Traces of a potential carcinogen have been found in samples of a diabetes drug produced by Merck, according to the U.S. Food & Drug Administration.
Sitagliptin, produced by Merck, is used by millions of people with Type 2 diabetes, The New York Times reported. The drug is used by diabetes patients to keep high blood sugar levels in check.
Merck markets the drug as Januvia and Janumet, the Times reported. Last year, sitagliptin generated more than $5 billion in revenue for Merck and was its third best-selling product.
The impurity, known as NTTP, belongs to the family of nitrosamine compounds that has been discovered in a number of medications in recent years, the Times reported.
Merck confirmed in an email to Bloomberg that it “recently detected a nitrosamine identified as NTTP in some batches of our sitagliptin-containing medicines.”
Despite discovering the impurities, the FDA will allow Merck to continue to sell the drug on a temporary basis, the agency said in a statement.
“To avoid a shortage and help ensure patients have access to an adequate supply of the medicine, FDA will not object to the temporary distribution of sitagliptin containing NTTP above the acceptable intake limit of 37 ng (nanograms) per day, and up to 246.7 ng per day,” the FDA said. “It could be dangerous for patients with this condition to stop taking their sitagliptin without first talking to their health care professional.”
In its statement, the FDA called the additional cancer risk “minimal.”
“Agency scientists evaluated the risk of exposure to NTTP at interim acceptable intake levels up to 246.7 ng per day and determined that it presents minimal additional cancer risk when compared to a lifetime of exposure to NTTP at the 37 ng per day level,” the FDA said in its statement.
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