Novartis' Sandoz Unit Halts Zantac Distribution

N-nitrosodimethylamine molecule

Contamination of some lots of ranitidine (Zantac) led the Novartis Sandoz unit today to stop distribution of the drug while the issue is being investigated.

Ranitidine, available in both prescription and over the counter forms, is a histamine-2 inhibitor antacid, used to treat gastroesophageal reflux and to help prevent gastric and intestinal ulcers.

The FDA last week issued a statement warning that some lots of ranitidine were found to contain N-nitrosodimethylamine (NDMA), classified as a probable human carcinogen. NDMA, part of the nitrosamine chemical family, is also a “known environmental contaminant” and last year was found in popular angiotensin receptor blockers used to treat hypertension.

“A precautionary distribution stop of all Sandoz ranitidine-containing medicines in all our markets will remain in place under further clarification, this includes capsules in the USA," according to a Novartis statement quoted by Dow Jones. "Our internal investigation is ongoing to determine further details. In case of concerns, adequate additional measures will be implemented in alignment with relevant Health Authorities as required."

The FDA has not identified individual products as there is currently no recall in effect and advises patients to “consider using other OCT medicines approved for their condition.” There are other drugs in the same and other classes approved for “the same or similar uses as ranitidine.”

The FDA emphasizes that patients taking prescription ranitidine who wish to switch to another medication should consult their physicians.

Consumers and health care professionals should report any adverse reactions with ranitidine to the FDA’s MedWatch program to help the agency better understand the scope of the problem:

• Complete and submit the report online at www.fda.gov/medwatch/report.htm

• Download and complete the appropriate form, then submit it via fax at 1-800-FDA-0178