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Duloxetine (Cymbalta), Insulin U-500 (Humulin R), Nitroglycerin (Nitrostat) and Natalizumab (Tysabri) were among 20 drugs flagged this week by the U.S. Food and Drug Administration in a report that lists drugs “being evaluated for potential safety issues.” The drugs have been identified based on a review of reports in FDA’s Adverse Event Reporting System.
The report is the first in what the FDA said would be quarterly reports listing drugs under review.
According to the FDA, the appearance of a drug on this list does not mean FDA “has concluded that the drug has the listed risk, or that FDA has identified a causal relationship between the drug and the listed risk.”
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