Carcinogenic chemical concerns spur drug recall

Carcinogenic chemical concerns spur drug recall

The Food and Drug Administration of Thailand (FDA) yesterday announced the recall of Losartan, a medication mainly used to treat high blood pressure, due to concerns about carcinogenic contamination.

Dr Thares Karasnairaviwong, FDA secretary-general, urged patients not to panic as there have not yet been any reports of negative health impacts, and patients can still use this medication produced under a different formula.

Berlin Pharmaceutical Industry, a local manufacturer, had informed the FDA of its voluntary recall decision after other countries recalled similar products.

The firm is the only manufacturer in Thailand that has imported the problematic chemical from the India-based Hetero Lab Limited.

There are 142 batches under two formulas: Lanzaar 50, under licence number 1A 20/53 (NG) and Lanzaar 100, under licence number 1A 3/58 (NG).

Patients can return those targeted medicines to hospitals, medical clinics and pharmacies.

FDA deputy secretary-general, Dr Surachoke Tangwiwat said patients can use other Losartan formulas. For more information, patients can contact the FDA's Hotline at 1556.

The decision came after the US-based Macleods Pharmaceuticals Limited, last week reportedly informed the US-FDA that it is voluntarily recalling some of the Losartan formulas.

The manufacturer reportedly said they detected trace amounts of an impurity called N-nitrosodiethylamine (NDEA), another pharmaceutical ingredient the FDA has classified as a "probable human carcinogen".

They have also detected trace amounts of N-Nitroso N-methyl-4-aminobutyric acid (NMBA), which is classified as a potential cancer-causing substance.

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