China FDA Warns Of Serious Propylthiouracil Adverse Reactions
This article was originally published in PharmAsia News
Executive Summary
The China FDA recently published the 63rd issue of its “Bulletin of Adverse Drug Reaction Information” that warned of serious adverse reactions caused by propylthiouracil.
The China FDA recently published the 63rd issue of its “Bulletin of Adverse Drug Reaction Information” that warned of serious adverse reactions caused by propylthiouracil, including liver function abnormalities, liver damage, hepatitis, elevated bilirubin, lowered leukopenia and agranulocytosis. Propylthiouracil is a thioamide drug used for the treatment of hyperthyroidism in adults. However, recent domestic adverse drug reaction monitoring data indicated that patients who used it long term are at risk of anti-neutrophil cytoplasmic antibody (ANCA)-related vasculitis, which can damage multiple body organs and systems. The CFDA suggested that medical staff inform patients of the potential adverse reactions and has asked manufacturers to revise the drug’s instructions. (Click Here For More - Chinese Language)
"China FDA: Proylthiouracil Can Cause Serious Adverse Reactions Such As Hepatitis" – health.people.com.cn (9/23/2014)