Cardiologists are re-evaluating how they prescribe a popular heart medication after a major clinical study found the drug may cause dangerous bleeding in patients who take it along with aspirin to ward off a first heart attack. (nytimes.com 13.2.2006)

Plavix (clopidogrel bisulfate) (fda.gov (March 2010))

 

Blodpropp- og hjertemedisin kan gi beinskjørhet
forskning.no 13.2.2013
Verdens nest mest brukte legemiddel kan øke risikoen for beinskjørhet.

Blodfortynnende medisin som gis til millioner av pasienter ser ut til å øke risikoen for beinskjørhet.

En stor dansk studie peker for første gang på at behandling mot blodpropp og hjertesykdommer har en alvorlig bivirkning.

Legemiddelet Plavix blir gitt til millioner av mennesker i en rekke ulike land. Men nå viser danske forskere at den blodfortynnende medisinen antagelig øker risikoen for beinskjørhet.

– Det ser ut til at risikoen er økt med om lag 50 prosent, primært hos de som har tatt medisinen i mer enn et år. Det er veldig interessant fordi det er et av de mest solgte medikamentene i verden. Den skadelige effekten kan være svært stor, sier Niklas Rye Jørgensen, overlege ved Glostrup Hospital. (...)

(Anm: Clopidogrel and the risk of osteoporotic fractures: a nationwide cohort study. Journal of Internal Medicine 213;272(4):385–393 (October 2012).)

(Anm: Clopidogrel (Plavix), a P2Y12 receptor antagonist, inhibits bone cell function in vitro and decreases trabecular bone in vivo. Journal of Bone and Mineral Research 213;27(11):2373–2386 (November 2012).)

Blodfortynner kan gi benskjørhet
aftenposten.no 8.2.2013
Planix er verdens nest mest foreskrevne medikament, og anvendes som behandling mot blodpropp og hjertesykdom. Nå viser en dansk studie at medikamentet kan gi økt risiko for osteoporose. Det er virkestoffet clopidogrel som mistenkes for å ha den uheldige effekten. Undersøkelsen omfattet 70 000 dansker som ble behandlet med clopidogrel gjennom tiåret 1998-2008. De fikk sykdomsutviklingen sammenholdt med en kontrollgruppe på 230 000 personer. Man fant at risikoen for å knekke hofter og håndledd, samt at ryggsøylen falt sammen, økte med opp til 50 prosent blant de som fikk medikamenter som inneholdt clopidogrel. Forskerne bak studien advarer imidlertid mot å slutte å bruke Planix, fordi man ikke kan si sikkert om det er noen årsakssammenheng. Det kan tenkes at pasienter som får skrevet ut medisinen, er særlig utsatt av andre årsaker. Studien er publisert i Journal of Internal Medicine. (...)

Certain Antidepressants With Blood Thinners May Pose Risk for Heart Patients (Enkelte antidepressiva kan sammen med blodtynnende legemidler utgjøre en risiko for hjertepasienter)
health.yahoo.com 26.9.2011
MONDAY, Sept. 26 (HealthDay News) -- Heart attack patients who take both selective serotonin reuptake inhibitor (SSRI) antidepressants and antiplatelet drugs such as aspirin or Plavix have a higher risk for bleeding than those who take anti-clotting drugs only, a new study finds.

Commonly prescribed SSRIs include Zoloft, Prozac, Paxil and Lexapro.

Antiplatelet drugs prevent blood cells from sticking together and forming a blood clot. Heart attack patients are commonly prescribed antiplatelet therapy to reduce their risk of another heart attack. But there's an increased risk of bleeding, which increases even further when certain other drugs are taken at the same time.

It so happens that many heart attack patients have depression symptoms and are prescribed antidepressants, noted the researchers at McGill University in Montreal.
"We're always concerned about how other medicines might interact with the medicines we know are essential to heart health and recovery after heart attack," said Dr. Kirk Garratt, clinical director of interventional cardiovascular research at Lenox Hill Hospital in New York City. "Although SSRIs are used in only a few cardiac patients, learning that SSRIs can increase [the] risk of bleeding complications could have important implications for how we care for patients after stents and other heart procedures."

In the Canadian study, the researchers looked at more than 27,000 heart attack patients, aged 50 and older, and found that patients taking aspirin or Plavix alone had a similar risk of bleeding. But taking an SSRI antidepressant and aspirin increased the risk of bleeding by 42 percent, and taking an SSRI with both aspirin and clopidogrel (dual antiplatelet therapy) increased the risk by 57 percent.

Bleeding included gastrointestinal bleeding, hemorrhagic stroke or other bleeding that required hospitalization or occurred in the hospital during treatment.
The researchers also found that the risk of bleeding was lower in women and in patients who had angioplasty after their heart attack.

The study appears Sept. 26 in the Canadian Medical Association Journal. (...)

(Anm: Risk of bleeding associated with combined use of selective serotonin reuptake inhibitors and antiplatelet therapy following acute myocardial infarction. CMAJ ( September 26).)

