The FDA has put a new "black box" warning on the anti-clotting drug Plavix, the second best-selling drug in the world.
A black box warning (also sometimes called a black label warning or boxed warning) is a type of warning that appears on the package insert for prescription drugs that may cause serious adverse effects. It is so named for the black border that usually surrounds the text of the warning.
A black box warning means that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects. The U.S. Food and Drug Administration (FDA) can require a pharmaceutical company to place a black box warning on the labeling of a prescription drug, or in literature describing it. It is the strongest warning that the FDA requires.
The new label for Plavix warns that normal doses of Plavix have a potentially deadly lack of effect in 2% to 14% of patients.
Such patients are so-called "poor metabolizers" who carry a variant CYP2C19 gene affecting the enzyme that converts Plavix into its active form.
A less strident warning about poor metabolizers first appeared on the Plavix labels in May 2009. Based on new information from a drugmaker-funded study and other research, the FDA has now strengthened the warning.
HealthDay News had said in 2009 that patients taking the clot-preventing Plavix following stent implantation should stay away from PPIs, or proton pump inhibitors. Stents are implanted in artery-opening cardiac surgeries and PPIs, said HealthDay News, include drugs such as Nexium, Prevacid, and Prilosec.
Data on nearly 17,000 Plavix users—who took the drug for over one year following stent implantation—were analyzed, said HealthDay News, citing Eric J. Stanek, senior director of research at drug distributor Medco Health Solutions. The team found that the incidence of cardiovascular events was 51 percent greater in patients taking the Plavix-PPI combination over those on Plavix alone, said Stanek, according to HealthDay News. "Considering all the available evidence, PPI use should be limited in patients taking clopidogrel, based on the physician's judgment," Stanek said.
Talk to your doctor before you make any decisions regarding medications you are taking.
As far back as November 23, 1998 the Federal Drug Administration (FDA) expressed its concern with the claims made by the drug manufacturer, Bristol-Myers Squibb/Sanofi Pharmaceuticals about Plavix. A number of patients were instructed (as recommended by the manufacturer) to take Plavix along with aspirin.
A study published by the New England Journal of Medicine states that although doctors believed the combination of Plavix and aspirin would reduce the risk of a second heart attack, the study actually found that the combination not only does not help, but doubles the risk of death, heart attack or stroke in people with no history of heart disease. It was also found to be associated with increased risk for moderate and serious bleeding. To further cite the New England Journal of Medicine, the cost and risk of Plavix do not justify its use for the prevention of coronary artery disease and heart attack.