January 9, 2020- Emery Pharma says that recent tests indicate that levels of NDMA – a known carcinogen – in Zantac can increase during storage, especially if the drug is exposed to high heat and even while it remains in the package. The researchers found that stored Zantac medication exposed to high heat can produce unacceptably high levels of NDMA in as few as five days.
Based on these findings, Emery Pharma has urged the FDA to recall Zantac and all similar ranitidine drugs. A Citizen Petition was filed by Emery Pharma, requesting that the FDA suspend sales and recall all ranitidine-based products due to the threat of NDMA exposure to consumers.
Valisure had filed a similar Citizen Petition early last October 2019 after its tests indicated that heat from manufacturing could create high levels of NDMA. According to Valisure, they tested a number of ranitidine-containing heartburn medications, and all of the batches tested, regardless of dose forms, “detected extremely high levels” of NDMA in every lot.
In response, the FDA asked drug-makers to test all batches of ranitidine-containing products that they produce to ensure consumers are not exposed to dangerous levels of NDMA.
Many of the manufacturers discontinued the production and sales of their ranitidine-containing drugs after conducting these tests.
Reference: Palmer, Eric. “Lab Finds NDMA in Zantac Can Develop during Storage.” FiercePharma, 3 Jan. 2020, https://www.fiercepharma.com/manufacturing/lab-finds-ndma-zantac-can-develop-during-storage-bloomberg.
Gayle Gerling Pettinga
Born and raised in Evansville, Gayle is a respected, experienced lawyer and a valued community leader. She graduated near the top of her class at Indiana University’s prestigious Maurer School of Law. She’s practiced law with one of the largest firms in Indianapolis as well as one of the largest pharmaceutical companies in the world. And that means she knows how big law firms and big companies think and how they operate – and she will put that knowledge to work for you.
Gayle has received numerous awards and honors including Martindale-Hubbell — Peer Review Rated: AV®, American Institute of Personal Injury Attorneys 10 Best Attorneys in Indiana for Exceptional and Outstanding Client Service, and YWCA Evansville 100 Years, 100 Women Honoree, 2011.
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