Personal Injury Law

New Black Box Warning for Plavix

By Paul Napoli

The U.S. Food and Drug Administration announced today that the partnership of Bristol-Myers Squibb and Sanofi Pharmaceuticals must add a black box warning, the agency's highest alert, to their prescription drug Plavix (clopidogrel) to warn of reduced effectiveness in people who cannot metabolize the drug to convert it to its active form.

'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.

Plavix is an anti-blood clotting drug prescribed to reduce the risk of heart attack, unstable angina, stroke and cardiovascular death in patients with cardiovascular disease by keeping platelets in the blood from sticking together and forming clots. It is ranked as the second best selling drug of 2009 with over $9 billion dollars in sales.

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 and therefore do not receive the drug's therapeutic benefits. It is estimated that 2 percent to 14 percent of the U.S. population are 'poor metabolizers' and may not receive the full benefit of Plavix treatment and may remain at risk for heart attack, stroke, and cardiovascular death. Physicians should consider alternative dosing of Plavix for these patients, or consider using other anti-platelet medications.

The FDA added this warning to the drug's label in May 2009, but after further study the agency decided it important enough to warrant the use of a black box.

How do you know if you are a 'poor metabolizer'? There is a test to assess the CYP2C19 genotype available from your physician. The FDA advises Plavix users to discuss this concern with their physician and warns not stop taking Plavix unless directed by their physician. If you are confirmed to be a 'poor metabolizer', your physician should consider alternative dosing of Plavix or use of other anti-platelet medications.

All Plavix users should be aware that in November 2009, the FDA released a public health advisory warning the public of the dangerous drug interaction between Plavix and Prilosec and Prilosec OTC (omeprazole). They found that Prilosec and Prilosec OTC reduce the anti-blood clotting effects by blocking the conversion of Plavix into its active form. The FDA warned that these other drugs should also be avoided in combination with clopidogrel because they may have a similar interaction include: esomeprazole (Nexium), cimetidine (which is available by prescription Tagamet and OTC as Tagamet HB), fluconazole (Diflucan), ketoconazole (Nizoral), voriconazole (VFEND), etravirine (Intelence), felbamate (Felbatol), fluoxetine (Prozac, Serafem, Symbyax), fluvoxamine (Luvox), and ticlopidine (Ticlid).

If you have suffered an adverse reaction or injury, or someone in your family has died due to a dangerous prescription drug, you may be entitled to compensation. Please contact Napoli Bern Ripka, LLP at 888-529-4669 to discuss your options for filing a claim and recovering compensation for your medical expenses, lost wages, pain and suffering or the wrongful death of a loved one.

Full post as published by New York City Personal Injury Lawyer on March 17, 2010 (boomark / email).