Chicago – The number of serious injuries and deaths reported to the U.S. Food and Drug Administration from drugs 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 report is expected to add momentum to reform the federal government’s monitoring of prescription drugs.
The study said the dramatic rise in “adverse events” reported to the FDA point out myriad problems with the monitoring of drugs before approval and after they are on the market.
Incidents resulting in death or serious injuries such as birth defects, disability and hospitalization were examined.
The report suggested that the FDA and the health care system, including doctors, hospitals and other caregivers, are lacking in their ability to manage medications.
Insulin, for example, was among the top drugs cited for causing disability or other “serious outcomes.” Although reasons for adverse events were not disclosed, the report’s lead author said mismanagement of the medication can cause low blood sugar, which can lead to balance issues, accidents and unconsciousness.
“There is plenty of blame to go around,” said Thomas Moore, the study’s lead author and a senior scientist for drug safety and policy at the Institute for Safe Medication Practices of Huntington Valley, Pa. “This is a direct set of data that shows that the system is failing and it is getting worse. We are in denial about drug safety.”
Reports of serious adverse events jumped to 89,842 in 2005 from 34,966 in 1998. Meanwhile, the number of “fatal adverse drug events” nearly tripled to 15,107 in 2005, from 5,519 in 1998.
Most problem drugs are not those pulled from the market.
The most frequent suspect drugs in death and “serious nonfatal outcomes” were pain narcotics Oxycodone and Fentanyl. “We are not managing some of the familiar drugs well,” Moore said.
The FDA said the increase in reported “adverse events” is not necessarily a bad thing, particularly if doctors and drug companies are making more reports. Underreporting of adverse events has been a problem in the past, the FDA said.
“More reporting to us gives us more information on which to evaluate a drug’s safety once it is on the market,” said FDA spokeswoman Julie Zawisza.
