Concerns over the safety of the U.S. drug supply were recharged as Glenmark Pharmaceuticals initiated the recall all of nearly 2,000 lots of its Zantac generics from the U.S. market because they may contain elevated levels of a possible cancer-causing impurity.
The voluntary recall came even as Connecticut Congresswoman Rosa DeLaura sent a scathing letter to the heads of HHS and the FDA calling on them to have all ranitidine drugs pulled from the U.S.
"Due to a historically very high perception of safety, ranitidine is heavily prescribed to adults and infants and sold over-the-counter…. FDA's failure to stop companies from selling ranitidine makes the United States government complicit in exposing infants and adults to the risk of cancer,” reads the letter to FDA Director Stephen Hahn and his boss Alex Azar, secretary of Health and Human Services.
Glenmark is recalling 1,840 lots of unexpired 150 mg and 300 mg ranitidine tablets to the consumer level. It said both were manufactured at FDA approved manufacturing facilities in India, about half at its own plant in Goa and the rest by Strides Pharma Science at a plant in Puducherry. It also stopped distributing the drug in the U.S.
Glenmark said it is committed to product and consumer safety and it working with the FDA as it formulates guidelines for acceptable levels of NDMA in ranitidine products.
Glenmark’s recall comes months after many other drugmakers, including Zantac maker Sanofi, cleared their products from the market. Novartis was the first to act, pulling its products as soon as the FDA warned of the risk of NDMA in the products.
Congresswoman DeLaura represents the Connecticut district where the analytical online pharmacy Valisure is based. It was Valisure that alerted the FDA to the presence of NDMA in the heartburn medicines after its testing found high levels of it in “every lot it tested across multiple manufacturers and dose forms.” The company also filed a citizen petition against the FDA saying it needed to act because the risk from NDMA in ranitidine drugs was so pervasive.
The FDA initially dismissed the risk as no greater than that from eating grilled meats that also can contain NDMA but then later said early tests found “unacceptable levels" of NDMA in samples of ranitidine. Still, while it has alerted drugmakers that they need to test for NDMA in their drugs, it has not insisted they pull them from the market.
In a statement Wednesday, Valisure CEO David Light supported DeLauro’s request that the FDA require a universal recall of ranitidine from the market, pointing out there are alternative antacids on the market that don’t contain NDMA.
“Scientific evidence strongly suggests that ranitidine is fundamentally unstable, is able to directly form the carcinogen NDMA and all products containing ranitidine possess a cancer risk…..Valisure recognizes that this is an area of ongoing study but believes the current evidence is more than sufficient to warrant a complete recall of all ranitidine containing products, an action that has been taken by a multitude of countries around the world,” the company’s statement says.