Friday, May 23, 2008 | 2:05 a.m.
The Food and Drug Administration is considering a proposal that would require TV advertisements for prescription drugs to include information on how patients can report any side effects they suffer.
Federal regulations require drug ads to mention the side effects that have been noted in clinical trials of a drug. But a poll by Consumer Reports this year showed that only 35 percent of prescription drug users surveyed were aware that the side effects they suffer can — and should — be reported.
Federal legislation passed last year requires that such information be included in print advertisements for drugs.
In April, Rep. Rosa DeLauro, D-Conn., and Rep. Jan Schakowsky, D-Ill., called on the FDA to come up with a regulation requiring the same for TV ads. Some drugs can bring about serious side effects — such as suicidal thoughts — in some patients, and the FDA needs to know about them, lawmakers said.
Kim Witczak, who founded a patient advocacy group after her husband committed suicide while taking the antidepressant Zoloft, told the Associated Press this week that the number of patients in a drug’s clinical trials is small, but “it’s really when millions of people start taking them that we see side effects that might not have been known to the company.”
The FDA is responsible for tracking the side effects of prescription and over-the-counter medicines after they are approved for the market. But FDA officials have admitted they typically learn about fewer than 1 in 10 side effects, the Los Angeles Times reported in April.
Pharmaceutical companies supported adding the contact information in print ads. The industry has yet to take a position on the proposed regulation for TV ads, the AP reports.
This regulation should be enacted. Patients should have complete information about the medicines being touted in advertisements. That includes not only the benefits that drugs can offer, but also any adverse effects they may cause and whom patients should notify if they do.
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