Popular diabetes drug found to contain potential carcinogen

An impurity known as nitrosamine was present in some samples of the drug, which has the chemical identify of sitagliptin, the US Meals and Drug Administration mentioned Tuesday. The company mentioned it was allowing Merck to proceed to promote medicine containing sitagliptin with higher-than-allowed ranges of nitrosamine as a way to keep away from shortages.

Merck confirmed in an electronic mail that it “just lately detected a nitrosamine recognized as NTTP in some batches of our sitagliptin-containing medicines.” The corporate is working with well being authorities around the globe and has put in place extra qc to verify the medicine meet the FDA’s interim limits.

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Merck confirmed it discovered NTTP in three medicine that comprise sitagliptin: Januvia, Janumet and Steglujan. Nitrosamine ranges in a associated extended-release remedy, Janumet XR, have been too low to be measured, Merck mentioned.

Januvia is Merck’s third best-selling drug with $3.3 billion in gross sales final yr, based on Bloomberg information. Janumet had income of just about $2 billion final yr.

Sitagliptin, used to regulate excessive blood sugar in sufferers with kind 2 diabetes, is one in a string of medicines discovered to be contaminated with nitrosamines since 2018. One other well-liked diabetes drug known as metformin was amongst these affected, together with sure blood stress capsules and Pfizer Inc.’s smoking cessation drug, Chantix.

4 years in the past, pharmaceutical firms found that some blood stress capsules have been tainted with N-Nitrosodimethylamine, or NDMA, kicking off a years-long examination of generally used medicines that uncovered a number of situations of contamination. NDMA doubtless can improve the chance of most cancers after extended publicity on the ranges detected within the medicine.

Merck shares fell as a lot as 1.9% following information of the FDA assertion, however recovered to achieve 1.2% on the New York shut.

The nitrosamine found in sitagliptin is named Nitroso-STG-19, or NTTP.

“Though there are not any information out there to straight consider the carcinogenic potential of NTTP, FDA used data out there on carefully associated nitrosamine compounds to calculate lifetime publicity limits for NTTP,” the company mentioned.

The FDA permits 37 nanograms per day of nitrosamine in a drug, although it’s permitting as much as 246.7 nanograms in sitagliptin to keep away from shortages. The company mentioned that its calculations present the distinction in most cancers danger is minimal.

“We stay assured within the security, efficacy and high quality of our sitagliptin-containing medicines,” Merck mentioned. “No vital influence on provide of those medicines for sufferers is anticipated.”

The FDA advisable sufferers proceed on their sitagliptin medicine till they speak to a health-care supplier.

“FDA recommends prescribers proceed to make use of sitagliptin when clinically acceptable to forestall a niche in affected person therapy,” based on the company.

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