The FDA announced earlier this month that it is requiring manufacturers of prescription and over-the-counter (OTC) ranitidine-containing drugs to remove the drugs from the market, effective immediately. The FDA’s decision marks the latest step in an ongoing investigation into the presence of a carcinogen known as N-Nitrosodimethylamine (NDMA), which has been found in ranitidine medications. These medications, commonly known by the brand name Zantac, are widely used to treat heartburn and certain stomach and throat problems and there have been increasing concerns about the potential for the tainted medications to expose users to an increased risk of cancer. If you have been diagnosed with bladder cancer, esophageal cancer, colon cancer or another type of cancer, and you believe ranitidine or Zantac to be the cause, contact a knowledgeable Zantac cancer lawyer as soon as possible to discuss your legal options.
Ranitidine (Zantac) is an antacid medication approved by the FDA to treat and prevent heartburn. The drug is also used to treat stomach ulcers, gastroesophageal reflux disease (GERD) and conditions associated with too much acid in the stomach. Ranitidine belongs to a group of drugs called histamine-2 (H2) blockers, which work by reducing the amount of acid produced by the stomach. Prior to the wave of recalls, Zantac and its generic ranitidine were used by millions of people across the United States to treat and prevent heartburn, acid reflux and other common stomach acid-related conditions. Now, many of these people are pursuing lawsuits against the manufacturers of Zantac and generic ranitidine products, alleging that they developed cancer due to exposure to N-Nitrosodimethylamine (NDMA). NDMA is considered a probable human carcinogen, which means consumers exposed to NDMA in ranitidine products may face an increased risk of cancer.
The FDA’s ranitidine market withdrawal request was released on April 1, after the agency determined that the NDMA in some ranitidine products “increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity.” Prior to the withdrawal request, the FDA issued a statement in September 2019, warning consumers and the medical community about the detection of NDMA in ranitidine (Zantac) medications. According to the statement, the FDA had tested numerous ranitidine products and found NDMA at low levels, but FDA officials did not deem it necessary at that time to recommend that consumers stop taking ranitidine.
New testing, however, confirms that “NDMA levels increase in ranitidine even under normal storage conditions, and NDMA has been found to increase significantly in samples stored at higher temperatures, including temperatures the product may be exposed to during distribution and handling by consumers.” In this new statement, which highlights concerns about the potential risk of NDMA exposure, the FDA also notes that the older a ranitidine drug product is, or the longer it has been since the drug was manufactured, the greater the level of the carcinogen. According to the FDA, “These conditions may raise the level of NDMA in the ranitidine product above the acceptable daily intake limit.”
Since the FDA’s warning in September 2019, nearly every version of ranitidine and Zantac has been recalled due to concerns about the cancer-causing impurity. And now, as a result of the FDA’s ranitidine market withdrawal request, ranitidine products will no longer be available for new or existing prescriptions or for OTC use anywhere in the United States. The FDA sent letters to all manufacturers of ranitidine products requesting that they remove their products from the market, effective immediately. According to the agency, consumers taking prescription ranitidine should discuss other treatment options with their healthcare providers and those taking OTC ranitidine should stop taking the drug, dispose of it properly and find another approved OTC product that does not carry the same risks from NDMA exposure.
In the midst of the Zantac/ranitidine recalls, serious concerns have been raised about the risk of exposure to NDMA in other pharmaceutical drugs, as a number of popular medications have been found to contain the carcinogen at potentially toxic levels. In the year leading up to the ranitidine recall, NDMA was found in several popular angiotensin II receptor blockers used to control high blood pressure and treat heart failure in patients, including valsartan (brand name Diovan), losartan (Cozaar) and irbesartan (Avapro). Several months after ranitidine was recalled in September, the FDA also recalled several lots of nizatidine (Axid), an antacid that is similar to ranitidine in chemical structure and was also found to contain trace amounts of NDMA. And just last month, the independent pharmacy Valisure identified high levels of NDMA in metformin, a prescription drug used to control high blood sugar in patients with Type 2 diabetes.