Saphras Allergic Reaction Warning Issued by FDA
Reports of severe and potentially life-threatening allergic reactions have been linked to the side effects of Saphris, a relatively new atypical antipsychotic sold by Merck & Co.
The FDA issued a drug safety communication on September 1, indicating that it has identified at least 52 cases of Saphris Type 1 hypersensitivity reactions through the FDA’s Adverse Event Reporting System (AERS). The agency reports that 19 cases resulted in hospitalization or emergency room visits, and seven patients required therapeutic interventions.
The warning label for the drug is being updated to include information about the risk of Saphras allergic reactions, which the FDA said could be life-threatening.
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Symptoms of a reaction to Saphras could include anaphylaxis, swelling of the deeper layers of the skin (angioedema), low blood pressure, rapid heart rate, swollen tongue, difficulty breathing, wheezing and rash. In some cases multiple symptoms occurred following just one dose.
Saphris (asenapine maleate) is an atypical antipsychotic approved by the FDA in August 2009 to treat symptoms of schizophrenia and bipolar disorder. Since approval, the drug has been prescribed about 235,000 times to about 87,000 patients in the United States.
The FDA warned patients to seek emergency medical attention immediately if they develop signs of a Saphris allergic reaction. The agency also asked that serious Saphris side effects be reported to the AERS.
Healthcare professionals were advised to educate patients in the signs and symptoms of Saphris hypersensitivity and to watch for anaphylaxis, angioedema, hypotension, tachycardia, swollen tongue, dyspnea, wheezing and rash in patients taking the antipsychotic. While some patients were able to resume Saphris treatments with no further reactions, the FDA contraindicated the drug for any patient that has shown signs of Saphris hypersensitivity.
Saphris reactions and other side effects can be reported to the FDA’s AERS at MedWatch Online or by calling 1-800-332-1088.
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