Depression Drugs Could Worsen Bleeding After MI (Legemidler mot depresjons kan forverre blødning etter hjerteinfarkt)
medpagetoday.com 26.9.2011
Depression may accompany myocardial infarction (MI) but prescribing selective serotonin reuptake inhibitors (SSRIs), combined with antiplatelet therapy, carries an increased risk of bleeding, researchers found.

Following MI, those taking aspirin with an SSRI had a 42% increased risk of bleeding compared with taking aspirin alone, reported Elham Rahme, PhD, from McGill University in Montreal, and colleagues.

The risk increased to 49% when patients were taking an SSRI with both aspirin and clopidogrel (Plavix) compared with aspirin alone, according to the study published online in CMAJ.

And when patients added an SSRI on top of dual antiplatelet therapy, the risk of bleeding was 57% higher compared with dual antiplatelet therapy alone.

The risk of bleeding with antiplatelet therapy is always a concern, but it may be increased with other medication use, Rahme and colleagues wrote.

They noted that up to 20% of patients with cardiovascular disease suffer from depression and most of them are prescribed SSRIs. (...)

(Anm: Risk of bleeding associated with combined use of selective serotonin reuptake inhibitors and antiplatelet therapy following acute myocardial infarction. CMAJ ( September 26).)

Summary Box: FDA puts black box warning on Plavix
forbes.com 12.3.2010
PLAVIX PROBLEM: The Food and Drug Administration is adding its strongest warning to the label for Plavix, cautioning that some patients do not respond to the blockbuster blood thinner.

GENETIC CAUSE: A small percentage of people have a genetic variation that prevents them from making an enzyme needed to break down Plavix. (...)

Boxed Warning Added to Clopidogrel Label, Testing Suggested
medpagetoday.com 12.3.2010
Prescribing information for clopidogrel (Plavix) will now include a boxed warning that the drug can be less effective in poor metabolizers, the FDA indicated.

The new warning suggests that many if not all patients on clopidogrel should undergo genetic testing to determine whether they have variants of the CYP2C19 gene associated with poor metabolism of the antiplatelet drug. (...)

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. (...)

(Anm: Bare én av ti nordmenn som rammes av hjerneslag får behandling i tide (tv2.no 16.2.2014).)

(Anm: – Får du hjerneslag har du dårlig tid. Dersom du rammes av hjerneslag risikerer du å miste to millioner hjerneceller hvert minutt. Får du ikke behandling innen 4,5 timer, er risikoen for invaliditet og uførhet stor. (…) Slagambulanse med CT. (nrk.no 8.2.2016).)

(Anm: Ja til ny akuttmetode: Flere slagpasienter kan få tilbud om å «fiske ut» blodpropp av hjernen. To år etter mange andre land gis det nå klarsignal til å videreføre ny og effektiv behandlingsmetode for slagpasienter. I fjor fikk bare 150 pasienter inngrepet - som opptil tusen kan ha nytte av hvert år. (aftenposten.no 2.5.2017).)

(Anm: - Plutselig oppstått dobbeltsyn (- Visuelle komplikasjoner er vanlig etter hjerneslag) Sudden onset double vision BMJ 2014;348:g3286 (19 May 2014).)

(Anm: En av tre blev dement efter återkommande stroke. (…) Den nya analysen, som publiceras i dag, torsdag, på tidskriften Lancet Neurologys hemsida, baseras på 22 sjukhusstudier och åtta populationsstudier. Undersökningarna är utförda mellan 1950 och 2009. (dagensmedicin.se 24.9.2009).)

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. (...)

Dårlig respons på Plavix
dagensmedisin.no 29.1.2009
Opptil 30 prosent av hjertepasienter som får Plavix, kan ha dårlig respons på legemiddelet på grunn av en genvariant - og dermed økt risiko for nytt infarkt eller stenttrombose. Resultatene vekker stor interesse hos norske leger.
Lisbeth Nilsen

Blodplatehemmeren Plavix (klopidogrel) forskrives blant annet etter akutt hjerteinfarkt og utblokking av årene. Virkestoffet i legemiddelet aktiveres i leveren ved CYP450-enzymer.

To nylig publiserte studier i New England Journal of Medicine (Mega m.fl.) og The Lancet (Collet m.fl) viser nå at den beskyttende effekten på stenttromboser og nye kardiovaskulære hendelser reduseres sterkt hos personer med en genvariant av et leverenzym. (...)

FDA reviews benefits of Plavix in certain patients
forbes.com 28.1.2009
Federal health officials are investigating whether the blood thinner Plavix - the world's second-best-selling drug and used by millions to reduce the risk of heart attack and stroke - may be less effective in some patients.

The Food and Drug Administration said Monday it is reviewing reports that certain heartburn medications can neutralize the benefits of Plavix. The agency said it is also investigating whether patients from certain genetic backgrounds also don't reap the drug's benefits.

