Study Says Drug Companies Often Do Not Report Serious Side Effects

The FDA relies on reporting by drug manufacturers and other entities, including physicians, medical facilities, and even individual consumers, to report adverse effects of drugs; thus, if a side-effect goes unreported, the agency is unable to take action against unsafe medications.

“Strikingly, AEs [adverse events] with patient death were more likely to be delayed”, the authors wrote.

Drug manufacturers, under U.S. regulations, are required to notify the FDA when it becomes aware of serious complications associated with disabilities, birth defects, deaths, hospitalizations and any previously unknown side effects, faster than minor complications already highlighted on the drug label.

A spokesperson for PhRMA, an organization that represents the pharmaceutical industry, said, “Patient safety is the highest priority for biopharmaceutical companies, which diligently submit hundreds of thousands of safety reports to the FDA every year”.

In an editor’s note, Rita F. Redberg, MS, MSc, editor of JAMA Internal Medicine, suggested that the FDA should consider revoking a drug’s approval or suspending sales for companies that do not comply with the regulations regarding reporting of adverse events.

Of those, 40,000 deaths were reported late including nearly 12,000 deaths that manufacturers finally reported to the FDA one year after learning of them.

Dr. Pinar Karaca-Mandic, from the University of Minnesota School of Public Health, Minneapolis, and coauthors examined data from the FDA Adverse Event Reporting System for adverse event reports received from January 2004 through June 2014. “Physicians and their patients must be knowledgeable of benefits, harms and alternatives for a wide choice of treatments, especially those recently approved for which clinical experience is limited”. “For example, among events that involved a patient death, about 6 percent were reported within 16 to 90 days, about 3 percent within 91 to 180 days, and about 3 percent were delayed more than 180 days”. However, serious adverse events resulting in a patient being admitted to the hospital, or causing a congenital anomaly in offspring, must be reported to the FDA.

Massachusetts said the reasons behind the holdup need to be studied more. They found that for 36 of the studies, or 63 percent, patient consent forms didn’t include these warnings.

“Our findings are likely an underestimate of overall under-reporting or misreporting, given the anecdotal evidence of FDA warning letters to manufacturers alleging downward misclassification of serious AEs”.