Drugmakers are recalling generic versions of heartburn drug Zantac sold at Walgreens, Walmart and Rite Aid over concerns the medications contain a probable carcinogen.
Drug manufacturer Apotex said it’s recalling 75 mg and 150 mg ranitidine tablets sold over the counter at the three chain pharmacies because the drugs might contain low levels of the cancer-causing impurity NDMA.
The Walgreens versions of recalled products are sold under the store brand name Wal-Zan. The Walmart and Rite Aid labeled versions are described as ranitidine tablets. Consumers can see a list of recalled products here.
Tuesday, Novartis-owned Sandoz recalled 30-count, 50-count and 500-count bottles of ranitidine capsules prescribed to treat ulcers and reflux. The recall follows the company’s announcement last week that it would halt shipments of the stomach-acid-reducing drugs.
British drugmaker GlaxoSmithKline is recalling ranitidine products in India and Hong Kong, a spokeswoman said. The pharmaceutical giant does not sell versions of the drug in the USA.
The recalls follow a Food and Drug Administration announcement this month about unacceptable levels of the probable carcinogen NDMA in the heartburn drug Zantac and its generic versions. The agency is testing Zantac and its generic versions but has not asked drugmakers to recall the products.
Sanofi, which makes the brand-name drug Zantac, has no plans to halt shipments in the USA.
”The FDA reported that the levels of N-nitrosodimethylamine (NDMA) in ranitidine in preliminary tests barely exceed amounts found in common foods,” Sanofi spokeswoman Ashleigh Koss said in an email. ”We are working closely with the FDA and are conducting our own robust investigations to ensure we continue to meet the highest quality safety and quality standards.”
NDMA is one of three cancer-causing substances identified in widespread recalls of the blood pressure and heart medications losartan, valsartan and irbesartan since July 2018. Those drugs were contaminated with cancer-causing impurities through manufacturing flaws at pharmaceutical ingredient plants in China and India.
The source of the cancer-causing impurity in Zantac and related drugs might be the chemical form of the drug itself, said David Light, CEO of Valisure, a New Haven, Connecticut-based online pharmacy and laboratory.
Valisure’s testing found Zantac and generic versions contained NDMA levels significantly higher than the FDA’s recommended daily limits. That prompted the FDA to conduct its own tests of the drugs. It did not find the same levels of the probable carcinogen that Valisure did, but the levels were high enough to warrant followup testing.
Light said his company’s testing simulated how the drug breaks down in the stomach. Those results suggested an enzyme found in the body might interact with the ranitidine molecule in a way that unleashes the carcinogen.
”All of this data put together is showing a very, very strong scientific story that the drug itself is very unstable,” Light said. “This isn’t just like valsartan where it was very bad manufacturing practices. This appears to be a fundamental problem with the molecule itself.”
The European Medicines Agency is reviewing data to evaluate whether consumers who take ranitidine drugs face any risk from exposure to NDMA. Canada and European nations such as Austria, Germany and Switzerland have halted shipments and initiated recalls of versions or ranitidine.
Read more at usatoday.com.