FDA Warns of Allergic Reactions with Merck’s Saphris

Merck & Co Inc.’s Saphris has been associated with severe allergic reactions, according to a Food and Drug Administration report. The drug’s label has been revised to include information about the newly discovered risk.

Saphris, first approved in 2009, is used to treat symptoms of schizophrenia and bipolar disorder. Since then, an estimated 235,000 prescriptions have been written for about 87,000 patients in the U.S. Allergic reactions noted may include anaphylaxis, swelling, low blood pressure and swollen tongue, the FDA said in a notice on its website. Agency staff that searched the FDA’s adverse event reporting system discovered 52 reports of type I hypersensitivity reactions following asenapine dosing. In eight cases, patients experienced extreme reactions following their first dose of the drug.

The agency said Saphris should not be used in patients with a known hypersensitivity to the drug. Symptoms of hypersensitivity may include low blood pressure, swollen tongue, tachycardia, and dyspnea, as well as rashes and wheezing. Patients should immediately seek medical attention if they develop and signs or symptoms of an allergic reaction while taking Saphris.

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