Public Often Unaware of a Drug’s Safety Record — Or Lack of One

By Alan Mozes
HealthDay Reporter

MONDAY, Sept. 12 (HealthDay News) — Many patients mistakenly believe that medications approved by the U.S. Food and Drug Administration are foolproof and free of harmful side effects, a new study finds.

But when informed of safety concerns about a drug, they tend to make a safer choice.

“There are important gaps in what people know about approved drugs, and a lot of misconceptions,” said study co-author Dr. Steven Woloshin, co-director of the Outcomes Group at the VA Medical Center in White River Junction, Vt.

“Until they are given good information, people may be exposing themselves to drugs that may confer less benefit than they think they are getting, or more harm than they think they are being exposed to,” added Woloshin, who is also with the Dartmouth Institute for Health Policy and Clinical Practice in Hanover, N.H.

Far from a foolproof seal of safety and benefit, FDA-approved drugs often run into trouble after they show up in pharmacies and medicine cabinets, he and his colleague Dr. Lisa M. Schwartz report in the Sept. 12 issue of Archives of Internal Medicine.

One driver of this dynamic is the 1992 Prescription Drug User Fee Act (PDUFA), which now mandates that the FDA approve new drugs within 10 months of submission or face funding cuts.

Such fast-tracking can compromise safety, as noted in a study published in the New England Journal of Medicine in March 2008. That investigation revealed that drugs funneled through quickly in order to meet PDUFA deadlines were five times more likely to get taken off the market because of safety issues after winning FDA approval. Such meds are also more likely to need dosage alterations and get slapped with a black-label warning post-FDA approval.

Vioxx, for instance, was yanked from the market in 2004 when concerns arose about potential cardiac side effects six months following FDA-approval, the authors of the current study noted.

Against that backdrop, Woloshin and Schwartz conducted a pair of Internet-based studies involving nearly 3,000 American adults.

At the outset, almost 40 percent said they thought the FDA only approved “extremely effective” drugs, while one-quarter believed FDA approval means no serious side effects.

The first trial involved offering patients two cholesterol drug choices: one shown only to reduce cholesterol, and a second shown to directly lower heart attack risk. The second trial involved two heartburn drugs, a new one, and one in use for eight years.

Participants in each case were divided into three groups, with each group receiving different degrees of information about drug safety and effectiveness.

Those given the most information ultimately made better drug choices, the study found.

About 60 percent of those uninformed about the cholesterol drug options chose the one shown to reduce heart attacks. But that figure rose to 70 percent among those told of the distinctions and among those instructed to ask for the drug shown to affect cardiac risk.

Results were similar in the heartburn drug group. While just one-third of those given no information chose the older drug option, that figure rose to 53 percent among those told that one was old and one was new, and among those informed that less is known about the safety profile of newer drugs.

“So what we have here,” said Woloshin, “is not just a question of focusing people’s attention on the potential harm side of drugs, but also on whether or not a new drug really works. Is there really a benefit here? Is this drug worth it? These are the questions we think patients need to be asking.”

Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group in Washington, D.C., also believes in encouraging consumers to view the medications they’re prescribed with a more critical eye.

“Patients need to be aware that almost any drug has potential side effects,” he said. “And for newly approved drugs there’s often insufficient information about serious risks, some of which may have gone undetected during the approval process and won’t be detected until they’re used in the real-world setting on a wide-scale basis.”

His organization supports a “do-not-use-for-seven-years rule,” Carome said. “Unless a new drug is a breakthrough medication for a condition for which there were no previously good options, we recommend that people not take it for at least seven years.”

Harvard University’s Daniel Carpenter, a professor of government, said “the term ‘FDA-approved’ gives patients a mental and emotional security about a drug.” But it’s possible that people attach too much subconscious trust to this stamp of approval, he added.

“So I’m in sympathy,” he continued, “with the policy recommendation that patients ought to be made aware, for example, that we know less about an FDA-approved drug that has been on the market for a day or a year than we do about drugs that have been on the market for five or 10 years.”

But how to get that message across effectively in real-world practice will need a lot more research, he said.

Writing in the same journal issue, Dr. Deborah Grady, of the department of medicine at the University of California, San Francisco, recommended that the job of selecting the safer, better drug be left to properly trained clinicians.

More information

For more on the FDA drug approval process, visit the U.S. Food and Drug Administration.

SOURCES: Steven Woloshin, M.D., M.S., co-director, Outcomes Group, VA Medical Center, White River Junction, Vt., and Dartmouth Institute for Health Policy and Clinical Practice, Hanover, N.H.; Michael Carome, M.D., deputy director, Public Citizen’s Health Research Group, Washington, D.C.; Daniel Carpenter, Ph.D., Allie S. Freed professor of government, Harvard University, Cambridge, Mass.; Sept. 12, 2011, Archives of Internal Medicine

Last Updated: Sept. 12, 2011