Recalls Underway for Zantac and Axid Antacids Because of Cancer Impurity

Drug companies are recalling batches of Zantac (Ranitidine) and Axid (Nizatidine) proton-pump inhibitors because of contamination by a cancer-causing impurity.

  • Mylan Pharmaceuticals is conducting a voluntary nationwide recall, to the consumer level, of three lots of Nizatidine Capsules, (including the 150mg and 300mg strengths).
  • Appco Pharma LLC is voluntarily recalling prescription ranitidine hydrochloride capsules.
  • Northwind Pharmaceuticals is voluntarily recalling prescription ranitidine tablets (150 mg and 300 mg), manufactured by Glenmark Pharmaceutical Inc.

The antacid drugs are being recalled due to detected trace amounts of NDMA, a cancer-causing impurity. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables. It has been classified as a probable human carcinogen, according to the International Agency for Research on Cancer.

FDA is alerting patients and health care professionals to the voluntary recalls of ranitidine and Nizatidine.

Used by millions

Zantac is a heartburn medication used by millions of Americans. OTC ranitidine is commonly used to relieve and prevent heartburn. Prescription strengths are also used to treat and prevent more serious ulcers in the stomach and intestines. Multiple companies sell generic versions of both the OTC and prescription products.

Mylan’s bottles of Nizatidine were distributed nationwide to wholesalers, mail order pharmacies, retail pharmacies, and a distributor between June 2017 and August 2018.
Nizatidine is indicated for the short-term treatment of active duodenal ulcers and active benign gastric ulcers, and for endoscopically diagnosed esophagitis and associated heartburn due to gastroesophageal reflux disease (GERD).

Both Zantac and Axid are proton pump inhibitors (PPIs) that reduce the production of acid by blocking the enzyme in the wall of the stomach that produces acid that is responsible for most ulcers in the esophagus, stomach, and duodenum.

Active litigation

As of December 16, 2019, there are 13,245 lawsuits in IN RE: Proton-Pump Inhibitor Products Liability Litigation (No. II) before US District Judge Claire C. Cecchi in MDL 2789.

The lawsuits involve people who’ve taken prescription and over-the-counter PPIs such as:

  • Dexilant (dexlansoprazole)
  • Nexium (esomeprazole) and Nexium 24Hr
  • Prevacid (lansoprazole) and Prevacid 24HR
  • Prilosec (omeprazole) and Prilosec OTC
  • Protonix (pantoprazole)

The MDL plaintiffs allege that the heartburn drugs they took damaged their kidneys. They claim that the PPI manufacturers — such as Takeda Pharmaceuticals, AstraZeneca Pharmaceuticals, Pfizer Inc. and The Procter & Gamble Co. — should have known about the risks of these drugs and warned them.

Consumers who’ve filed suit allege the blockbuster drugs have caused them to develop serious kidney problems including:

  • Acute Interstitial Nephritis (AIN)
  • Acute Kidney Injury
  • Chronic Kidney Disease (CKD)
  • End Stage Renal Disease (ESRD)

The proton-pump litigation has proceeded since the MDL was created in 2017.

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