UC IrvineWestern Journal of Emergency Medicine: Integrating Emergency Care with Population Health

TitleThe Effect of the FDA VVarning on the Use of Droperidol by U.S. Emergency Physicians

Permalinkhttps://escholarship.org/uc/item/0vh5m5rf

JournalWestern Journal of Emergency Medicine: Integrating Emergency Care with Population Health, 4(1)

ISSN1936-900X

AuthorsRichards, John RWeiss, Steven JBretz, Stephen Wet al.

Publication Date2003

Copyright InformationCopyright 2003 by the author(s). All rights reserved unless otherwise indicated. Contact the author(s) for any necessary permissions. Learn more at https://escholarship.org/terms Peer reviewed

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The Californir! Journai of Ealer~eiicv Medicine IV: I.San-Rlar 1003

ORIGINAL RESEARCH

The Effect sf the FDA VVBrning on the Use of Droperidol by U.S. Emergency Phy sisians

John R, Richards, M.D. Steven 9. PNeiss. M.D.

Stephen W. Bi'etz, M.D. Aaron B. Schneir, M.D.

Dauna Rinetti Roberz W. D~rler. M.D.

Division of E~nerge~lcy Medicine (JRR. SJW, DR: RUJD), University of California, D;lvis Meiiical Center

Szcramento. California

Depaitr~xnt of Erncrgci~cy 1b:Icciicinc (SWB). San Francisco Generai Hohpiiai

San Franciscc. California

Del7au~1ierli oi'Ei~lergency Medicine !ASS). Divisinil of h!l;tciicai Tc3xicoEogy

liriirersiiy olrai ifonii t , Siln Diego Medical Ceni-,- San Diego Divisioii, Califorriiz. Poison Contrcl Syscciii

San Diegil, Ca'iiIomia

Address for relirii~ts:

John R. Richards; M.D. Division of Ei-i;ergci~cy ?~fedicine 23 1.5 Stocktori Borrievard Sacrsmciito; CA 9581 7 (916'j 734-1537 Tax (9 16) 734-7950 e-mall: jrrichards@ucdir~~is.ed~.r

E'rescntcd at the Arncricd~i Calllcge i>f Eiiiesgeilcy Pliysi- ciims Research Fcrum, October 2002

WBST&\CT: Objective: To determine if emergency phq iiciatls~ IEP) UFG o!'drcq7eridr>! i-12s chiingrri sirice 1112 United Scales Food a.nd Driig Aclniinihzratio~: (FDA) warning of December 2001 coxicerning QT irikrrt al proiorgatioi:, iorsarie J e po i~ tes , 2nd s~~cidcii de:.r",l: and ro qu:.r> EP nl,ii?iofij rcgzrding droy?eri:'.cl hefclre 2nd ~ifter t l i ~ FDA. i;var.r,ing aiid regarding potcx"lal aItcrilbt:il;c drugi.

Methods: An internet-based survey was designed with y~~eslions regarding droperidol use in the emergency de- partment (ED). Data coiiected included EP demographics, use of droperidcd before and ~ifier the FDA warniiig, use of alterilative drugs, and incidence of arrhythmias. A repre- sentative sample of EPs were contacted by e-!nail and asked to complete the survey. Results: A total of 2,000 e-mails resulted in 506 (25%) com- plered surveys. There was no aecond mailing. Respond- ers" average years practicing was 12.6 2 9.2. EP responders worked in pivatelcommunity (n=278, 55%). academic/ county jn=187,37%), and HMO (i1=41,89) hospitals. The ~ ~ ~ a j o r i t y (11~455, 90%) used droperidol and were aware of the FDA warning (n=460.9 i %). Droperidol was no longer avaiiable at i 22 (24%) ofthe respondents' EDs as aresult of the FDA warning. Prior to the FDA warning EPs who had used droperidcli used it as an antiemetic jn=408,90%), for conrroi of agiiaticm (n=330.73%); for treatment of headache (n=247, 54%), and for treatment of vertigo jn=106. 23%). After the FDA warning, 387 (85%) of EPs reported their use of droperidol had decreased or ceased altogether, and 68 (158) always oh~btined an elecrrocardiogra~n prior to ad- ministraiion. Of' tilose who used droperidol fix agitation: 137 (42%) felt there were no other drugs with greater effi- cacy. Haloperidol was the most cited alternative agent in=160, 79%) fc>c;i!o\+ ed by benzodiazepines (it=223,68%). Of those w l ~ o usecl cira>peridoi for antiernesis; 116 (28%) felr there were no other drugs with grealer efficacy than droperidoi: promethazine was rhz most cited alternative agent (n=2OO. 64%). 'Two (0.4% j EPs reported 21-rhythxnias in patients who received droperidol. Only 37 (8%) EPs re- ported they were unconcerned with potential loss of droperidol frol-i~ the nlaritet, Conc%iasion: Basecl 031 this survey EP use of droperidol has decreased cirarnaticaliy as a result ofthe FDA warning. However. EPs he!ieve that there are fevv: or no alternative anriernelic drugs that have an improved adverse ePfecl pro- file,

