Adverse Drug Reports Skyrocket in Four Years
According to a QuarterWatch report by the Institute for Safe Medication Practices (ISMP), the amount of complaints reported to the Food and Drug Administration (FDA) for serious prescription drug events has increased by 90% over the last four years.
In an investigation looking into why the four year increase occurred, the ISMP reported that the increase stems from three groups:
- Adverse reports for new drugs not commonly used in 2008 accounted for 23% of the growth.
- Drugs seen in all four years accounted for 40% of the growth.
- The remaining 37% were exceptional conditions involving suspicious drugs, such as Chantix and Pradaxa.
FDA Waivers Result in Incomplete Data
More than a decade ago, adverse reports were manually entered into an FDA computer and data storage was expensive. Due to this, the FDA decided to manage the increasing number of adverse event reports by giving waivers to companies allowing them to not report “non-serious” events.
- “Non-serious” events do not involve death, disability, hospitalization, or do not require life-threatening intervention.
- The ISMP reported that this waiver policy is obsolete and creates too many problems.
- Granting waivers, the ISMP reported, means that comparison of drugs can be deceptive due to thousands of non-serious reports not being submitted. Also, many “non-serious” events can be indications of far more serious ones. And finally, manufactures differ in their application of the term “not serious.”
- For example, Abbott Laboratory reported 19,000 non-serious events over four quarters for adalimunab. If Abbott had applied for a waiver, it could have not reported these events.
Problematic Drugs Linked to Adverse Events
In total, the FDA established 57,393 reports that included dangerous drug side effects and problems during the first quarter of 2012, an increase of 23.8% from the previous quarter. ISMP concluded that some of the most problematic adverse events included withdrawal problems linked to Cymbalta, Actos bladder cancer problems, problematic reactions to the blood pressure drug Tekturna, and blood clots linked to Xarelto.
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