Analysis of FDA data shows near-tripling of reported deaths and drug reactions in 7 years

By: LINDSEY TANNER - Associated Press | Wednesday, September 12, 2007 12:29 AM PDT ∞

CHICAGO -- Reports of dangerous side effects and deaths from widely used medicines almost tripled between 1998 and 2005, an analysis of U.S. drug data found.

The number of deaths and serious injuries from prescription and over-the-counter drugs climbed from 34,966 to 89,842 during the study of reports to the Food and Drug Administration.

Potent narcotic painkillers including Oxycontin, sold generically as oxycodone, were among 15 drugs most often linked with deaths in the study. Drugs frequently linked with serious nonfatal complications included insulin, the arthritis drugs Vioxx and Remicade, and the antidepressant Paxil.

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.

The analysis appears in this week's issue of Archives of Internal Medicine. Its authors are Thomas Moore and Michael Cohen of the Institute for Safe Medication Practices, a nonprofit educational group that analyzes drug safety issues; and Dr. Curt Furberg of Wake Forest University School of Medicine.

They analyzed excerpts of reports on serious side effects received by the FDA between January 1998 and December 2005. A total of 467,809 serious complications were found. Reported deaths nearly tripled, rising from 5,519 to 15,107.

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.

The FDA issued a statement saying it is aware of the growing number of reported problems and takes them seriously, but the reason for the increase "is not completely known."

"While some of this has to do with the increasing number of prescriptions, there are clearly other factors responsible for this increase, such as the increase in public attention to drug safety, and use of the Internet to make it easier for the public to submit," Dr. Gerald Dal Pan of the FDA's surveillance and epidemiology office said in the statement.

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."