The Korean regulator would add a precaution label to argatroban, a treatment for acute cerebral thrombosis, warning that the drug could raise hemorrhage risk in pregnant women, fetuses, and newborns.
The Ministry of Food and Drug Safety said Monday that it would place the warning on five argatroban-containing medicines.
Argatroban-based drugs are indicated for improvement of limb ulcer, pain, and cold feeling in patients with chronic arterial occlusion (thromboangiitis obliterans, also known as Buerger disease, arteriosclerosis obliterans), and for improvement of neurological symptoms caused by acute cerebral thrombosis (motor paralysis) and daily movements (walking, standing, keeping seated, and eating).
The five authorized drugs that contain argatroban are Hyundai Pharm’s Novastan Inj., Mitsubishi Tanabe Pharma Korea’s Novastan Hi Inj., Shinpoong Pharm’s Notrobin Inj., Dongkook Pharm’s Argaron Inj., and Kolon Pharmaceutical’s Tromban Inj.
The adding of the warning was based on the U.S. Food and Drug Administration’s safety information, the ministry said. The FDA noted argatroban could raise the risk of hemorrhage in pregnant women, fetuses, and newborns if the drug is administered to the pregnant women or nursing mothers.
The FDA also noted that clearance in pediatric patients (0.16L/hr/kg) was 50 percent lower compared to healthy adults (0.31L/hr/kg), requiring particular attention to the administration of argatroban in pediatric patients.
The food and drug safety ministry said it decided to add the warnings to the five authorized drugs in Korea and collect expert opinions until April 12.