Merck says it is working to reduce levels of cancer-causing compounds in popular diabetes drugs

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Pharmaceutical company Merck said it is working to reduce levels of a cancer-causing organic compound found in some of its popular type 2 diabetes drugs. The compound, called nitrosamines or NTTP, can come from chemical reactions that can form in drugs during the manufacturing process. Nitrosamines are also found in fresh fruits and vegetables, grilled meat and fish, water and air. Merck told CNN it has identified the root cause of nitrosamines in some batches of its products containing sitagliptin, the active ingredient found in its drugs Januvia, Janumet and Steglujan, which are used to control blood sugar in patients with type 2 diabetes. Merck said it had submitted a detailed report to health authorities about the results of its investigation into the contamination. “The company has already initiated additional quality controls and expects to be able to consistently reduce NTTP levels to achieve a long-term acceptable daily intake level this year, although specific timelines will be based on the progress of time to implement process modifications and interactions with the FDA and other health authorities.” , Merck said in an emailed statement. The US Food and Drug Administration said NTTP could increase the risk of cancer if people were exposed to it above what the agency considers “acceptable levels” for long periods of time. Patients , who use drugs that have a potential contaminant should talk to their health care providers before they decide whether they want to stop taking the drugs because of cancer risk concerns, the FDA said.The agency did not provide any details about its process for working with Merck. In an email to CNN, the FDA said it “is committed to ensuring that a drug that I am accepted by Americans, safe and effective.’ “When we discover defects in the quality of medicines that pose a potential danger to patients, we make every effort to understand the problems and provide our best advice to the public as quickly and accurately as possible. We will continue to investigate and work to ensure that these types of impurities do not exceed acceptable limits so that patients can continue to take their medication without worry,” the FDA said in an email. In order to avoid shortages of stiagliptin, the FDA relaxed its standards in August the tolerable limit for nitrosamine contamination from 37 nanograms to 246.7 nanograms.FDA scientists determined that if a person took the drug at up to 246.7 ng per day it would represent “minimal additional cancer risk” compared to lifetime exposure to the compound of life at 37 ng per day Cancer-causing compounds have been identified in recent years In 2018, elevated levels of the carcinogenic compound NDMA were found in drugs used to control high blood pressure, heart failure, and heartburn, and the FDA is working with , acid reflux, and diabetes.In these cases, the FDA asked the manufacturers to recall this I medicine because of impurities. In 2020, the FDA shared guidelines for pharmaceutical companies to identify and prevent the introduction of this potentially cancer-causing chemical into their drug products.

Pharmaceutical company Merck said it is working to reduce levels of a cancer-causing organic compound found in some of its popular type 2 diabetes drugs.

The compound, called nitrosamines or NTTPs, can occur as a result of chemical reactions that can form in drugs during the manufacturing process. Nitrosamines are also found in fresh fruits and vegetables, grilled meat and fish, water and air.

Merck told CNN it has identified the root cause of the nitrosamine formation in certain batches of its products containing sitagliptin, the active ingredient in its drugs Januvia, Janumet and Steglujan, which are used to control blood sugar in patients with type 2 diabetes.

Merck said it had submitted a detailed report to health authorities about the contamination found by the investigation.

“The company has already implemented additional quality controls and expects to be able to consistently reduce NTTP levels to achieve long-term acceptable daily intake levels this year, although specific timelines will be based on progress in implementing process modifications and interactions with the FDA and other health authorities Merck said in an emailed statement.

The US Food and Drug Administration has said that NTTP may increase the risk of cancer if people are exposed to it more than the agency believes “acceptable levels” over long periods of time. Patients using medications that have a potential contaminant should talk with their healthcare providers before deciding whether they want to stop taking the medication because of concerns about cancer risk. FDA said.

The agency did not provide any details about its process with Merck. In an email to CNN, the FDA said it “is committed to ensuring that the medicines Americans take are safe and effective.”

“When we discover deficiencies in the quality of medicines that pose a potential risk to patients, we make every effort to understand the issues and provide our best advice to the public as quickly and accurately as possible. We will continue to investigate and work to ensure these types of impurities. do not exceed the acceptable limits so that patients can continue to take their medication without concern,” the FDA said in an email.

To avoid a shortage of stiagliptin, FDA in August relaxed its standards for the permissible limit of the pollutant nitrosamine from 37 nanograms to 246.7 nanograms.

FDA scientists determined that if a person took the drug at a dosage of up to 246.7 ng per day, it would result in a “minimal additional risk of cancer” compared to lifetime exposure to the compound at 37 ng per day.

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In recent years, cancer-causing compounds have been found in other common drugs, and the FDA is working with international regulators to address and mitigate drug contamination issues.

In 2018, elevated levels of the cancer-causing compound NDMA have been found in drugs used to control high blood pressure, heart failure, heartburn, acid reflux, and diabetes. In these cases, the FDA asked manufacturers to recall these drugs because of impurities.

In 2020The FDA has shared guidance for pharmaceutical companies to identify and prevent the introduction of this potentially cancer-causing chemical into their medicinal products.

Merck says it is working to reduce levels of cancer-causing compounds in popular diabetes drugs

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