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The agency said it would require manufacturers of the drugs to place “black box warnings” — the FDA’s most severe — on the labels of all of the drugs. The advisory applies to drugs including ...
The agency called for the drugs to include a strong "black box" warning ... a similar warning for other, newer antipsychotic drugs in 2005. Those drugs — which include Abilify, from Bristol ...
The FDA has mandated that the package for Abilify carry a "black box" warning concerning its use in the treatment of dementia-related psychosis. Today's settlement resolves government allegations ...
A team of JAMA authors urged the FDA in 2014 to add “black box” warnings to dopamine agonists ... Otsuka’s antipsychotic Abilify has a gambling urge risk on its label, and just last month ...