University of Minnesota Study Discovers Delay in Reports of Adverse Reactions to FDA

By Staff Writer

A new study from the University of Minnesota uncovered information showing that drug makers have been neglecting their duties when it comes to reporting about adverse reactions to their products. The numbers suggest that drug makers fail to report truthfully in around 10 percent of cases—some of which have resulted in wrongful death.

Pinar Karaca-Mandic (and co-authors) compiled adverse reaction reports that were submitted to the Food and Drug Administration (FDA) from 2004-2014. During this time, 1.6 million adverse reaction reports were submitted to the FDA. Of these, 160,383 missed the 15-day requirement. Furthermore, of the 160,383 events recorded, 40,464 reactions resulted in death.

Current federal regulations state that the following individuals have a legal obligation for reporting defective drugs:

• Health care workers
• Medication manufacturers
• Drug registration holders
• Health care professionals assisting with drug trials

The FDA has strict regulations stating that drug makers are required to report any adverse reaction to a medication within 15 days of the incident; however, it appears that reporting is being delayed in one out of 10 cases. The authors of the study stated that adverse reactions that were bad enough to lead to death were the most likely to be delayed.

JAMA Internal Medicine journal ran the findings of the University of Minnesota study. JAMA’s editor, Rita Redberg, commented that “Such reporting delays should never occur, as they mean that more patients are exposed to potentially avoidable serious harm, including death.”

She also suggested that rather than reporting findings to the manufacturer, physicians who run into adverse reactions should report them directly to the FDA.

What constitutes a serious adverse reaction?

According to the FDA, a serious adverse event associated with a medical product includes:

• Death
• Life-threatening illness/injury (i.e. high risk of death if medication continues)
• Hospitalization (ER visits that don’t lead to hospitalization should be reclassified into one of the other categories)
• Birth defect
• Disability
• Other serious events (these include breathing problems and seizures that don’t lead to hospitalization, as well as drug dependence/abuse)

Get in touch with Gilreath & Associates to schedule a free consultation with one our unsafe drug and pharmaceutical liability attorneys located in Nashville, Knoxville and Memphis if you or a loved one suffered a serious or even fatal side effect from taking an FDA-approved drug.

For more information concerning defective medical products and our other practice areas, browse our blog and knowledge center.

Posted in Uncategorized | No Comments »