(Reuters) - The U.S. Food and Drug Administration warned on Thursday that serious allergic reactions have been reported with the use of Merck & Co Inc's (MRK.N) antipsychotic drug Saphris.
The agency said the drug's label has been revised to include information about the risk.
Saphris, first approved in 2009, is used to treat symptoms of schizophrenia and bipolar disorder.
Doctors should closely monitor patients for reactions including anaphylaxis, swelling, low blood pressure and swollen tongue, the FDA said in a notice on its website.
The agency said Saphris should not be used in patients with a known hypersensitivity to the drug and patients should seek emergency medical attention if they develop any signs and symptoms of a serious allergic reaction while taking Saphris.
Thursday, September 01, 2011
FDA warns of allergy risk with Merck's antipsychotic Saphris | Reuters
via uk.reuters.com
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The drug Saphris should have never been allowed on the market. The FDA was warned of its drop dead sudden death side effects in a significant briefing document and they approved it anyway.
HOW on earth would a patient (or imagine a patient in a locked psych ward w/out an advocate)ever know they are allergic to this new antipsychotic? UNTIL they take it!
It's deplorable how much the FDA approved drugs for the mental health population without regard for their immediate and long term safety.
This warning is just the beginning,, surely there are Saphris lawsuits already moving forward.
Buyer beware!
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