Aciloc (Ranitidine): Why Was This Heartburn Medication Withdrawn?

IMPORTANT SAFETY WARNING: This product, containing Ranitidine, has been withdrawn from the market in Egypt and globally due to safety concerns. This information is for historical and educational purposes only. Do NOT use this medication. Consult your doctor or pharmacist for safe and effective alternatives.

ACILOC® (Ranitidine): Information on a Withdrawn Medication

Summary

ACILOC was a brand of medication containing the active ingredient Ranitidine, formerly manufactured by Sigma Pharmaceutical Industries. It was used to treat and prevent conditions related to excessive stomach acid, such as peptic ulcers and GERD. As with all ranitidine-containing products, ACILOC was withdrawn from the market globally around 2020. This action was taken due to the discovery that ranitidine could contain an impurity called N-nitrosodimethylamine (NDMA), which is classified as a probable human carcinogen.

Regulatory Status: Withdrawn from Market

In 2019-2020, health authorities worldwide, including the U.S. FDA and the European Medicines Agency, found that ranitidine could degrade over time to form an impurity called N-nitrosodimethylamine (NDMA). As NDMA is classified as a probable human carcinogen, a global recall was issued as a precautionary measure. ACILOC is no longer authorized for sale or use.

Safe Alternatives to Ranitidine

If you were previously using ACILOC or any ranitidine product, there are several safe and effective alternatives available. You should consult your doctor or pharmacist to find the best option for you. Common alternatives include:

• Other H2-Receptor Antagonists: Such as Famotidine (e.g., Antodine®, Famotak®) or Nizatidine. These have not been found to have the same NDMA issue.
• Proton Pump Inhibitors (PPIs): A very effective class of drugs for reducing stomach acid. Examples include Omeprazole (e.g., Losec®, Omepak®), Esomeprazole (e.g., Nexium®), and Pantoprazole (e.g., Controloc®).
• Antacids: For immediate, short-term relief of heartburn (e.g., Gaviscon®, Maalox®).

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Historical Product Information

Manufacturer

Sigma Pharmaceutical Industries, Egypt.

Category & Active Ingredient

• Category: H2-Receptor Antagonist (for peptic ulcers).
• Active Ingredient: Ranitidine.

Formerly Available Forms & Strengths

Prior to its withdrawal, ACILOC was available in several forms:

• ACILOC 75 mg Film-Coated Tablets
• ACILOC 150 mg Effervescent Granules (in sachets)
• ACILOC 300 mg Film-Coated Tablets

Mechanism of Action (How it Worked)

Ranitidine was an H2-receptor antagonist. It worked by selectively blocking histamine H2 receptors on the stomach's parietal cells. This action inhibited gastric acid secretion, leading to reduced stomach acidity and allowing acid-related damage to heal.

Former Indications

• Treatment and prevention of peptic ulcers (gastric and duodenal).
• Gastroesophageal Reflux Disease (GERD).
• Zollinger-Ellison syndrome and other hypersecretory conditions.
• Relief of heartburn and acid indigestion.

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Frequently Asked Questions (FAQ)

I have an old box of ACILOC. Is it safe to use?
No. It is strongly recommended that you do not use any remaining ranitidine products. You should dispose of them safely and speak to a pharmacist about a suitable replacement.

Why were so many different brands of Ranitidine withdrawn?
The issue was not with a specific brand but with the active ingredient, Ranitidine, itself. The potential to form the NDMA impurity was inherent to the molecule's structure, which is why the withdrawal affected all ranitidine products from all manufacturers.

Are the alternatives like Famotidine as effective?
Yes, for many people, other H2-blockers like Famotidine are just as effective. In some cases, Proton Pump Inhibitors (PPIs) like Omeprazole may be considered even more effective for certain conditions. Your doctor can help you choose the best one for your needs.

References

1. U.S. Food and Drug Administration (FDA): Official announcements regarding the Ranitidine withdrawal. FDA Ranitidine Information Page
2. European Medicines Agency (EMA): European regulatory updates on Ranitidine. EMA Ranitidine Referral Page