FDA Red Flags Drugs Due to Safety Issues

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.” It is on the list only because FDA has identified a potential safety issue.

“My message to patients is this: Don’t stop taking your medicine,” Janet Woodcock, M.D., director at FDA”s Center for Drug Evaluation and Research, Washington, said in a statement. “If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently.”

On the list, called “Potential Signals of Serious Risks/New Safety Information” and accessible at FDA.gov, Duloxetine (Cymbalta) was flagged for “urinary retention,” Insulin U-500 (Humulin R) was listed due to “dosing confusion,” Nitroglycerin (Nitrostat) was cited for “overdose due to labeling confusion” and Natalizumab (Tysabri), which is used in for patients with Multiple Sclerosis, drew the FDA’s attention because of “skin melanomas.”

Drugs that appear on the AERS-based table “are identified by FDA reviewers based on reports from the FDA’s AERS database, which contains millions of reports of adverse events submitted to FDA by drug manufacturers, healthcare professionals and patients. For a drug to appear on this report, an FDA reviewer will have determined there is a reason to examine a drug more closely based on either the seriousness or number of AERS reports associated with the drug. The drugs for which issues have been identified are under evaluation for the listed potential risk.

“Over the past two years, FDA has become much more proactive in our communication about possible safety problems,” said Woodcock. “Patients and health care professionals have told us that they want to be informed about possible safety problems sooner. They want to know when FDA is in the early stages of looking into a potential safety problem. Congress took note of this when it directed us to post this quarterly report of potential safety issues.”