Plavix "Black Box" Warning:
An Attorney For You is Investigating Injury Claims Associated with Plavix. Call us today (866) 939-1585 or fill out our form for legal assistance.
March 12, 2010: The FDA announced today that a "black-boxed" warning has been added to the anti-blood clotting drug Plavix (clopidogrel). This is to alert patients and health care professionals that the drug can be less effective in people who cannot metabolize the drug to convert it to its active form.
Plavix reduces the risk of heart attack, unstable angina, stroke, and cardiovascular death in patients with cardiovascular disease by making platelets less likely to form blood clots. Plavix does not have its anti-platelet effects until it is metabolized into its active form by the liver enzyme, CYP2C19. People who have reduced functioning of their CYP2C19 liver enzyme cannot effectively convert Plavix to its active form. As a result, Plavix may be less effective in altering platelet activity in those people.
These "poor metabolizers" may not receive the full benefit of Plavix treatment and may remain at risk for heart attack, stroke, and cardiovascular death. "We want to highlight this warning to make sure health care professionals use the best information possible to treat their patients," said Mary Ross Southworth, Pharm.D., a clinical analyst in the Division of Cardiovascular and Renal Products in the FDA's Center for Drug Evaluation and Research.
In May 2009, the FDA added this warning to the drug's label. After reviewing more data, the agency felt it was important to highlight this risk in a boxed warning. It is estimated that 2 percent to 14 percent of the U.S. population are poor metabolizers. The FDA recommends that health care professionals consider alternative dosing of Plavix for these patients, or consider using other anti-platelet medications. Tests are available to assess CYP2C19 genotype to determine if a patient is a poor metabolizer.
Patients should not stop taking Plavix unless told to do so by their health care professional. They should talk with their health care professional if they have any concerns about Plavix.
If you or someone you love has been injured by the use of Plavix, please contact our services today. We can help you get in touch with specialized attorneys who deal specifically with Plavix Lawsuits.
An Attorney For You is a free consumer service. We are
not a law firm. We help consumers find the best representation for their
legal needs. Our service allows the consumer to review responses by many
law firms. This process introduces competition amongst the law firms and
allows the consumer to find superior legal representation.
Fill out one simple form and get responses from Plavix Attorneys
competing for your case. Email up to 10 law firms in one click; you review
the responses in order to choose the right attorney for you.
| 
