South Korea’s health authorities said they plan to add newly reported adverse reactions to linezolid-based and idarubicin-based medications in their approval conditions. Linezolid is an antibiotic to treat infections and idarubicin is used to treat acute and chronic myelocytic leukemia.
The Ministry of Food and Drug Safety said Monday that it would add toxic epidermal necrolysis to adverse drug reactions of linezolid-based therapies, and pancytopenia to those of idarubicin drugs, respectively.
Ministry officials said they spotted the two additional adverse drug reactions through “signal” detection, based on adverse drug reaction reports collected locally from 1989 to 2016. However, the causal relationship between the ingredient and the adverse drug reaction, in both cases, has not been proved.
A “signal” refers to information worth analyzing on a new potential causal relationship between an adverse event and a drug, among the reported data from sources. The Korea Institute of Drug Safety & Risk Management collects such signals by analyzing adverse drug reactions among locally-approved drugs. Then, the ministry gets advice from its committee for medicinal products and changes the approval conditions of the drugs.
Pharmaceutical products that will face changes in approval conditions concerning linezolid are Pfizer Korea’s Zyvox Tab. and Zyvox Injection, Hanall Biopharma’s Linezolid Tab. and Linezolid Injection, CJ HealthCare’s Cinezolid Tab. and Cinezolid Injection, Korea United Pharm’s Linoxazole Tab., Hanmi Pharm’s Lizolid Tab, Yungjin Pharmaceutical’s Linezolin Tab., and JW Life Science’s Linezolid Inj. JW.
Idarubicin-based drugs with changed approval conditions include Pfizer Korea’s Zevedos Injection, Korus Pharm’s Korus Idarubicin Injection, Teva Handok’s Idaralem Injection, Hanlim’s Zavel Injection, Korea United Pharm’s Zaverusin Injection, JW Pharma’s Idaru Injection, Boryung Pharm’s Idarubicin HCL Injection, Daehan New Pharm’s DHNP Idarubicin HCL Inj., Kwangdong Pharm’s Irubisin Injection, and Hanlim’s Zabel Cap.
Drugmakers with any opposing opinion can submit their views and reasons to the ministry’s Pharmaceutical Safety Evaluation Division by Nov. 21.