The European Medicines Agency (EMA) recently issued a press release to announce it has confirmed prior recommendations to suspend ranitidine from the market. The statement came after one of the drug makers selling the generic Zantac requested the EMA re-examine its decision to ban the drug in April 2020.
What is Zantac?
Zantac (generic name ranitidine hydrochloride) is used to treat gastroesophageal reflux disease (GERD), Zollinger-Ellison syndrome, and any other acid reflux condition in the stomach. The said drug can also be taken to treat ulcers and heartburn. GlaxoSmithKline, a European pharmaceutical company, first developed and patented Zantac.
Zantac has been in the market since 1983. It was made available in prescription and over-the-counter form. With its success in the U.S., it has become the first drug to make a billion. This year, the FDA already requested the manufacturers to withdraw the drug from the market immediately based on the result of their investigations involving its cancer-causing ingredient. However, some drug companies, including Sanofi-Aventis U.S., already made a voluntary recall of the drug last year. Moreover, other companies such as Walmart, CVS, Rite Aid, and Walgreens decided to remove the product from its shelves in 2019.
- Related: Sanofi Accused of Deleting Emails Tied to Zantac Recall Due to Deadly NDMA Cancer Impurities
What is NDMA?
The carcinogen in question is known as N-Nitrosodimethylamine or NDMA. The chemical has been found to cause cancer since the 1970s if taken in high amounts. It can affect the breasts, gastrointestinal tract, lungs, thyroid, ovaries, cervix, testicles, and prostate. NDMA is a very common contaminant and can be easily found in our food and water in very low doses.
The Centers for Disease Control and Prevention (CDC) has constantly warned the public about NDMA, even in low doses. However, after a series of tests and studies, the FDA stated that a daily intake of 96 ng of NDMA is not harmful to our bodies. Furthermore, the FDA emphasized that it is vital not to exceed the 96 ng daily limit.
What Happens Next?
Thousands of Zantac lawsuits are now being pursued by former users of the medication diagnosed with breast cancer, testicular cancer, kidney cancer, stomach cancer, and other health problems following years of exposure to NDMA in Zantac.
Given common questions of fact and law raised in complaints filed throughout the federal court system, the Zantac litigation has been centralized and consolidated in the U.S. District Court for the Southern District of Florida, where the cases are being overseen by U.S. District Judge Robin L. Rosenberg during coordinated discovery and pretrial proceedings.