Reader Poll: What's Your Opinion of FDA Watch Lists?

April 14, 2016

In the second quarter of 2015, the US Food and Drug Administration (FDA) identified stroke and thromboembolic events as a "potential signal of a serious risk" for seven SGLT-2 inhibitors through its FDA Adverse Event Reporting System (FAERS).

By law, the FDA must publish quarterly watch lists of drugs with possible serious adverse effects that were spotted the quarter before. So the watch list for the second quarter of 2015 that raised questions about SGLT-2 inhibitors should have been published before September 30, 2015. However, the FDA didn’t issue it until February 5, 2016.

FDA critics say the agency's early warning system for drug safety needs fixing. The FDA has admitted that understaffing as well as balancing the workload of new drug approvals with tracking potential adverse drug effects, given its limited resources, account for the delayed watch list reports.


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