Should prescription drugs do double duty?

Nervous about giving a big presentation? Your doctor might prescribe a blood pressure drug like generic propranolol to calm you. Can’t sleep? You might leave the doctor’s office with a prescription for generic trazodone, an antidepressant often used for insomnia.

But neither drug is approved by the Food and Drug Administration to solve these problems, according to Consumer Reports. Doctors routinely (and legally) prescribe drugs “off label” – that is, for conditions not approved by the FDA – for any use they see fit. Most don’t tell their patients.

The results of this practice are alarming. A recent analysis in the journal JAMA Internal Medicine revealed that more than 80 percent of off-label prescribing by doctors lacked strong scientific evidence. And patients were 54 percent more likely to experience some kind of harm as a result, compared with those taking the same drug for an approved use.

“Surprisingly, many doctors may not even realize a drug is not approved for the condition they’re prescribing it for,” says Lisa McGiffert, director of Consumer Reports’ Safe Patient Project. “It’s no wonder so many people are harmed.”

Drug companies have been forbidden to promote drugs to consumers (and doctors) for nonFDA-approved uses since 1962. That’s when Congress strengthened the agency’s regulatory power after the thalidomide tragedy, when samples of the unapproved drug were given to pregnant women in the U.S. to treat morning sickness – leading to birth defects.

But FDA rules prohibiting advertising on TV, in magazines and elsewhere for unapproved, off-label uses could soon change. Last November, the agency held a two-day hearing to gather input on whether to give drug and medical-device companies more leeway in promoting off-label use of their products. It was prompted by two recent federal district court rulings that found truthful promoting of off-label use to be a form of protected free speech.

The pharmaceutical industry is lobbying to lift the off-label marketing ban. But a new nationally representative survey of 1,011 adults by Consumer Reports found that 84 percent of people don’t want drug companies to be allowed to advertise drugs for a use that hasn’t been approved by the FDA.

How you can make a difference

When considering new medication, ask your doctor whether it’s been approved for your condition, suggests Consumer Reports Medical Director Orly Avitzur, M.D. “If not, ask why he or she recommends it.” Here are some other tips:

• Go to the National Institutes of Health’s DailyMed website (dailymed. nlm.nih.gov), search for the drug, then click “Indications & Usage” to see whether your condition is listed.

• If it’s an off-label use, ask whether good research supports using it for your condition.

• Find out whether your health insurer covers payment for off-label use. Some may require evidence of effectiveness or failure with conventional treatments, especially if the drug is expensive.

“Always make sure someone has thoroughly explained the risks and benefits of a medication to you, as well as other options,” Avitzur says.

To learn more, visit ConsumerReports.org.