Last, week the FDA announced a black box warning on Plavix to alert doctors and patients that the drug may not work effectively in some patients. Plavix has been under a microscope for some time now for severe and life threatening side effects including heart attacks, strokes, gastrointestinal bleeding, thrombocytopenia, TTP blood disorders, and ulcers. A weaker warning about some patients being poor metabolizers of Plavix first appeared on the drug’s label last May. Now the FDA is pushing a complete black box warning on Plavix. Often, for many drugs, a black box warning is a harbinger of a future withdrawal or a recall.
Plaintiffs’ lawyers handling Plavix lawsuits would tell you this new warning is overdue. A New England Journal of Medicine study underscores these concerns about Plavix, finding that Plavix users were 12 times more likely than those taking aspirin and a heartburn pill to experience severe gastrointestinal bleeding and chronic ulcers. More research also indicates that taking Plavix with aspirin, as often prescribed, doubles the risk of stroke, heart attack and death in patients that have elevated cholesterol but with no significant history of heart disease.
The FDA further suggested to doctors that they should consider another anti-clotting drug for patients who are found through genetic testing – which is available – to be poor metabolizers of Plavix. It is worth underscoring that being a poor metabolizer of Plavix is not a rare thing. A study done at the University of Maryland found that approximately one-third of the population may have this gene variant that would limit the efficacy of Plavix. The new label does not go quite this far but does warn that normal doses of Plavix have a potentially deadly lack of effect in 2% to 14% of patients.
Plavix lawsuits claim that the makers of Plavix concealed the risks associated with Plavix and that many doctors would never have prescribed Plavix if the true level of risk had been properly divulged. This new black box requirement underscores how this warming should have read.
If you have suffered any of these injuries that you suspect may be linked to Plavix, contact us today at 800-553-8082 or get a free Plavix case evaluation with an attorney who can help you understand your legal rights and options.