Study Finds Consumers Unclear on FDA Drug Approvals

Navigating the world of prescription drugs can be confusing, and a new study confirms that American consumers are not clear about the safety of approved drugs. The Report appears in the Archives of Internal Medicine.

Reuters Health wrote that, for the most part, consumers believe drugs approved by the U.S. Food and Drug Administration (FDA) are safer and more efficacious because they won agency approval, according to a new study. But, specifically, in the first years following approval, the researchers note that questions remain concerning how a drug acts and if it causes adverse reactions, explained Reuters Health.

For example, said Reuters Health, the FDA-approved the painkiller Vioxx, which was pulled in 2004 after post-approval evidence revealed links to increased heart attack and stroke risks.

The Internet survey of nearly 3,000 U.S. consumers found that 25 percent said they believed that the agency only approves medications without significant side effects, while 39 percent believed that the only drugs that receive approval are “extremely effective,” wrote Reuters Health. In fact, approval is just a matter of proving a drug’s “benefits are judged to be greater than the harms. It doesn’t mean that they’re big and important,” said Dr. Steven Woloshin, a study author from White River Junction VA Medical Center in Vermont, reported Reuters Health.

Survey participants were asked about two situations to see if teaching patients about medication options could change how they choose what drugs are the safest and most effective, said Reuters. In one, patients were to decide between a hypothetical cholesterol drug shown to reduce cholesterol and another that also reduced cholesterol but increased heart attack risk. With everything else being the same, said Reuters Health, choosing the drug with an obvious “bad outcome,” was actually the best option; however, only 59 percent chose that drug. The other choice was between an emerging and an older heartburn drug that worked just as well, but cited the same side effects; 34 percent picked the older drug, according to Reuters Health.

Participants were provided with a short statement that discussed how new is not always the best and that drug researchers do not always have sufficient time to research safety issues. “New often just means we know less about it… because it takes time for a drug to establish its track record,” Woloshin told Reuters Health.

Patients fared better after the statement, with 71 percent opting to take the cholesterol drug with better clinical benefit and 53 percent picking the older, better researched drug, the researchers said. “We were happy that these very simple statements had an effect,” Woloshin told Reuters Health, but noted that an explanation may not always be effective. Woloshin called for a one-page FDA fact sheet to provide benefit and adverse effect information and a statement that “new is not necessarily better.”

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