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What antacid was discontinued? The ranitidine (Zantac) recall explained

3 min read

In April 2020, the U.S. Food and Drug Administration (FDA) requested that all ranitidine products, including the popular brand-name Zantac, be pulled from the market. This action answers the question, what antacid was discontinued?, and followed an investigation that discovered a probable human carcinogen in the medication.

Quick Summary

The popular antacid ranitidine, sold under the brand name Zantac, was recalled and discontinued in 2020 after the FDA found it could contain increasing levels of a cancer-causing chemical, NDMA. The new product, Zantac 360, uses the active ingredient famotidine.

Key Points

  • Ranitidine (Zantac) was discontinued: The popular antacid ranitidine, known by the brand name Zantac, was removed from the market by the FDA in April 2020 due to contamination concerns.

  • NDMA was the contaminant: The medication was found to contain unacceptable and increasing levels of N-nitrosodimethylamine (NDMA), a probable human carcinogen.

  • NDMA levels increased over time: FDA testing determined that NDMA levels in ranitidine products could increase during storage, especially in higher temperatures, posing a growing risk to consumers.

  • The new Zantac is different: A new product, Zantac 360, was introduced with a different active ingredient, famotidine (the same as Pepcid AC), and is considered a safe alternative.

  • Safe alternatives are available: Safe alternatives to ranitidine include other H2 blockers like famotidine (Pepcid) and cimetidine (Tagamet), as well as Proton Pump Inhibitors (PPIs) like omeprazole (Prilosec).

  • Proper disposal is crucial: Unused ranitidine medication should be mixed with an unappealing substance like coffee grounds, sealed in a bag, and thrown in the trash, not flushed.

In This Article

The Ranitidine (Zantac) Recall

For decades, ranitidine was a widely used medication for treating heartburn and other acid-related conditions, available both over-the-counter and by prescription as Zantac and generic versions. However, this changed in 2019.

The Discovery and Initial Actions

The discontinuation of ranitidine began in September 2019 when NDMA, a probable human carcinogen, was detected in ranitidine products. Initially, voluntary recalls were issued for specific batches, and major retailers removed the product from shelves. A full market removal was not immediately mandated as the FDA conducted further testing.

The FDA's Conclusion and Market Withdrawal

By April 2020, FDA testing confirmed that NDMA levels in some ranitidine products could increase over time, particularly at higher temperatures. This posed a potential risk as the medication aged in storage. Consequently, the FDA requested the complete removal of all ranitidine products from the U.S. market, making them unavailable for purchase.

What is NDMA and Why is it a Concern?

NDMA is found in low levels in some foods and water and is considered a probable human carcinogen based on animal studies. The concern with ranitidine was the chemical's instability, which allowed NDMA levels to increase over time to potentially unsafe levels for long-term users.

Ranitidine Alternatives: Finding a Safe Substitute

Several safe and effective alternatives are available for those who previously used ranitidine. These primarily include H2 blockers and Proton Pump Inhibitors (PPIs).

Comparison Table: Ranitidine vs. Other Heartburn Medications

Feature Original Zantac (Ranitidine) New Zantac 360 (Famotidine) Pepcid (Famotidine) Prilosec (Omeprazole)
Active Ingredient Ranitidine Famotidine Famotidine Omeprazole
Drug Class H2 Blocker H2 Blocker H2 Blocker Proton Pump Inhibitor (PPI)
NDMA Contamination Yes, led to recall No NDMA concern identified No NDMA concern identified No NDMA concern identified
Mechanism Blocks histamine receptors to reduce stomach acid Blocks histamine receptors to reduce stomach acid Blocks histamine receptors to reduce stomach acid Binds to stomach pumps to prevent acid production
Effect Speed Starts working relatively quickly Works quickly (15-30 minutes) Works quickly (15-30 minutes) Takes 1-4 days for full effect
Duration Up to 12 hours Up to 12 hours Up to 12 hours Up to 24 hours

List of Common Alternatives

  • Famotidine (Pepcid, Zantac 360): A widely available H2 blocker that reduces stomach acid. Zantac 360 is a reformulated version containing famotidine.
  • Cimetidine (Tagamet): Another H2 blocker available over-the-counter for managing acid reflux.
  • Nizatidine (Axid): While some liquid forms were recalled, nizatidine capsules are available by prescription.
  • Omeprazole (Prilosec): A PPI that blocks acid production. It offers long-lasting relief but takes longer to become fully effective.
  • Other PPIs: Over-the-counter options include esomeprazole (Nexium) and lansoprazole (Prevacid).

Safely Disposing of Old Ranitidine

The FDA advises against flushing recalled medications like ranitidine to prevent water contamination. Recommended disposal steps are:

  1. Mix: Combine the medication with an unappealing substance such as dirt or used coffee grounds in a sealed bag or container.
  2. Seal and Conceal: Place the sealed container in your household trash.
  3. Remove Personal Info: Scratch out personal information on the original container's label before discarding it.

Conclusion

The discontinuation of ranitidine (Zantac) was a necessary public safety measure due to increasing NDMA levels. Numerous safe alternatives are available for managing heartburn and related conditions. Consult a healthcare provider for personalized treatment options and follow FDA guidelines for safe disposal of any remaining ranitidine. For official information, refer to the FDA website.(https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market)

Frequently Asked Questions

The antacid medication that was recalled and fully discontinued is ranitidine, most widely known by its brand name, Zantac. This action was requested by the FDA in April 2020.

Zantac (ranitidine) was recalled because it was found to contain increasing levels of N-nitrosodimethylamine (NDMA), a probable human carcinogen. The level of NDMA was shown to increase over time, especially in warmer storage conditions.

NDMA, or N-nitrosodimethylamine, is an environmental contaminant that is classified as a probable human carcinogen based on animal studies. It was the impurity found in ranitidine that led to its recall.

Yes, the new product, Zantac 360, is safe because its active ingredient is famotidine, not ranitidine. The FDA has not found any NDMA contamination in famotidine-based medications.

Safe alternatives to ranitidine include other H2 blockers such as famotidine (Pepcid, Zantac 360) and cimetidine (Tagamet), as well as Proton Pump Inhibitors (PPIs) like omeprazole (Prilosec), esomeprazole (Nexium), and lansoprazole (Prevacid).

You should stop taking any old ranitidine and dispose of it properly. The FDA recommends mixing it with an unappealing substance (like cat litter) in a sealed bag and throwing it in the household trash. Do not flush it down the toilet.

The FDA has tested other acid-reducing medications and has not found NDMA in unacceptable levels in most alternatives, including famotidine (Pepcid), cimetidine (Tagamet), and popular PPIs. However, some liquid versions of nizatidine were also recalled.

References

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Medical Disclaimer

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