(Haldol, Haldol decanoate, and Haldol lactate)
Johnson and Johnson and FDA informed healthcare professionals that the WARNINGS section of the prescribing information for haloperidol has been revised to include a new Cardiovascular subsection regarding cases of sudden death, QT prolongation and Torsades de Pointes(TdP) in patients treated with haloperidol, especially when given intravenously, or at doses higher than recommended. Although injectable haloperidol is only approved by the FDA for intramuscular injection, there is considerable evidence that the intravenous administration of haloperidol is a relatively common off-label clinical practice.
There are at least 28 case reports of QT prolongation and TdP, some with fatal outcome in the context of off-label intravenous haloperidol. Healthcare professionals should consider this new risk information when making individual treatment decisions for their patients.
Source: FDA MedWatch
The FDA has been monitoring cases of serious skin reaction, including erythema multiforme (EM), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN). In its post-marketing reviews of adverse event reports associated with the use of modafinil. The product labeling for modafinil has been recently updated to include a bolded warning for serious rash. Although modafinil was approved for use in narcolepsy, shift-work sleep disorder, and other wakeful conditions, many doctors have used modafinil off-label to treat ADHD and depression with fatigue.
Source: FDA Drug Safety Newsletter, October 2007
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