On April 1, 2020, the U.S. Food and Drug Administration (FDA) asked manufacturers of over-the-counter ranitidine medications to withdraw their products from the market immediately. The FDA also advised consumers to stop taking Zantac and other ranitidine drugs right away, encouraging them to safely dispose of any pills or tablets they may have and refrain from buying more.
Since last fall, ranitidine drugs, particularly the brand-name medication, Zantac, have been under intense federal scrutiny. On September 19, 2020, the online pharmacy, Valisure, sent a citizen’s position the FDA, urging the federal agency to investigate Zantac and its generic versions.
According to the complaint, Zantac and other ranitidine medications exhibited extremely high levels of N-nitrosodimethylamine (NDMA), which is classified as a probable human carcinogen or a substance that could cause cancer. FDA testing revealed that many brands had ranitidine levels that were well above the recommended daily intake.
Ranitidine is an H2 (histamine-2) blocker used to relieve and prevent heartburn. Most people know ranitidine by the name Zantac. This popular brand-name heartburn medication is sold worldwide and manufactured and distributed by a company called Sanofi.
Zantac was first recalled in October “due to inconsistencies in preliminary test results,” and an association with NDMA.
NDMA is an environmental contaminant we come into contact with every day. It can be found in water, dairy products, vegetables, and grilled meats, but we are typically exposed in small doses. Small amounts of NDMA are not harmful and largely unavoidable, but the pollutant can build up over time and has the potential to cause cancer.
Levels of NDMA in Zantac exceeded the permissible daily intake levels of NDMA, originally set by the FDA.
Taking Zantac once or twice should not expose you to dangerous levels of NDMA, but if you’ve been taking the medication for over a year, you may want to speak to an attorney about your legal options.
Even if you haven’t been diagnosed with cancer, NDMA buildup could increase your risk of the disease significantly.
At Goodman Acker, P.C., we find this unacceptable and are prepared to take action against Sanofi.
Your initial consultation will be free, and we look forward to hearing your story.
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