Posted by Phillipa on September 1, 2011, at 19:26:01
Seems Sapris has some horrible side effects some fatal. Phillipa
From Medscape Medical News > Alerts, Approvals and Safety Changes > Medscape Alerts
Atypical Antipsychotic Linked to Life-Threatening Reactions
Caroline CasselsAuthors and Disclosures
Posted: 09/01/2011
September 1, 2011 The US Food and Drug Administration (FDA) has issued a warning about possible severe allergic reactions, including anaphylaxis and angioedema, to the atypical antipsychotic asenapine maleate (Saphris, Merck).A search of the FDA's Adverse Event Reporting System identified 52 cases of allergic reactions with the drug's use. Of these cases, 15 reported a resolution of symptoms after asenapine maleate discontinuation, whereas 2 of these cases reported a reappearance of symptoms after reintroduction of the drug. Nineteen cases resulted in hospitalization or emergency department visits, and therapeutic interventions were reported in 7 cases.
According to the FDA warning, 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 1 hypersensitivity reaction after asenapine maleate use. Eight cases reported hypersensitivity reactions after just 1 dose of asenapine maleate. The reactions reported after use of a single dose included possible angioedema, respiratory distress, and possible anaphylaxis.
"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," the FDA reports.
The FDA also notes that the drug's label has been revised to include information about this risk and advises healthcare professionals not to use it in patients with a known hypersensitivity to asenapine maleate.
In addition, physicians should counsel patients receiving the drug about the signs and symptoms of a serious allergic reaction.
Used to treat symptoms of schizophrenia and bipolar disorder, Saphris was approved in 2009. It is estimated that as of June 2011, approximately 235,000 prescriptions were dispensed for Saphris, and approximately 87,000 patients received a dispensed prescription for the drug from US outpatient retail pharmacies.
Adverse events related to asenapine maleate can be communicated to MedWatch, the FDA's adverse event and reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.
poster:Phillipa
thread:995551
URL: http://www.dr-bob.org/babble/20110822/msgs/995551.html