Merck Is Set to Remove Cancer-Causing Chemical From Top Diabetes Drugs
- FDA had permitted drugs’ sales while issue under investigation
- Nitrosamines have been found in a variety of medical products
Merck & Co. has discovered how its blockbuster diabetes medications have become contaminated with a potential carcinogen and believes it can resolve the problem by the end of the year.
Merck submitted a report to the US Food and Drug Administration and other regulators after identifying the root cause for the presence of a nitrosamine called NTTP in certain batches of the drugs, according to a person familiar with the situation who asked not to be named discussing matters that aren’t public. The work has the potential to prevent hundreds of thousands of diabetes patients from being exposed to low levels of potentially cancer-causing nitrosamines, an impurity that’s been found in Merck’s Januvia and Janumet, along with many other widely used medications.