New Delhi: The US Food and Drug Administration has alerted about a drug — sold in India and elsewhere to treat stomach pain and heartburn — that contains low-levels of cancer-causing substances.
The drug, 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.
“Some Ranitidine medicines, including some products commonly known as the brand name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels,” the FDA said Friday.
NDMA is classified as a probable human carcinogen — a substance that could cause cancer — based on results from laboratory tests, it added.
Zantac is manufactured by French pharma major, Sanofi. The company said it doesn’t sell the drug in India.
Ranitidine reduces the amount of acid production in the stomach. It is commonly prescribed by doctors in India to cure acid-related cough, indigestion, stomach pain and heartburn.
The FDA is still evaluating whether the low-levels of NDMA — found in both the generic and brand versions of Ranitidine — pose any kind of risk to patients.
Another top health regulator, European Medicines Agency, quoted by Bloomberg, 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”.
Contacted for a comment, Sanofi in an email reply to ThePrint, said: “Sanofi takes patient safety seriously, and we are committed to working with the FDA. Zantac OTC (over the counter) has been around for over a decade and meets all the specified safety requirements for use in the OTC market.”
A senior official at the Central Drugs Standard Control Organisation (CDSCO), the apex drug regulation body in India, told ThePrint: “We have noted the alert issued by the FDA, but we will wait for the final results of the investigations before taking any action here.
“Also, FDA has clarified that its not an emergency and the levels of Ranitidine in preliminary tests barely exceed amounts that one might find in common foods. Hence, we will wait and watch,” the official said, requesting anonymity.
Those who wish to discontinue should talk to doctors, FDA
The FDA, on the other hand, has also advised patients to “trust that their medicines are as safe as they can be and that the benefits of taking them outweigh any risk to their health”.
Those who wish to discontinue using the medicine should talk to their healthcare professionals about other treatment options, it added.
The FDA has further said that although NDMA may cause harm in large amounts, “the levels the FDA is finding in Ranitidine from preliminary tests barely exceed amounts you might expect to find in common foods”.
Following the investigations, the FDA had advised recall of the drugs, which are also manufactured by Indian drug-makers like Macleods Pharmaceuticals and Lupin.