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Off-Label Drug Use: What You Need to Know

Prescription drugs are often prescribed for uses other than what the FDA has approved. Find out why.
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Benefits of Off-Label Drug Use continued...

Beta-blockers are another example of beneficial off-label prescribing. Such medications are FDA-approved for the treatment of high blood pressure, but are widely recognized by cardiologists as a standard of care for patients with heart failure. And in fact, some beta blockers are now formally approved to treat heart failure. It's not uncommon for off-label uses to eventually get approved by the FDA.

Other drugs commonly prescribed off-label include tricyclic antidepressants for chronic pain, and antipsychotics for attention deficit hyperactivity disorder (ADHD) "Name the drug, and one can come up with off-label uses," Alexander says.

 

A Risky Practice?

There is debate about off-label drug use. Doctors emphasize that off-label prescribing has its place in medical practice, but they also admit that using a drug off-label can raise the risk of lawsuits should a patient have unwanted or bad side effects.

"Off-label prescribing can expose patients to risky and ineffective treatments," medical ethics professor Rebecca Dresser and Joel Frader, MD, write in the fall 2009 issue of The Journal of Law, Medicine & Ethics.  

Fen-Phen is one of the best examples of off-label use with a poor outcome. The FDA approved medications fenfluramine hydrochloride and phentermine hydrocholoride as individual, short-term treatments for obesity. But doctors eventually began prescribing the two drugs together after an article describing the cocktail's dramatic weight loss effects appeared in a medical journal and numerous mainstream publications.

That off-label drug combination had devastating results: Many patients ended up with severe, and potentially deadly, heart valve damage, an outcome that triggered a multi-billion dollar lawsuit. In 1997, the FDA ordered Fen-Phen off the market.

Although some off-label therapies can be beneficial and even lifesaving for some patients, in most cases, there is little or no scientific evidence to prove they work. In a recent commentary in the Archives of Internal Medicine, three scientists from the National Institutes of Health (NIH) Clinical Center's department of bioethics say that "off-label use has been identified as one aspect of problematic drug prescribing," in part because of inadequate data regarding drug safety and effectiveness for the off-label use.

 

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