Anticoagulant medication Dabigatran Etexilate Capsules USP 75 mg and 150 mg are not registered in Malaysia, says Health Director-General Tan Sri Dr Noor Hisham Abdullah (pix).
He said the Ministry of Health (MOH) had checked the registered products database of the National Pharmaceutical Regulatory Agency (NPRA) 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 (ADI) level.
“Dabigatran Etexilate Capsules USP 75 mg and 150 mg are not registered in Malaysia.
“As a reminder, products that are not registered through the Drug Control Authority (DCA) are not allowed to be marketed in Malaysia,“ said Dr Noor Hisham in a statement today.
He said the products were oral anticoagulants used to reduce the risk of stroke and blood clots.
According to him, nitrosamine impurities were commonly found in water and food, including cured and grilled meats, dairy products and vegetables.
“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