SERIOUS SIDE EFFECTS NOT MENTIONED ON DRUG LABELS UP 87% SINCE 1998

MARCY E. MULLINS, USA TODAY The Food and Drug Administration received 2 and 1/2 times more reports of serious health problems linked to medication in 2005 than it did in 1998, a study reports. . . Reports of serious problems grew four times faster than the total number of U.S. outpatient prescriptions, the authors write in the Archives of Internal Medicine. Such medication-related health problems account for an estimated 3% to 6% of hospital admissions, they write.

"The overall message is that the drug-safety evaluation system is not working," says co-author Curt Furberg, a medical epidemiologist at Wake Forest University in Winston-Salem, N.C., and former member of the FDA's drug safety and risk management advisory panel. "Harmful drugs are getting into the marketplace."

Another possible explanation: Doctors and patients simply have become more likely to submit the voluntary adverse-event reports, especially in light of high-profile safety withdrawals and lawsuits, the study's authors write. But if that were true, they say, reports would have increased for all medications, which was not the case. . .

In addition, reports of serious reactions not mentioned on a label represented 87% of the increase from 1998 to 2005, the authors write.