FDA changes to the labeling of drugs are rarely a good thing for the companies that make and sell them -- just look at the black-box warning for GlaxoSmithKline's
The FDA announced yesterday that it was updating the labeling of Bristol-Myers Squibb's
The new packaging will now recommend to doctors that patients have a genetic test to determine if they carry variations in two specific genes that would predispose them to bleeding caused by warfarin. As many as one-third of patients may have a genetic variation that causes the drug to be metabolized differently than the general population.
In the immediate future, the change might have a negative effect on sales. Many insurers, such as Aetna
The large variation in the doses needed to give patients safe and effective treatment has probably already discouraged some doctors from prescribing warfarin. Making the genetic test -- and the formulas to determine proper dosage -- widely available will ultimately give doctors greater confidence to prescribe the drug.
One clear winner in the FDA decision is the lab testing companies, including Laboratory Corporation of America
The FDA currently has genetic variation recommendations on four other drugs, including Pfizer's
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Fool contributor Brian Orelli, Ph.D., has genotyped more mice than he cares to discuss, but never any humans. He doesn't own shares of any company mentioned in this article. The Fool's disclosure policy is type AB-, the most rare indeed.