Evidence-based review of the black-box warning for droperidol

Jackson, Cherry W.; Sheehan, Amy; Reddan, Jennifer G.

doi:10.2146/ajhp060505

Cited by 114 publications

(50 citation statements)

References 28 publications

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“…Despite the FDA warning, there is no significant evidence that low doses of droperidol used for nausea or vomiting are associated with torsade de pointes. We believe that the FDA black box warning is overly cautious, because the current evidence does not support the need for these monitoring requirements when low doses are used (9). A single low dose of intravenous (i.v.)…”

Section: Droperidolmentioning

confidence: 99%

Antiemetic Therapy for Nausea and Vomiting in the Emergency Department

Patanwala

Amini

Hays

et al. 2010

The Journal of Emergency Medicine

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Section: Droperidolmentioning

confidence: 99%

Antiemetic Therapy for Nausea and Vomiting in the Emergency Department

Patanwala

Amini

Hays

et al. 2010

The Journal of Emergency Medicine

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“…In particular, FGAs are known to cause both cardiac-related side effects and movement-related side effects such as tardive dyskinesia or dystonia (8,9,(17)(18)(19). Given the black box warning by the U.S. Food and Drug Administration (FDA) issued in 2001, the safety profile of droperidol remains a controversial topic in ED literature, with several studies suggesting its safety in everyday clinical use (19)(20)(21)(22)(23)(24)(25). Although haloperidol has not received a black-box warning from the FDA, the risk of motorrelated side effects is quite common in practice.…”

Section: Introductionmentioning

confidence: 99%

First-generation Antipsychotics Are Often Prescribed in the Emergency Department but Are Often Not Administered with Adjunctive Medications

Campillo¹,

Castillo

Vilke

et al. 2015

The Journal of Emergency Medicine

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, Abstract-Background: Although first-generation antipsychotics (FGAs) have long been used in the emergency department (ED) to treat acute agitation, little is known about how these medications are used in modern clinical practice. In particular, little work has been published about whether ED clinicians administer FGAs with adjunctive medications in accordance with expert guidelines or the prescribing practices of FGAs over time. Objectives: 1) To provide a comparison of the frequency with which FGAs are administered with adjunctive benzodiazepines or anticholinergic medications. 2) To analyze the prescribing trends for FGAs over time, particularly in the years after the U.S. Food and Drug Administration (FDA) black-box warning for droperidol. Methods: This is a structured review of a retrospective cohort of patients receiving haloperidol or droperidol in two EDs over a 7-year period. Results: Haloperidol or droperidol was administered on 2833 patient visits during the study period, with haloperidol being administered most often. Adjunctive medications are administered less than half of the time. The use of droperidol has remained relatively static, whereas the use of haloperidol has increased. Conclusions: First-generation antipsychotics are still widely utilized in the ED. When administered, these medications are used with adjunctive medications that may decrease side effects less than half of the time. Droperidol use has remained unchanged in the years after the FDA black-box warning, whereas use of haloperidol has continued to rise. Ó 2015 Elsevier Inc.

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“…A ''black box'' warning was placed on droperidol with regard to the risks of prolonged QTc and torsades de pointes by the Food and Drug Administration (FDA) of the United States. 21 Other studies, however, seemed to report that droperidol was safe in this aspect. [22][23][24] Nuttall and colleagues and Fortney and colleagues reported that IV droperidol up to 1.25 mg was safe in adult surgical patients.…”

Section: Discussionmentioning

confidence: 96%

Are butyrophenones effective for the treatment of primary headache in the emergency department?

Leong

Kelly

2011

CJEM

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Objectives: Butyrophenones have been reported to provide effective migraine relief in the emergency department (ED). We conducted a systematic review of the evidence for their use in the ED. Data source: We searched the Cochrane, Medline, Embase, and CINAHL databases. Study selection: Included studies were randomized trials of a parenteral butyrophenone (droperidol, haloperidol) versus placebo or a comparator in migraine or benign headache with results available in English. Study quality was determined using the Jadad score. Six articles were included. Data extraction: Primary outcomes were subjective or objective headache relief (. 50% improvement in visual analogue scale scores). Secondary outcomes included side effects. We reported pooled odds ratios (ORs) with their 95% confidence intervals (CIs) for subjective or objective headache relief for butyrophenones versus placebo or comparator agents. Data synthesis: Three studies reported subjective headache relief with a butyrophenone versus placebo or meperidine in migraine. Two studies reported objective headache relief with droperidol versus prochlorperazine, whereas one study compared droperidol versus olanzapine in benign headache. The pooled OR for subjective headache relief was 8.08 (95% CI 1.54-42.30) for a butyrophenone versus placebo, whereas it was 1.50 (95% CI 0.33-6.77) for droperidol versus meperidine in migraine. The pooled OR for objective headache relief was 2.96 (95% CI 1.36-6.43) for droperidol versus prochlorperazine in benign headache. Rates of side effects were 10 to 45%; akathesia and sedation were the most common. Conclusions: Butyrophenones are effective for the relief of migraine or benign headache. However, adverse effects make it difficult to recommend butyrophenones above agents with similar effectiveness and fewer problems. RÉ SUMÉObjectif : Il a é té signalé que les butyrophé nones soulageaient les migraines dans les services d'urgence. Nous avons procé dé à une analyse systé matique sur leur utilisation à l'urgence. Source des donné es : Nous avons interrogé les bases de donné es Cochrane, Medline, Embase et CINAHL. Sé lection des é tudes : Nous avons retenu les essais randomisé s d'un butyrophé none parenté ral (dropé ridol, halopé ridol) contre un placebo ou un comparateur en cas de migraine ou de cé phalé e bé nigne. Les ré sultats devaient ê tre disponibles en anglais. Nous avons é valué la qualité des essais selon le score de Jadad. Six articles ont é té retenus. Extraction des donné es : Les principaux critè res d'é valuation é taient le soulagement subjectif ou objectif de maux de tê te (. 50 % d'amé lioration selon l'é chelle visuelle analogique). Les critè res secondaires d'é valuation é taient entre autres les effets secondaires. Nous avons inclus les rapports de cotes combiné s (RC) avec intervalle de confiance à 95 % (IC) pour le soulagement subjectif ou objectif de maux de tê te pour le groupe butyrophé nones par rapport au groupe placebo ou autres comparateurs. Synthè se des donné es : Trois é tudes ont signal...

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Evidence-based review of the black-box warning for droperidol

Cited by 114 publications

References 28 publications

Antiemetic Therapy for Nausea and Vomiting in the Emergency Department

Antiemetic Therapy for Nausea and Vomiting in the Emergency Department

First-generation Antipsychotics Are Often Prescribed in the Emergency Department but Are Often Not Administered with Adjunctive Medications

Are butyrophenones effective for the treatment of primary headache in the emergency department?

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