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Reports of Adverse Drug Effects Have Doubled Over the Last Decade

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Adverse drug effects reported to the FDA over the last decade have more than doubled, according to a new study. Deaths associated with adverse effects have also more than doubled.

“A change of this magnitude ought to be cause for alarm,” says Thomas J. Moore, senior scientist, drug safety and policy, for the Institute for Safe Medication Practices in Huntingdon Valley, Pa., and the lead author of the study.

Moore and his colleagues analyzed serious adverse drug events voluntarily reported to the FDA though the Adverse Events Reporting System (AERS), known as the “MedWatch” reports, from 1998 to 2005. A serious adverse drug event is defined as one that results in death, a birth defect, disability, hospitalization, was life-threatening, or needed intervention to avoid harm.

The most common drugs found to be associated with adverse side effects include insulin, Tylenol (over-the-counter pain reliever), Paxil (anti-depressant) and Celebrex (anti-inflammatory) along with the painkiller Fentanyl.

The new study was published in the September 10, 2007 issue of the Archives of Internal Medicine.

In total, 467,809 serious events were reported during 1998 to 2005. However, annually the numbers increased 2.6 from the years 1008 to 2005. In 1998, 34,996 adverse events were reported but by 2005, the number had increased to 89,842.

Adverse drug event fatalities increased from 5,510 to 15,107 – a 2.7 increase.

View the list of drugs identified in fatal events.

For more information on this topic, please refer to our section on FDA Drugs.