The Food and Drug Administration said that traces of a potential carcinogen were found in samples of a popular diabetes drug produced by Merck, the latest example of which impurities were detected in best-selling pharmaceutical products.
Millions of people with type 2 diabetes rely on the drug, sitagliptin, to keep high blood sugar levels under control. Merck markets the drug as Januvia and Janumet. Last year, sitagliptin generated more than $5 billion in revenue for Merck and was its third best-selling product.
Despite the detection of impurities in some batches, the FDA will allow Merck to temporarily continue selling the drug, saying the risks outweigh the immediate medical needs of patients. “It may be dangerous for patients with this condition to stop taking their sitagliptin without first talking to their healthcare professional,” the agency said in a statement.
Merck, which first detected the contamination and reported it to regulators, said it was trying to address the problem and would work with health officials around the world. “We are confident in the safety, efficacy and quality of our sitagliptin-containing drugs,” the company said, adding that it did not anticipate shortages of the drug, which was first approved by the FDA in 2006.
The impurity, known as NTTP, belongs to the family of nitrosamine compounds, which have been discovered in several drugs in recent years. Since 2018, federal regulators have alerted the public to nitrosamine contamination in samples of the heartburn drug Zantac, the antibiotic rifampin, and the smoking-cessation drug Chantix.
The FDA has described NTTP as a “potential human carcinogen,” based largely on laboratory testing. The agency lacks data to directly evaluate NTTP’s carcinogenic potential and instead said it uses information about a closely related compound to determine exposure limits. Agency scientists have set the lifetime exposure to nitrosamine in the drug at 37 nanograms per day, although this would allow sitagliptin up to 246 nanograms for the time being.
In its statement, the FDA called the additional cancer risk “minimal.”
(This story has not been edited by seemayo staff and is published from a rss feed)