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FDA Pulls Zantac

On April 1, 2020, the FDA announced its request for manufacturers of ranitidine products (Zantac) to immediately withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market. This is the most recent step in the ongoing investigation into N-Nitrosodimethylamine (NDMA) in ranitidine medication. Ranitidine is the common name of popular prescription and over the counter (OTC) drug, Zantac. The latest development comes after the agency determined that the impurity of NDMA in some ranitidine products increases over time and when the product is stored at higher than room temperatures, resulting in unsafe levels of the impurity.

Given the FDA’s announcement, ranitidine products will no longer be available for new or existing prescriptions or for OTC use in the United States. The FDA originally did not observe unacceptable levels of NDMA in ranitidine samples that were tested. However, as they did not know how long the product was or was going to be stored, they ultimately decided that the products should not be available to consumers and patients. NDMA is a probable human carcinogen, meaning that it is a substance that could cause cancer.

The FDA became aware of the presence of NDMA in ranitidine in the summer of 2019, but did not suspect that it could cause adverse health risks, given that low levels of NDMA is commonly ingested in foods and water. After further testing and evaluation prompted by third-party laboratories, the FDA confirmed that levels of NDMA in ranitidine increase over time and in normal storage conditions. Laboratory testing also revealed that NDMA levels in ranitidine are found to increase in samples stored at higher temperatures, even temperatures that the product is likely to be exposed to during distribution and handling by consumers.

The older a ranitidine product is or the longer the length of time since its production means that there is a greater level of NDMA impurity. The greater level of NDMA presence pushes it over the acceptable daily intake limit. The FDA is advising consumers to immediately stop taking OTC and prescription ranitidine products and to safely dispose of the medicines. Given the current COVID-19 pandemic, the FDA recommends patients and consumers to refrain from taking the ranitidine medicines to a drug take-back location and to instead follow the medication’s specific disposal instructions or the agency’s recommended steps to disposing of medication at home.

Additionally, the FDA advises patients taking prescription or OTC ranitidine medicines to contact a health care professional about other treatment options. If you or a loved one have taken ranitidine (Zantac) for heartburn, stomach ulcers, acid reflux, or similar conditions and developed cancer, you may be entitled to financial compensation. At Spiros Law, P..C., we represent clients who have been physically harmed by the use of Zantac, such as developing stomach, bladder, colorectal, liver, or esophageal cancers. If you have taken Zantac or another ranitidine product and believe it was the cause of your cancer, contact us today at (815) 929-9292 to receive a free consultation. Our physical offices are currently closed due to the Illinois “shelter-in-place” order, but our staff is still available to speak with over the phone, on email, and through online video meetings.