Plavix (clopidogrel) is a
blood thinner that prevents blood platelets sticking together to form clots. It
is prescribed for stroke reduction, heart attack prevention and to prevent
clotting when drug coated stents are used in patients with arteriosclerosis. Marketed by a partnership of Sanofi-Aventis
and Bristol-Myers Squibb, Plavix is an antiplatelet drug that works by
preventing platelets in the blood from sticking together and forming clots. It
is a blockbuster medication, generating annual sales of over $6 billion for Bristol
Myers Squibb Co. and Sanofi-Aventis. In 2010, $4.6 billion in retail sales made
Plavix #3 on a list of Top 200 Pharmaceutical Sales in the United States.
The manufacturers promoted Plavix as a safer alternative to
aspirin, which reduces the risk of gastrointestinal problems. However, lawsuits
already filed allege that Plavix actually provides no benefits over taking
aspirin alone and could actually increase the risk of heart attacks, strokes,
gastrointestinal bleeding, severe ulcers and a rare blood disorder known as TTP, or thrombotic thrombocytopenic purpora. These lawsuits also
allege that the drug makers failed to provide adequate warnings and information
to doctors about the potential problems from Plavix and that the Defendants concealed their knowledge of
Plavix defects from the Plaintiffs, the FDA, the public in general and/or the
medical community specifically.
The
U.S. Food and Drug Administration (FDA) approved Plavix in 1997. In 2003, a stroke prevention
study conducted by the National Institute of Neurological Disorders and Stroke
found that combination aspirin-Plavix therapy may significantly increase the
risk of life-threatening bleeding. Of the 3,000 participants followed by the
study, 6.5% with the Plavix-aspirin combination experienced an adverse bleeding
event. By comparison, 3.3% of those who took aspirin alone developed similar
bleeding symptoms. The study also found that the combination therapy was
responsible for a death rate of 5.8%.
[nlm.nih.gov/databases/alerts/2011_ninds_stroke.html]
A more recent study, published in the New England Journal of
Medicine in April 2006, found that, "Overall, clopidogrel plus aspirin was
not significantly more effective than aspirin alone in reducing the rate of
myocardial infarction, stroke, or death from cardiovascular causes."
[nejm.org/doi/full/10.1056/NEJMoa060989]
Because Plavix side
effects can include ulcers and gastrointestinal bleeding, doctors often
prescribe Proton Pump Inhibitors (PPI’s) to reduce stomach acid in patients
taking Plavix. In November 2009, the FDA released an advisory saying that
taking the Proton Pump Inhibitor omeprazole (marketed as Prilosec/Prilosec OTC)
in conjunction with Plavix significantly reduced the effectiveness of Plavix
and patients at risk for heart attack or stroke may not be getting the
anti-clotting benefits. The makers of Plavix agreed to update the drug labeling
to include a warning about drug interaction with omeprazole and to conduct
further studies into other drug interactions.
If you or a loved experienced serious,
life-threatening internal bleeding, heart attacks, strokes, or a blood
disorder, and you believe Plavix is to blame, please contact Booth Samuels at booths@pittmandutton.com or toll
free at 1-866-515-8880.
