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FDA Warns Against Zantac Due to Cancer Risks

Many drugmakers pulled Zantac months ago when initial reports began linking Zantac with cancer. The Food and Drug Administration (FDA) recently instructed consumers to throw out any Zantac medications that they have.

The FDA also requested companies to stop selling Zantac after finding that the cancer-causing contaminants can build up in Zantac when it is stored for an extended period of time. The agency also requested that people who take Zantac in prescription form speak with their physician about alternatives before discontinuing treatment.

Initial Requests to Withdraw Zantac

Many manufacturers pulled their Zantac (ranitidine) products from availability months ago when initial concerns were raised by an outside pharmacy. Around the same time, major pharmacy chains like CVS, Rite Aid, and Walgreens discontinued the sale of all Zantac products.

The FDA stated that a contaminant that was a type of nitrosamine known as N-nitrosodimethylamine (NDMA) can likely cause cancer in humans. Besides Zantac, other potential NDMA sources include beer, chewing tobacco, cosmetics, cured meats, fish, tobacco smoke, and other toiletry products.

In a statement following the FDA’s announcement, the Sanofi company, which manufactures Zantac, stated that it recalled the product in October 2019 and that consumers and retailers were instructed to either destroy or return the product.

This recall came after Zantac has been available as an over-the-counter medication for 20 years.

The FDA’s Zantac Investigation

The FDA investigation into Zantac was motivated in part by the online pharmacy, Valisure, which petitioned the agency to request the recall of all products containing ranitidine.

Valisure argued that its tests had found that Zantac and other products with ranitidine contained dangerously high levels of NDMA that were well above the FDA’s acceptable daily limit. Valisure tests medications that it sells for quality. Zantac was one of the first medications the company tested because a co-founder’s infant daughter had been prescribed it in syrup form.

While testing the product, Valisure speculated that the source of NDMA was due to the “inherent instability” of the ranitidine molecule, which under high temperature can degrade and create NDMA. At first, the FDA fought Valisure over the company’s testing methods and argued that the results were invalid because the company heated the product.

The FDA Changes Position to Support Valisure

Only last week, the company confirmed Valisure’s findings and commented that the impurity in some products containing ranitidine increases over time when the medication is stored at higher than room temperature.

To help gain a better understanding of the dangerous nature of the product, Valisure is also currently researching what the long-term effects of taking the medication are. The founder and chief executive of Valisure has since expressed contentedness with the role that Valisure played in the recall of Zantac.

Speak with a Defective Drug Attorney Today

If you or a loved one is experiencing adverse side effects as a result of Zantac, you should not hesitate to speak with a knowledgeable defective drug attorney. Contact Cohen & Jaffe, LLP today to schedule a free case evaluation.

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