OTC Drugs Bear Fewer Warnings than Their Prescription Predecessors

Generally, when a prescription drug becomes available over the counter (OTC), it’s a good thing—it’s less expensive and available more quickly. But as a recent report on MedPage Today explains, often, something gets lost in the translation from Rx to OTC. And that loss has the real potential to harm patients.

Advertising for the newly prescription-free drug is much less likely to warn about potential risks, according to research published in the Journal of the American Medical Association (JAMA).

In the study, 7 in 10 ads for four prescription medications explained the drugs’ potential harms; only 11 in 100 ads for the same four drugs did so once they became available without a prescription.

As the study authors wrote, "Pharmaceuticals do not lose their capacity for harm after moving from behind the pharmacist's counter to in front of it. Closer attention should be paid to how such drugs are promoted to consumers."

Regulatory oversight for prescription medicine, including advertising claims, is the responsibility of the FDA. When the same drugs move to over-the-counter status, that oversight shifts to the Federal Trade Commission (FTC). Those agencies have different standards when it comes to product promotion.

The FDA requires that ads contain a "fair balance" of risks and benefits; the FTC demands only for a "reasonable consumer" standard of truthfulness. That excuses manufacturers—and their advertising copywriters—from explicitly describing both harms and benefits. So guess what? The promo balance tilts noticeably to the benefits side of things.

The researchers studied at all print and broadcast ads from four commonly used drugs that moved from prescription to OTC status: the antihistamine loratadine (Claritin); the gastroesophageal reflux medicine omeprazole (Prilosec); the weight-loss medicine orlistat (Alli); and the antihistamine cetirizine (Zyrtec).

They analyzed advertising that ran two years before and six months after the drugs achieved OTC status. Once they were available over the counter, nearly 100 percent of the ads described the drugs’ benefits, versus slightly more than 8 in 10 when they available only by prescription.

So the gap in mentioning potential harms—from 7 in 10 prescription drugs to 11 in 100 OTC—was huge. Except for print ads for orlistat, the researchers said, no OTC ads mentioned contraindications or adverse effects.

And if someone wanted to research drug effects, his or her ability to get complete information is complicated by the fact that the OTC drug information was less likely to mention the generic names. As the researchers wrote, those are "key tools for consumers seeking independent information on risks, benefits, and costs."

The small sample of only four products might not represent how all prescription-to-OTC drugs are described in their promotional efforts. The researchers note that even the FDA’s direct-to-consumer advertising regulations "do not necessarily result in balanced presentations of risks and benefits, and these guidelines are known to be inconsistently enforced."

Couple that with the less-information-is-more-sales behavior of Big Pharma, and the researchers conclude that patients get "even less information for making an informed decision, at a time when [they] must have more knowledge of whether their medications' potential benefits are worth their risks and costs."

To learn more about the risks of drug treatment, whether by prescription or over-the-counter medicine, see our backgrounder about medication errors.


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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