Drug Safety Developments

FDA warns Pfizer's antipsychotic could cause fatal skin reaction

Quoted from http://www.reuters.com/article/2014/12/11/us-pfizer-fda-antipsychotic-idUSKBN0JP1Q620141211

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FDA warns Pfizer's antipsychotic could cause fatal skin reaction

Thu Dec 11, 2014 10:01am EST

 

(Reuters) - Pfizer Inc's antipsychotic Geodon and generic versions of the drug can trigger a potentially fatal skin reaction, the U.S. Food and Drug Administration warned on Thursday.

A new warning has been added to the drug's label to describe the condition - known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) - which may start as a rash and spread all over.

Other symptoms include fever, swollen lymph nodes and organ inflammation.

Geodon, known generically as ziprasidone, is used to treat schizophrenia and bipolar I disorder by reducing hallucinations, delusions and other psychotic symptoms.

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US FDA panel backs antipsychotic drugs for kids

Quoted from http://www.reuters.com/article/marketsNews/idINN1046473820090610?rpc=44

US FDA panel backs antipsychotic drugs for kids

Wed Jun 10, 2009 4:47pm EDT

By Susan Heavey

ADELPHI, Md., June 10 (Reuters) - Three widely used antipsychotic medications appear safe and effective overall in treating children and teenagers with schizophrenia or bipolar disorder, a U.S. advisory panel said on Wednesday.

The Food and Drug Administration's panel of outside experts backed wider use of the pills -- Eli Lilly and Co's (LLY.N) Zyprexa, AstraZeneca's (AZN.L) Seroquel and Pfizer's (PFE.N) Geodon -- but expressed concern over long-term effects the medications may have in younger patients....

"I'm concerned about the lack of true long-term studies" especially in younger patients "who will have a long lifetime, hopefully," said panel member Ruth Day, a researcher at Duke University.

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