In both cases, FDA said patients may have trouble metabolizing Plavix, reducing its ability to prevent deadly blood clots. (...)

Lilly's Prasugrel Pleases FDA Panel
forbes.com 30.1.2009
Advisory board recommends approval of the blood thinner, but has some concerns. (...)

The panel wrote that "prasugrel appeared to be superior to established treatment for the prevention of nonfatal myocardial infarction," but it recommended certain patient population restrictions due to safety concerns. Prasugrel holds an increased risk of bleeding, but the panel seems confident the benefits of the drug outweigh the risk. The potential link to cancer is also a safety factor mentioned in the notes. While the association with cancer could be due to chance -- the data showed 27 cases of cancer in prasugrel patients compared with 19 in Plavix -- there is a chance that the drug could carry a black box warning if approved, the highest warning issued by the FDA. A black box on the drug could inhibit its ability to truly compete with Plavix. (...)

FDA Probes Safety of Popular Heart Stent
forbes.com 3.12.2006
Millions of chest pain and heart attack sufferers thought they were getting a phenomenal medical advance when tiny coils that ooze medicine were placed in their arteries to keep them from squeezing shut again.

These gizmos, called drug-coated stents, worked so much better than plain old metal ones that 6 million people worldwide received them in the few years they have been available. It was a modern record for any medical device.
Now their long-term safety is in question.

Doctors think these stents may raise the risk of life-threatening blood clots months and even years later unless people stay on Plavix, an anti-clotting drug whose long-term safety in stent patients has not been established.
Thousands of people are being urged to take the $4-a-day drug until more is known. (...)

FDA Approves Expanded Use for Plavix
forbes.com 18.7.2006
The popular blood-thinning drug Plavix received expanded federal approval Thursday to prevent the sudden blockage of arteries that can lead to heart attack, stroke and death.

The approval means Plavix may be used to treat patients who have had a type of severe heart attack called acute ST-segment elevation myocardial infarction, or STEMI, and who are not going to have angioplasty to clear blocked arteries, the Food and Drug Administration said.

The sudden, total blockage of an artery can provoke the type of heart attack. An estimated 500,000 Americans suffer such heart attacks each year, according to the American Heart Association.

In 1997, Plavix, now the world's second best-selling drug, received FDA approval to thin the blood and prevent clots that can block arteries.

The expanded approval comes as Bristol-Myers Squibb Co. and Sanofi-Aventis SA seek a court injunction to block Canadian drug company Apotex Corp. from selling a less expensive, generic version of Plavix. Sales of the drug last year were about $5.9 billion. A court hearing on the motion is set for Friday.

Serious side effects of Plavix, also known as clopidogrel bisulfate, include bleeding and, rarely, low white blood cell counts and low platelet counts with spontaneous bleeding and clotting, the FDA said. (...)

Questions Are Raised About the Safety of a Major Heart Drug
nytimes.com 13.2.2006
ATLANTA, March 13 — Cardiologists are re-evaluating how they prescribe a popular heart medication after a major clinical study found the drug may cause dangerous bleeding in patients who take it along with aspirin to ward off a first heart attack.

The anticlotting drug Plavix generated more than $6 billion in sales worldwide last year.

The announcement of the results of the study, which will be published in the New England Journal of Medicine on April 20, created a buzz at the meeting, one of the world's largest gatherings of cardiologists, partly because of the implications for patients, and partly because the results might have been disclosed to a financial analyst before its release Sunday.

A Bloomberg News article on Thursday covering ongoing studies of the drug quoted financial analysts as expecting the study to find that the drug was of no help in preventing a first heart attack among at-risk patients.

That story was of such concern to the conference organizers, the American College of Cardiology, that they almost took the rare step of refusing to publicly release the study at the conference, said Amy Murphy, a spokeswoman for the organization. (...)

Previously, several large clinical trials had indicated Plavix taken with aspirin could benefit patients with advanced heart disease — particularly those who had a blocked vessel reopened with a metal coil called a stent, and in 2002, the American Heart Association and the American College of Cardiology issued a joint statement endorsing the short-term use of Plavix as part of the treatment regimen for patients evaluated in the emergency room with a mild heart attack or who are at high risk of having a heart attack.

Plavix seemed to work so well that many physicians began prescribing it, along with standard low-dose aspirin therapy, to prevent a heart attack or stroke in patients who had established risk factors for heart disease, such as high blood pressure, high cholesterol, diabetes, or a history of smoking. (...)

(Anm: Acetylsalisylsyre (Acetylsalicylic Acid). Stoffet brukes mot smerter og feber og finnes under flere varemerkebeskyttede navn, blant annet Dispril, Aspirin og Globoid.(no.wikipedia.org).)

(Anm: Risk of Upper Gastrointestinal Bleeding With Low-Dose Acetylsalicylic Acid Alone and in Combination With Clopidogrel and Other Medications.Circulation. 2011;123:1108-1115 (March 15).)


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