The Food and Medicine Administration said that samples of a popular diabetic drug developed by Merck had evidence of a possible carcinogen. This is the most recent case in which contaminants were discovered in top-selling pharmaceutical items.
Sitagliptin is a medication that has helped millions of individuals with type 2 diabetes maintain normal blood sugar levels and control their condition. Januvia and Janumet are both brand names for the medication that Merck sells. More than $5 billion in sales was produced for Merck by the drug sitagliptin in 2017, making it the company’s third best-selling product overall.
The Food and Medicine Administration (FDA) has decided to allow Merck to continue selling the drug temporarily despite the discovery of contaminants in certain batches of the drug. The FDA has determined that the risks are outweighed by the acute medical requirements of patients. According to a statement released by the regulatory organisation, “it might be harmful for people with this disease to discontinue taking their sitagliptin without first consulting to their health care practitioner.”
Merck, the company that discovered the contamination initially and reported it to the appropriate authorities, said that it was attempting to find a solution to the issue and would collaborate with health authorities located across the globe. “We remain confidence in the safety, effectiveness, and quality of our sitagliptin-containing medications,” the business said, adding that it did not expect any shortages of the medication, which was first authorised by the FDA in the year 2006.
In recent years, a number of drugs have been found to contain an impurity known as NTTP. This impurity is a member of the nitrosamine chemical family and goes by the name NTTP. Since 2018, federal officials have been warning the general public about the presence of nitrosamine contamination in samples of the prescription Zantac, which is used to treat heartburn, as well as the antibiotic rifampin and the drug Chantix, which is used to help people quit smoking.
Because much of the research on NTTP has been conducted in laboratories, the Food and Drug Administration has classified it as a “probable human carcinogen.” Because the FDA does not have the data necessary to directly analyse the carcinogenic risk of NTTP, it has said that it utilised information on a substance that is closely related to arrive at the exposure limits. The agency’s scientists have determined that an individual’s lifetime exposure to nitrosamine in medicine should not exceed 37 nanograms per day; but, for the time being, the government will permit up to 246 nanograms in the case of sitagliptin.