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What is Ranitox Syrup used for?: Understanding the Recalled Medication

4 min read

In April 2020, the U.S. Food and Drug Administration (FDA) requested the withdrawal of all ranitidine drugs, including branded syrups like Ranitox, due to the presence of a probable human carcinogen. This crucial safety action means the question, What is Ranitox Syrup used for?, now primarily relates to a medication that is no longer available.

Quick Summary

Ranitox Syrup was formerly used to treat and prevent excess stomach acid issues like heartburn and ulcers. It was recalled globally because it was found to contain unsafe levels of a potential carcinogen, N-nitrosodimethylamine (NDMA). Safer alternatives are now widely available for these conditions.

Key Points

  • Ranitox was a ranitidine-based syrup. Before its recall, Ranitox Syrup was used to treat conditions caused by excess stomach acid, including heartburn, ulcers, and GERD.

  • The medication was globally recalled due to NDMA contamination. In April 2020, all ranitidine products were voluntarily removed from the market due to unacceptable levels of N-nitrosodimethylamine (NDMA), a probable carcinogen.

  • NDMA levels in ranitidine increased over time. Testing revealed that the impurity, NDMA, could form and increase to unsafe levels as the product was stored.

  • Safer alternatives are available. Alternative H2 blockers like famotidine (Pepcid) and proton pump inhibitors (PPIs) like omeprazole (Prilosec) are now recommended for patients who previously used ranitidine.

  • Proper disposal is necessary for any remaining product. The FDA advises anyone with ranitidine products to dispose of them safely and not to continue using them.

In This Article

Ranitox: A History of Use Before Recall

Before its global recall, Ranitox Syrup was a brand-name medication containing the active ingredient ranitidine. Ranitidine belonged to a class of drugs known as histamine-2 (H2) receptor antagonists, or H2 blockers. Its primary function was to reduce the amount of acid produced by the stomach, thereby treating a range of acid-related conditions. The drug was available by both prescription and over-the-counter (OTC) formulations, though its widespread availability ceased in 2020 following the FDA's request for its removal from the market.

Some of the specific conditions that Ranitox Syrup was previously used for include:

  • Gastroesophageal Reflux Disease (GERD) and Heartburn: Ranitidine was commonly used to relieve and prevent the symptoms of acid reflux, such as heartburn and indigestion.
  • Stomach and Intestinal Ulcers: It was prescribed for both the short-term treatment and the long-term maintenance therapy of duodenal and gastric ulcers, helping to heal the affected tissue.
  • Zollinger-Ellison Syndrome: For rare conditions involving pathological hypersecretion of stomach acid, Ranitox was used to manage the excessive acid production.
  • Erosive Esophagitis: The syrup was also indicated for the treatment of esophagitis, which is the inflammation of the esophagus caused by stomach acid.

The Unacceptable Risk: Why Ranitox Was Recalled

In September 2019, an independent laboratory detected a chemical called N-nitrosodimethylamine (NDMA) in ranitidine products. NDMA is classified as a probable human carcinogen, meaning it could potentially cause cancer. Initially, the FDA believed the levels were low, but further investigation revealed a critical problem. The NDMA levels were found to increase over time, especially when the medication was stored at higher than room temperatures.

This meant that even if a product had safe levels of NDMA when it was manufactured, it could accumulate dangerous levels by the time a patient consumed it. As a result, in April 2020, the FDA determined it could no longer guarantee the safety of these products and requested that all ranitidine manufacturers withdraw their products from the market immediately. The subsequent withdrawal included all ranitidine formulations, including syrups like Ranitox, capsules, and tablets, both prescription and OTC.

What are the Modern Alternatives to Ranitox?

Because Ranitox and all other ranitidine products are no longer available, patients need to explore safer, FDA-approved alternatives for treating acid-related conditions. Fortunately, several other classes of medication are available. The FDA has tested many of these alternatives, including other H2 blockers and proton pump inhibitors, and has found no NDMA contamination to date.

