Samples of Popular Diabetes Drugs Contain Potential Carcinogen, F.D.A. Said

Tests found nitrosamine contamination in some Januvia samples, but regulators will allow Merck to continue selling the drug for now.
The Food and Drug Administration says traces of a potential carcinogen have been found in samples of a popular diabetes drug produced by Merck, the latest case in which impurities have been detected in top-selling pharmaceuticals.
Millions of people with type 2 diabetes rely on the drug, sitagliptin, to control their high blood sugar. Merck markets the drug under the names Januvia and Janumet. Last year, sitagliptin generated more than $5 billion in revenue for Merck and was its third best-selling product.
Despite the discovery of impurities in some lots, the F.D.A. will allow Merck to temporarily continue selling the drug, saying the risks are outweighed by the immediate medical needs of patients. "It could 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 resolve the issue and would work with health authorities around the world. "We remain 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 the F.D.A. first approved in 2006.
The impurity, known as NTTP, belongs to the family of nitrosamine compounds that have been discovered in recent years in a number of drugs. Since 2018, federal regulators have alerted the public to nitrosamine contamination of samples of the heartburn drug Zantac, the antibiotic rifampin, and the smoking cessation drug Chantix.
The F.D.A. described NTTP as a "probable human carcinogen", based largely on laboratory testing. The agency lacks data to directly assess the carcinogenic potential of NTTP and instead said it used information on a closely related compound to determine exposure limits. Agency scientists set lifetime exposure to nitrosamine in drugs at 37 nanograms per day, although it allows up to 246 nanograms of sitagliptin at this time.
In its statement, the F.D.A. called the additional risk of cancer "minimal".

Health Aug 12, 2022 0 87 Add to Reading List

Samples of Popular Diabetes Drugs Contain Potential Carcinogen, F.D.A. Said

Tests found nitrosamine contamination in some Januvia samples, but regulators will allow Merck to continue selling the drug for now.

The Food and Drug Administration says traces of a potential carcinogen have been found in samples of a popular diabetes drug produced by Merck, the latest case in which impurities have been detected in top-selling pharmaceuticals.

Millions of people with type 2 diabetes rely on the drug, sitagliptin, to control their high blood sugar. Merck markets the drug under the names Januvia and Janumet. Last year, sitagliptin generated more than $5 billion in revenue for Merck and was its third best-selling product.

Despite the discovery of impurities in some lots, the F.D.A. will allow Merck to temporarily continue selling the drug, saying the risks are outweighed by the immediate medical needs of patients. "It could 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 resolve the issue and would work with health authorities around the world. "We remain 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 the F.D.A. first approved in 2006.

The impurity, known as NTTP, belongs to the family of nitrosamine compounds that have been discovered in recent years in a number of drugs. Since 2018, federal regulators have alerted the public to nitrosamine contamination of samples of the heartburn drug Zantac, the antibiotic rifampin, and the smoking cessation drug Chantix.

The F.D.A. described NTTP as a "probable human carcinogen", based largely on laboratory testing. The agency lacks data to directly assess the carcinogenic potential of NTTP and instead said it used information on a closely related compound to determine exposure limits. Agency scientists set lifetime exposure to nitrosamine in drugs at 37 nanograms per day, although it allows up to 246 nanograms of sitagliptin at this time.

In its statement, the F.D.A. called the additional risk of cancer "minimal".