Off-label Drugs Not Researched for Safety

Beth Janicek

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There is a recent study which has identified 14 drugs which needed the most pressing research into off-label use. The study says that physicians and patients should be most concerned about the antidepressants and the antipsychotic drugs on the list. The FDA only requires that the drug companies test the drugs for the use that they are seeking approval. For example on the list is Seroquel which has been approved by the FDA to treat schizophrenia and short term episodes of bipolar disease but the drug is more commonly prescribed as maintenance therapy for bipolar disease and yet there has not been ample research by the drug company for the FDA to approve the drug for this purpose. Therefore, it has not been proven to be safe for this treatment or effective.

Once a drug is approved by the FDA then according to PLoS Medicine, industry-paid "nationally known, influential academic physicians" help create "buzz" about off-label uses by writing about them for publication or presentation at scientific meetings.

This is of concern because many of these drugs have serious side effects. For example, Seroquel had added to its label the risk of diabetes and hyperglycemia. There may be other safety risks with these drugs that are unknown because there has not been sufficient testing.

Off-label use is legal and accounts for roughly half of all prescriptions written. I think the most important part is that patients need to be made aware that the drug they are being prescribed is for an off-label use so that they can make an informed decision on whether they want to use the drug. In a recent article in PLoS Medicine, the authors argued that the doctors had an ethical duty and an extension of informed consent to tell the patients about the off-label use. I could not agree more!