Key words: droperidol. Ii~zpsine. emergency medicine: FDA avarnilag

INTRODUCTION: In December 2001 the FDA :ssued a %Jack box uars~ing~' (E~glitc 11, i l s most sersous alert, c3n the use of dropendoi, ;u~d this bx, a\ tollowed soon thereafter by 21 s~rmilar \wa.r,arng by the Canadfan Hedth Protec- t1si-i Erarich ' ' This walnang w a\ sn respocce kc3 con- rems s\ el pot? -ti;s,l prolonga~ios,~ of t5e QT Imiterb al. twwde de poineb, ; l i d s~iddeu death after adminis- tratlm 239 d r ~ p e n d o i . ' ~ Prior to theie warnings, dnspei:nol was zxtensrvclj uscd 11: the ED fot myralad mdlc;it~ons, ~ ~ s l u d m g co-2 ti ol of agdt~itiola and p\yrlao-

Cases of QT prolongation and/or torsades de pointes have been reported in patients receiving INAPSINE at doses at or below recommended doses. Some cases have occurred in patients with no known risk factors for QT prolongation and some cases have been fatal.

Due to its potential for serious proarrhythmic effects and death, INAPSINE should be reserved for use in the treatment of patients who fail to show an acceptable response to other adequate treatments, either because of insufficient effectiveness or the inability to achieve an effective dose due to intolerable adverse effects from those drugs (see Warnings, Adverse Reactions, Contraindications, and Precautions).

Cases of QT prolongation and serious arrhythmias (e.g., torsades de pointes) have been reported in patients treated with INAPSINE. Based on these reports, all patients should undergo a 12-lead ECG prior to administration of INAPSINE to determine if a prolonged QT interval (i.e., QTc greater than 440 msec for males or 450 msec for females) is present. If there is a prolonged QT interval, INAPSINE should NOT be administered. For patients in whom the potential benefit of INAPSINE treatment is felt to outweigh the risks of potentially serious arrhythmias, ECG monitoring should be performed prior to treatment and continued for 2-3 hours after completing treatment to monitor for arrhythmias.

INAPSINE is contraindicated in patients with known or suspected QT prolongation, including patients with congenital long QT syndrome.

INAPSINE should be administered with extreme caution to patients who may be at risk for development of prolonged QT syndrome (e.g., congestive heart failure, bradycardia, use of a diuretic, cardiac hypertrophy, hypokalemia, hypomagnesemia, or administration of other drugs known to increase the QT interval). Other risk factors may include age over 65 years, alcohol abuse, and use of agents such as benzodiazepines, volatile anesthetics, and PV opiates. Droperidol should be initiated at a low dose and adjusted upward, with caution, as needed to achieve the desired effect.

Figure I. FDA Black Box Warning for Use of Droperidol (InapsineB).

sis,"12 nausea and emesis,13 l8 headache,lS " ver- tigo,?*-" and atypical pain syndr~mes .~"~~ Dmperidol was commonly used by anesthesiologists for treat- ment of postoperahive nausea and vorniting (POW), constihtting 30% of the P O W market, with over 25 million units sold in 2000.2Vn its oral form, dsoperidol was used as an antipsychotic agent by psychiatrists, especially in Europe.' Before the FDA w a ~ n g , only doses greater than 25 mg were col~cidered to be at risk for QT interval proBongation and arrhythmia. Across the world, EPs. anesthesiologists, psychia- hists, and pl~amacists reacted with skepticism to there new rertrictions on the use of droperidol.' 2s-35 The purpose of this survey study war to determine i f droperidol use by EPs has changed since the FDA warning.

