February 4, 2015 — The Institute for Safe Medication Practices (ISMP), a non-profit consumer advocacy group, has published a study (PDF) with concerning evidence that major drug-makers are not submitting complete information about drug side effects to the FDA.

The FDA uses a system of voluntary adverse event reports by patients and doctors to track medication side effects. Drug-makers are required to notify the FDA about adverse events they receive, but the ISMP says the reports are often lacking valuable information the FDA needs to monitor drug safety.

For example, Gilead’s blockbuster Hepatitis C treatment Sovaldi had basic information in only 39% of the adverse-event reports submitted to the FDA in the first quarter of 2014. In comparison, a competing medication, Incivek, had “reasonably complete” information in 71% of reports for the same time.

Overall, the ISMP found that 36% of reports did not include the patient’s age, 44% had no event date, and 50% of serious reports submitted by manufacturers did not contain age, gender, and an event date.

According to the ISMP:

“To interact with a consumer or health professional about a serious adverse drug event without getting the patient’s age in 36% of the cases signals inadequate quality control and weak systems.”

Reports collected by the FDA itself met basic standards in 85% of cases. Conclusions were based on nearly 850,000 case reports received by the FDA in the year before March 2014.

The ISMP is recommending that the FDA’s adverse event reporting system (FAERS) “badly needs a thorough overhaul, if not a comprehensive redesign.” The investigators warned about serious gaps in adverse event reporting in children, generic medications, and birth defects.


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