After OTC Shift, Ads Deemphasize Drug Harms

A new study finds that after prescription drugs are made available OTC, their ads downplay adverse effects that may be associated with them.

Direct-to-consumer advertising for prescription medications that have been made available OTC dramatically deemphasizes harm that may result from taking them, according to the results of a study published in the September 12, 2012, edition of the Journal of the American Medical Association. The study looked at ads for 4 widely used medications: the allergy drugs loratadine (Claritin) and cetirizine (Zyrtec), the acid-reflux drug omeprazole (Prilosec), and the weight-loss drug orlistat (Xenical/Alli).

The researchers analyzed all print and television advertising for the medications for the 24 months before and 6 months after they shifted from prescription to OTC—133 ads in all. (Loratadine was made available OTC in 2002, omeprazole in 2004, orlistat in 2007, and cetirizine in 2008.) Each ad was analyzed based on descriptive characteristics, presentation of health benefits (both specific indications and claims regarding general health improvement), and potential health harms (including adverse effects, contraindications, warnings, and precautions).

The results showed that 70% of the ads that ran when the medications were available by prescription only presented potential harms compared with just 11% of the ads that ran after the switch to OTC. In addition, 94% of the ads during the prescription-only period mentioned the medications’ generic names, compared with just 52% of the postswitch ads. (Failure to mention a drug’s generic name deprives consumers of a key tool for seeking information on the risks, benefits, and costs of a medication.)

The explanation for the shift in emphasis is that prescription drug advertising is regulated by the FDA, while OTC drug advertising is regulated by the Federal Trade Commission (FTC). The FDA requires that ads for prescription drugs present a “fair balance” of risks and benefits, while the FTC merely requires that ads not be misleading to “a reasonable consumer.” (This is the same standard applied to all consumer products.)

In an online interview, lead study author Jeremy Greene, MD, PhD, of Brigham and Women’s Hospital in Boston, suggests that possible ways to address the situation highlighted by the study include having the FDA continue to oversee advertising of prescription medications once they become available OTC or having the FTC apply different standards to OTC drug advertising than it does to other products. He notes, however, that the FDA’s “fair balance” standard creates problems of its own as risk and potential side effects are frequently presented in an extended list that threatens to overwhelm consumers with “risk fatigue.”

Nonetheless, Dr. Greene argues that the problem illuminated by the study is an important one, as patients frequently assume that if a medication is available OTC it must be safe. As examples of the hazards of OTC medications, he points to acetaminophen, which has been implicated as a major cause of emergency department visits and liver failure, and ibuprofen, which can cause gastrointestinal bleeding and has been associated with an increased risk of heart disease.