FDA Calls for Removal of Acid Reflux Rx

FDA requests that all Zantac (ranitidine) be removed from the market

(RxWiki News) The US Food and Drug Administration (FDA) is requesting that a common antacid medication be removed from the market.

This medication is found under the brand name Zantac and the active ingredient ranitidine.

In late September of last year, the FDA issued a statement about low levels of a possible cancer-causing impurity found in some ranitidine products. The recall has expanded over the last few months.

The possible cancer-causing impurity (a nitrosamine impurity) the FDA found in ranitidine products is called N-nitrosodimethylamine (NDMA). These drugs are available over the counter (OTC) and via prescription.

These drugs work to prevent heartburn and provide relief tied to acid ingestion by reducing the amount of acid the stomach makes. The prescription version is used to treat and prevent ulcers of the stomach; it also treats gastroesophageal reflux disease (GERD).

Now, the FDA is requesting that all manufacturers remove both prescription and OTC ranitidine products from the market immediately. As a result of this request for removal, ranitidine will no longer be available in the US.

The FDA said it has found that the impurity in some medications can actually increase over time — especially when the medication is kept at higher temperatures (even during transport). Recent tests also indicated that the older a ranitidine product is, the higher the level of NDMA.

These two situations place the NDMA levels above the acceptable daily intake limit, putting people at risk. Last year, the FDA said, there was not enough evidence to make the recommendation to stop taking ranitidine.

"We didn’t observe unacceptable levels of NDMA in many of the samples that we tested," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, in a press release. "However, since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured."

NDMA is commonly found at low levels in water and some foods. Low levels are not thought to increase your risk for cancer. However, continuous exposure to higher levels may increase the risk of cancer, the FDA noted.

The FDA encouraged people to stop taking OTC ranitidine and stop buying the drug. Speak with your health care provider about other treatment options.

If you are taking prescription ranitidine, be advised that there are approved medications that are similar to ranitidine and treat the same conditions. Speak with your health care provider about other treatment options.

If you have any other questions or concerns, speak with your health care provider.