The FDA announced in August that Merck discovered the probable carcinogen in Januvia and Janumet during mandatory chemical testing. To avoid shortages, the FDA permitted Merck to continue selling the medications even though they contained nitrosamine levels that exceeded allowable levels.
According to the individual, Merck has found the underlying cause of the presence of a nitrosamine termed NTTP in specific batches of the medications and has submitted a report on its findings to regulators. According to the source, the contaminant is formed primarily during storage and production.
Since then, the business has enhanced its quality control procedures for the medications and expects to be able to regularly lower impurity levels to acceptable levels this year, according to the source, with the exact timing for completion reliant on feedback from the FDA.
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Nitrosamines, a class of chemical compounds associated with cancer in animal studies, have been discovered in some commonly used drugs, including those used to treat high blood pressure and heartburn. While the scope of the risk is unknown, Bloomberg Intelligence analyst Holly Forum estimates that GSK Plc, Sanofi, and other businesses that manufactured Zantac face hundreds of state court cases that may cost them up to $3.75 billion.
Four years ago, pharmaceutical companies discovered that some blood pressure pills were contaminated with N-nitrosodimethylamine, or NDMA, launching a years-long investigation into commonly used medications that uncovered several cases of contamination. At the quantities identified in the medications, NDMA is expected to raise the risk of cancer following sustained exposure.
Source: Medindia
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