[09-01-2011] The U.S. Food and Drug Administration (FDA) is warning the public that serious allergic reactions have been reported with the use of the antipsychotic medication Saphris (asenapine maleate). The Contraindications, Warnings and Precautions, Adverse Reactions, and Patient Counseling Information sections of the Saphris drug label have been revised to include information about this risk and to inform healthcare professionals that Saphris should not be used in patients with a known hypersensitivity to the drug.
Facts about Saphris (asenapine maleate)
In a class of medications called atypical antipsychotics.
Used to treat symptoms of schizophrenia and bipolar disorder.
From approval in August 2009 to June 2011, approximately 235,000 prescriptions were dispensed for Saphris and approximately 87,000 patients received a dispensed prescription for Saphris from U.S. outpatient retail pharmacies.1,2
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.
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.
Patients should seek emergency medical attention immediately if they develop any signs and symptoms of a serious allergic reaction while taking Saphris.
Additional 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
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History of Saphris, the FDA had warning of the dangers of Saphris and approved it anyway
Death can come suddenly without warning: antipsychotic SAPHRIS study pending for kids
Death from antipsychotic asenapine (Saphris) can come suddenly and without warning Phen-fen type toxicity
The FDA Psychopharmacologic Drugs Advisory Committee meeting briefing book (1067 pages)
"Death from asenapine(Saphris) can come suddenly and without warning in otherwise young healthy individuals due to arrhythmias or strokes." -page 895/1067, June 18, 2008
PDF of 1067 pages, briefing book for the July 2009 FDA Psychopharmacologic Drugs Advisory Committee(meeting materials) at the FDA website, Saphris the atypical antipsychotic-- sublingual immediate release--under the tongue pill. Zyprexa was used in one trial vs. Saphris, yet there was no placebo control in the 40 week trial for bipolar mania(page 403). Proposed regimens 5-10 mg SZ, BP1 10 mg., no water/food for 10 minutes after taking.(page 479)
Page 895/1067
document dated 6-18-2008
"Death from asenapine(Saphris) can come suddenly and without warning in otherwise young healthy individuals due to arrhythmias or strokes with symptoms easily misattributed to something else such as orthostatic hypotension. More likely most serious cardiovascular toxicities are cumulative resulting in a Phen-fen type toxicity especially when dosed for over a year, although symptoms which are likely to be misattributed to something else, (e.g. fatigue) may occur as soon as the first dose."
page 896/1067
document dated 6-18-2008
"With respect to benefit there is insufficient data to presently support use in schizophrenia and as for bipolar disorder the data indicted that only the most severely ill may benefit with a few weeks of treatment but possibly not beyond that. Thus even efficacy in bipolar disorder1 needs to be confirmed.
After further review, this reviewer believes that asenapine(Saphris) is unacceptably dangerous at this time, there was inadequate information submitted to assess safety and such information was expected. There is insufficient information to determine if it will have the effects it purports to as suggested in the labeling.
In conclusion the Food Drug and Cosmetics Act require that asenapine not be approved based on the following subsections and criteria:"....(go to PDF page 896 to continue reading this page)
Ronald Kavanagh, Senior Reviewer, 6-18-2008
hat tip FDA warns of allergy risk with Saphris PHARMAGOSSIP
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