Drug Notebook

FDA Alerts

Special Alerts:

[Posted 09/17/2007] 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. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Haloperidol and http://www.fda.gov/cder/drug/InfoSheets/HCP/haloperidol.htm.

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haloperidol
(hal oh PER i doll)

Before taking haloperidol, tell your doctor if you are taking any of the following medicines:

  • lithium (Eskalith, Lithobid, others);

  • a blood thinner such as warfarin (Coumadin); or

  • rifampin (Rifadin, Rifamate, Rimactane).

This list is not complete and there may be other drugs that can interact with haloperidol. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • dizziness, fainting, fast or pounding heartbeat;

  • restless muscle movements in your eyes, tongue, jaw, or neck;

  • tremor (uncontrolled shaking);

  • fever, stiff muscles, confusion, sweating, fast or uneven heartbeats;

  • stabbing chest pain, feeling short of breath, cough with yellow or green mucus;

  • sudden mood changes;

  • confusion, agitation, hallucinations, unusual thoughts or behavior; or

  • jaundice (yellowing of your skin or eyes).

Less serious side effects may include:

  • headache, dizziness, drowsiness;

  • sleep problems (insomnia);

  • feeling restless or anxious;

  • mild skin rash or itching;

  • breast enlargement, irregular menstrual periods, loss of interest in sex; or

  • dry mouth, blurred vision, urinating less than usual.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

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