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Pharmacies Pull Zantac After FDA Product Alert

If you’re looking for Zantac, chances are your local big-box pharmacy has pulled it from the shelves.

Following a product alert from the U.S. Food and Drug Administration, stores have removed the name-brand drug because it contains a nitrosamine impurity called N-nitrosodimethylamine (NDMA). (1) , Walmart, CVS, Kroger, Rite Aid, and Walgreens are among the retailers who have removed Zantac from its shelves.

N-nitrosodimethylamine is classified as a “probable human carcinogen” — a substance that could cause cancer — based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

Ranitidine is an over-the-counter and prescription drug. Ranitidine is an H2 (histamine-2) blocker, which decreases the amount of acid created by the stomach. Over-the-counter ranitidine is approved to prevent and relieve heartburn associated with acid ingestion and sour stomach. Prescription ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.

In a statement released Saturday, CVS said (2):

CVS Pharmacy has suspended the sale of all Zantac brand and CVS Health brand ranitidine products until further notice. … The FDA is continuing to evaluate whether low levels of NDMA in ranitidine pose a risk to patients. The levels that FDA is finding in ranitidine from preliminary tests barely exceed amounts found in common foods. … Zantac brand products and CVS brand ranitidine products have not been recalled, and the FDA is not recommending that patients stop taking ranitidine at this time. However, customers who purchased these products can return them to CVS for a refund. … Ranitidine is an H2 Blocker that is taken to provide heartburn relief. CVS Pharmacy will continue to sell other over-the-counter H2 Blockers, including Pepcid, Tagamet and its respective generic equivalents, famotidine and cimetidine.

The FDA is not calling for individuals to stop taking ranitidine. However, patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options. People taking OTC ranitidine could consider using other OTC medicines approved for their condition. There are multiple drugs on the market — Pepcid, Tagamet, and its respective generic equivalents — approved for the same or similar uses as ranitidine.

The FDA recommends the drugmakers use a low-heat method of testing the antacids and not the high-temperature method used by a “third-party laboratory,” which actually generates NDMA and so displays much greater levels of the impurity. The FDA also has asked drugmakers to send samples to the agency for testing.

That “third party” was the online pharmacy Valisure, which alerted the FDA and the industry to the presence of N-nitrosodimethylamine in the heartburn medicines. Valisure filed a Citizen Petition with the FDA seeking to have the agency pull ranitidine drugs from the market and create viable tests for NDMA. (3)

N-nitrosodimethylamine is one of the three impurities the FDA discovered last year in certain blood-pressure meds that led to a global recall.

On Sept. 13, a class action lawsuit was filed in the U.S. District Court for the Northern District of California accusing Sanofi and Boehringer Ingelheim of knowingly manufacturing and selling over-the-counter Zantac containing N-nitrosodimethylamine.

The lawsuit seeks to represent anyone who purchased over-the-counter Zantac between Jan. 1, 2010, and the present. Attorneys seek repayment for those who bought the drug, as well as a permanent injunction from the court under the Legal Remedies Act requiring the drug makers to either cease selling Zantac or add a warning to the label.

Zantac was the first drug to total $1 billion in sales.

The FDA has established a permissible intake limit of 96 ng of NDMA per day, but recent testing using FDA-approved methods had detected more than 2,500,000 ng of NDMA per 150 mg tablet of Zantac. In other words, each Zantac tablet contains 26,000 times the amount of NDMA that can be safely ingested.

To put the level of NDMA in Zantac in perspective, the recent recalls for blood-pressure drugs that had a similar problem with NDMA contamination — those drugs only had up to 17,000 nanograms of NDMA per pill. (4)

 

Citations

(1) Statement alerting patients and health care professionals of NDMA found in samples of ranitidine. https://www.fda.gov/news-events/press-announcements/statement-alerting-patients-and-health-care-professionals-ndma-found-samples-ranitidine

(2) CVS Pharmacy Statement Regarding Zantac and Other Ranitidine Products. https://cvshealth.com/newsroom/press-releases/cvs-pharmacy-statement-regarding-zantac-and-other-ranitidine-products

(3) FDA now says impurity level in Zantac and other antacids is too high. https://www.fiercepharma.com/manufacturing/fda-now-says-impurity-level-zantac-and-other-antacids-too-high

(4) Zantac Class Action Lawsuit Accuses Sanofi of Hiding Cancer Risk. https://dailyhornet.com/2019/zantac-class-action-accuses-sanofi-of-hiding-cancer-risk/