Is metformin recalled
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Summary
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Some studies suggest that metformin has been recalled due to nitrosamine impurities, while other studies indicate that most metformin products still meet quality and safety standards.
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Metformin Recalls Due to Nitrosamine Impurities
Introduction to Metformin Recalls
Metformin, a widely used medication for managing type 2 diabetes, has faced scrutiny due to the detection of nitrosamine impurities, specifically N-nitrosodimethylamine (NDMA). NDMA is a potential carcinogen, and its presence in pharmaceuticals has led to several recalls to ensure patient safety.
Detection of NDMA in Metformin
International Regulatory Efforts
International regulatory bodies have been actively monitoring metformin for nitrosamine impurities. A comprehensive analysis of 1090 samples, including both active pharmaceutical ingredients (APIs) and finished dosage forms (FDFs), revealed that NDMA was detected in some batches of metformin products. Specifically, 17.8% of the FDF samples tested had NDMA levels above the acceptable intake (AI) limit of 96 ng per day, while 82.2% met the safety standards.
Specific Recalls
In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) recalled a batch of Rosemont Pharmaceuticals' metformin oral solution due to NDMA levels exceeding the acceptable limit. The recall was a precautionary measure, and patients were advised to continue their medication while seeking advice from healthcare professionals.
Root Causes of NDMA Formation
Manufacturing Processes
Research has identified several factors contributing to NDMA formation during the manufacturing of metformin tablets. Key factors include the use of water and heat during intra-granulation and the presence of nitrite/nitrate in excipients. Certain excipients, such as polyvinyl pyrrolidone and hydroxypropyl cellulose, did not result in detectable NDMA levels even when water and heat were used. However, other excipients like hydroxypropyl methyl cellulose (HPMC) did contribute to NDMA formation under similar conditions.
Regulatory Actions and Industry Response
FDA Guidance
The FDA has issued guidance to the pharmaceutical industry to control nitrosamine impurities in drug products. This guidance is part of a broader effort to ensure the safety and efficacy of medications. The FDA database indicates that over 1400 product lots, including metformin, have been recalled due to unacceptable levels of nitrosamines.
Ongoing Collaboration
Regulatory agencies continue to collaborate with marketing authorization holders to understand the root causes of nitrosamine formation and implement corrective actions. This collaboration aims to mitigate the presence of NDMA in future batches of metformin and other affected drugs.
Conclusion
While some batches of metformin have been recalled due to NDMA impurities, extensive regulatory efforts are in place to monitor and address this issue. The majority of metformin products continue to meet safety standards, and ongoing research and regulatory actions are focused on preventing future contamination. Patients are advised to consult healthcare professionals for guidance and continue their prescribed treatments unless otherwise directed.
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