Mid September saw the beginning of the FDA’s announcements regarding ranitidine medicines and their possible carcinogenic properties. Ranitidine is the active ingredient in the popular over the counter antacid medicine Zantac, causing widespread calls for pharmacies to pull the drug and generics from their shelves.
The Known Risks of Zantac
Due to the oral delivery of the drug, the largest risk to consumers is stomach, intestinal, and liver cancers, as that’s where the drug gets broken down. While ranitidine itself isn’t a carcinogen, research has found that it can break down into a substance called NDMA, which is a probable carcinogen and has clear health risks associated with it.
Prior to the findings in September that NDMA was showing up in samples at a higher rate than is safe for human consumption, it was known that trace amounts of the substance were present in the drug. It was believed and advertised at the time as a lesser amount than appeared in some commercial meats, and shouldn’t be considered a threat. Since the FDA began extensive testing of various forms of ranitidine, multiple manufacturers have ordered recalls of their generic versions of Zantac.
Current Ranitidine Recalls
- Sandoz: Issued a recall September 24, 2019 after impurities were found in their capsules.
- Apotex Corp.: Issued a recall of their ranitidine product September 23, 2019.
- Reddy’s Laboratories Ltd: Issued a recall in Mid-October, 2019
- Sanofi: Sanofi, manufacturer of Zantac, recalled the over-the-counter version of their drug on October 18, 2019
- Perrigo Company Plc: Recalled their over-the-counter tablets on October 23, 2019
- Novitium Pharma LLC: Recalled their ranitidine capsules on October 25, 2019
- Lannett Company, Inc.: Recalled their prescription syrup on October 25, 2019
- Aurobindo Pharma USA: Recalled their over-the-counter generic medicine on November 11, 2019
- Amneal Pharmaceuticals LLC: Recalled their prescription tablets and syrup on November 8, 2019
- American Health Packaging: recalled their ranitidine syrup, manufactured by Lannett Company, on November 8, 2019
What to Do If Currently Taking Prescription Ranitidine
The FDA is not currently recommending ending or changing plans for patients still taking a prescription antacid containing ranitidine. There are ranitidine alternatives, but changes should be made with the consultation of a doctor.
For over-the-counter ranitidine users, the FDA recommends considering alternative antacids that have shown no traces of NDMA. However, there could be dangers associated with these as well, so it’s important to talk with your doctor to understand the risks.
- Pepcid (famotidine)
- Tagamet (cimetidine)
- Nexium (esomeprazole)
- Prevacid (lansoprazole)
- Prilosec (omeprazole)
Not all ranitidine products are being recalled, since not all ranitidine products have shown dangerous levels of NDMA. If you are worried about the medications you are currently taking, keep an eye on the FDA’s page on Updates and Press Announcements on NDMA in Zantac (ranitidine).
If You Are Having Adverse Events Due to a Ranitidine Product
If you have been suffering from adverse side effects from taking a ranitidine product then you should seek medical assistance immediately to discuss options. You are also encouraged to fill out the FDA’s MedWatch Voluntary Reporting Form to ensure your symptoms are recorded and taken note of by the manufacturer.
Holding the Manufacturers Accountable
Only a small percentage of drugs ever successfully make it from development to market, meaning manufacturers of name-brand drugs spend huge amounts on research and development for drugs that may never turn a profit. This can make it tempting to cut corners during research to save money and get the drug on the market faster. Once they get on the market, generic manufacturers begin to study the formula for mass production.
Any risks should be found during the extensive testing drugs go through prior to entering the market, and when risks are missed this is a failure on behalf of the manufacturer.
When Sanofi released Zantac, despite the drug containing the potential to break down into a carcinogenic substance, it failed its consumers. Berman & Simmons is here to help hold them accountable.
If you or a family member has been diagnosed with cancer after taking Zantac, you might be entitled to compensation. Contact the attorneys at Berman & Simmons to learn more and discuss your case.