April 3, 2020

Around the nation: FDA pulls Zantac, other heartburn drugs off the market

Daily Briefing

    The move comes after the agency found elevated levels of a potential carcinogen in the drugs, in today's bite-sized hospital and health industry news from Georgia, Maryland, and Ohio.

    • Georgia: Home Depot on Wednesday announced it would halt sales of N95 masks at all 2,300 of its North American stores to free up the masks for health care providers. The move comes amid a nationwide shortage of the protective equipment. "We stopped restocking stores a couple weeks ago to prioritize shipments for hospitals and first responders," said Sara Gorman, a spokesperson for Home Depot. "As an extra precaution, we locked them down with a stop sale beginning last week" (Vigdor, New York Times, 4/2).

    • Maryland: FDA on Wednesday ordered that Sanofi's Zantac and other generic heartburn medications containing ranitidine be pulled from the market after the agency found elevated levels of a potential carcinogen in the drugs. FDA also ordered consumers stop taking the medication as soon as possible. According to the agency, levels of the potential carcinogen can increase in some of the products over time, even when they're kept in normal storage conditions. "[S]ince 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," Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, said (Armental/Kellaher, Wall Street Journal, 4/1; Thomas, New York Times, 4/1; Dwyer, NPR, 4/1).

    • Ohio: U.S. District Judge Dan Polster on Tuesday rejected a bid by major pharmacy chains facing lawsuits that accuse them of fueling the U.S. opioid epidemic to shift their liability to doctors. The pharmacies, which include CVS Health and Walgreens Boots Alliance, filed complaints against doctors claiming they wrote "bad" prescriptions. Polster said the "[p]laintiffs' theory and intended proof do not rely on whether prescribers made negligent or fraudulent representations," adding that claims against the prescribers would further delay trials against the pharmacies (Raymond, Reuters, 4/1; Gillispie, Associated Press, 4/1).

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