By: Chang Ming-hsuan, Han Ting-ting and Matthew Mazzetta
The ban will apply to drugs with the active ingredient ranitidine, which contains traces of the contaminant and probable carcinogen N-Nitrosodimethylamine (NDMA), the agency said, citing international studies.
The studies have also found that the NDMA levels in drug products increase over time and with exposure to heat, sometimes in excess of the acceptable daily intake of 96 nanograms, the FDA said.
On the Taiwan market, there are 36 drug products that contain ranitidine, 29 of which are prescription drugs and seven over-the-counter medications, all for the treatment of stomach ulcers, the FDA said in a press release. [FULL STORY]