FDA Requests Removal of Zantac From the Market Immediately
On April 1st, the Food and Drug Administration (FDA) announced its request for all prescription and over-the-counter ranitidine drugs to be removed from the market immediately. This decision was made based on an ongoing investigation of possible carcinogenic effects of the contaminant N-nitrosodimethylamine, or NDMA. Here, the pharmaceutical liability attorneys at Peter Angelos, P.C. discuss the FDA’s investigation of ranitidine drugs, and health risks that the potentially carcinogenic contaminants pose to the public.
The FDA Has Prompted an Ongoing Investigation of NDMA As a Carcinogenic
NDMA, one of the contaminants found in ranitidine drugs, including Zantac, has been under investigation by the FDA since 2019. In a study by the World Health Organization (WHO), NDMA was considered a potent carcinogen to animals, and classified to be a probable carcinogen to humans. While low levels of NDMA are generally considered non-toxic to humans, sustained levels of NDMA in the body may lead to a higher risk of cancer. Due to the frequent use of ranitidine medications such as Zantac, usually taken 1-2 times per day, the FDA requests that consumers evaluate the potential risks associated with this drug and consider potential alternatives to this medication.
Additionally, after the initial investigation from third-party laboratories in 2019, the FDA evaluated and prompted these laboratories to conduct additional research. This research showed that levels of NDMA significantly increased in ranitidine medicines such as Zantac, even under normal storage conditions, manufacturing and general handling by consumers. Prior to the requested removal of Zantac from the market, two other corporations including Appco Pharma, LLC and Northwind Pharmaceuticals voluntarily recalled their products containing NDMA from the market due to potential carcinogenic risks to consumers.
Consumers Should Dispose of Medications Containing NDMA Properly
With the announcement of the removal of ranitidine drug Zantac from the market, the FDA has also sent letters to all other manufacturers of ranitidine requesting they withdraw their products from the market. Consumers who currently have access to Zantac or similar medication containing NDMA should dispose of any medication that they currently have, and not buy more until further notice. In light of the current COVID-19 pandemic, the FDA recommends that consumers not take these medications to a drug take-back location, but rather, follow instructions on the medication’s information packet to properly dispose of these medications at home. It is also recommended that you consult your healthcare provider to discuss alternative options for over the counter medications. The FDA has stated that they will continue to provide updates as this investigation proceeds, ensuring that only safe, high-quality drugs are available on the market.
Seek Help With a Pharmaceutical Liability Attorney at Peter Angelos, P.C.
With the array of over-the-counter medication currently on the market, it is important for companies to continuously monitor the safety of their products, and communicate potential risks to consumers. Zantac and other ranitidine medications have been found to contain an unsafe level of NDMA, a potential carcinogen, and may result in adverse health consequences for consumers. If you or a loved one has concerns about the potential effects of Zantac on your health, schedule a free consultation with the Law Offices of Peter Angelos P.C. today.