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WASHINGTON, April 11 (Xinhuanet) -- The US Food and Drug Administration (FDA)
on Monday ordered new warnings on antipsychotic drugs because they have been in
studies linked to higher mortality among the old people who take the drug for
dementia-related symptoms.
The agency said it is asking manufactures of atypical antipsychotic drugs
to add to their labeling a boxed warning noting the risks and that the drugs are
not approved to treat symptoms of dementia in the elderly.
The drugs are approved for treating schizophrenia and mania. They include
Bristol-Myers Squibb and Otsuka America Pharmaceutical's Abilify, Eli Lilly and
Co.'s Zyprexa, AstraZenecaPharmaceuticals LP's Seroquel, Johnson and Johnson's
Risperdal, Novartis AG's Clozaril and Pfizer Inc.'s Geodon. The warning
orderalso affects Eli Lilly and Co.'s Symbyax, which is approved for treatment
of depressive episodes associated with bipolar disorder.
Patients should consult their doctors before taking the drugs for
dementia-related symptoms, said the FDA.
An analysis of 17 studies involving four drugs showed the rate of death for the
elderly patients with dementia who took the drugs was about 1.6 to 1.7 times
that for placebo users. The FDA said the causes of death varied, but most seemed
to be heart-related or from infections.
The four atypical antipsychotics tested cover all the three classes of the
drug based on their chemical structure, according to the agency. Enditem
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