Generic Axid Recall Issued Over Presence of Cancer-Causing Chemical NDMA

Following massive Zantac recalls issued in recent months, due to the discovery that the active ingredient produces high levels of the cancer-causing chemical N-Nitrosodimethylamine (NDMA), another heartburn drug is being pulled from the market, after Mylan’s generic Axid version was also found to contain unsafe levels of the carcinogen.

The FDA announced the generic nizatidine capsule recall on January 8, after trace amounts of NDMA were detected in capsules sold by Mylan, which contained an active ingredient manufactured by Solara Active Pharma Sciences Limited.

Axid (nizatidine) is a short-term ulcer treatment, and is also approved for the treatment of esophagitis and heartburn caused by gastroesophageal reflux disease (GERD). It is also approved as a maintenance therapy, for duodenal ulcer patients, who may take the medication for up to a year.

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Concerns about NDMA in Zantac emerged in September 2019, when an independent pharmacy found high levels of the cancer-causing chemical across all doses and lots of the widely used heartburn drug. As a result, the FDA has launched an investigation, and is evaluating whether the active ingredient ranitidine may be inherently unstable, and result in the chemical byproduct under certain conditions.

In early November, when the FDA was still testing various versions of Zantac for NDMA, the agency noted that some testing had found excessive levels of NDMA in Axid and its generic equivalents, raising concerns about this other heartburn treatment. At that time, the agnecy requested that manufacturers of the affected drugs issue voluntary Axid recalls, and the announcement this week appears to be the first.

The recall impacts three lots of Nizatidine Capsules, USP, sold by Mylan, which is a generic equivalent of Axid. It includes bottles of 60 150mg capsules with an NDC number of 0378-5150-91, a lot number of 2086746 and an expiry of May 2020. It also includes bottles of 30 300mg capsules with NDC number 0378-5300-93 and lot numbers 3082876 and 3082877, and an expiry of Jan 2020.

Mylan is advising wholesalers, retailers and consumers in possession of the recalled capsules to contact Stericycle at 888-628-0727 to return the recalled products.

Zantac Cancer Lawsuits

The recall comes as a growing number of Zantac lawsuits are now being filed by users of that recalled heartburn drug, who indicate they have been diagnosed with various forms of cancer as NDMA contained in the tablets travelled through their digestive system, including stomach cancer, bladder cancer, kidney cancer, liver cancer, colorectal cancer and other diseases.

The FDA first warned about the Zantac problems on September 13, indicating several different versions of the heartburn drug have been found to contain the impurity, which could cause cancer. As a result, major retailers have removed Zantac from store shelves, and nearly every version of the medication has now been recalled.

As the number of claims filed nationwide continues to grow, the U.S. Judicial Panel on Multidistrict Litigation (JPML) is set to consider oral arguments later this month on a request to centralize and consolidate the cases before one judge for coordinated pretrial proceedings.

If users of nizatidine-based heartburn drugs were exposed to similar levels cancer-causing agents, Axid lawsuits may soon be filed by former users diagnosed with cancer in prior years.


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