The FDA is being criticized today for approving for sale prescription drugs that eventually led to a doubling of patient injuries from 1998 to 2005. Thomas Moore and colleagues at the Institute for Safe Medication Practices in Huntingdon Valley, Pennsylvania released a study in Archives of Internal Medicine involving patient deaths and injuries from taking prescription drugs.
The number of serious injuries and deaths from drugs reported to the U.S. Food and Drug Administration more than doubled between 1998 and 2005, according to a report in Monday’s Archives of Internal Medicine published by the American Medical Association.
The study revealed that deaths from taking prescription drugs increased 300 percent.
Serious adverse event reports jumped to 89,842 in 2005 from 34,966 in 1998. Meanwhile, the number of “fatal adverse drug events” increased nearly threefold to 15,107 in 2005 from 5,519 in 1998.
“The overall relative increase was four times faster than the growth in total U.S. outpatient prescriptions, which grew in the same period from 2.7 billion to 3.8 billion,” the authors wrote.
Pain medication and immune system drugs accounted for the largest number of deaths.
“Contrary to our expectations, drugs related to safety withdrawals were a modest share of all reported events and declined in importance over time,” the authors wrote. “Among the most frequently reported drugs associated with fatal events, we observed a disproportionate contribution of pain medications and drugs that modify the immune system.”
What were the top drugs for injury or death?
A total of 1,489 drug products were named in adverse event reports, but 298 drugs accounted for 87.1% of reported events.
Source: Moore TJ “Serious Adverse Drug Events Reported to the Food and Drug Administration, 1998-2005” Arch Intern Med 2007; 167:1752-1759