Report Underscores Dangers of Medicines

A recent study reported in the Archives of Internal Medicine has concluded that reports to the Food and Drug Administration of dangerous side effects and deaths from widely used medicines almost tripled between 1998 and 2005. The number of deaths and serious injuries from prescription and over-the-counter drugs climbed from 34,966 to 89,842 during the time period.
Powerful narcotic painkillers such as Oxycontin, were among 15 drugs most often linked with deaths in the study. Other drugs such as insulin, the arthritis drugs Vioxx and Remicade, and the antidepressant Paxil were frequently linked to serious nonfatal complications.
The report adds to recent criticism of FDA oversight on drug safety, including its handling of serious problems connected with Vioxx, which was removed from the market in 2004. “This growing toll of serious injury shows that the existing system is not adequately protecting patients and underscores the importance of recent reports urging far-reaching legislative, policy and institutional changes,” the authors said.
A disproportionate number of complications occurred in elderly patients. Women were more often victims than men, 55.5 percent compared to 45.5 percent. Children were involved in 7.4 percent of the problems.
Sen. Charles Grassley, an Iowa Republican and frequent FDA critic, said the report is another indication that the FDA’s review of drugs already on the market “must be rigorous and timely.”