It’s been over two years since carcinogenic nitrosamines were discovered in some widely used drugs. The discovery occurred in 2018 when the contaminant was found in active pharmaceutical ingredients in Valsartan, a blood pressure medication. Since then, the contaminant has been found in several other drugs taken by millions of people each year.
The Latest Update
In 2019, the contaminant was found in ranitidine medications (commonly known as Zantac) and Nizatidine. Almost immediately, the FDA requested the removal of all Ranitidine drugs from the market. Most recently, the agency announced levels of the carcinogen that are above its acceptable intake limit in metformin, a prescription drug used to control high blood sugar in patients with type 2 diabetes.
After more than a year of numerous recalls and multiple warning letters, the FDA on September 1 released its guidance in Control of Nitrosamine Impurities in Human Drugs, which outlines in 24 pages how to detect and prevent unacceptable levels of nitrosamine impurities
What’s Inside The Guidance:
What It Means For Manufacturers
With the FDA’s increased understanding of how nitrosamine impurities form in drugs, it now not only knows how to catch it, but also how to prevent it. And now that the guidance is available to drug manufacturers, they too will be expected to take the appropriate steps to catch and prevent the contaminant. The proof is in the agency’s words as it clearly states in the guidance, “drug manufacturers are responsible for mitigating these impurities.”
Expect the FDA to maintain its focus on the nitrosamine issue. If you’re a drug manufacturer, be prepared to prove the safety of your product or risk seeing an increase in recalls and litigation. The best thing you can do now is familiarize yourself with the guidance, treat the FDA’s recommendations as requirements, and follow the agency’s recommended remedial steps. Now that the FDA had laid out its position in writing, it’s your responsibility to prevent nitrosamine contamination before the agency’s investigators find it.
Stay on top of the latest in Recalls with Expert Solutions! Our Quarterly Recall Index insights keep you up-to-date with recall trends, while our blogs and Expert Spotlight provide timely information from industry specialists.Subscribe Now
Stericycle Expert Solutions focuses on helping customers by providing proven, customer-centric, scalable services that protect people and brands, promote health and safeguard the environment.Find Out More
If you're ready to get started with our extensive suite of services then contact us today. We have a team of experts ready to assist you!Contact Us today