METHODS Study Design and Population This survey study was specifically designed for, and addressed to practicing EPs in the United States, in-

academic/universiQ> countyipt~b- lic, p~ivate/communi@> md health maintenance orga- nizatioi~ ( m O ) EDs. A questionnaire was de\ieloped in hyper text makup language (HTNIE) format tasii~g Dreamweaver (Macromedia, Sari Francisco. Califor- nia), and a survey world wide web (WWW) page was set up on a dedicated server. Upon completion of the HTML survey, data was collected using ColdFusion (Macromedia, San Francisco. Califor- nia) in an Access (Microsoft, Wedmsnd, Washing- ton) database for hi-ther andy sis. This study was ap- proved by the hsdtk~tional Review Board of the Uni- versity of California, Davis Medical Centeir.

Survey Content and Administration The first section of the survey contained questions regauding El? demogr;~p%nics, includil~g type of hospi- tal staffed, surrounding population sewed, and years practicing emergency medicine. We obtained re- sponses on howledge of the FDA waning and prior use of dropendo1 in the ED. Culrent availability of

droperidol in the respondent's particular ED and dis- continuation after the FDA walling were also que- ried. The next section of the s ~ ~ ~ v e y involved ody those physicians who use or had used droperado1 in the ED. Specific indicaeioras such as nausea and emesis, agi- tation. and headache were listed, and frequency of use of ciroperidol before and after the FDA war~~ing was detemined. Emergency physicians who contin- ued to use drope6dol despite the FDA !yarning were aslced if they now obtained an eelctrocxdioga-m prior to administration. 3pinion regarding efficacy of droperidol and preferred alternative pharmaceutical agents for t l~e Bndics?'bions of agitkltlon and psychosis, as well as nausea and emesis, were queried. In addi- tion, adverse outcomes in the f o m ~ of arrhythmia or sudden death from droperidol administration were tabulated. Finally, EP opinion of the validity of the

g and concern regarding loss of drope:r;ldol avi6lability altogether were also i~acluded in the ques- tio~~raire.

A;? e-r-mil conea~ning La solacttation letter deialilng the pu~yos: of tbc stvdy a hy perllnh lzrading to the xeeah web page v as w i t :o a SB\I of2,000 EPc). E%cG- uonlc in21i zddre4ces were obta~ned raxadoady rn pro- pol-tlon ko xnembsrahlp nulxber Lcrn published direc- ti;nes of clx -4mesncdn Colkeg of Emergencq Pnj sl- crars. Socsety of Academic Enxrgency Medicme. and Amersia~~ Aii?dt:my oEEmergency Mcd~csne. A sangle broadcast nnailing was perfornied In the Spnng of 2002, and there were no repeat e-mails To emure pnvacy and freedom o f o p l s ~ ~ o ~ ~ , no adenlifaer$ were s~.ied foi respondent<. such aa Hogging ori~~ternet pro- vider (IP) s;- e-mail acldresses, ccjok~es, ol survey coding

Data Analysis Gompaa-isons between drope~dol use before and af- ter the FDA warning werc made asmg fne two-sample Vi~lcoxon EU& sum test for non-pa arnetric v;viables. Statibtical signlficai7ce is ascumed at a level of P < 0 ~ 0 5 ~ Data are rcpdried a<? mesn 2 standal d devia- tion.

RESULTS

Table 1. Clinlczl lndrcatiolls for Droperidol use 111 !he ED. n - 6%)

EPs who uie or used Droperidol 455 (100)

Emesis Nausea Agitation Psychosis Headache Anxiety Vertigo Abdominal pain Chronic musculoskeletal pain Co~~scious sedation Amnesia Chest pain

From 2,080 e-mails iient out there were 506 (25%) fully completes$ surveys. There were 122 (6%) in- 17alid e-man1 addresses, and one EP returned the e- mail u~~willmg to pafl~cipate in the seirvey, Respocd- ers' ak7erage years practicing was 12.6 + 9.2, Elmer- gency phy\ician responders worked ira plrt atei~orn- m u t ~ ~ f y (n=27S, 55%). 3cadem1clci3untj {n= 187, 37%), anci HMO bn=4 1, 8%) i-~osp~taals. One 11~1i.8-

dred twes7ty four (25% j dejcrlbed :heir pract~ce set- iing as inner city, 299 (59%) a\ urban. and 83 ( 16%) as r~iral. The mkajo~itg' (11~455. 90%) had u\ed droperidol and were av,are of the FDA warning (n=460,91%). Droperidol war i?o longer available in 122 (24%) ofthe respondents ED3 following the FDA warning. Pnor to the FDA warnzing 90% (n--408) of EPs who had used droperidol, used it as an antiemet~c. and 73% (11x330) for ccsntsol of agita- tion. Eb le H l~sts all ~I inicd indications for si-soper'rdol ac indicated by the respondents.

