The drug has been found to have levels of a carcinogen above what the US FDA prescribes
United States (US) pharma major, Sandoz Inc issued a ‘voluntary recall’ of popular drug ranitidine on September 23, 2019, after confirmation that it had a carcinogenic substance in it.
“Sandoz Inc is voluntarily recalling all quantities and lots within expiry, of Ranitidine Hydrochloride capsules in the US to the consumer level because of confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the Food and Drug Administration (FDA) in batches of Sandoz Ranitidine Hydrochloride capsules,” the voluntary recall notice read.
Sandoz has withdrawn 14 batches of the drug which it manufactured in 2017 and 2018 and which were set to expire in 2020 and 2021.
According to the FDA, NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.
“Sandoz will be notifying its distributors and customers via overnight mail and via the Sandoz website, and will arrange for return of all recalled products,” the notice said.
“Wholesalers (direct customers) will be asked to immediately stop distribution and return any stock to Sandoz, and contact the retail pharmacies in their group to do the same. Pharmacies will be asked to immediately stop dispensing Sandoz Ranitidine Hydrochloride capsules and return remaining stock to Sandoz by contacting Stericycle to request a recall packet,” it added.
Ranitidine is a prescription drug but is also sold over the counter (OTC). As an OTC drug, it is used to decrease the volume of acid produced in the stomach. It is also used to prevent and relieve heartburn associated with acid ingestion and sour stomach.
As a prescription drug, it has multiple uses, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease or GERD.
On September 13, the US FDA had first said it was looking into possible contamination of ranitidine with NDMA. On September 23, the federal agency issued another alert, stating it was testing ranitidine products from multiple manufacturers.
It said although NDMA might cause harm in large amounts, the levels the FDA was finding in ranitidine from preliminary tests, barely exceeded amounts one might expect to find in common foods.
“The FDA is evaluating whether the low levels of NDMA in ranitidine pose a risk to patients. FDA will post that information when it is available,” the statement said.
It also clarified that it was not calling for individuals to stop taking ranitidine at this time; however, patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options.
“People taking OTC ranitidine could consider using other OTC medicines approved for their condition. There are multiple drugs on the market that are approved for the same or similar uses as ranitidine,” the FDA alert said.
Besides the FDA, the European Medicine Agency has also launched a similar enquiry, the results of which are awaited.
The Singapore drug regulator banned the supply of the drug in the country early this month. In its notification it said, “Eight brands of ranitidine medicines have been found to contain trace amounts of a nitrosamine impurity, NDMA, which are above the internationally acceptable level. As a precautionary measure, the Health Sciences Authority is stopping the sale and supply of the affected ranitidine medicines at clinics, hospitals and pharmacies
Meanwhile, in India, Central Drugs Standard Control Organisation (CDSCO) has also asked state drug controllers to ensure that the drug is safe.
“A letter has been issued by the drug controller general of India to all the state authorities to check for any impurities in ranitidine. They have been asked to ensure safety of all patients who consume this drug,” a senior official in CDSCO office told Down To Earth on the condition of anonymity.
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