Plavix (Clopidogrel)
Plavix
is a prescription medicine that when taken daily can help reduce your risk of having a future heart attack or stroke. It is recommended for people who have suffered from a recent heart attack or recent stroke, or who have been diagnosed with peripheral artery disease, or P.A.D.—poor circulation in the legs that may cause pain during exercise, such as walking, and may be relieved by rest.
What are the side effects?
In a study done by Charisma on clopidogrel - Plavix - for high atherothrombotic risk and ischemic stabilization management and avoidance, randomised 15,603 patients with previous
cardiovascular or peripheral arterial disease or multiple risk factors to daily clopidogrel (Plavix) (75 mg) or placebo, plus aspirin (75–162mg). Results were reported at the American College of Cardiology annual scientific session in Atlanta, Georgia, this week and online in The New England Journal of Medicine (12 March).
They show the rate of myocardial infarction, stroke, or death from cardiovascular causes in the subgroup of more than 12,000 patients with established vascular disease was reduced by 12.5 per cent (6.9 per cent with clopidogrel versus 7.9 per cent with placebo; P=0.046) after a median follow-up of 28 months. However, patients with risk factors but no documented disease showed no reduction, with a trend to increased risk of events (6.6 per cent with clopidogrel versus 5.5 per cent with placebo; P=0.20). This dichotomy meant that results for the entire group did not reach significance (6.8 per cent versus 7.3 per cent; P=0.22).
The lead investigator, Deepak Bhatt, Cleveland Clinic, Ohio, said: “The findings confirmed previous studies showing benefit with clopidogrel plus aspirin in patients with symptomatic atherothrombosis but showed the potential harm outweighed the benefit in those who only had risk factors.” .
What actions has the FDA taken?
In 2003 the FDA required label changes to the Plavix patient information insert stating that Plavix increased the risk of intracranial bleeding, GI (gastrointestinal bleeding), ulcerative colitis, lycophytic colitis, strokes, and heart attacks.
- Plavix is
contraindicated in patients with active pathologic bleeding such as peptic ulcer or intracranial hemorrhage. PLAVIX should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery, or coadministration with NSAIDs or
warfarin.
- The rates of major and minor bleeding were higher in patients treated with PLAVIX plus aspirin compared with placebo plus aspirin in a clinical trial.
- As
part of the worldwide post marketing experience with PLAVIX, there have been cases of reported thrombotic thrombocytopenic purpura (TTP), some with fatal outcome. TTP has been reported rarely following use of PLAVIX, sometimes after a short exposure (<2 weeks). TTP is a serious condition that can be fatal and requires urgent treatment including plasmapheresis (plasma exchange).
- In
clinical trials, the most common clinically important side effects were pruritus, purpura, diarrhea, and rash; infrequent events included intracranial hemorrhage (0.4 percent) and severe neutropenia (0.05 percent).
Plavix News Archive>>.
If you or a loved one have taken Plavix - Clopidogrel - and have experienced any of the Plavix side effects listed you may be entitled to compensation. Contact the Plavix attorneys of Ennis & Ennis today for a free confidential case evaluation. Our on staff nurse and lawyers are standing by to answer any questions you may have regarding Plavix side effects, a possible Plaix class action lawsuit, or any other type of Plavix litigation.
