MHRA issues drug alert on contaminated Zantac

  • Medicines and Healthcare products Regulatory Agency

  • curated by Dawn O'Shea
  • UK Medical News
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Zantac (ranitidine) is the latest drug to be added to the list of medicines found to be contaminated with the potential carcinogen, N-nitrosodimethylamine (NDMA).

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an alert to healthcare professionals to inform them that GlaxoSmithKline is recalling four types of Zantac.

The MHRA says the recall is a precautionary measure and patients do not need to stop taking Zantac immediately. At the next routine appointment, the patient should be informed about the issue and made aware of the contamination.

An MHRA investigation into other ranitidine medicines which may also be affected is continuing and further updates will be provided as this investigation progresses. The MHRA has asked manufacturers to quarantine all ranitidine products which may contain the active pharmaceutical ingredient that is potentially affected by this issue.

The four products affected are Zantac 150 mg/10 mL syrup, Zantac 50 mg/2 mL injection, Zantac 150 mg tablets and Zantac 300 mg tablets. All four are prescription only medicines. Over-the-counter Zantac products produced are not affected by this recall.

The European Medicines Agency is currently conducting a review of NDMA and N‑nitrosodiethylamine (NDEA), another contaminant discovered early in the investigation.

The compounds are classified as ‘probable human carcinogens’. The latest estimates from the review set the highest possible cancer risk with these impurities would be 22 extra cases of cancer over a lifetime for every 100,000 patients taking the drug every day for six years at the highest dose of NDMA. NDEA has been estimated to lead to eight extra cases of cancer in 100,000 patients taking the medicine at the highest dose every day for four years.

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