FDA Announces New Recommendations for Acceptable Limits of Nitrosamine in Drugs
Guidance comes after a number of massive drug recalls issued in recent years due to nitrosamine contamination, which could increase cancer risks.
Guidance comes after a number of massive drug recalls issued in recent years due to nitrosamine contamination, which could increase cancer risks.
Merck indicates it has identified the cause of nitrosamine contaminants in some batches of Januvia and Janumet, which occurs during the manufacturing and storage process.
A federal judge ruled that, unlike in Zantac claims, Valsartan NDMA lawsuits do not require proof the drug turns into NDMA in the body, because high levels of the cancer-causing chemical were already present in the pills.
Valisure has regularly found cancer-causing chemicals in drugs and consumer products before the FDA in recent years.
The EU and Canada have set daily acceptable limits for all nitrosamines, but the FDA has not. During a meeting this week the U.S. regulators met to discuss how to bets address the problem with nitrosames in drugs.
The cancer-causing contaminant, a nitrosamine, was detected at levels exceeding the daily acceptable allowance set by the FDA, but there will be no recall due to fears of a shortage.
The valsartan settlement counsel will attempt to help parties resolve the litigation without the cases having to go to trial.
Patients with recalled Accuretic pills are being told to continue taking the drug until advised otherwise by a healthcare provider.
Data from more than a dozen clinical trials suggest long-term Valsartan use may increase the risk of lung cancer after only two years of use.
NDMA contamination has resulted in several major drug recalls in recent years, including Zantac and valsartan.