As a direct result of the FDA wafing, 85% (n=387) oEEPs reported theh use of dropekdol had decreased or ceased akogether (Figure 21, and this decline in frequency of use was significant (P < 0.1400%). The remaining 15% of EPs who still use droperidoi al- was s obtained an electrsc~~diogram psior to admin- istration. Of those EPs who used droperldo" f w rthc treatment of agitation in fhe ED, 42% (I 37) felt &ere were no other drugs with greater effncaey. Haloperk dol was the lnosl frequently c~ted alternative agent

303

250-

200

Respondents

in) 150

! 00

50

0 -

=Before FDA Warn ing

n A f t e r FDA Warning

never 1 -4 lmonih I-4lweek I -4lshi%

Frequency of Use

Figare 2, Frequency of Droperidsl Use before and after the FDA Warning

79% (r-r=260) foliorn7ed by benzodiazepines m 68% (n=223) (Table 2). Or" tho% who used ctroperidol for antierz~esis, 28% ((n= 1 I&) felt there were no other & X I ~ S with greater efilcacy, md promethalzine was the most cited alterxlative agent by 63% in=%68)(Table 3). TWO (0.4%) EFs repor-ted arI~yt'ranGas in patitie~~ts who received droperidol, but no cleat115 were repomd.

Opinion regarding overall utiiity of droperidol as a drug in the ED declined sig~ficantly as a result of the FDA warning (P < 0.009), tvith ZOO (44%) EPs rat- ing droperidol as "extremely rascful'' prim to the U ~ ~ I T I -

ing. and just 69 (15%) giving it the s;mx rating after the warning. Tlaree huladred and four respondents (67%) aaaswered that the FDA t c arning had a direct affect on their ability to ireat patients in the ED Emer- gency physicians were q ~ ~ e ~ l e d sn their opm?on of the FDA warning, and 242 (53%) felt it was ur~justified. Twenty (4%) EQs felt the warning was completely appropriate, and two (0.4%) felt droperidol should be banned altogether. Onzly 37 (8%) EBs reported they were unconcerned with potential loss of droperidol from the market, as has occurred in Eu- rope.

DISCUSSION

The results of this survey demonstrate the impact the FDA warning on dl-operidoi has had on prac"rcing EPs' use of the drug. Those paaicipating in the bur- vey now use droperidol rn~lch less frequeaztly or not at all, and many now have no access to Qoper;dol. h also outlines the skepticism many EPs harbor towad the validity and ;113pmpnaateness of the FDA wm~ing, md that alternative naedicaiions may not be perceived to be as effective as dropesidol for a variety of indi- cations. The ackrraI practice experience of EPs does

Table 2. Equal or More Effectwe Alterndt~z e Drugs than Droper~dnl for Aglratlon in i11e ED

11 - @i?-) EP\ vl ho use or uced dropelidol for agitation 330 (100)

Alternative agents

Haloperidol (HaldolO) Benzodiazepines Chlorpro~nazine (Thorazine@) Barbiturates Propnfol (Diprn an@) R~speridoilc iRisperdalO) 01 anzapine (ZyprexaO) Thioridamne (Me!larilO) Fluphenazine (Prolixin@) Diphenhydramine (BenadrylO)

Table 3. Equal or More Effective z41ternahve Drugs than Droperidol for Nausea and EmeGs in the ED.

n - IC/c) EPs t\ no use or used droperrdol for anuemes1s 8 ( I C Q

Promethazine (Phei~erganO) Meroclopramide (RcglanBj Onclansetroll (Zofran8) Prochiorperazi~~e (CorngazineO) Hydrosyzine (VistarilO) Ibiphei~i~ydl-amim (Bei~adrylO) Meclirine (Ailti\ ertO) Trimethobenzamide (TiganB) Dolasetiorl!A~~zernet@) Lorazepam (A:ivanO) Scopoiair~ine (Transberm ScopO) Granisetron il<.ytril,B) I)examethasone (DecadmnG) Ginger root

not seer11 to reflect the poter~tial -for adverse outcoime as stated by the FDA, Viihat is unique about &opekdl;":i. if is one of the dmgs used fcj; a wide r~ l -~ge i_- of sce~iinglgi ~:nreiated clinical indcal'roi.s, as

