LOS ANGELES - Novartis, a Swiss pharmaceutical company, halted worldwide distribution of its generic version of the popular heartburn medication Zantac after the U.S. Food and Drug Administration found traces of a possible carcinogen in it.
On Friday, the FDA announced it was investigating trace amounts of N-nitrosodimethylamine (NDMA) found in Zantac and other prescription and over-the-counter heartburn drugs.
“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,” Novartis spokeswoman Dana Kahn Cooper said.
Ranitidine medications are over-the-counter and prescription drugs that lower acid in the stomach.
NDMA is classified as a possible carcinogen based on laboratory test results, according to the FDA. The chemical often contaminates water and food, such as meat, dairy products and vegetables.
The agency said it was evaluating whether the low levels of NDMA found in the drugs pose a risk to users.
FDA officials are working with international regulators and people within the pharmaceutical industry to determine the source of the NDMA.
Cooper said Novartis is conducting its own investigation to determine where and how the traces of NDMA got into the medication.
The FDA urges consumers and health care professionals to report any symptoms or side effects they may experience while taking the medications to the FDA MedWatch program.