FDA warns of allergy risk with Merck antipsychotic drug

A new antipsychotic drug, Saphris (asenapine maleate), created by Merck & Co Inc, has been associated with serious allergic reactions, and the US Food and Drug Administration (FDA) have issued a warning about its use as well as revised the drug’s label to include information about the risk.

The drug should not be used by people with a known sensitivity to the drug, and doctors should closely monitor patients to whom the drug is administered for reactions including anaphylaxis, tongue swelling, general swelling, difficulty breathing, lightheadedness, itching and low blood pressure.

The FDA’s Adverse Event Reporting System (AERS) revealed that there had been 52 cases of Type 1 hypersensitivity to the drug, which typically means the patient must have been exposed to the drug previously. But 8 of these suffered hypersensitivity after just one dose. 15 experienced a resolution of symptoms once use of Saphris had been discontinued.

Source: The US Food and Drug Administration

First published in September 2009


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