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A study found that doctors commonly prescribe medications for off-label use, but almost never inform their patients of the fact. Using medications in this manner would not meet with approval from the U.S. Food and Drug Administration (FDA).

All drugs that reach the market have gone through clinical trials in order to determine their efficacy and safety in their intended purpose. Once the FDA feels the medication has met all of its requirements, it then approves the label for the medication. The drug is then used for its intended purpose according to the label.

The term “off-label” means using a medication to treat a problem that it was not originally intended for. It can also refer the use or form of a dosage of the drug that has not been approved by the FDA. A 2006 study found that one in five prescriptions were for off-label use.

Off-label drug use is not without its risks. One of the purposes of testing is to determine safe dosage of a drug for the problem it’s intended to treat. There are no published studies for proper dosage of a medication for off-label use. As a result, a patient could receive a dose that’s too high or too low, which causes more problems. There is also a higher risk of medication error due to lack of knowledge, experiencing side effects and adverse reactions.

While off-label drug use is not illegal in the United States, drug manufacturers are prohibited by law from promoting such uses. A major drug manufacturer recently settled a $3 billion case with the FDA for encouraging doctors to use certain medications off-label.

Source:, “Patients Often Kept in Dark About ‘Off-Label’ Drug Use: Study,” August 8, 2012

Our firm handles similar off-label cases like the ones mentioned in this article. For more information, please visit our whistleblower/qui tam page.