New Lawsuit Claims Plavix Caused Dangerous Bleeding

Last week, we wrote that <"">Plavix litigation is on the rise and expected to increase. Now, BNET is writing about another emerging Plavix lawsuit in which Beatrice Mills of Arizona needed to be hospitalized for uncontrolled bleeding after she took Plavix in 2009. The lawsuit claims Ms. Mills’ health was “permanently damaged” due to her treatment with the blood clot prevention medication.

Also, notes BNET, the lawsuit charges that the makers of Plavix falsely promoted the drug as offering better benefits over aspirin even though the U.S. Food and Drug Administration (FDA) warned not to tout the drug for this purpose.

Plavix is a joint effort by Bristol-Myers Squibb and Sanofi. While Bristol-Myers Squibb and Sanofi do not discuss the growing litigation, it seems that at least 20 lawsuits have been filed in New Jersey federal court alone, said BNET.

To date, we have written about dozens of other lawsuits. Last week we wrote that 40 new Plavix cases were filed in New Jersey state court. Those plaintiffs allege that Plavix offers no increased efficacy over aspirin, but does create a greater risk for adverse events; plaintiffs also allege that the makers of Plavix never warned patients about increased heart attack, stroke, and dangerous blood disorder risks, according to Lawyer USA Online. We previously wrote that 11 plaintiffs filed in Illinois state court, accused the makers of Plavix of conducting intense marketing via television ads saying that Plavix is a “super-aspirin,” even while the drug makers’ studies proved that Plavix risks significantly outweighed the drug’s benefits, noted Lawyer USA Online.

The popular drug, used to prevent blood clots in people at risk for a heart attack, has been linked to some serious side effects, especially bleeding. As a matter-of-fact, a recent study in the New England Journal of Medicine (NEJM), on which we just wrote, found that patients taking Plavix are 12 times likelier to suffer recurrent ulcers and Plavix gastrointestinal bleeding than those who received a combination of aspirin and a heartburn pill.

A 1996 study published in the journal, Lancet, discussed a significant Plavix study and the efficacy of Plavix versus aspirin at reducing cardiovascular issues, such as heart attacks. That study concluded that “Long-term administration of clopidogrel [Plavix] to patients with atherosclerotic vascular disease is more effective than aspirin in reducing the combined risk of ischaemic stroke, myocardial infarction, or vascular death,” quoted BNET. Meanwhile, the “Results” section of that same study concluded that where Plavix patients experienced a 5.32 percent increased risk for a cardiovascular event, aspirin patients experienced a similar 5.83 percent increased risk, a negligible difference. BNET pointed out that this prompted the FDA, in 1998, to warn the two drug makers to stop touting Plavix as offering increased benefits, saying that the difference was of “marginal statistical significance,” quoted BNET. The agency repeated the warning in 2001, telling the drug makers to stop inflating the significance of
the 1996 study and accusing the drug makers of including bogus figures in its advertising that did not match to the numbers on the Plavix label, said BNET.

Another two studies proved that Plavix was no better than aspirin in some patients and a 2005 NEJM publication of a study concluded: “… aspirin plus [Prilosec] was superior to clopidogrel [Plavix] in the prevention of recurrent ulcer bleeding. Our finding does not support the current recommendation that patients with major gastrointestinal intolerance of aspirin be given clopidogrel [Plavix],” quoted MSNBC.

Another 2006 study published in the NEJM, concluded that adding Plavix to long-term aspirin treatment for patients with more than one cardiovascular risk offered no benefit, said BNET, noting that Plavix’s own label indicates that there is a “Lack of established benefit of Plavix plus aspirin.” Still from 1996 through 2001, the drug makers ran an advertisement that suggests Plavix offered significant health benefits versus aspirin.

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