A Drug & Medical Device Recall And/Or Safety Alert Has Been Issued: Saphris (asenapine maleate): Drug Safety Communication: Serious Allergic Reactions. According to the Food & Drug Administration FDA’s MedWatch:
Reports of hypersensitivity reactions, including anaphylaxis (a life-threatening allergic reaction), angioedema, low blood pressure, rapid heart rate, swollen tongue, difficulty breathing, wheezing, or rash.
For more information on the drug or medical device recall or safety alert, read the Food & Drug Administration’s FDA’s drug or medical device recall or safety alert: Saphris (asenapine maleate): Drug Safety Communication: Serious Allergic Reactions.
To report an adverse reaction, problem or other issue with a drug or medical device, submit a drug or medical device complaint to the government at fda.gov or MedWatch.
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