FDA calls for clearer warnings in drug ads

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Nancy Ferrari

Twenty years ago, you probably wouldn’t have been able to name any of the numerous prescription medications available to you, let alone think to ask your doctor for a particular one by name. Today, the average (even perfectly healthy) consumer is barraged by hundreds, if not thousands, of “direct-to-consumer” advertisements for prescription drugs.

In 1997, the U.S. Food and Drug Administration (FDA) created specific guidelines for broadcast advertising related to prescription drugs. Ever since then, drug companies have taken advantage of this opportunity to promote their medicines for a wide range of conditions — from Alzheimer’s disease to low white blood cell counts due to cancer treatment, not to mention the myriad ads for over-the-counter products.

Glossing over side effects

Direct-to-consumer ads must, by law, include information on a drug’s risks and side effects as well as its benefits. Often, the former comes in the form of a rapidly recited list of potential problems. But because it is difficult if not impossible to cover all potential risks in a brief television spot, these ads must also point consumers to more complete information listed in a print ad or on a website.

This information is usually a lengthy and technical text compiled by the drug companies. Consumers have complained that the information is so unclear and hard to read that they barely bother.

In response, the FDA is now calling for a Drug Facts box that summarizes the most important risks of each drug, using plain English, color schemes and easily readable fonts.

Critics complain that the proposed box could still leave out a lot of valuable information.

Aside from any “black box” warnings and “contraindications” (situations in which a person should definitely not take the drug), the only guideline is that the box must list the “most serious and most common” side effects.

Meanwhile, the American Medical Association is calling for a ban on direct-to-consumer ads for prescription drugs and implantable meidcal devices, saying that they contribute to rising drug costs and patients’ demands for inappropriate treatment.

Don’t pressure your doctor

Informing consumers about new and potentially useful drugs is not necessarily a bad thing. However, a truly informed consumer should not rely solely on direct-to-consumer drug ads before making the decision to try a new one.

Buyer beware: A new medication will undoubtedly be more expensive than older medications that can do the job just as well.

If you see an ad for a drug that you think might help you, or be an improvement over medication you’re already taking, talk with your doctor. Be sure you understand the potential risks and side effects, both short- and long-term (and be aware that these are not as well understood in brand-new drugs).

If your doctor says “no,” be prepared to hear her or him out. No matter how innovative a new drug might be, it may not be the right drug for you. And if you’re still interested after a while, you can always revisit the issue down the road.

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