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Mixed results for 'off-label' drug use

January 13, 2012 12:00:00 AM PST
Off-label drugs are those that are meant for a specific condition but are used to treat another. There can be many benefits, but also potential dangers in using a drug in that manner. Here's what you need to consider if your doctor thinks you may benefit from using an off-label drug.

International opera star Marquita Lister was diagnosed with polymyositis. It attacks the lungs and muscles.

A medical team at National Rehabilitation Hospital in Washington, D.C., came up with an innovative form of therapy, including a drug normally used to treat lymphoma patients.

Doctors took a chance with the off-label drug use, and it paid off.

Lister pulled through. Experts say as many as 1 in 5 prescriptions in the United States is used for something it's not approved for by the Food and Drug Administration (FDA). And it's perfectly legal.

Antipsychotic drugs are often prescribed for dementia. Anxiety drugs are used as sleep aids, and some cancer drugs for eye problems.

Off-label drugs worked for Lister, but they aren't safe in all cases. Studies show some anti-psychotic drugs used to treat elderly patients with dementia did show benefits, but also increased risk of death.

Other studies found a drug used to help patients from bleeding uncontrollably during surgery increased the odds of blood clots when used off-label.

While studies and results may differ on the practice, off-label drugs got Lister back on stage. For her the risk was worth it.

Physicians are allowed to use their own judgment when it comes to off-label drugs, but the FDA bars drug-makers from promoting their products for off-label use.

Because of that, there's a legal battle brewing right now. Manufacturers are fighting it in court, claiming the ban violates First Amendment rights.


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