The FDA extended warning for intravenous haloperidol and torsades de pointes: How should institutions respond?

Abstract

While administration of IV haloperidol can be associated with QTP/TdP, this complication most often took place in the setting of concomitant risk factors. Importantly, the available data suggest that a total cumulative dose of IV haloperidol of <2 mg can safely be administered without ongoing electrocardiographic monitoring in patients without concomitant risk factors.

Comparative safety of antipsychotics in the WHO pharmacovigilance database: the haloperidol case

“…The IV route was approved in several other countries including Switzerland [5], Canada [6], France [7], Germany [8], Great Britain [9], and Italy [10] until June 2010, when the current controversy resulted in removal of this route from the labelling. While the package insert for IV haloperidol prior to September 2007 alerted healthcare professionals to the risk of cardiovascular side effects, recommendations regarding monitoring were inconclusive [11]. However, in May 2010, the Pharmacy and Therapeutics Committee of the German Physicians' Association (AkdÄ ) followed the FDA recommendation and sent out a drug safety letter regarding the use of IV haloperidol.…”

Evaluation and Management of Children and Adolescents With Acute Mental Health or Behavioral Problems. Part I: Common Clinical Challenges of Patients With Mental Health and/or Behavioral Emergencies

“…Data in some adult studies suggest that coadministration of a butyrophenone with a benzodiazepine may be more effective than either medication alone. other drugs that prolong the QT c ; administration of high doses of haloperidol 157,158 ; and underlying medical illness (eg, electrolyte abnormalities, hepatic or renal impairment, heart failure, elderly, congenital long QT syndromes). Among the typical and atypical antipsychotics, thioridazine and ziprasidone, respectively, are associated with the greatest degrees of QTc prolongation.…”

Evaluation and Management of Children With Acute Mental Health or Behavioral Problems. Part II: Recognition of Clinically Challenging Mental Health Related Conditions Presenting With Medical or Uncertain Symptoms

“…For most of the medications, however, the degree of QT c prolongation is small, which has given rise to a debate about the actual risk of dysrhythmias and torsades de pointes with antipsychotics e5 45, 47, 48, 55 -60 Of note, intravenous (IV) haloperidol has been studied 61 but carries an FDA non-black box warning because of deaths associated with high doses and IV administration. 62 Therefore, experts suggest that intramuscular dosing of antipsychotics in the ED is the parental preferred route of administration. Table 3 details the factors that are thought to increase the risk of QT c prolongation and sudden death.…”