Drug used to treat ulcers, heartburn recalled due to NDMA levels

WINNIPEG -- A prescription drug that is used to treat ulcers in the stomach and intestine, as well as heartburn has been recalled due to the presence of NDMA, which was at the maximum limit.

The Pendopharm Division of Pharmascience Inc. is recalling two lots of Axid (nizatidine) from the Canadian market. The Canadian government notes that tests show NDMA levels can increase over time with some nizatidine medications. The levels in the recalled products do not exceed the acceptable limit, but they could increase with time.

NDMA is a probable carcinogen for humans, which everyone is exposed to through foods, water and pollution. It does not pose a risk when ingested at low levels.

“A person taking a drug that contains NDMA at or below the acceptable level every day for 70 years is not expected to have an increased risk of cancer,” Health Canada said in a news release, noting it has been looking into the of NDMA and other nitrosamine impurities found in medications since the summer of 2018.

Those who take Axid, 150 mg, are urged to check the lot number or contact a pharmacist.

According to Health Canada, anyone taking a prescription nizatidine drug, including the recalled medication, shouldn’t stop taking it unless they have spoken with a doctor and received a different treatment.

Anyone who has taken a nizatidine drug and is concerned should contact a health-care provider.

The Pendopharm Division of Pharmascience Inc. can be reached at 1-888-550-6060 or [e-mail]

A description of the recalled product can be found online.