Reports of Adverse Drug Effects Up

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Reports of adverse drug effects reported to the U.S. Food and DrugAdministration (FDA) more than doubled in the last decade, according to a newstudy. Deaths associated with the serious effects also more than doubled.

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

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

The “hit list” of drugs often associated with adverse side effectsincludes the over-the-counter pain reliever acetaminophen (Tylenol) as well asinsulin, the antidepressant paroxetine (Paxil), the anti-inflammatory drugcelecoxib (Celebrex), and the painkiller fentanyl.

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

In all, 467,809 serious adverse events were reported during the years 1998to 2005. But annually, the number of reports rose 2.6-fold from the years 1998to 2005, Moore found. In 1998, 34,966 adverse events were reported, but by2005, the number had grown to 89,842.

Fatalities from adverse drug events rose from 5,519 in 1998 to 15,107, a2.7-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 seriousoutcomes:

  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 peopleagainst serious injury and death from prescription drugs,” Moore says. Therise in reports, he says, can’t be explained by the fact that doctors are morewilling 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 morethan the growth of outpatient prescriptions, he says.

“About 25% of the change [in numbers of reports] is explained by moredrug prescriptions to a growing, aging population.” As expected, thenumber 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, theyaccounted for 33.6% of the reported adverse drug effects, Moore says.

Children under age 18 accounted for 7.4% of the serious adverse effects, hesays, although they make up 25.8% of the population.

Biotechnology drugs, a whole new kind of drugs and products created bygenetic engineering, is another reason for the increase, Moore tells WebMD. Anexample is Remicade, prescribed for rheumatoid arthritis and other problems,which is on the list of drugs that commonly cause adverse effects, includingdeath.

“Painkillers have always been a problem, especially the opioids, but itseems to be getting worse,” Moore says. “They are being used more.”Fentanyl patches, for instance, made the list of common offenders, and Mooresay they are “hugely powerful and very addictive.”

Other Experts Weigh In

Another expert on medication safety agrees that the new report is cause forconcern. And the numbers reported in the recent study are probably “the tipof the iceberg,” says David W. Bates, MD, director of the Center ofExcellence for Patient Safety Research and Practice at Brigham and Women’sHospital in Boston and professor of medicine at Harvard Medical School inBoston. Many more adverse drug events, he suspects, go unreported.

Consumers may avoid problems, he says, by taking advantage of pharmacistconsults about drugs and knowing the potential side effects. “There is someevidence that if patients know about the possible adverse effects, they areless likely to have a problem,” Bates says.

“If I were taking any of the drugs on that list, I would indeed learn asignificant amount about their adverse effects,” Moore tells WebMD.”Consumers need information. They really need to know more about the drugsthey take.”

Moore says the FDA also needs to have much more authority to govern drugsafety.

Copyright 2020 Nexstar Broadcasting, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

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