The approval conditions of 72 combined drugs of atorvastatin and amlodipine besylate will add the case of immunity auxiliary necrotid muscle disease, an autoimmune muscle disease, related to the use of the statin.
A warning that bans the combined use of fusidate and atorvastatin will also be added.
The Ministry of Food and Drug Safety (MFDS)식품의약품안전처 Thursday ordered the revision of the approval conditions for the 72 products. In May, the ministry made the change in approval conditions for the single drug of atorvastatin and is now taking a similar step to its combined drugs.
To be affected by the measure are 72 products, including Caduet by Pfizer Korea한국화이자제약, Cardipair by Chong Kun Dang종근당, and Atovadipine by Daewoong Bio대웅바이오.
The newly added case of immunity auxiliary necrotid muscle disease is very rare. Muscle weakness and CK increase in blood occur, and the symptoms continue after the stoppage of statin injection. Also, it shows necrotid muscle without significant inflammation, and the symptoms improve after injecting immunodepressant.
The ministry also banned combining it with oral fusidate cause there was serious muscle abnormality such as rhabdomyolysis after people took fusidate and atorvastatin at the same time.
The ministry told makers and users to monitor such patients carefully and temporarily suspend the injection of atorvastatin.
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