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Chrissie Cole
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Reports of Adverse Drug Effects on the Rise

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According to a new study, reports of adverse drug affects reported to the Food and Drug Administration has doubled over the past decade. Deaths associated with serious adverse drug effects also 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.

The study was based on analysis of serious adverse drug events voluntarily reported to the FDA through the Adverse Events Reporting System (AERS), also known as “MedWatch” reports, from 1998 to 2005. A serious adverse drug event is a scenario that results in a birth defect, disability, death, hospitalization, life threatening and lastly needed intervention to avoid harm or further illness associated with certain drugs.

The list of drugs most commonly associated with adverse side effects include: Tylenol (acetaminophen), Paxil (anti-depressant and Celebrex (anti-inflammatory) along with Fentanyl (pain killer.)

The study was released in the September 10th issue of Archives of Internal Medicine.

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

Oxycodone (OxyContin and others)
Fentanyl (Duragesic and others)
Clozapine (Clozaril)
Morphine
Acetaminophen (Tylenol)
Methadone
Infliximab (Remicade)
Interferon beta (Rebif, Betaseron, Avonex)
Risperidone (Risperdal)
Etanercept (Enbrel)
Paclitaxel (Taxol)
Acetaminophen-hydrocodone (Vicodin, Lortab, and others)
Olanzapine (Zyprexa)
Rofecoxib (Vioxx)*
Paroxetine (Paxil)

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

Insulin

Infliximab (Remicade)

Interferon beta (Rebif, Betaseron, Avonex)

Paroxetine (Paxil)

Rofecoxib (Vioxx)*

Warfarin (Coumadin)

Atorvastatin (Lipitor)

Etanercept (Enbrel)

Celecoxib (Celebrex)

Phentermine (Pro-Fast)

Clozapine (Clozaril)

Interferon alfa (Alferon N, Infergen, Intron A, Roferon-A)

Simvastatin (Zocor)

Venlafaxine (Effexor)

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

For more information on this subject, please visit or section on Defective Drug and Product Lawsuits.