The approval conditions of nine medicines that include rivaroxaban, such as anticoagulant Xarelto(compound: rivaroxaban) by Bayer Korea바이엘코리아, will carry warnings about Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis.
The Ministry of Food and Drug Safety (MFDS)식품의약품안전처 said that it would add the warning of SJS and toxic epidermal necrolysis to the approval conditions of these products beginning Sep. 28.
This is the follow-up measure to European Commission (EU)’s disclosure of public safety information on their side effects in Europe.
In the post-market surveillance, the drugs showed serious side effect in the skin, including SJS and toxic epidermal necrolysis. Most side effects were reported within the first week of treatments.
The ministry collected opinions about the change of the approval conditions and reflected them in the conditions last month. Also, it added a new warning that if there are side effects such as skin rash or allergic reactions, people have to stop taking the drugs.
The products subject to revised approval conditions are Xarelto by Bayer Korea, SK Rivaroxaban by SK Chemical SK케미칼, and Rivaroxaban by Hanmi Pharmaceutical한미약품.
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