Like most Americans, you probably assume that if your doctor writes a prescription for you, the drug is approved by the U.S. Food and Drug Administration for your specific condition or aliment. But quite often, that's not the case. According to recent research, about one in five prescriptions are written "off label," that is, for conditions other than the ones for which they received FDA approval. The term stems from a drug's "labeling,"—detailed written descriptions of its intended use, safety, and efficacy based on studies submitted to the FDA by its manufacturer—that all prescription drugs must have to be marketed in the U.S.

Off-label prescribing is not restricted by law, and often is beneficial. Your doctor can prescribe any drug he or she thinks is most appropriate for your treatment. But while some drugs have solid scientific evidence to support their off-label use, the majority of them do not. For those reasons, we will regularly report on drugs prescribed off-label. Our aim with this series is to highlight common off-label uses, evaluate the available clinical evidence and safety information for those uses, and make recommendations to help you decide whether or not the off-label use is warranted and right for you.

Although many doctors regularly discuss off-label drug use with their patients, your doctor is not obligated to do so. Ask your doctor when a prescription is written if the drug has been approved by the FDA to treat your condition. If the answer is "no," ask why he or she thinks it will work better than a drug that's already been approved for your condition. Also ask about the evidence that supports its use in your case and about the alternatives.

There is another reason to be wary of drugs prescribed off-label: they can mean big business for pharmaceutical manufacturers. A recently passed FDA rule allows manufacturers to promote the off-label use of their drugs directly to doctors. The companies earn money from the additional sales of drugs used for reasons other than the approved one. They also save millions of dollars by avoiding the requisite application to the FDA with the documentation (clinical studies) needed to prove that a drug is safe and effective for a second (or third) condition or for a new group of patients, like children. One result is that there is often minimal clinical evidence to support a drug's off-label use, even if it is routinely prescribed that way.

We encourage you to read this information offered without charge. Print it out to discuss with your doctor. Decisions about your health are a matter of personal values, your health needs, and your doctor's input and medical expertise.

Our effort is supported by two groups: the American Society of Health-System Pharmacists, which provides detailed, scientific reports and analysis of the available evidence for each drug topic we cover, and, the Attorneys General, which provided a sizable grant to help develop and distribute this critical information.

We hope you find these articles useful. If you have questions or would like to tell us about your experience with one of these medications, please contact us by e-mail at: drugeditor@consumer.org.

As an example, here is a list of drugs commonly prescribed off label.