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Reports of Adverse Drug Effects Up

Increase Is ‘Cause for Alarm,’ Researchers Say
By
WebMD Health News
Reviewed by Louise Chang, MD

Reports of adverse drug effects reported to the U.S. Food and Drug Administration (FDA) more than doubled in the last decade, according to a new study. Deaths associated with the serious effects 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 "hit list" of drugs often associated with adverse side effects includes the over-the-counter pain reliever acetaminophen (Tylenol) as well as insulin, the antidepressant paroxetine (Paxil), the anti-inflammatory drug celecoxib (Celebrex), and the painkiller fentanyl.

The report is published in the Sept. 10 issue of the Archives of Internal Medicine.

In all, 467,809 serious adverse events were reported during the years 1998 to 2005. But annually, the number of reports rose 2.6-fold from the years 1998 to 2005, Moore found. In 1998, 34,966 adverse events were reported, but by 2005, the number had grown to 89,842.

Fatalities from adverse drug events rose from 5,519 in 1998 to 15,107, a 2.7-fold increase.

The Drug List

On the list of drugs most commonly identified in fatal events:

  1. Oxycodone (OxyContin and others)
  2. Fentanyl (Duragesic and others)
  3. Clozapine (Clozaril)
  4. Morphine
  5. Acetaminophen (Tylenol)
  6. Methadone
  7. Infliximab (Remicade)
  8. Interferon beta (Rebif, Betaseron, Avonex)
  9. Risperidone (Risperdal)
  10. Etanercept (Enbrel)
  11. Paclitaxel (Taxol)
  12. Acetaminophen-hydrocodone (Vicodin, Lortab, and others)
  13. Olanzapine (Zyprexa)
  14. Rofecoxib (Vioxx)*
  15. Paroxetine (Paxil)

Drugs on the list of those most commonly identified in disability or serious outcomes:

  1. Estrogens
  2. Insulin
  3. Infliximab (Remicade)
  4. Interferon beta (Rebif, Betaseron, Avonex)
  5. Paroxetine (Paxil)
  6. Rofecoxib (Vioxx)*
  7. Warfarin (Coumadin)
  8. Atorvastatin (Lipitor)
  9. Etanercept (Enbrel)
  10. Celecoxib (Celebrex)
  11. Phentermine (Pro-Fast)
  12. Clozapine (Clozaril)
  13. Interferon alfa (Alferon N, Infergen, Intron A, Roferon-A)
  14. Simvastatin (Zocor)
  15. Venlafaxine (Effexor)

* This drug is no longer available in the U.S.

What the Numbers Mean

"We are losing substantial amounts of ground in protecting people against serious injury and death from prescription drugs," Moore says. The rise in reports, he says, can't be explained by the fact that doctors are more willing to report adverse events under the voluntary reporting system.

Nor can the increase be explained totally by the rise in prescriptions, Moore says. The overall relative increase in adverse events was four times more than the growth of outpatient prescriptions, he says.

"About 25% of the change [in numbers of reports] is explained by more drug prescriptions to a growing, aging population." As expected, the number of adverse drug effects was higher in older people than younger ones. While people 65 and older account for 12.6% of the total U.S. population, they accounted for 33.6% of the reported adverse drug effects, Moore says.

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