The Zantac Recall and What You Can Do About GERD
Zantac (generic name ranitidine) is a common antacid which has been in use for years. It belongs to the same class at Pepcid, Tagamet, and Axid. It is a different class of drug as Prilosec, Protonix, Dexilent, and Nexium. Zantac has IV and oral forms. It has been used for the treatment of GERD/heartburn, ulcers, gastritis.
The Food and Drug Administration recently revealed that Zantac contains low levels of a cancer-causing contaminant known as N-Nitrosodimethylamine (NDMA). NDMA was previously identified in a blood pressure drug, leading to recalls. NDMA is associated with increased risk of cancers of the liver, stomach, bladder, kidney, and other organs. The risk is likely higher with prolonged exposure to NDMA. The agency determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures.
“We didn’t observe unacceptable levels of NDMA in many of the samples that we tested. However, since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.
On April 1, 2020 Food and Drug Administration requested manufacturers to withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. The FDA also advised consumers taking OTC ranitidine to stop taking any tablets or liquid they currently had, dispose of them properly and not buy more. They also advised patients taking prescription ranitidine to speak with their health care professional about other treatment options before stopping the medicine, as there are multiple drugs approved for the same uses as ranitidine that do not carry the same risks from NDMA. To date, the FDA’s testing has not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).
At Advanced Bariatric and Surgical Specialists, we hope to get patients off all antacids. Antacids have been recognized to have multiple side effects like bone loss/deterioration, kidney problems, clostridium difficile-associated diarrhea and low B12 levels. In addition, antacids do not stop the underlying problem, they simply reduce stomach acid which may mask the problem.
One of the common procedures we perform is the TIF procedure (trans-oral, incisionless fundoplication). We use a scope down the mouth to fold the stomach onto itself and tighten the valve at the lower end of the esophagus. There are no incisions with this procedure. However, it does require general anesthesia. Patients are placed on a modified diet for 6 weeks afterwards. Most patients undergoing TIF have significant improvement or resolution of their reflux.
- US FDA Press Release, FDA Requests Removal of All Ranitidine Products (Zantac) from the Market. April 1, 2020
- Drugwatch website>Proton pump inhibitors>Prilosec.
- Cadière, G., Buset, M., Muls, V. et al. Antireflux Transoral Incisionless Fundoplication Using EsophyX: 12-Month Results of a Prospective Multicenter Study. World J Surg 32,1676–1688 (2008).
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