Plavix Packaging to Contain New Warnings

Tuesday, August 10, 2010

The FDA has recently issued its strongest possible warning about the popular blood-thinning drug Plavix. The FDA warning states that some patients are unable to metabolize the drug. In short, their bodies can’t use the drug or their systems just ignore it. This is the result of a genetic trait, and many people who are taking Plavix may not be receiving any benefit from it nor even be aware of that fact. This can leave them at greater risk for heart disease and blood clots. From now on, the Plavix packaging will contain black box warnings about this so patients can be made aware.

The scale of Plavix sales cannot be overstated. In 2008, only the cholesterol-reducing drug Lipitor sold better. Millions of people use Plavix, and now a significant percentage of them may have to find an alternative. This is not to say that Plavix itself is dangerous, but information is key in treating illness. If doctors and patients are not aware that a medication isn’t working, it can slow down a switch to an alternative treatment that might be more successful. Unfortunately, genetic testing is one of the only ways to check for the trait and can cost up to $500. Doctors have stated that widespread genetic testing for the trait at this time would probably be premature, as the drug does work in over 97 percent of cases. But for those patients who have just learned of the new concerns involving the drug, uncertainties remain.

This incident involving Plavix illustrates the intermediary relationship that consumer advocacy groups, who protect us against dangerous drugs, maintain between consumers and manufacturers. Rather than waiting for harm to be done and lawsuits to be filed, private and public watchdogs bring information to light so that corrections can be made with the least possible disruption to everyone’s lives. Plavix is an effective drug that does a great deal of good. If this warning had not been communicated as early as it was, Plavix might have been caught in a storm of controversy later, and its ability to save lives would be reduced amid the conflict. As ever, information is key to a healthy, functioning society.

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