FDA: Zantac carcinogens no more dangerous than 'grilled or smoked meats'

Zantac
The FDA said levels of a possible carcinogen in tested lots of branded and generic Zantac were no higher than that found in smoked or grilled meats. (Sanofi)

Drugmakers may be recalling the heartburn med Zantac around the world, but the FDA wants consumers to stop worrying. Higher-than-recommended levels of a possible carcinogen in the pills are no more dangerous than a grilled ribeye, the agency said Monday. 

Testing of recalled lots of branded and generic Zantac showed levels of a contaminant known as N-Nitrosodimethylamine (NDMA) that were as much as nine times greater than the FDA's recommended limit––but the agency pooh-poohed the health risk in a release

Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said despite NDMA levels that were at times significantly above the acceptable limits, the amount of the compound found in the drugs was comparable to levels found in "grilled or smoked meats." Moreover, the FDA concluded that consuming Zantac didn't cause NDMA to form in the stomachs of patients, as had been previously posited.

Free Webinar

From Patient Adherence to Manufacturing Ease - Why Softgels Make Sense for Rx

THIS WEEK: Join Thermo Fisher Scientific’s upcoming webinar to learn why softgels offer numerous benefits for Rx drug development, including enhanced bioavailability, patient compliance and easy scale-up. Register Today!

"We understand the concern we’ve been hearing from parents and pediatricians and we’ll continue to investigate," Woodcock said.

RELATED: FDA now says impurity level in Zantac and other antacids is too high 

Suggested Articles

The U.K. became the first Western country to authorize a COVID vaccine, making the Pfizer/BioNTech shot the first mRNA vaccine for widespread use.

The new Community trial will first test Amgen's Otezla, Takeda's Takhzyro and UCB's zilucoplan in hospitalized patients.

Indivior faces a new lawsuit from RB, its former parent company, over a scheme to market opioid addiction therapy Suboxone Film.