An emerging study finds that blood thinner Plavix may only benefit smokers. Plavix (clopidogrel) is prescribed for the prevention of blood clots and heart attacks, and has been linked to serious side effects, including the heart attacks and strokes it is supposed to prevent, gastrointestinal and cerebral bleeding, bleeding ulcers, and thrombotic thrombocytopenic purpura (TTP), to name some.
A sub-analyses of large-scale clinical trials consistently revealed significant reductions in morbidity and death in smokers taking Plavix, said MedPageToday. No benefit was seen in nonsmokers and those smoking under a half-pack daily, wrote Paul A. Gurbel, MD, of Sinai Hospital of Baltimore, and colleagues, in a Journal of the American Medical Association viewpoint article. “These observations raise concerns about the costs and potential risks incurred by treating nonsmokers with clopidogrel,” they noted.
Gurbel pointed out that doctors should not recommend smoking to patients to improve the efficacy of Plavix, pointing out that other, newer anti-platelet agents might present a better alternatives for nonsmokers, said MedPageToday. “Evidence from these same studies consistently supports less or no clinical efficacy from clopidogrel therapy among patients who do not smoke,” wrote the team.
It seems, said the researchers, that smoking increases Plavix metabolism by activating a lesser-known but critical enzyme (cytochrome P450 (CYP) 1A2), MedPageToday explained. “This drug is pharmacodynamically ineffective in up to 30% to 35% of patients, so we have, in essence, given a placebo to 30% of patients with high-risk cardiovascular disease,” Gurbel argued in an interview with MedPageToday. “That is something everyone should take into consideration,” he added.
Meanwhile, Plavix lawsuits continue to be filed. Most recently, a Plavix lawsuit was filed on behalf of 64 Plavix patients who allege bleeding side effects. The group alleges it suffered strokes and heart attacks after taking Plavix and alleges the drug can cause heart attacks, internal bleeding, strokes, blood disorders, or death. This is just one of a number of lawsuits filed over Plavix adverse reactions.
The national law firm of Parker Waichman LLP filed 18 Plavix bleeding lawsuits on behalf of people who suffered serious gastrointestinal bleeding, allegedly due to their use of the medication. All of the lawsuits were filed on May 30th in the Supreme Court of New York, County of New York. Parker Waichman LLP also filed an additional six Plavix bleeding lawsuits on April 30, 2012, also in the Supreme Court of the State of New York, County of New York. The complaints allege that the plaintiffs’ use of Plavix caused them to suffer from a number of bleeding side effects, including gastrointestinal hemorrhage, cerebral hemorrhage, and the blood condition TTP.
The U.S. Food & Drug Administration (FDA) first approved Plavix in 1997 for prevention of heart attack and stroke. In 2005, the New England Journal of Medicine published a study comparing the effects of Plavix versus aspirin and Nexium (esomeprazole) in patients with ulcer bleeding. The study reported an 8.6% increased risk of recurrent bleeding in patients taking Plavix versus 0.7% among those taking aspirin and Nexium (for GERD). That same year, the FDA ordered that the Plavix label be updated to include information about reports linking Plavix to TTP, a condition marked by small clots through the entire circulatory system. According to the FDA, some reports of TTP in Plavix patients occurred after only a short exposure (less than two weeks).