Rare Disease Report

FDA Making it Easier to Check on Drug Safety Profiles

SEPTEMBER 28, 2017
James Radke
Today, the U.S. Food and Drug Administration (FDA) launched a web-based search tool that patients, caregivers, researchers, and clinicians can use to access data on adverse events associated with FDA approved drugs, including orphan drugs.

The FDA’s Adverse Event Reporting System (FAERS) dashboard allows users to search for and organize data by criteria like drugs, patient age, type of adverse event, year the adverse event occurred, etc. The FDA hopes the increased transparency will spur the submission of more detailed and complete reports from consumers, health care professionals and others.

Per the FDA: "Tools like the FDA Adverse Event Reporting System are critical to the FDA’s ability to help ensure the greatest level of transparency and help patients and providers make safe use of drug and biologic products after they are approved by the FDA," said FDA Commissioner Scott Gottlieb, M.D. "The FDA is committed to fully informing patients and providers of adverse events reported with medical products and this enhanced portal now provides patients, doctors and others with easier access to the data they are interested in."

For example, a search of Fabrazyme to treat Fabry disease brought up 4530 adverse events, of which 1757 were administrative site reactions.

Figure: Fabrazyme Adverse Events 

Even recently approved drugs can be examined. The recently approved Spinraza for spinal muscular atrophy has 303 adverse events listed for the year.

Figure: Spinraza Adverse Events

"Our focus on safety extends beyond approval," said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. "In fact, our staff spends a lot of time looking at FAERS reports received regarding approved drug and biologic products and these reports can be very valuable components of our safety assessments. By giving people a better understanding of these data, and the associated limitations, we hope the new interface will encourage people to submit more complete reports."

To see how your drug fairs in its safety profile, be sure to check out the FAERS site.

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