Your healthcare provider can recommend the best option based on your specific condition and medical history. Alternatives fall into a few primary categories:

Other H2 Blockers

These medications work in a similar way to ranitidine by blocking the histamine-2 receptors that signal the stomach to produce acid. Safer options include:

  • Famotidine (Pepcid, Zantac 360): Available in both over-the-counter and prescription strengths, famotidine is a common replacement for ranitidine.
  • Cimetidine (Tagamet HB): An older H2 blocker that is also available over-the-counter.

Proton Pump Inhibitors (PPIs)

PPIs are generally stronger acid blockers than H2 blockers and are often used for more severe or chronic acid-related conditions like GERD and erosive esophagitis. They work by blocking the proton pump, the final step of acid production. Common PPIs include:

  • Omeprazole (Prilosec): Widely available over-the-counter and by prescription.
  • Esomeprazole (Nexium): Available over-the-counter and by prescription.
  • Lansoprazole (Prevacid): Also available over-the-counter and by prescription.

Antacids

For immediate, occasional relief of heartburn, antacids can be used. They work by neutralizing stomach acid and are not for long-term use. Common examples include Tums and Rolaids.

Ranitox vs. Common Alternatives

Feature Ranitox (Ranitidine) Famotidine (Pepcid, Zantac 360) Omeprazole (Prilosec)
Drug Class H2 Blocker H2 Blocker Proton Pump Inhibitor (PPI)
Mechanism Reduces stomach acid production by blocking H2 receptors Reduces stomach acid production by blocking H2 receptors Blocks the proton pump to stop acid production
NDMA Contamination Yes, recalled in 2020 No NDMA contamination found No NDMA contamination found
Availability No longer available Widely available OTC and prescription Widely available OTC and prescription
Onset of Action Provides relief within 30-60 minutes Provides relief within 30-60 minutes May take 1-4 days for full effect, not for immediate relief
Duration of Relief Longer than antacids, but shorter than PPIs Provides relief for up to 12 hours Longest-lasting relief for chronic symptoms
Primary Use Formerly used for heartburn, GERD, and ulcers Occasional and chronic heartburn, GERD Chronic heartburn, GERD, and healing ulcers

Conclusion

Understanding what is Ranitox Syrup used for? provides context for its history as a medication for acid-related conditions. However, the critical takeaway is that this product, and all ranitidine-based medications, were recalled due to the presence of a probable carcinogen. Patients who once relied on Ranitox should not seek out or use expired products, but instead consult a healthcare professional. A number of safe, effective, and readily available alternatives, including other H2 blockers and PPIs, are now the standard of care for treating conditions formerly managed with ranitidine. For additional details regarding the recall and medication safety, the FDA's website is a reliable source of information.

Frequently Asked Questions

No, Ranitox Syrup and all other medications containing the active ingredient ranitidine were globally recalled in April 2020 and are no longer available for purchase.

NDMA stands for N-nitrosodimethylamine, a substance classified as a probable human carcinogen. The NDMA levels in ranitidine were found to increase over time and could pose a cancer risk to consumers.

You should stop taking the medication immediately and dispose of it properly. The FDA advises patients to consult with their healthcare provider about safe and appropriate alternative treatments.

Safe alternatives include other H2 blockers like famotidine (Pepcid, Zantac 360) and proton pump inhibitors (PPIs) like omeprazole (Prilosec) or esomeprazole (Nexium). Your doctor can help determine the best option for your condition.

While many alternatives are available over-the-counter, you should talk to your healthcare professional before stopping any medication or starting a new one, especially if you have an underlying medical condition.

No. The old Zantac contained ranitidine and was recalled. The new Zantac 360 is a reformulated product that contains famotidine, a different and safe H2 blocker.

The FDA has tested several alternatives, including famotidine (Pepcid) and omeprazole (Prilosec), and has not found NDMA contamination in these products to date.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.