Dr. Reddy Halts Distribution of Generic Zantac Worldwide Over NDMA Contamination Concerns

While health officials are continuing to evaluate the potential cancer risk from Zantac, after carcinogenic impurities were found in certain forms of the heartburn medication, Dr. Reddy’s has announced that it is halting all distribution of generic Zantac.

Earlier this month, the FDA announced that certain forms of Zantac (ranitidine) may contain N-nitrosodimethylamine (NDMA), which is a probably human carcinogen that has been linked to a risk of liver cancer, stomach cancer, colorectal cancer, esophageal cancer and other digestive tract cancers.

As a result of the findings, Dr. Reddy’s Laboratories Limited decided to suspend distribution of ranitidine, according to a report by BusinessLine. Officials from Dr. Reddy’s indicate that the suspension will be in place at least until they get more detailed information from the FDA.

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Side effects of Zantac may increase the risk of cancer, due to chemical impurities found in the heartburn drug.

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It marks the second company to remove Zantac from the market over the last week, after Novartis subsidiary Sandoz announced it was also suspending Zantac distribution on September 18.

NDMA found in Zantac is the same chemical contaminant that has resulted in massive valsartan recalls over the past year, after changes to manufacturing processes caused the cancer-causing byproduct to taint much of the U.S. supply for the widely used blood pressure drug.

Zantac is part of a different class of medications, which is used to treat heartburn associated with acid indigestion, as well as stomach ulcers, gastroesophageal reflux disease (GERD) and other stomach acid production problems.

According to the FDA statement issued September 13, NDMA levels were detected by the online pharmacy Valisure based in New Haven, Connecticut, which detected levels of NDMA in Zantac that were 26,000 times higher than the FDA’s permissible intake limit of 96 nanograms per day.

Valisure issued a press release saying it believed the FDA should push for a full Zantac recall.

In a citizen petition filed earlier this month by Valisure, experts suggest that it is likely NDMA contaminated Zantac since the drug was first introduced, raising serious health concerns for consumers who have used the medication long-term.

The pharmacy is working with researchers from Stanford University, indicating that the ranitidine molecule was inherently unstable, and that instability results in the creation of NDMA during the manufacturing process.

While the drug makers continue to allow existing inventory of the heartburn drug to be stocked on store shelves, a number of lawyers are now reviewing potential Zantac cancer lawsuits for individuals who may have avoided a diagnosis if other heartburn treatments had been used.


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