The government has ordered Dongwha Pharm, regarding its Clzapine Tab. (ingredient: clozapine), a medication for schizophrenia, to add obesity, sleep apnea syndrome, and fall to the list of precautions.
The Ministry of Food and Drug Safety said it would change approval conditions for Clzapine on March 26. The warnings should include obesity, myocarditis, pleural effusion, sleep apnea, fatal mycosis, intestinal infarction and intestinal ischemia, rhabdomyolysis, multiple serositis, and fall (associated with clozapine-induced seizure, drowsiness, orthostatic hypotension, motion and sensory instability).
Also, the treatment should add new precautions that the medication can cause seizures, drowsiness, orthostatic hypotension, motion and sensory instability, which may lead to falls and, consequently, fractures or other injuries.
The warnings should also state that the evaluation of the risk of falls should be made before the start of the treatment and that a periodic review is required for patients who take long-term antipsychotic medicines.
Clozaril by Novartis, the original clozapine-containing drug, already includes such warnings in its approval conditions. Thus, Clzapine is the only drug that has to add warnings this time, the ministry said.
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