September 3, 2011

The antipsychotic drug Saphris (asenapine maleate) was approved by the FDA (U.S. Food and Drug Administration) on August 13, 2009. Saphris is an atypical antipsychotic medication used to treat the symptoms of schizophrenia and bipolar disorder. From its FDA-approval in August, 2009 to June, 2011, about 235,000 prescriptions for Saphris for about 87,000 patients were filled at outpatient retail pharmacies in the United States.

From its FDA-approval in August, 2009 through September 7, 2010, there were 52 reported cases of reactions associated with the use of Saphris. The reactions included anaphylaxis (a severe, whole-body allergic reaction to a chemical that has become an allergen), angioedema (a swelling, similar to hives, but the swelling is beneath the skin rather than on the surface), hypotension (low blood pressure), tachycardia (the heart beating too fast), swollen tongue, dyspnea (shortness of breath), wheezing, and rash. Some of the reported cases of reactions to using Saphris included more than one reaction; eight of the cases involved reactions after one dose of Saphris, including possible angioedema, respiratory distress, and anaphylaxis.

Fifteen of the 52 reported cases involved resolution of the symptoms after the patients stopped taking Saphris (two of these cases had a reappearance of the symptoms when the patients began taking Saphris again). Nineteen of the 52 cases required hospitalization or an emergency room visit, requiring medical treatment in seven of the cases.

The FDA warns that patients taking Saphris should seek emergency medical attention if they experience any of the following while using Saphris: difficulty breathing, swelling of the face, throat, or tongue, feeling light-headed, or itching.


If you are taking Saphris, you should talk to your prescribing health care provider regarding your use of Saphris. If you had any of the signs or symptoms of an allergic reaction to Saphris, you should promptly discuss your reaction to the use of Saphris with your prescribing health care provider.

If you suffered serious or permanent injuries as a result of taking Saphris, you may wish to seek legal advice regarding your possible right to compensation for your losses. Many medical malpractice lawyers also handle claims involving medication errors and medication reactions. Visit our website to be connected with local medical malpractice lawyers who may be able to advise you regarding your legal rights. Our toll free telephone number is 800-295-3959.

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