FDA Announces Public Recall of Zantac & Other Ranitidine Medications
By Snyder Sarno D'Aniello Maceri & da Costa LLC on April 08, 2020
Last week, the U.S. Food and Drug Administration (FDA) announced a public recall of all over the counter Ranitidine drugs. Ranitidine is a popular ingredient in antacids and operates by reducing the amount of acid within the stomach. Histamine-2 blockers (like ranitidine) reduce the acid along the lining of the stomach and are used to treat a variety of conditions, like heartburn or conditions causing over acidity within the stomach and lining. While the intended effects of ranitidine are altruistic in nature, the medications chemical composition possess the ability to break down into far more dangerous compositions. Problems arise when the medication is stored above room temperature where the components of the medication break down or decompose.
Ranitidine is the generic name of a drug more popularly known as Zantac. Ranitidine or ranitidine hydrochloride (C13H22N4O3S) breaks down under certain temperatures and creates nitrosodimethylamine ((CH3)2NNO) also known as NDMA. The reaction to the increase in temperature breaks down the molecules and rearranges the chemical composition. While the exact reaction that occurs has not been definitively determined the end result is a combination of materials including newly formed NDMA. NDMA is a suspect carcinogen, the threat is substantiated enough where the FDA decided to take action.
Recent FDA testing confirms that, “NDMA levels increase in ranitidine even under normal storage conditions, and NDMA has been found to increase significantly in samples stored at higher temperatures, including temperatures the product may be exposed to during distribution and handling by consumers. The testing also showed that the older a ranitidine product is, or the longer the length of time since it was manufactured, the greater the level of NDMA.” (FDA.gov) The FDA testing did however clear several medications that treat similar symptoms without the Ranitidine as the main ingredient, that list includes Pepcid, Tagamet, Nexium, Prevacid and Prilosec.
Since the release of this information an influx of lawsuits have been filed against the drug manufacturers. The suits claim that the manufacturers were aware that NDMA was being created by ranitidine but that they neglected to disclose that information to consumers. Without disclosing this information consumers were inadvertently poisoning themselves with a possible carcinogen for quite some time while major manufacturers financially benefited from their consumers' innocence and trust.
If you feel that you or a loved one may be the victim of NDMA poisoning from a ranitidine product please contact Paul M. da Costa, Esq. at Snyder Sarno D’Aniello Maceri & da Costa LLC today. You can schedule a consultation via email (firstname.lastname@example.org) or call us at (973) 274-5200. Our product liability team, led by Paul M. da Costa, Esq., is more than capable to answer any questions about your case.
Mr. da Costa has handled a vast array of product liability, medical malpractice and personal injury cases. Through his tenacious and diligent advocacy, Mr. da Costa makes it his priority to “right the wrongs” that have been forced upon his clients. Mr. da Costa is not afraid to take cases to trial because he is a firm believer that pursuing the truth through litigation will prevent potential future wrongs. For a sampling of some of his seven figure verdicts click here. Paul M. da Costa and his team work tirelessly fighting aggressively to provide their clients with the strategic legal representation required to obtain substantial verdicts and settlements.
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 United States Federal Food and Drug Administration: https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market
 Medpagetoday.com: https://www.medpagetoday.com/special-reports/exclusives/82550
 US National Library of Medicine National Institutes of Health: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4123930/
 Harvard University Medical School: https://www.health.harvard.edu/blog/popular-heartburn-drug-ranitidine-recalled-what-you-need-to-know-and-do-2019092817911
 Drugs.com: https://www.drugs.com/ranitidine.html
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