When prescription drugs become available over-the-counter (OTC), their advertising lacks balance, according to new research, which says that benefits are highlighted over risk information.
The study involved an intense review of marketing for four medications that moved from prescription to OTC status and found that a mere 11% of those ads discussed side effects, versus 70% when the drugs were available as prescription only, said Reuters.
“In many, many cases information about risks simply disappeared from the ads once the drugs became over-the-counter,” study lead Dr. Jeremy Greene of Johns Hopkins University in Baltimore, told Reuters. “A commitment to fair balance in drug promotion is clearly lost when a drug moves from prescription-only to over-the-counter status.” The study was published in the Journal of the American Medical Association and was supported by CVS Caremark.
The research involved a sampling of 133 television and print direct-to-consumer ads for Claritin (loratidine), Zyrtec (cetirizine), Xenical/Alli (orlistat), and Prilosec (omeprazole), said Reuters.
The U.S. Food and Drug Administration (FDA) watches over prescription drug ads, requiring those ads to present a so-called “fair balance” of drugs’ risks and benefits, explained Reuters. OTC drug ads are not regulated by the FDA, but by the Federal Trade Commission, which does not have a “fair balance” requirement. Because of this, said Greene, consumers wrongly assume that safety is not of concern when a drug becomes available as an OTC medication.
Although federal law mandates that drug makers must advise consumers about their medications’ harmful or deadly side effects, marketing strategies tend to minimize these harmful effects while playing up a drug’s benefits. As we’ve long written, although drug makers must indicate a drug’s adverse effects on its labeling, drug marketing campaigns often obscure drug side effects.
For example, the popular pain killer, ibuprofen, can cause stomach bleeding ulcers and acetaminophen, the key ingredient in Tylenol, can lead to liver toxicity, Reuters explained. In fact, the pain killer acetaminophen is to blame for most ER poisoning visits in this country, said Greene. “These happen to be two examples of over-the-counter drugs that are rightly placed in the sphere of self-medication,” he said, “yet they certainly demonstrate that just because a drug is over-the-counter it doesn’t mean it’s without risks.”
Last year, similar results were seen in another study published by University of Wisconsin-Madison School of Pharmacy researchers, said Reuters. That study included three drugs that the recent study reviewed; prescription version ads revealed a similar number of benefits and risks. Once the drugs went OTC, benefits outpaced risks a massive five-fold. “Consumers can go into a gas station or a grocery store and buy these drugs without ever talking to a doctor or a pharmacist,” said Adrienne Faerber, who worked on the earlier research. “If they have questions or aren’t aware of the side effects of these drugs, they won’t get the information they need,” Faerber told Reuters.
Greene’s research also turned up another worrisome problem—that generic names are often omitted from OTC ads. “The generic name is a very powerful tool for the patient as a consumer in that it helps tie together scientific information on the drug from different places,” Greene told Reuters Health. “It’s concerning to us that the consumer is left without that information.”
Some 100,000 Americans die every year over complications from prescribed drugs; another 1.5 million people become ill or seriously injured over medication mistakes. These figures are worrisome when considering that, according to a 2010 study on which we previously wrote, 65% of all Americans takes a prescription medication. Even more concerning is that when drugs move to OTC status, marketing requirements become more relaxed and consumers are provided with slanted information on medication risks.