Date: 1 September 2011
Source: U.S. Food and Drug Administration website (www.fda.gov)
Link: www.fda.gov/Drugs/DrugSafety/ucm270243.htm#pat
[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.
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.
* Patients should
seek emergency medical attention immediately if they develop any signs and
symptoms of a serious allergic reaction such as:
o Difficulty
breathing
o Swelling
of the face, tongue or throat
o Feeling
lightheaded
o Itching
* Serious side
effects from the use of Saphris should be reported to the FDA MedWatch program,
using the information in the "Contact Us" box at the bottom of this
page.
Additional Information for Healthcare Professionals
* Type I
hypersensitivity reactions, including anaphylaxis and angioedema, have been
observed in patients treated with Saphris. In several cases, these reactions
occurred after the first dose.
* The
hypersensitivity reactions included: anaphylaxis, angioedema, hypotension,
tachycardia, swollen tongue, dyspnea, wheezing, and rash.
* Saphris is
contraindicated in patients with a known hypersensitivity to the product.
* Patients should
be educated to recognize the signs and symptoms of a serious allergic reaction
and advised to contact a healthcare professional immediately if they experience
any of these symptoms while taking Saphris.
* Adverse events
involving Saphris should be reported to the FDA MedWatch program using the
information in the "Contact Us" box at the bottom of this page.
Data Summary
Saphris (asenapine maleate) was FDA-approved on August 13,
2009. A search of the AERS database from approval through September 7, 2010
identified 52 cases that reported Type I hypersensitivity reactions associated
with Saphris use. Reported signs and symptoms included anaphylaxis, angioedema,
hypotension, tachycardia, swollen tongue, dyspnea, wheezing, and rash. Some of
the cases reported the occurrence of more than one hypersensitivity reaction
following Saphris use. Eight cases reported hypersensitivity reactions after
just one dose of Saphris. The reactions reported following one dose included
possible angioedema, respiratory distress, and possible anaphylaxis.
Type I hypersensitivity reactions typically require a
history of previous exposure to the drug. However, the absence of a known prior
exposure does not exclude the reaction, because sensitization may have occurred
to a cross-reactive compound in the past even if the patient showed no signs of
allergy to the sensitizing product. To date, no specific drug has shown
cross-reactivity with Saphris.
Of the 52 cases, 15 reported a resolution of symptoms
following Saphris discontinuation, while two of these cases reported a
reappearance of symptoms upon reintroduction of Saphris. Nineteen of the cases
resulted in hospitalization or emergency room visits, and therapeutic
interventions were reported in seven cases.
Although many of the cases have limited information, the
findings from the cases are consistent with hypersensitivity reactions,
including anaphylaxis, and support a temporal association between the onset of
the reactions and Saphris use.
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
References
1. SDI, Vector
One®: National (VONA). August 2009-June 2011. Data extracted August 2011.
2. SDI, Vector One®: Total Patient
Tracker (TPT). August 2009-June 2011. Data extracted August 2011.
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