Anti-blood clotting drug Lixiana (ingredient: edoxaban), manufactured by Daiichi Sankyo Korea, will have to add dizziness, headache and abdominal pain to its precautions label, the government said Wednesday.
The Ministry of Food and Drug Safety ordered the pharmaceutical company to make changes in approval conditions as of Nov. 9, following the recent order of the European Commission to beef up details about the drug’s safety information.
The ministry has worked out the changes based on local and overseas approvals before making notice of changes in September and has since collected the drugmakers’ opinions.
Lixiana is an anti-blood clotting therapy, effective in reducing risks of stroke and systemic embolism for patients suffering non-valvular atrial fibrillation as well as treating deep vein thrombosis and pulmonary embolism. Compared to anticoagulant Warfarin, Lixiana lowered the risk of significant hemorrhage by 20 percent, internal bleeding in a cranial cavity by 53 percent, and the risk of a fatal bleeding by 45 percent.
The drug also reduced risks of bleeding for high-risk patients with associated diseases such as hypertension, cardiac insufficiency, and diabetes, as well as for the elderly, patients with a kidney disorder and aspirin takers. Patients can take Lixiana tablet once a day, regardless of meals, due to its non-relevance to foods. The drug is the first anticoagulant developed in Asia.
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