Even brief explanations help patients make better medication decisions

Many believe the FDA approves only "extremely effective" prescription drugs that have no serious side effects, a study says.

By Tanya Albert Henry — Posted Sept. 23, 2011

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Patients can choose safer, more effective medications if they are told about a drug's harms and benefits and they understand that newer doesn't always mean better when it comes to prescription drugs, a study says.

The study in the Sept. 12 Archives of Internal Medicine involved an Internet-based randomized trial of about 3,000 people. Thirty-nine percent of respondents believed that the Food and Drug Administration approves only "extremely effective" drugs, and 25% believed the FDA approves only drugs without serious side effects (link).

Participants made better choices about medications when they were given explanations about the drugs.

For example, after a 23-word explanation about a drug's benefits and unknowns, 12% more people correctly chose a drug that reduced myocardial infarctions over one known to improve only cholesterol levels. A 37-word explanation about new drug safety led to 19% more people correctly choosing a heartburn drug with a longer track record, the study found.

Consequently, doctors need to be aware of drug benefits and safety when they choose what medication to prescribe, said Steven Woloshin, MD, study co-author and co-director of the VA Outcomes Group for the White River Junction VA Medical Center in Vermont.

"And doctors and patients need to think about using drugs with a track record," said Dr. Woloshin, a professor of medicine at Dartmouth Medical School.

The study noted several examples of drugs that were heavily marketed to consumers when they came on the market and then were found to be ineffective or unsafe. Among the drugs cited was Vioxx, which was pulled from the market after it was discovered that it caused myocardial infarction and strokes.

Dr. Woloshin and his co-author believe "explanations about surrogate outcomes and new drugs should appear prominently in the professional label, patient information and [direct-to-consumer] drug advertisements."

The authors concluded: "If the FDA is serious about improving the state of consumer information about prescription drugs, it needs to do a better job routinely communicating what it knows -- and does not know -- about how well drugs work."

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