The Denver Post

Drugstores recalling Zantac-like heartburn drugs over cancer risk

- By Kim Bellware and Carolyn Y. Johnson

CVS pulled Zantac and its own generic form of the popular heartburn medication from its shelves this weekend over concerns that the products may contain small levels of nitrosodim­ethylamine, or NDMA, a possible cancercaus­ing chemical linked to liver damage. CVS, the largest pharmacy chain in the country, said Saturday it was suspending sales “out of an abundance of caution.”

The decision by the pharmacy giant adds to a flurry of worldwide concern about the drug. Major manufactur­ers of the generic form, ranitidine, have announced recalls, and other countries have requested that companies halt distributi­on of the drug or issued recalls. The U.S. Food and Drug Administra­tion has been investigat­ing the possible risk to patients, as well.

The FDA has stopped short of calling for people to stop taking the drug but has advised patients to talk to their doctors about taking an alternativ­e prescripti­on to ranitidine, an anti-heartburn medication that’s commonly used in prescripti­on and over-thecounter medicines to treat issues like ulcers and acid reflux.

Exposure to low levels of NDMA does not pose an acute risk to patients. The chemical is classified as a probable carcinogen and is present in the environmen­t and in food, such as grilled meat.

Sandoz, a division of the pharmaceut­ical giant Novartis, halted distributi­on of ranitidine in midSeptemb­er and then announced it was recalling lots after the impurity was detected above acceptable levels last week. Apotex Corp., another manufactur­er, recalled ranitidine tablets last week on a “precaution­ary basis” after learning from the FDA and other global regulators that the drug can contain the impurity, regardless of the manufactur­er. Drug recalls are typically executed by the individual manufactur­ers and subsequent­ly announced by the FDA.

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