The FDA is recalling Irbesartan and Losartan, more angiotensin II receptor blockers (ARBs), after discovering traces of NDEA in them.
This new recall is for Losartan sold by Sandoz.
The recall is only for the 100mg/25mg tablets and does not involve other versions of the losartan drug.
This recall impacts less then 1% for the total losartan drug products in the US market. However, it is only the tip of the iceberg for pharmaceutical products from the same manufacturer found tainted with amounts NDMA and NDEA that are not safe by the FDA’s standards.
The active ingredient in the recalled lot of losartan tested positive for NDEA.
NDEA is a suspected human and animal carcinogen. It was found within an ingredient that was made and supplied by the Zhejiang Huahai Pharmaceutical Company Co. Ltd. This same company supplied the tainted active ingredient used in the recalled lots of valsartan.
After the European Medicines Agency, (EMA), and then the FDA, confirmed the presence of NDMA and NDEA impurities in Valsartan, the FDA launched an investigation, including an inspection of the Zhejiang Huahai facility. They found traces of both NDEA and NDMA.
At the end of September, the FDA placed the Chinese company on an import alert, which means that any active pharmaceutical products or finished products from the company would not enter the United States.
Valsartan is used in blood pressure medication and some vaccine products, among others.
In August, 2018, FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research, released a statement on the FDA’s ongoing investigation into valsartan impurities and recalls.
They described what caused the impurity in the drugs, what the FDA is doing about it, and the risk assessment for patients who have been taking the tainted drug.
The scientists working for the FDA estimated that, “if 8,000 people took the highest valsartan dose (320 mg) from NDMA-affected medicines daily for four years, (this is the amount of time they estimated the affected drugs were being marketed), there may be one additional case of cancer over the lifetimes of these 8,000 people beyond the average cancer rate among Americans.”
That estimate was based on the highest daily dose, however many people may have taken lower doses, and therefore their risks would be less.
FDA expects the actual cancer risk to most consumers to be lower than the estimate.
The losartan recall is for lot number JB8912. If you are taking losartan, you can check the lot number on the bottle and see if the numbers match.
If your drug is on the recall list, the FDA suggests that you continue to take it until you can get a replacement from a Doctor or Pharmacist.
Questions regarding this recall can be directed to Sandoz Inc. at 1-800-525-8747 Monday-Friday 8:30 AM – 5:00 PM (EST) or email email@example.com.
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