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Research published in the May 9 Archives of Internal Medicine estimated that 21 percent of the prescriptions written in 2001 in the United States were for drugs that were not deemed to be safe and effective to treat the diseases or symptoms for which they were prescribed.
The study found that in 2001, there were 150 million off-label prescriptions. “Off-label” prescriptions are those prescriptions used to treat conditions other than the ones they are approved to treat by the Food and Drug...
Research published in the May 9 Archives of Internal Medicine estimated that 21 percent of the prescriptions written in 2001 in the United States were for drugs that were not deemed to be safe and effective to treat the diseases or symptoms for which they were prescribed.
The study found that in 2001, there were 150 million off-label prescriptions. “Off-label” prescriptions are those prescriptions used to treat conditions other than the ones they are approved to treat by the Food and Drug Administration (FDA). Most off-label drug mentions (73 percent) had little or no scientific support.
The largest number of prescriptions written for drugs prescribed off-label were heart medications (excluding cholesterol and high blood pressure-lowering drugs), which were prescribed off-label 46 percent of the time. The legal standard for marketing a new drug in the United States requires that there is substantial evidence of the drug’s efficacy. Congress created this standard in 1962 to provide the public with a level of certainty that a new drug will do what its manufacturer claims it will do. Congress delegated the authority for determining substantial evidence to the Food and Drug Administration (FDA).
The FDA-approved uses for a drug are listed in its FDA-approved professional product label in the “Indications and Usage” section.
There is no legal restriction that prevents physicians from prescribing drugs for off-label uses. There is also no legal requirement that physicians inform patients when they prescribe drugs for off-label uses.
In the study, the researchers used nationally representative data available from a market-research firm that documented physician prescribing practices by diagnosis. The researchers examined the overall frequency and clinical circumstances of off-label prescribing for commonly used drugs. The researchers also assessed the strength of the scientific evidence to support the off-label uses: whether the prescribed drug was FDA-approved, whether it was prescribed off-label with strong scientific support or with little or no scientific support.
In 2001, the researchers estimated that there were 150 million off-label prescriptions, or 21 percent of overall prescription use in the United States, among the sampled drugs.
While heart medications ranked highest for the total number of prescriptions for off-label use, gabapentin (NEURONTIN, 83 percent) and the antidepressant amitriptyline hydrochloride (ELAVIL, 81 percent) had the greatest proportion of off-label use among specific medications.
The authors of the study were from the Dartmouth Medical School, Massachusetts Institute of Technology, and Stanford Prevention Research Center. They concluded:
“Off-label medication use is common in outpatient care, and most occurs without scientific support. Efforts should be made to scrutinize under-evaluated off-label prescribing that compromises patient safety or represents wasteful medication use.”
What You Can Do
You can determine if you have been prescribed a drug for an off-label use by checking the drug’s professional product label. If you have been prescribed a drug for an off-label use, ask your physician about the science supporting the use of the drug and ask if a drug that is approved for that use could be substituted.
