The maker of a generic version of a popular heartburn medication is stopping worldwide distribution over concerns the drug could be contaminated with a cancer-causing substance.
September 25, 2019
Novartis AG’s Sandoz unit said Wednesday it would stop distribution of generic versions of the stomach drug Zantac after regulators in the U.S. and Europe began investigating the potential contamination, according to Bloomberg. Some versions of Zantac, also known by the generic name ranitidine, have been recalled in Europe and Canada.
Regulators first said last week they were looking into the potential contamination. Concerns arose over both generic heartburn and antacid medications and Zantac itself, made by Sanofi, according to the Los Angeles Times.
The medications all treat heartburn and other stomach issues.
The chemical involved is known as N-Nitrosodimethylamine, or NDMA, and is a common industrial byproduct that is considered a likely human carcinogen, the Times said. The substance also occurs in some cooked or cured meats.
NDMA contamination has sparked a series of recalls of multiple blood pressure drugs since last year.
For now, the Food and Drug Administration is not recommending a recall of heartburn medications and is not recommending that anyone stop taking the drugs under investigation, according to USA Today. The agency recommended people talk with their doctors or pharmacists if they want to discontinue prescriptions.
Anyone taking non-prescription versions of the drugs can switch to other over-the-counter medications, the FDA said, according to USA Today. There are multiple drugs available for the same or similar uses.
"It's really important to have people not panic over this," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, according to USA Today. "People who have taken ranitidine or Zantac on and off. This is not really a high risk situation. But contaminants should not be in these drugs. We're going to make sure they get out."
Woodcock noted that preliminary tests detected low levels of NDMA that equal or slightly exceeded the amounts found in foods such as cured and grilled meats, USA Today said.
The NDMA issues have raised questions about the global pharmaceutical supply chain, according to the Times. Many of the medications involved were made in China or India, prompting unease about the quality of generic drug manufacturing overseas.
Poor quality controls and efforts to conceal manufacturing problems from the FDA have complicated oversight of overseas producers, the Times said.
https://www.syracuse.com/business/2019/09/maker-halts-distribution-of-generic-zantac-over-cancer-worries.html
