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New Study Finds Risk in Off Label Use of Drugs

In the United States physicians are permitted to prescribe medications to patients to treat conditions that are not specifically listed in the label, or product insert, for that medication. All medication labels must be approved by the FDA, and those labels list the conditions and diseases that FDA believes the drug is safe and effective in treating. If a physician uses a drug to treat a condition NOT listed in the label this use in called off-label use. There is less scientific evidence to support non-approved uses.

In a study released last week and reported on in the New York Times physicians could identify the approved use for drugs they regularly prescribed only half the time. In other words, the physicians that took part in the study could not correctly identify the FDA approved uses for half the drugs they were asked about. The study reported that the greatest confusion surrounded the approved uses of psychiatric drugs.

The lead author of the study said that off-label uses often did not have the same level of scientific scrutiny as FDA approved uses.

As consumers of medical care and services, we should be advocates for ourselves. When a doctor prescribes a medication for you that you havent taken before, ask him to go through the label with you. Ask about the possible side effects, and if there any special instructions concerning the medication. Ask him or her if the drug has been approved by the FDA to treat your condition, and if not, ask why he or she thinks the drug is right for you.