Heartburn Medication Recall Update

The US Food and Drug Administration (FDA) has released an update about the recall of a common heartburn medication.

The FDA has discovered that some medications used for acid reflux contain low levels of a possible cancer-causing impurity. These medications are found under the names ranitidine (active ingredient) and Zantac (brand). These drugs are available over the counter and via prescription.

These medications 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).

The possible cancer-causing impurity (a nitrosamine impurity) the FDA found is called N-nitrosodimethylamine (NDMA).

Two weeks ago, the FDA released information about this discovery and its plan to determine whether the low levels of NDMA found in some ranitidine medications would place people at risk. Now, the FDA is issuing a statement about the voluntary recall of the following:

• 14 lots of prescription ranitidine capsules distributed by Sandoz Inc.
• Over-the-counter (OTC) ranitidine tablets (75 mg and 150 mg) labeled by Walgreens, Walmart, and Rite-Aid and manufactured by Apotex Corp (all pack sizes and formats)
• OTC ranitidine tablets labeled by CVS

Novartis, which owns Sandoz, actually stopped distributing generic versions of ranitidine over these concerns.

The FDA encouraged consumers to refer to the recall instructions provided by the specific company. These details can be found on the FDA's website.

Not all ranitidine products have been recalled. According to health officials, consumers can continue to take ranitidine that has not been recalled. Note that other OTC medications are approved to treat the same conditions as ranitidine.

The FDA recommended that consumers taking the prescription version speak with their doctor about other treatment options. The agency also encouraged people to report any side effects tied to ranitidine to the FDA’s MedWatch program.

Speak with your health care provider if you have any questions.

Written by Anyssa Garza, PharmD, BCMAS