Recently, multiple ranitidine and Zantac manufacturers recalled their products due to concerns that they contain high levels of NDMA, a likely carcinogen.
What Is Zantac (Ranitidine)?
Zantac, the most popular brand of ranitidine, is used to help reduce stomach acid. The medication is commonly prescribed to treat ulcers, gastroesophageal reflux disease (GERD), chronic indigestion, and Zollinger-Ellison syndrome. It comes in both over-the-counter and prescription strengths that may be taken by mouth or administered via injection into muscle or vein.
Ranitidine belongs to a class of drugs known as H2 blockers that work by reducing the amount of acid in the stomach produces. H2 receptors are present on the cells in the stomach lining. A histamine chemical normally stimulates these receptors to produce acid to the body help digest food. Ranitidine blocks these receptors, and prevents histamine from producing its normal effect, which causes the stomach to produce less acid.
The manufacturers of Zantac and generic ranitidine products have warned patients and healthcare providers about the following potential side effects, but to this day have never warned about any potential exposure to a carcinogen:
Contamination of Zantac with Carcinogenic Chemical NDMA
Valisure, an online pharmacy that regularly tests the drugs it sells, detected levels of dimethylformamide (DMF) in blood pressure back in the spring of 2019. DMF is a solvent that can form nitrosamine impurities like N-Nitrosodimethylamine (NDMA) – which is classified by the World Health Organization (WHO) and the International Agency for Research on Cancer (IARC) as a probable carcinogen.
The FDA had been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure drugs since July 2018, and had recommended numerous recalls after discovering unacceptable levels of these contaminants.
Valisure’s testing found NDMA levels in ranitidine pills at “extremely high levels” in excess of 3,000,000 ng per tablet. The FDA’s established permissible daily intake of the toxin is 96 ng. On September 9, 2019, Valisure submitted a citizen petition to the FDA, requesting they take action to protect public health, including recalling all ranitidine products in the U.S. due to the concerns.
On September 13, 2019, the FDA published a safety communication warning that some ranitidine medicines, including Zantac, had tested positive for N-Nitrosodimethylamine (NDMA) in the lab.
Soon after that, Sandoz, a generic maker of the drug, recalled 14 lots of ranitidine hydrochloride capsules because of confirmed contamination of NDMA above levels deemed safe by the FDA. Those lot numbers are listed on the FDA’s news site. Other generic makers like Glaxo-Smith-Kline and Dr. Reddy’s Laboratories stopped shipping their ranitidine products but stopped short of implementing any recalls.
Types of Injuries Associated with Zantac
Because of the complexity involved in determining if you have a case against these manufacturers, it’s important you contact one of our Zantac attorneys today. You could be entitled to financial restitution for lost wages, unpaid medical bills, pain and suffering, and a loss of quality of life due to the defendant’s failure to warn healthcare providers and the public about the dangers of taking Zantac, and did not reveal that Zantac could produce NDMA in the human body. We have helped many in similar situations and we can help you begin the process. Our experienced legal team can evaluate your specific case with no out-of-pocket cost to you—the evaluation is free.