Too Much Drug Safety Information Harms

Ruzanna Harutyunyan's picture

The Wall Street Journal on Tuesday examined how "consumers are receiving a flood of safety information about the drugs they take -- so much that it risks scaring some people." According to the Journal, a recent "series of prescription medication scares" has prompted the media, consumer advocacy groups and FDA to release more information regarding the safety of prescription medications. However, the proliferation of such information "might overwhelm patients and raise undue alarm," according to some medical professionals. The Journal warns that patients "may forget about the benefits of a medication if they focus only on risk," and "the health consequences associated with stopping a medication ... may be far worse than the possibility of a side effect."

According to a Pfizer survey conducted in March of 300 medical professionals, 89% of respondents said they were at least somewhat concerned that patients would stop taking medications if potentially negative safety information was released too early. In addition, a 2008 study by the Kaiser Family Foundation, Harvard School of Public Health and USA Today found that 27% of U.S. residents feel "very confident" in the safety of prescription drugs sold in the U.S. and a little more than half feel that drug companies do enough to test and monitor drug safety. However, drug industry officials say the skepticism regarding drug safety might only be temporary, the Journal reports.

Drug industry experts say that one potential problem is that many patients take "safe" to mean virtually no risk, Timothy Lesar, director of Clinical Pharmacy Services at Albany Medical Center and a member of FDA's drug safety advisory committee, said. He said, "There are no guarantees and there are always risks," adding, "If we're going to take risk, we need to make sure there are benefits here."


Efforts at Clarity

Pharmaceutical companies such as Pfizer, Wyeth and Johnson & Johnson are "ramping up efforts to be more open about drug safety," and FDA also is "taking steps to continue alerting consumers about drug-safety issues while trying not to cause unnecessary worry," the Journal reports. According to FDA drug safety official Paul Seligman, FDA intends to change its early notification letters about drug-safety concerns to list the number of adverse events that have occurred compared with the number of people taking the drug and post such concerns on WebMD.

Seligman said that the effects of providing more safety information are not yet clear, adding that FDA plans to study consumers' reactions and use of safety information. He said, "We're always aware and want to strive to make sure that this (safety) information is provided in a way that outweighs any unintended consequences" (Wang, Wall Street Journal, 12/9).

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