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LAWSUITS NEWS & LEGAL INFORMATION

Serious Allergic Reactions Reported with Saphris


Washington, DC: FDA is notifying healthcare professionals and patients that serious allergic reactions have been reported with the use of Saphris (asenapine maleate). A search of the FDA's Adverse Event Reporting System (AERS) database identified 52 cases of Type I hypersensitivity reactions (allergic reactions) with Saphris use (see Data Summary below).

Hypersensitivity reactions can be classified into four categories (Type I to Type IV). Signs and symptoms of Type I hypersensitivity reactions may include anaphylaxis (a life-threatening allergic reaction), angioedema (swelling of the deeper layers of the skin), low blood pressure, rapid heart rate, swollen tongue, difficulty breathing, wheezing, or rash. These signs and symptoms are consistent with the reactions reported in the 52 cases. Several cases reported multiple hypersensitivity reactions occurring at the same time, with some of these reactions occurring after the first dose of Saphris.

Saphris (asenapine maleate) is used to treat symptoms of schizophrenia and bipolar disorder. 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.

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Published on Sep-1-11


READER COMMENTS

Posted by

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I was prescribed 10mg saphris 2x a day for approximately 2.5 months. Abut 2.5 weeks ago I went to the emergency room with chest pain I thought was from a panic attack. 7 minutes later I was in cardiac arrest and was shocked back to life in front of my husband. I was lifeflighted to another hospital and had another heart attack upon arrival to a stent was immediately placed in my heart. I am 44 years old. Where can I turn for help? It's in my medical notes that the saphris caused fthe heart attacks

Posted by

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My name is Kamal Blanchard Campbell. I am a male who took Saphris from May 2015 to June 2015. I took 10mg twice a day. My symptoms included wheezing. fainting spells, sinus pressure. I felt weak and thought that I needed to see my PCP. He diagnosed me as having allergies and put me on a nasal spray , Zyrtec and some eye drops. I took them for a year or more. This was succeeding to trips to Englewood Hospital ER. They said my luekotrines were very elevated and put me on Wellbutrin SR to contradict my stimulated blood results.

Posted by

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September 2014 I was prescribed Saphris for treatment of Psychosis and Bipolar disorder. I took the medication for about 6 - 7 weeks during that time I was sick all the time with nausea and vomiting. I didn't know what was wrong I figured it was just the flu. Around the last week I took this medication I became severely nauseated and vomited constantly. I was also experienced severe stomach pain. j I went to the emergency room in Atlantic, IA. I was told I had liver failure and that my readings were off the charts and that if I didn't come in that day I could have been dead by that night. I was admitted to the University of Nebraska in Omaha, NE. I was stabilized and upon release I was told to stop taking Saphris immediately and to inform my prescribing physician. I did all of that. It took 8 months to bring my body back to normality. I was told by 2 doctors that my liver failure was caused by whatever I was taking. I told them I was only prescribed 2 medications, Zoloft and Saphris. I informed my physician and she took me off any anti-psychotics medication for 3 - 4 months.

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