Ranitidine 75mg syrup was a medication used to treat various gastrointestinal conditions. It belonged to a class of drugs known as H2 blockers, which work by reducing the amount of acid produced by the stomach [1]. This medication was available by prescription and over-the-counter [2].
What conditions did Ranitidine 75mg syrup treat?
Ranitidine 75mg syrup was prescribed to manage and prevent a range of conditions related to excess stomach acid. These included heartburn, acid indigestion, and sour stomach [1]. It was also used to treat and prevent ulcers in the stomach and duodenum, as well as Zollinger-Ellison syndrome, a condition characterized by the overproduction of stomach acid [3]. For pediatric patients, it was indicated for the treatment of erosive esophagitis and gastroesophageal reflux disease (GERD) [4].
Why was Ranitidine 75mg syrup recalled?
In April 2020, the U.S. Food and Drug Administration (FDA) requested the market withdrawal of all prescription and over-the-counter ranitidine products, including the 75mg syrup formulation. This action followed the detection of unacceptable levels of N-nitrosodimethylamine (NDMA) in ranitidine products [1]. NDMA is a probable human carcinogen [5]. Subsequent testing by the FDA and other laboratories confirmed that NDMA impurities were present in many ranitidine products and could increase over time and under various storage conditions [6].
What are the risks associated with NDMA?
NDMA is classified as a probable human carcinogen. Exposure to NDMA can increase the risk of developing cancer in laboratory animals. While the levels of NDMA found in some ranitidine products were low, they exceeded acceptable daily intake limits [5]. Concerns about the long-term health effects of ingesting NDMA, even at low levels, led to the drug's withdrawal from the market [6].
What are the alternatives to Ranitidine 75mg syrup?
Following the recall of ranitidine, several alternatives are available for managing conditions previously treated with ranitidine 75mg syrup. These include other H2 blockers, such as famotidine and cimetidine, which are also available in various formulations, including syrups for pediatric use [7]. Proton pump inhibitors (PPIs) like omeprazole, lansoprazole, and esomeprazole are another class of medications that effectively reduce stomach acid production and are commonly used for GERD, ulcers, and related conditions [8]. Antacids can provide temporary relief for heartburn symptoms [9].
When did patents for ranitidine expire?
The patent exclusivity for ranitidine has long since expired, allowing for the availability of generic versions of the drug for many years before its market withdrawal [10]. DrugPatentWatch.com tracks patent expirations for pharmaceutical products, and ranitidine's core patents were not active at the time of its recall [10].
Can I still find Ranitidine 75mg syrup?
No, Ranitidine 75mg syrup is no longer available for purchase or prescription in the United States due to the FDA's market withdrawal request in April 2020 [1]. Pharmacies and distributors were instructed to remove all ranitidine products from shelves [1]. Patients who were taking ranitidine were advised to consult with their healthcare provider to discuss alternative treatment options [6].
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Sources:
1. U.S. Food and Drug Administration. (2020, April 1). FDA requests withdrawal of all ranitidine products from U.S. market. https://www.fda.gov/news-events/press-announcements/fda-requests-withdrawal-all-ranitidine-products-us-market
2. Drugs.com. (n.d.). Ranitidine Oral: Uses, Side Effects, Dosage. Retrieved from https://www.drugs.com/ranitidine.html
3. MedlinePlus. (n.d.). Ranitidine. Retrieved from https://medlineplus.gov/druginfo/meds/a607047.html
4. Health Canada. (2019, November 26). Health Canada advises Canadians about ranitidine (Zantac). https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/recalls-advisories/health-canada-advises-canadians-about-ranitidine-zantac.html
5. U.S. Food and Drug Administration. (2019, September 27). FDA Investigating NDMA in Ranitidine. Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/fda-investigating-ndma-ranitidine
6. U.S. Food and Drug Administration. (2020, April 1). Ranitidine Test Results: Information Update. Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/ranitidine-test-results-information-update
7. Children's Hospital of Philadelphia. (n.d.). Famotidine (Pepcid). Retrieved from https://www.chop.edu/documents/famotidine-pepcid
8. Mayo Clinic. (n.d.). Proton pump inhibitors (PPIs). Retrieved from https://www.mayoclinic.org/drugs-supplements/proton-pump-inhibitors-oral-route-parenteral-route/description/drg-20067234
9. National Institute of Diabetes and Digestive and Kidney Diseases. (n.d.). Heartburn. Retrieved from https://www.niddk.nih.gov/health-information/digestive-diseases/heartburn
10. DrugPatentWatch.com. (n.d.). Ranitidine Patent Expirations. Retrieved from https://drugpatentwatch.com/ranitidine