Recall of Blood Pressure Medicines Due to Cancer Risk

Henrietta Brewer
March 5, 2019

And then there's Macleods Pharmaceuticals Limited, which announced on February 22, 2019, that it was initiating a recall on just one of its lots of Losartan tablets after traces of NDEA were detected by officials. Incidentally, Hetero Labs Limited was also listed as the source of the contamination in both recalls.

A voluntary recall of multiple medicines for high blood pressure is expanding, according to the Food and Drug Administration.

But patients should speak with their doctor to discuss the recall before they stop taking the drug. The impurity in the Torrent Pharmaceuticals products is N-Methylnitrosobutyric acid (NMBA), a "potential human carcinogen", which was found in an active pharmaceutical ingredient used in the medication.

This is the latest of more than 30 blood pressure medicine recalls.

A series of drugs have been identified as potentially unsafe since an initial recall began seven months ago.

Camber Pharmaceuticals is voluntarily recalling thousands of bottles of the blood pressure drug Losartan due to traces of a potential carcinogen. Camber has not received any reports of adverse reactions to the recalled blood pressure medication to date.

Now, the FDA is "deeply concerned" about the presence of a third impurity in certain ARB medications, Commissioner Dr. Scott Gottlieb said in the news release.

According to USA Today, since 2015, the FDA has inspected more foreign factories than domestic ones, but a 2017 Government Accountability Office report found that in mid-2016, almost 1,000 foreign factories that produce U.S. drugs had gone uninspected. "Over the past few months, the FDA has conducted a major investigation and has worked with drug companies to address the presence of impurities in these products", Gottlieb said. "The FDA is committed to implementing measures to prevent the formation of these impurities during drug manufacturing processes in the future".

The recalled medication was distributed nationwide at retail pharmacies and from other mail-order pharmacies.

From a community pharmacy perspective, this recall has been hard because many pharmacies don't keep the lot numbers of medications after they're dispensed, Freeman said: "That information is not tracked effectively".

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