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> FDA’s Latest Drug Safety List Includes Abilify, Plan B
FDAnews Drug Daily Bulletin
Feb. 16, 2009
| Vol.
6 No.
31
FDA’s Latest Drug Safety List Includes Abilify, Plan B
Postmarketing surveillance by the FDA revealed potential risks of heart and blood disorders associated with Bristol-Myers Squibb and Otsuka’s schizophrenia drug Abilify. Abilify (aripiprazole) was associated with problems including torsades de pointes (a form of abnormally fast heart rate), hepatotoxicity and blood disorders called dyscrasias, according to a review the FDA conducted as part of its pilot Post-Marketing Safety Evaluation of New Molecular Entities program. Another prominent drug on the list is Duramed’s contraceptive Plan B (levonorgestrel), which was associated with syncope and loss of consciousness.
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