Jakarta. The National Drug and Food Control Agency, or BPOM, announced on Friday that it had ordered the suspension of production and sales and a recall of all products containing ranitidine, following a report of possible contamination that may cause cancer.

Ranitidine is commonly found in medication used to treat peptic and gastric ulcers.

The action is based on a warning by the United States Food and Drug Administration and European Medicine Agency on Sept. 13 that small amounts of nitrosodimethylamine (NDMA) had been discovered in a sample of ranitidine products.

BPOM head Penny Lukito said studies have determined that the safe level of NDMA intake is 96 nanograms per day.

"There's risk of a carcinogenic effect if consumed long-term, based on the study. If not used long-term, the carcinogenic effect should be absent," Penny said.

The agency ordered pharmaceutical firms licensed to produce medicines that may contain more than the acceptable level of NDMA to stop production and distribution and to recall distributed products.

In Indonesia, ranitidine can be found in Zantac and Rinadin, among others.

"On Oct. 9, the BPOM found that there were many ranitidine products exceeding safe levels of NDMA. We decided to order pharmaceutical companies holding licenses for ranitidine products to stop all production and distribution," Penny said.

The BPOM continues to test samples of ranitidine products, but Penny said no deadline had been set for the completion of the process.

"[The tests] will take time. There are 67 ranitidine products in total in Indonesia. From the 10 samples we have tested, six were confirmed positive," she said, adding that the suspension was temporary until a more comprehensive study could be undertaken.

Alternatives

Speaking at the same event, Dr. Prasetyo Widhi Buwono of the Indonesian Medical Association (IDI) said the temporary suspension was unlikely to affect people who currently take ranitidine.

"What are the other medications [that can be used to treat peptic and gastric ulcers]? Ranitidine is classified as a histamine blocker, which stops the secretion of gastric acid. Other products that can be used as substitutes are famotidine; antacids to neutralize gastric acid; and sucralfate, which covers the damaged walls of the stomach, so it makes no contact with gastric acid. Another widely distributed group is proton-pump inhibitors, such as Omeprazole and Lansoprazole, which have a stronger effect against gastric acid," the medical specialist said.

He added that antacids and proton-pump inhibitors are covered by BPJS Kesehatan, the national health insurance scheme.

However, he said there were also ways to avoid peptic and gastric ulcers, and gastroesophageal reflux disease – commonly known as heartburn.

"Reduce or avoid certain foods, such as spicy and oily foods; take enough rest; eat timely; and one we usually forget: manage stress and anxiety," he said.