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NDMA Discovered in a Second Antacid; Manufacturer Issues Recall

Drugmaker Mylan Pharmaceuticals, Inc. has issued a voluntary recall for three lots of the antacid Nizatidine (Axid) after traces of N-Nitrosodimethylamine (NDMA) were discovered in the active ingredient. Although no adverse events have been reported, Mylan is notifying all distributors, retailers, and customers, and has been making arrangements for the return of the affected products.

NDMA is an industrial byproduct that is also found in a number of processed foods, particularly smoked meats, as well as tobacco products. The International Agency for Research on Cancer has classified the substance as a probable human carcinogen.

NDMA contamination has been found in a number of prescriptions containing active pharmaceutical ingredients (API) manufactured in India and China. The issue first came to public attention in 2018, when NDMA was found in valsartan, an angiotensin-receptor blocker (ARB) used to treat hypertension. Since then, it has been detected in other ARB medications (losartan, olmesartan, and irbesartan), and another antacid, ranitidine (Zantac). Recently, health authorities in Singapore reported that NDMA had also been found in metformin, a common treatment for type-2 diabetes.

The most recent contamination has been traced back to Solara Active Pharma Sciences Ltd., a company located in Tamilnadu, India, from which Mylan obtains its API. The company is currently carrying out its own internal investigation into the matter.

It is not precisely known what is causing the contamination of these medications. However, in the first case involving valsartan, investigators found that changes in the manufacturing process at a plant in China had resulted in an unintended chemical reaction, causing the formation of NDMA. Another API manufacturer of contaminated sartan, Hetero Labs, had received a warning letter from the FDA in 2017 for failing to have “an adequate ongoing program for monitoring process control to ensure stable manufacturing operations and consistent drug quality.”

Nizatidine is used to treat various forms of peptic ulcer disease as well as acid reflux and the prevention of stress ulcers. Like ranitidine and famotidine (Pepcid), nizatidine is a histamine H2 receptor antagonist, which works by disabling acid production in the parietal cells lining the stomach. Introduced by Eli Lilly and approved in 1987, nizatidine was the last drug of its class to be introduced before the arrival of proton pump inhibitors.

The specific lots of nizatidine that are being recalled were distributed to pharmacies and wholesalers between June 2017 and August 2018, and include the following lot numbers:

  1. 3086746 (150 mg., expiration date May 2020)
  2. 3082876 (300 mg., expiration date January 2020)
  3. 3082876 (300 mg., expiration January 2020)

Anyone who has a recalled product can call Stericycle at (888) 628-0727 during normal business hours to arrange for returns.

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