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Drug Manufacturers Delaying Reporting Adverse Events Study Finds


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All prescription drugs come with some side effects. Some are relatively minor, such as itching or rashes, while others are severe or life-threatening, such as strokes or even death. When a medication causes an adverse event, manufacturers are required to report the incident within 15 days of discovery. However, a recent study conducted by researchers at the University of Minnesota found that 10% of adverse events were not reported to the Food and Drug Administration (FDA) in a timely manner.  Worse still, it’s estimated that only 2% of adverse events are ever reported.

These delays put patients in harm’s way, as they start using the drug or continue to use the drug not knowing that others may have suffered an injury or serious side effect from the same drug.  The study examined adverse events reported during a 10-year period, ranging from January 2004 to January 2014. There were 1.6 million reports during that time, with 95% of them coming from the drug companies. Just over 10% or 160,383 adverse event reports were received after the 15-day window. Nearly 25% of late reports, involved patient deaths.

Some reports were delayed by more than six months. Of the late reports, 6% were reported within 90 days, 3% took up to 180 days and another 3% were received after six months. While the reasoning could be that manufacturers spend the extra time confirming the cause of death in these cases, delaying these reports for many months could place other patients in harm’s way, or prevent patients from being able to weith the benefits and risks of a drug therapy.

What is an Adverse Event?

An adverse event is an incident that causes a serious medical outcome, even death. What follows is a partial list of types of adverse events that have been reported to the FDA, and associated with the use of a prescription drug:

  • Stroke
  • Heart attack
  • Congestive Heart Failure
  • Cognitive Disability
  • Physical Disability
  • Organ Failure
  • Birth Defect
  • Seizure
  • Breathing Difficulties
  • Death

If you or a loved one has suffered a serious medication side effect, contact the experienced Drug Lawsuit Attorneys of Nadrich & Cohen, LLP. Call 1-800-718-4658 now, for a free consultation.

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