The Zantac Recall and What You Can Do About GERD
Zantac is one of the most commonly prescribed medications for gastroesophageal reflux disease/GERD or chronic acid reflux. While most patients experiencing occasional reflux can do quite well with antacids, like Tums, once acid reflux turns chronic, it becomes more difficult to manage and requires medical intervention. Typically, patients were put on one of two medications – both of which are available over the counter:
- H2 antagonists that block the histamine receptors in the stomach to reduce the amount of acid produced. Common brand names are Zantac (ranitidine) and Pepcid
- Proton Pump Inhibitors (PPIs) like omeprazole also block the production of acid in the stomach – brand names of omeprazole are Prilosec and Zegerid
Both options can be effective for many patients as a first line of defense against reflux.
What went wrong?
However, in September 2019, independent lab testing showed that there may be unacceptable levels of NDMA – a chemical classified as a probable human carcinogen – in ranitidine products. This information was reported to the Food and Drug Administration (FDA) and an investigation was opened. By early October, many retail pharmacies had already removed Zantac and generic equivalents from their shelves out of an abundance of caution. Last week, the FDA moved to recall all products containing ranitidine as a result of elevated levels of NDMA. The FDA discovered, through their own testing and that of third-party laboratories, that storing ranitidine in higher than room temperature conditions caused the concentration of NDMA to increase. Further, the longer the product is stored, the higher the concentration as well. While the chemical occurs in many foods and even water, its levels are very low and would not be expected to cause any adverse effects. However, the cumulative use of ranitidine over time may increase that risk to unacceptable levels.
What are the next steps?
The bottom line is that any products containing ranitidine will be or have already been removed from the shelves of stores and pharmacies throughout the country. It is likely that production will end permanently. The FDA also suggested that all patients taking Zantac or its generic equivalent should stop doing so immediately. Any excess product that patients may have around the house should be disposed of properly.
However, this is not a reason to be concerned. There are other products including H2 blockers such as Pepcid and Proton Pump Inhibitors (PPIs) like omeprazole that can be purchased over the counter and have an excellent track record of both safety and effectiveness. Speak to your doctor about the best way forward, if you have been relying on ranitidine for your management of GERD.
Treating the symptoms versus a Cure
The biggest issue with medical treatment of gastroesophageal reflux disease is that the medications taken to control it simply address the symptoms – they are not a cure for the underlying condition which can either be the weakness in the lower esophageal sphincter (LES) or a hiatal hernia. Regardless of the cause, many patients do not respond well to medical management. Some have trouble with the side effects, while others do not see significant improvement. In cases such as these, there are curative, surgical options to address GERD.
First, is the fundoplication, where the top of the stomach is wrapped around the lower part of the esophagus to add pressure to the LES. This can be performed as a full wrap – Nissen – or a partial wrap – Dor or Toupet.
The second option, known as the LINX Reflux Management System is an implanted device about the diameter of a quarter that looks much like a bracelet composed of titanium beads. This bracelet is placed around the LES and adds pressure to keep it closed when food or drink is not being consumed.
Many patients who are not suitable candidate for medical management may benefit immensely from either of these procedures. Each has its own benefits and risks and can be discussed during your consultation. Please contact us to learn more about your surgical options for the treatment of GERD.