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Woody Witczak was prescribed a drug called Zoloft to help him sleep. A few months later, Woody committed suicide. His wife learned later that Zoloft was approved to treat depression and anxiety, but not sleep problems. It had been prescribed to Woody “off label.”

Frank Johnson (not his real name) was prescribed ketaconazole to slow his advancing prostate cancer. He has taken it for almost two years and his PSA, the test used to measure prostate cancer, is under control. Ketaconozole is an anti-fungal drug, not a prostate cancer drug. It was prescribed for Frank “off label.”

An off label drug may be prescribed to treat your medical problem even though it is untested and unproven for that use, and has never been approved by the FDA for treating your particular problem. In some cases, like Frank’s, off label drugs work very well and the outcomes are positive. But hearing Woody’s story, we can see that an off label drug prescription does not always work well.

Why would a doctor prescribe a drug off label?

The answer is simple: doctors prescribe the drug they think will help their patients. An off label drug has been approved for use by the FDA – just not for that particular use. There are hundreds of off label drugs that are prescribed and used every day.

As long as your doctor has credible information on which to base his off label recommendation, then that prescription might be a good answer for you. Credible information comes from medical journals, or sometimes from medical peers through conferences or publications of their proceedings.

The problem is, the doctor’s information may not have come from a credible source. Earlier this month, Pfizer Pharmaceuticals was fined $2.3 billion for fraudulent promotion of four drugs for off label use. Doctors thought they were getting credible information from Pfizer about tested uses for those drugs (Bextra, Geodon, Zyvox and Lyrica), but they were not. Patients died before Pfizer was caught.

The bottom line for us patients? We need to question any prescription the doctor gives us. Read the information provided by your pharmacy, go online to look up your drug, or even ask your doctor if your new prescription is off label. Then, if you begin to feel any strange side effects, report them to your doctor immediately.

More information about FDA approvals and off label drugs can be found at my About.com Patient Empowerment website.