Prescribed version of heartburn drug Zantac recalled worldwide as a 'precaution'

Canadian consumers who grab Zantac and other medications containing ranitidine off the pharmacy shelf can continue to do so despite a global recall of the prescribed version.

In Canada, Sanofi is the only manufacturer of branded Zantac, and it's only available over-the-counter, the company said. Since prescription Zantac is not sold in this country, Tuesday's global recall by GlaxoSmithKline of prescription-only Zantac products does not apply in Canada.

"There were some impurities found in the manufacturing plant that is used to manufacture the prescription strengths of Zantac and ranitidine. It does not affect the non-prescription strengths because they're made at a different facility," said Barry Power, senior director of digital content at the Canadian Pharmacists Association.

Over-the-counter ranitidine is approved to prevent and relieve heartburn associated with acid indigestion and sour stomach. The prescription versions are used to reduce stomach acid to prevent and treat conditions, such as heartburn, ulcers of the stomach and intestinesand gastroesophageal reflux disease (GERD), Health Canada said.

Ranitidine works by blocking the action of acid-producing cells in the stomach.

"Sanofi in Canada has not recalled Zantac, a lower dose, over-the-counter ranitidine medication. In order to comply with Health Canada's guidance, as a precautionary measure, Sanofi in Canada is holding all distribution of Zantac until further notice no further action is required for product currently on the market," Sanofi Canada spokesperson Christine Homsy said Wednesday.

The affected products are under voluntary recall by generic companies or subject to distribution halts, where existing stocks can still be sold, because regulators worldwide have detected an impurity called N-nitrosodimethylamine (NDMA).

Alternative options

NDMA is classified as a probable human carcinogen, meaning long-term exposure to levels above what is considered safe could increase the risk of cancer. If someone was prescribed a medication containing ranitidine, contact your pharmacy, Power said.

People can be switched to famotidine (brand name Pepcid) or another medication that achieves the same effect on stomach acids, he said.

Health Canada advised consumers:

• Talk to your doctor or pharmacist at your earliest convenience about alternative, non-ranitidine treatment options appropriate for your health circumstances.
• Individuals taking a prescription ranitidine drug, including a recalled product, should not stop taking it unless they have spoken to their health-care provider and obtained alternative treatment, as the risk of not treating the condition may be greater than the risk related to NDMA exposure.

Dr. Emily McDonald, an assistant professor of medicine at the McGill University Health Centre in Montreal, said this isa good opportunity to check if the medication is still needed.

"People can try and come off of it and see how they feel and see if their reflux symptoms return. They could use calcium antacids" for mild symptoms,McDonald said in an email.

McDonald, an internal medicine physician,also suggested optimizing non-medical options, including:

• Avoid caffeine, chocolate, alcohol and mint.
• Elevate the head of the bed to sleep.
• Avoid meals before bedtime.

Last week, the U.S. Food and Drug Administrationsaid its early, limited testing has found "unacceptable levels of NDMA in samples of ranitidine."

Impurity testing

U.S. and European health regulators said last month they were reviewing the safety of ranitidine, after online pharmacy Valisure flagged the impurities.

The FDA said Valisure's higher-temperature testing method generated very high levels of NDMA from the ranitidine drugs. The FDA said its lower temperature testing method has shown lower levels.

Last year, NDMA was found in some blood pressure medicines from a class of drugs known as angiotensin II receptor blockers, or ARBs, which also led to recalls.

Health Canada said it estimated that among those taking the largest dose of the blood pressure medication valsartan (320 mg/day), the potential increased risk of cancer over a lifetime could be one additional case of cancer for every 11,600 people taking the product.