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Updated Guidance From The FDA Regarding Ranitidine, Zantac

Here is what is known about the ranitidine Zantac cancer recall and what consumers need to do

Thursday, June 18, 2020 - The US Food and Drug Administration (FDA) has issued guidance for patients and health care workers regarding taking Zantac (ranitidine), the world's best-selling heartburn and acid reflux medication, prescribed by doctors over 15 million times per year. Several months ago, the FDA requested that Sanofi, the maker of Zantac and other ranitidine manufacturers voluntarily withdraw the product from the market in the United States both in over-the-counter and prescription form. The move left an unfulfilled need for those who depend on the drug to alleviate their acid reflux and heartburn symptoms.

The FDA has stated that it will consider allowing a company's ranitidine product back on to the US market only if the drug's manufacturer can demonstrate, "through scientific data, that their ranitidine product is stable and the NDMA levels do not increase over time to unsafe levels."

In response to the Zantac, ranitidine recalls hundreds of individuals with stomach, bladder, esophageal, prostate, breast, and other forms of cancer have contacted a Zantac attorney to see if they qualify to file a claim for the drug causing their life-threatening condition.

The catalyst for the ranitidine (Zantac) recall occurred when the FDA was alerted to the presence of elevated levels of N-nitrosodimethylamine (NDMA) in Zantac tablets tested by online drug testing pharmacy Valisure who sent a citizen's petition to the agency.

The FDA responded by conducting tests that confirmed the Valisure accusations and at the time presumed that the impurity was caused by increases in temperature and older drugs. According to the FDA, "Based on these findings, FDA has determined that many currently marketed ranitidine products could expose consumers to unacceptable health risks. All ranitidine products, including the oral liquid/syrup, will be withdrawn by their manufacturers and will not be available on the U.S. market."

Because ranitidine is an elective medicine for a non-lethal medical condition and not a life-saving treatment, the FDA is requesting that consumer stop taking over the counter ranitidine and dispose of any inventory of the drug they may have, as well as asking doctors to refrain from prescribing the medicine until further testing can be conducted. During the current Covid19 pandemic the FDA has issued special guidance about the drug's disposal and "recommend patients and consumers not take their medicines to a drug take-back location but follow the specific disposal instructions in the medication guide or package insert, or follow steps to safely dispose of these medications at home." This included injectable forms of ranitidine.

Consumers should speak by phone with their health care professional to inquire about alternative drugs and lifestyle changes that could alleviate their condition. Famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec), are all brand name antacid medications that have tested negative for NDMA are. Pepcid is also being touted as a potential treatment for Covid19, although no studies have been conducted yet.

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OnderLaw, LLC is a St. Louis personal injury law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. The Onder Law Firm has represented clients throughout the United States in pharmaceutical and medical device litigation such as Pradaxa, Lexapro and Yasmin/Yaz, where the firm's attorneys held significant leadership roles in the litigation, as well as Actos, DePuy, Risperdal and others. The Onder Law Firm has won more than $300 million in four talcum powder ovarian cancer lawsuits in St. Louis. Law firms throughout the nation often seek its experience and expertise on complex litigation.

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