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Ranitidine Could Be Back On The Market In Canada If The Manufacturer Meets Certain Conditions

Sanofi is exercising caution until the reasons for the drug's NDMA problems are settled

Friday, December 4, 2020 - If one were to follow the money they would find that Sanofi, the maker of Zantac suffered a great financial loss when the best-selling heartburn drug was recalled. The company is said to have taken a $145 million loss as a result of no longer being able to sell the drug. The Wall Street Journal told readers that the company is working with the government to try and find the cause of NDMA contamination and that there were no plans to reintroduce the product in the US. Canada, however, is another story. Canada has taken the lead in readmitting ranitidine (Zantac) back into the market and it could be only a matter of time before the United States follows suit. Health Canada, the Canadian version of the Food and Drug Administration in the United States, recalled all ranitidine drugs both generic and brand name in October 2019, out of an abundance of caution when the agency learned of the potential risk to human health. Over 15 million people are prescribed Zantac every month to alleviate the symptoms of heartburn indigestion, acid reflux, and gastrointestinal disease. Zantac stomach cancer lawyers offer a free consultation and no obligation to Americans nationwide before filing a claim.

In 2019, Ranitidine was found to contain highly elevated levels of a deadly substance called N-nitrosodimethylamine (NDMA), thousands of times greater than the FDA's allowable limit of 96 nanograms per tablet, when tested by online testing pharmacy Valisure. The FDA called N-nitrosodimethylamine (NDMA) an "impurity" however, the compound is a known carcinogen. Research scientists inject N-nitrosodimethylamine (NDMA) into laboratory test animals to induce cancer tumors to be studied.

Heartburn and indigestion drugs are among the most popular sold to consumers over the counter and by prescription. Rather than ignore the problem Canada has taken steps to reintroduce ranitidine to consumers that need the medicine. "Health Canada has been evaluating the issue to identify potential causes and risk mitigation measures. Based on its evaluation, Health Canada permitted companies wishing to resume sales to do so provided they test every batch of ranitidine product before releasing it and regularly throughout its shelf life, to demonstrate that products do not contain higher than accepted levels of NDMA. Some companies resumed sales in January and February 2020. To sell ranitidine in Canada, drug companies must comply with the following instructions. "continue to test every batch of ranitidine product before releasing it and test it regularly throughout its shelf life; conduct more frequent testing if NDMA is detected within a certain range below the accepted limit, to enable faster detection of any increases in NDMA; conduct additional testing to evaluate the potential for NDMA formation under different storage conditions (e.g., above room temperature); and provide all of the above test data to Health Canada, along with any information to help further evaluate the potential formation of NDMA from ranitidine in the body."

Scientists in the government and the private sector are working to try and pinpoint how the Zantac NDMA contamination occurred and to fix the problem. Heartburn, acid reflux, and GERD are serious health problems that could lead to cancer if not treated properly. Individuals that have taken Zantac regularly for many years are filing lawsuits seeking monetary reimbursement for their expenses and pain and suffering.

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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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