After a thorough investigation, the U.S. Food and Drug Administration (FDA) has requested that manufacturers immediately withdraw all prescription and over-the-counter (OTC) ranitidine medications, commonly known by the brand name Zantac, from the market. The FDA has taken this drastic and unusual step due to new testing and evaluations showing an increased cancer risk associated with use of ranitidine (Zantac).
It was discovered last summer that there were elevated levels of a possible cancer-causing chemical known as N-Nitrosodimethylamine (NDMA) in ranitidine (Zantac) medications. Although it did not pull the drugs from the market at that time, the FDA started to warn the public about the possible cancer risks from ranitidine (Zantac) in September 2019. Several drug makers then issued voluntary recalls of various ranitidine (Zantac) medications due to the potential risk.
So what prompted the FDA to advise pulling ranitidine (Zantac) products from the market?
More recent FDA testing confirmed that NDMA levels increase in ranitidine (Zantac) under normal storage conditions, and NDMA has been found to increase significantly in samples stored at higher temperatures. This includes temperatures that the product may be exposed to during normal distribution and handling by consumers.
The testing also showed that the older a ranitidine (Zantac) product is, or the longer the length of time since it was manufactured, the greater the level of NDMA is likely to be. All of these conditions can raise the level of NDMA in ranitidine (Zantac) products, increasing the risk of cancer.
While low levels of NDMA are sometimes ingested in food and water, exposure to higher levels of NDMA, like those found in the recent FDA testing of ranitidine (Zantac) products, can cause an increased risk of cancer.
Zantac and other ranitidine medicines are H2 (histamine-2) blockers used to treat heartburn, sour stomach and acid indigestion. Prescription strength ranitidine (Zantac) products are also used to treat and prevent ulcers and gastroesophageal reflux disease.
The FDA is advising consumers to stop taking and dispose of any over the counter ranitidine (Zantac) tablets or liquid that they currently have at home. The FDA is also advising patients who are taking prescription ranitidine to speak with their doctor about other treatment options, as there are many other drugs that can be used to treat the same conditions ranitidine (Zantac) has been used to treat. To date, the FDA’s testing has not found NDMA in those other drugs, including famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).
If you or a loved one developed cancer after taking ranitidine (Zantac), please contact the attorneys at Childers, Schlueter & Smith at 800-641-0098 or fill out our online contact form. All initial inquiries are free of charge and without obligation.
Focusing his practice on helping individuals harmed by pharmaceutical products and medical devices, Andy Childers has been named a 2018 Super Lawyer in the Class Actions/Mass Torts category—helping his clients receive settlements in excess of $250 million to date. In addition to mass torts, Mr. Childers handles cases for those suffering from Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN)—horrific allergic reactions that cause the person’s skin to slough off, and that can lead to blindness, permanent disability, or death.