Serious drug side effects likely underreported to FDA, study finds

Underreporting prescription drug side effects may be much more common than previously thought, indicated a report released Dec. 4 by the Institute for Safe Medicines Practices. 

Researchers from the institute — a nonprofit organization that acts as a watchdog for prescription drug safety — analyzed five commonly used prescription drugs and found that only a small fraction of adverse reactions patients experienced to those drugs were reported to the FDA. 

The FDA has a database called the FDA Adverse Event Reporting System, or FAERS, which has long been known as an "imperfect" tool for alerting regulators and the medical community about potential problems with drugs, according to STAT

The five drugs included in the study were Boehringer Ingelheim Pharmaceuticals' Mobic, a painkiller, Pfizer's Celebrex, another painkiller, Bristol-Myers Squibb's Eliquis, a blood thinner, AbbVie's Humira, a rheumatoid arthritis treatment, and Janssen Pharmaceuticals' Risperdal, an antipsychotic.

In total, the five drugs caused an estimated 276,000 serious adverse events in patients in 2017 — the most recent year researchers could access enough data — and the researchers found that only 1 percent of those were reported to the FDA's database. 

The authors wrote that the study "emphasize[s] the need for better surveillance of the risk of injury from the therapeutic use of drugs and more aggressive interventions to reduce risk and assure safe use."

The authors noted that their study was limited to data from patients who took the drugs continuously for a year. Many patients only take the drugs for a short time. The authors also noted that many adverse event reports are filed voluntarily, according to STAT

Read the full article here

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