers beware: Seasonal indulgences such as eggnog and fruitcake might give you heartburn, but the acid-fighting medicine you take for relief might lead to something worse, researchers say.

People on popular prescription drugs for treating acid reflux — Prilosec, Prevacid and Nexium — seem more prone to getting a potentially dangerous diarrhea caused by the bacterium Clostridium difficile, new research shows. C-diff, as it's known, can cause severe diarrhea and crampy intestinal inflammation called colitis.

Dr. Sandra Dial and colleagues at McGill University in Montreal examined data on more than 18,000 patients in the United Kingdom from 1994 to 2004. During that time, 1,672 cases of C-diff were diagnosed, and the numbers increased from less than 1 per 100,000 in 1994 to 22 per 100,000 last year.

Patients with prescriptions for powerful acid fighters called proton pump inhibitors, which include Prilosec and Prevacid, were almost three times more likely to be diagnosed with the bug than those not taking the drugs.

Those on less potent prescription drugs called H2 receptor antagonists, which include Pepcid and Zantac, were two times more likely than nonusers to get C-diff infections.

The widely used and heavily promoted drugs reduce levels of gastric acid that can keep C-diff at bay. (...)