The FDA requires a black-box warning on anti-clotting drug Plavix

The Food and Drug Administration said Friday that it will require a new black-box warning on the label of the popular anti-clotting drug Plavix to indicate that some patients do not metabolize the drug properly and may receive little benefit from it. The warning indicates that the drug is dangerous only in the sense that it doesn't work in those patients and thus may leave them unprotected against heart attacks and strokes.

Plavix, known generically as clopidogrel, is one of the most popular drugs in the world, with U.S. sales of $3.8 billion in 2008 and worldwide sales of $6.6 billion in 2009, according to IMS Health. It is used to prevent clotting of blood in patients who have stents or other prostheses or conditions that predispose them to clotting, and thus strokes and heart attacks. Technically, clopidogrel is a pro-drug that must be converted into its active form in the body by enzymes in the liver, particularly one called CYP2C19. As much as 14% of the population have an inactive or a less-active form of this enzyme, so the active form is not produced or produced only in limited quantities in the body. Very limited studies have hinted that giving higher doses of clopidogrel might yield higher blood levels of the active form, but the FDA cautioned that no clinical trial has verified this.

There is a genetic test to identify patients with the aberrant form of the enzyme, and the agency recommends that physicians order the test if there are any doubts about using the drug. There are also other alternatives that may be prescribed instead of Plavix, including aspirin. Patients should not stop taking Plavix unless told to do so by their physicians, the FDA said.

The new warning appears on the label of the drug in a black box — hence the name — which is considered the most severe form of warning.

— Thomas H. Maugh II

Comments

[Kristine Ashcraft]

I applaud the FDA on this relabeling of Plavix.
It will greatly benefit patients by furthering the adoption of personalized medicine to improve healthcare outcomes, saving lives and money.

[John Mikes]

I dislike the clendestine "warning" effecting 14% of the population without any proposed solution. There is little chance to execute the $500(?) test in masses for patients using up b$8 worth of Plavix yearly. The maker of Plavix should rush out a 'quick-and-dirty' (secondary) test indicating the effectiveness of the drug.
Is the 'aspirin-combination' effective on the Plavix as well, or only by the aspirin efficiency itself?

[Diane W]

I highly recommend that anyone taking Plavix look the medication up on line to see what and how many adverse side affects accompany taking the drug; the worst of which, in my opinion, is LEUKEMIA. Of particular note is that some doctors (Cardiologists) are also recommending their patients take the daily low dose aspirin which is also a blood thinner. How thin does your blood have to be? Normal blood platelets (clotting element that keeps your blood inside your body where it belongs) number in the hundreds of thousands can plummet to such low levels the patient can bleed out (meaning that you can bleed from everywhere without sustaining a cut) and dye. Patients who take such prescription medications need to become thoroughly informed about all aspects of the medication IT COULD SAVE YOUR LIFE!

[Nicole]

The public should also know that every person metabolizes everything differently, food, medication, etc. Every item a person consumes is metabolized different whether it is a food, drink or pill. This is why some people are thin, fat, lose weight easily or harder. People in general should be aware that every medication effects others differently and to take care of yourself. Eat properly, exercise, routine health care, your health is your own personal responsibility.