Authorities in the US discovered that Merck & Co.’s Januvia, a popular drug for diabetesis contaminated with a potential carcinogen
An impurity called nitrosamina in some samples of the drug, which has the chemical name of sitagliptin, The US Food and Drug Administration (FDA) said on Tuesday.
The agency said it was allowing Merck to continue selling sitagliptin-containing drugs with nitrosamine levels higher than allowed. to avoid shortages.
Merck confirmed in an email that it “recently detected a nitrosamine identified as NTTP in some lots of our sitagliptin-containing medicines.” The company is working with health authorities around the world and has implemented additional quality checks to make sure the medicines meet with the provisional limits of the FDA.
Merck confirmed that it found NTTP in three medicines containing sitagliptin: Januvia, Janumet y Steglujan.
One of Merck’s most lucrative drugs, in the middle
Januvia is Merck’s third best-selling drug with $3.3 billion in sales last year, according to data from Bloomberg. Janumet had revenue of nearly $2 billion last year.
Sitagliptin, which is used to control high blood sugar levels in patients with type 2 diabetes, it is one of a number of drugs that have been found to be contaminated with nitrosamines since 2018. Another popular diabetes drug called metformin was among those affected, along with certain blood pressure pills and Chantix, the drug for stop smoking from Pfizer.
Four years ago, pharmaceutical companies discovered that some blood pressure pills were contaminated with N-nitrosodimethylamine, or NDMA, kicking off a multi-year review of commonly used drugs that uncovered several cases of contamination. It is likely that NDMA may increase the risk of cancer after a prolonged exposure to the levels detected in the drugs.
Merck shares fell as much as 1.9 percent on news of the FDA statement, but recovered to gain 1.2 percent at the close.