FDA Drug Safety Communication: Serious allergic reactions reported with the use of Saphris (asenapine maleate)
Source: Drugs.com
Sept. 01, 2011
Issue: FDA notified healthcare professionals and patients that serious allergic reactions have been reported with the use of Saphris (asenapine maleate). 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.
BACKGROUND: Saphris (asenapine maleate) is used to treat symptoms of schizophrenia and bipolar disorder.
RECOMMENDATION: Healthcare professionals should be aware of the risk of hypersensitivity reactions with Saphris and counsel patients who are receiving the drug about how to recognize the signs and symptoms of a serious allergic reaction. Saphris should not be used in patients with a known hypersensitivity to the drug.
Information for Patients
Additional information on asenipine
Source: Drugs.com
Sept. 01, 2011
Issue: FDA notified healthcare professionals and patients that serious allergic reactions have been reported with the use of Saphris (asenapine maleate). 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.
BACKGROUND: Saphris (asenapine maleate) is used to treat symptoms of schizophrenia and bipolar disorder.
RECOMMENDATION: Healthcare professionals should be aware of the risk of hypersensitivity reactions with Saphris and counsel patients who are receiving the drug about how to recognize the signs and symptoms of a serious allergic reaction. Saphris should not be used in patients with a known hypersensitivity to the drug.
Information for Patients
- Serious allergic reactions have been reported in patients treated with Saphris.
- Patients should seek emergency medical attention immediately if they develop any signs and symptoms of a serious allergic reaction such as: Difficulty breathing
- Swelling of the face, tongue or throat
- Feeling lightheaded
- Itching
Additional information on asenipine
