Off-label Prescriptions A Common Practice

May 2006

When the Food and Drug Administration (FDA) approves a drug that does not mean it is safe for every kind of use. But findings show that one in seven prescriptions for common drugs are being used in ways that haven’t been approved by the FDA. A practice by doctors called “off-label” use.

Drug manufacturers get FDA approval for a drug’s specific use, but once the FDA approves a drug, a doctor can prescribe it any way they want. A study using data from the 2001 IMS Health National Disease and Therapeutic Index found:

• 150 million prescriptions for 160 of the most common drugs were for off-label use.
• 15% of the prescriptions were for off-label uses that lacked scientific supported data.
• Off-label prescribing was most common among heart drugs and seizure drugs.
• Off-label prescriptions were least common among drugs used to treat diabetes, pain relievers and cholesterol lowering medications.

Patients taking prescription drugs are advised to ask their doctors if their prescriptions are off-label.

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