Pfizer settlement: Be wary of off-label drug use

The record $2.3 billion that pharmaceutical giant Pfizer agreed to pay Tuesday for illegally promoting several of its drugs should serve as a warning to consumers to be very skeptical of drug ads and to watch out for doctors prescribing drugs for conditions for which they are not approved.

In a settlement with the U.S. Department of Justice, Pfizer pled guilty to a criminal charge and agreed to pay the fine for illegally promoting four drugs—Bextra, an anti-inflammatory drug; Geodon, an antipsychotic; Zyvox, an antibiotic; and Lyrica, an anti-seizure medication—for uses that had not been approved by the Food and Drug Administration.

While it’s illegal for pharmaceutical makers to promote their medications for uses that haven’t been FDA approved, it’s common and perfectly legal for doctors to do so. This practice is called off-label drug prescribing and in some cases, it can be beneficial because there may be evidence that the drug works well for treating a condition for which it has not received FDA approval. But in most cases, the evidence to support the off-label use is lacking.

Our Recommendations: When you’re given a prescription, ask your doctor if the drug has been approved by the FDA to treat your condition. If the answer is "no," ask why he or she thinks it will work better than a drug that's already been approved for your condition. Also ask about the evidence that supports its use in your case and about the alternatives.

Our Best Buy Drugs project regularly covers off-label drug prescribing. Find out which drugs are commonly prescribed off-label and see if we have a Best Buy Drugs report for drugs to treat your condition.

—Steve Mitchell, associate editor, Consumer Reports Best Buy Drugs