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Friday, February 06, 2009

Antidepressant Labels to Carry New Warning of Life-Threatening Side Effect

Source LA Times

The LA Times reported on Feb 5th that the FDA has ordered a wide range of antidepressants to carry new warnings of an unusual but potentially deadly side effect seen most often in the first few weeks of treatment or when a patient increases dosages. The labels of two classes of new-generation medications for depression -- selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) must now notify patients that malignant neuroleptic syndrome has been linked to the use of these drugs.

Among the drug companies ordered to revise their labels to alert patients of the danger were those making Celexa, Cymbalta, Effexor, Lexapro, Paxil, Pexeva, Pristiq, Prozac, Venlafaxine and Zoloft. The orders were dated Feb. 4, but disseminated this morning in a public notice of FDA actions.

Here's the letter the FDA sent to GlaxoSmithKline regarding Paxil and malignant neuroleptic syndrome.

Full story here

Hat tip Ruth Francis

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