New Delhi: The US Food and Drug Administration Wednesday announced the withdrawal of all prescription and over-the-counter (OTC) ranitidine drugs from the market citing contamination by carcinogens.
It is the latest move in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications. Ranitidine is commonly prescribed by doctors in India to cure acid-related cough, indigestion, stomach pain and heartburn.
Ranitidine is available in India under the brand names of Aciloc and Zinetac, manufactured by Cadila Pharmaceuticals and GlaxoSmithKline Pharmaceuticals, respectively. These two are the top companies that sell the drug in India. However, the US has specifically named Sanofi’s brand Zantac.
“The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity,” FDA said in the press statement.
“As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S,” it added.
The Indian drug regulator, the Central Drug Standards Control Organisation (CDSCO), is now reviewing the FDA decision. “We are evaluating the findings of the US FDA in the Indian context,” said a senior CDSCO official.
The FDA had on 13 September warned about ranitidine as it contains low-levels of N-nitrosodimethylamine (NDMA) — a substance that causes cancer.
Days after the US health regulator FDA, the Modi government had also written to drug regulators in all states and union territories to check the samples of the medicines as a precaution.
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What is NDMA?
NDMA is a probable human carcinogen — a substance that could cause cancer. “Low levels of NDMA are commonly ingested in the diet, for example NDMA is present in foods and in water. These low levels would not be expected to lead to an increase in the risk of cancer,” the FDA has said in its press statement.
However, it further says, sustained higher levels of exposure may increase the risk of cancer in humans.
Another top health regulator, European Medicines Agency, was quoted by Bloomberg, as having said that it “is evaluating the data to assess whether patients using ranitidine are at any risk from NDMA and will provide information about this as soon as it is available”.
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