Sandra E. Garcia
c.2019 The New York Times Company
Pharmacy chains Walgreens and CVS have stopped selling heartburn medicine Zantac and its generic versions after the Food and Drug Administration warned this month that it had detected low levels of a cancer-causing chemical in samples of the drug.
A Walgreens spokesman said Monday the company had pulled the drug from its shelves “while the FDA continues its review of the products.”
Walgreens and CVS, which announced its move Saturday, both noted that the drug, which is known as ranitidine, has not been recalled. The companies said customers who had bought the products could return them for a refund.
The FDA has said it is investigating the source of the contamination as well as the risk to patients, recommending that they talk to their doctors and that those who take over-the-counter versions consider switching to a different medication.
Zantac, the brand-name version of the drug, is sold by Sanofi, but generic versions are widely sold.
This month, drugmaker Novartis said its generic-drug division, Sandoz, had stopped distributing a prescription form of ranitidine worldwide while it investigates the FDA’s findings. GlaxoSmithKline has also stopped shipping its generic version of the drug, as well as Dr. Reddy’s Laboratories, a major generic manufacturer.
The companies, including Sanofi, have stopped short of recalling their products in the United States. Monday, Sanofi said the levels of the contaminant the FDA had found in “preliminary tests barely exceed amounts found in common foods.”
Last week, Apotex, which makes store-branded versions of Zantac for Walgreens, Walmart and Rite-Aid, recalled its ranitidine products.
The European Medicines Agency is also reviewing the drug. Canada has ordered a halt to all distribution of ranitidine while it investigates.
In its warning Sept. 13, the FDA said it had found low levels of a cancer-causing contaminant, a type of nitrosamine called nitrosodimethylamine, or NDMA, in the heartburn medications.
Nitrosamines can cause tumors in the liver and other organs in lab animals, and they are believed to be carcinogenic in humans. NDMA can form during manufacturing if the chemical reactions used to make the drug are not carefully controlled, the FDA has said.