What is off-label drug use?

In the United States before a drug is approved by the Food and Drug Administration (FDA), it must undergo extensive testing. These tests, known as clinical trials, are used to determine if a drug safely works the way it is expected, to treat a specific medical condition. Once the FDA is satisfied that the drug works and is safe, a “drug label” is created.

This drug label isn’t the actual label placed on the bottle, but one that that is made available to all health professionals who sell or prescribe the medication. It indicates how a drug is to be given, including dosing information and the medical conditions for which it was approved. When a drug is used in a way that is different from that described in the FDA-approved drug label, it’s said to be an “off-label” use. This may involve differences in dosage, the medical condition the drug is used to treat, or how it is given (route.)

Legal Concerns

Aside from some controlled substances, doctors may legally prescribe drugs in a manner inconsistent with the drug label. However, there are rules prohibiting drugmakers from marketing their drugs to treat conditions not approved by the FDA.

Recent federal and state lawsuits claimed that pharmaceutical company Abbott Laboratories marketed its drug, Depakote, for off-label uses. Depakote, an anti-seizure and mood-stabilizing drug, is approved by the FDA to treat epilepsy, bipolar disorder and to prevent migraines. Earlier this year, Abbott said it will pay $1.6 billion to settle allegations that it improperly marketed the powerful neurological medication for off-label uses. Depakote has also been linked to serious birth defects when taken by pregnant women.

The FDA has ramped up its investigation of off-label drug marketing, resulting in enormous settlements from drug makers.

  • GlaxoSmithKline paid $3 billion to settle civil and criminal charges for illegal marketing of diabetes drug Avandia and others, including Paxil, Wellbutrin, Advair, Lamictal and Zofran
  • Pfizer Inc. paid $2.3 billion for similar allegations about its painkiller Bextra
  • Eli Lilly & Co. settled for $1.4 billion for Zyprexa, used to treat schizophrenia.

What this means to you

When your doctor prescribes a medication, be sure to ask if the treatment is consistent with the drug label.  If it isn’t, find out about the risks and benefits, if there is evidence to support the drug’s off-label use to treat your medical condition, and if off-label use will affect your insurance coverage.

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