Top 5 “off-label” uses for common prescription medications

In the United States, prescription medications come onto the market with very specific instructions for use; however, there is something in medical practice known as “off-label use,” and this practice is commonplace around the country.

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Off-label use is defined by the American Cancer Society as administration of a medication for a different disease or medical condition than which it was approved; administration of a medication at a different dose than approved; and/or administration of a medication through a different route other than was approved.

And while this sounds like it could be risky–and is, indeed, at times–off-label drug use is legal in the United States with the exception of controlled substances. In fact, up to 20 percent of all prescriptions in the country are given with off-label instructions.

So what are some of the prescription medications used “off label?”

You might be surprised what they are and what they are used for.

• Singulair: Take this medication for asthma or allergies? While that was the intended purpose for this prescription when it hit the market, Discovery reports doctors are also using Singulair for treatment of chronic obstructive pulmonary disease (COPD) and atopic dermatitis in children. These off-label uses are common despite the  fact Singulair comes with warnings or psychosis risks among those taking it and has little data behind it to support the off-label uses.
• Botox: Botox is known as a substance used in cosmetic surgery, but the injection was originally approved to treat wrinkles and excessive underarm sweating, though in 2010, it gained approval to treat stroke-induced muscle spasms in the arms and hands. Since then, however, Botox has been used to treat headaches, muscle stiffness and juvenile cerebral palsy off-label. These uses were marketed by the manufacturer despite not having approval, which led to a multimillion dollar settlement in court for false advertising. Botox remains only approved for its original purposes, though the latest research suggests it may have implications for treatment of depression.
• Adderall: Most individuals who are familiar with attention-deficit or hyperactivity disorders in children have heard of the medication Adderall. This prescription medication is considered highly effective for it’s intended use, but one of its common side-effects has gained it some off-label attention. Adderall often causes children to lose weight, and with childhood obesity a major concern in the country, doctors have started dispensing the drug to overweight children who have no attention or hyperactivity disorders.
• Topamax: Topamax is a headache and anti-seizure medication approved by the FDA only for those uses. Nearly 13 percent of people who take Topamax experience vision issues, one of the many undesirable side-effects of this prescription. Despite the known risks, Topamax is commonly used off-label for mood stabilization, treatment of alcoholism, weight loss, and pain management.
• Warfarin: Approved by the FDA as a treatment for blood clots, Warfarin is one of the most common medications prescribed to seniors. Unfortunately, it is also one of the top medication-related reasons older patients visit emergency rooms. When taken incorrectly, Warfarin can cause life-threatening bleeding conditions. Though it has saved thousands of lives, the off-label use for Warfarin is increasing, especially when it comes to treatment of high blood pressure.

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So, should we be wary of off-label medication use?

The answer is ‘yes,’ but all medication comes with a risk, even when used for its intended purpose. There are a number of medications that are used off-label successfully with proven research behind these “extra” uses. In these situations, off-label use is only off-label because of the money it costs a drug company to gain FDA approval for additional conditions.

If you are concerned with the off-label use of a medication you have been prescribed, call the drug manufacturer and ask for the data resources supporting the use for which it has been prescribed. In some situations the company may refuse, for legal reasons, to comment, but may be able to direct you to a university or research facility that can answer your questions.