Dr Noor Hisham: Anticoagulant medication Dabigatran Etexilate not registered in Malaysia

PUTRAJAYA, March 29 — Anticoagulant medication Dabigatran Etexilate Capsules USP 75mg and 150mg are not registered in Malaysia, says Health Director-General Tan Sri Dr Noor Hisham Abdullah.

He said the Ministry of Health had checked the registered products database of the National Pharmaceutical Regulatory Agency to confirm the matter following an article published on the medscape.com website titled ‘Dabigatran Recalled Over Potential Carcinogen’ on March 23. The article reported that Ascend Laboratories LLC carried out a consumer-level recall of the product following the detection of nitrosamine impurity ‘N-nitroso-dabigatran’ which exceeded the global Acceptable Daily Intake level.“As a reminder, products that are not registered through the Drug Control Authority are not allowed to be marketed in Malaysia,” said Dr Noor Hisham in a statement today.

“Exposure to nitrosamines that exceed the ADI level in the long term has the potential to increase the risk of cancer among consumers,” he said, adding that the NPRA was continuously monitoring medical products to ensure their quality, safety and effectiveness. — Bernama

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