Drug Safety Communication: Asenapine Maleate [Saphris] Associated with Serious Allergic Reactions

Last Updated on September 2, 2011 by Joseph Gut – thasso

September 01, 2011 – Asenapine Maleate [Saphris] is used to treat symptoms of schizophrenia and bipolar disorder. The American Food and Drug Administration (FDA) has notified healthcare professionals and patients that serious allergic reactions have been reported with the use of Asenapine Maleate [Saphris]. The Contraindications, Warnings and Precautions, Adverse Reactions, and Patient Counseling Information sections have been revised to include information about type I hypersensitivity reactions which may include anaphylaxis, angioedema, low blood pressure, rapid heart rate, swollen tongue, difficulty breathing, wheezing, or rash. In several cases, these reactions occurred after the first dose.

Healthcare professionals should be aware of the risk of hypersensitivity reactions with Asenapine Maleate [Saphris] and counsel patients who are receiving the drug about how to recognize the signs and symptoms of a serious allergic reaction. Asenapine Maleate [Saphris] should not be used in patients with a known hypersensitivity to the drug.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program as follows: Complete and submit the report online at www.fda.gov/MedWatch/report.htm. Alternatively, download form or call +1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to +1-800-FDA-0178. Read here the MedWatch safety alert, including links to the Drug Safety Communication with Data Summary,  and prescribing information.

Ph.D.; Professor in Pharmacology and Toxicology. Senior expert in theragenomic and personalized medicine and individualized drug safety. Senior expert in pharmaco- and toxicogenetics. Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.

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