Regulators in the U.S. and Europe are investigating why traces of a possible carcinogen were found in certain heartburn drugs, including Zantac, more than a year after the same impurity was found in some blood pressure pills, a revelation that has raised questions about the safety of the pharmaceutical supply chain.
At issue is NDMA, an organic chemical that was once used to make rocket fuel and is an unintended by-product of certain chemical reactions. Last year, the substance was detected in a class of medicines known as angiotensin II receptor blockers, notably, valsartan, prompting an increasing spate of product recalls even as regulators have attempted to reassure consumers that cancer risks are low.
“The agency is examining levels of NDMA in ranitidine and evaluating any possible risk to patients,” the FDA said in its statement. The agency is not telling consumers to stop taking ranitidine medications, “at this time,” but did say consumers “could consider using other OTC medicines.”
On a larger scale, the episode has raised questions about regulatory oversight, especially since some of the suppliers are located in India and China, where quality control problems are a regular — and growing — problem.
Read full, original post: FDA and EMA are now probing carcinogen in Zantac and other heartburn meds