. ~ . % . refiecred 311 recent emergency mecI.~cme iitera- 5.7 iC. i 9 -2 i its ey ,.. ,\

A -, ~ ~ r l ~ ~ t ~ j md exbeineky ihsw cost -spay

also exp1i.n the outcTy f:hat accompa.~~':cd 'its loss in Europe" Mter file co~nplete avi tl~ds-k~~h~d of tboperidol in Europe by 95s rna~au&~-l,ctui~er Janssen-Giiag, Trzme~. arnd cofieagues emphasized the d'iscsntinurdon was in response to adverse events liraited with chronic, 1argc k or;?% ~ O S ~ S given to psvchn:' 1 r i i ~ i "-' IC p&t$iie~~tS, 1109 the sIq I a1 qa3- bl ;ntravealo~s -. doses give11 $0 POTPJ patient^.^" r 7 !:his g r o u ~ called for a distirsciion to be made be- + < en '= the two indications so that low-dose i111rave- niius dropefidol could be used in the perjoperative setting. I-Hiaines et a1 also emphasized this distinction, and mentioned the consequences to the national he~alth budget in the Lhnited Kh~gdom Gor-n loss of &ope~idol and rise of the newer serotonin type 3 antagonist^.^' A similar protest was heard frorn Lehot and Ferry in France,.Q

FoilovV~ing the FDA w i ~ ~ i c g , an even stronger outc~=y occu~~ed in the United States, In an article investigat- ing the actual adverse outcomes listed by the FDA, Horo\vitz and associates, refenjng to droperidol as

"one of the most used emergency medications now," suggested the link between droperidol and QT inter- val prolongation. torsade de pointes, and sudden c ; ~ - diac death was not at a13 clear.' They noted many of the deaths or adverse outcolnes provided by the FDA were patients who were already critically ill and/or concomitantly taking several potea~tially mhytlmoge~lic ~~~edirsations. Bailey et d similzly in- vestigated the actual adverse cases used by the FDA to justify the wdming and reached the same conclm- sion." Can and colleagues determined the cost of preventing PONV was over 40 times higher to the patient when ondansetron was used indead of droperidol. and "rat prior to ihe FDA warnirrg droperidof had a 50% ~onarhet share.:" Thic group wrote "we believe thas the recent black box warning by the FDA is totally unj~~stified," and called for the FDA to lift the ban $'or Iow-dose droperidol.

Kintear emphasized the seroto9ln type 3 antagonists,

s ~ ~ h as ondansetron and doiasetron, also bad poten- tial for QT mter\ al plolongat~on allhi torsade de pointes that .ji as Iargely bekg ignored by the FDA'? An up- Gated Lrst of dri~gs that prolong llle QT ~nterval or 1Pldtlce torsack de pomtes may by forind on the 111ternet ($;a, x , i r M c x ~ a ~ c ~ ~ ) . and incidde chlorprsaraz~ne, ~loEase~zon, ~Joperidol, nspendone. Ihiofida~ine, and ~:prassdone, dl d n ~ ~ i g ~ I1sted31 by surtey respofidents as potenanal altenxabtes to dr-operidok (Tables 2 and 3). Ma24 EPs and anestl-ies~olsgisr are concerned that t ~ ~ a ,lAb iestrictior~ of droperidol and huted avaiiab~Ety oi

pochHoqerazln3eze forcmg them to use of more ea- pensi\a: serotonin typc 3 antagonasts srach as i~ndansetroi~." Thew drugs do not have a record of extz~slve use, 111rmaq have ssmlar adverse effects, a id are extremely expensave.

LIMITATIONS The most important limitation ofthis study is that it is a survey based or? srzbjective answers and opinions of a small sarnple of EPs, z ~ d nnay not reflect act~eal practice. F-kar"r~ermore, those who responded may have been motivated to do so because of a stronger than a-zTerage positive or negative opinion regarding droperidoi. There were many non-responders, and several inaccurate, invalid, of- expired e-mail ad- dresses. The loss of these potential survey partici-

pants may have affected the results of the study. In 10. Hick JE. Mahoney BD. Eappe M. Prehospital sedation

order to maintain respondents' privacy, follow up sur- veys were not e-mailed to ~mn-i-esponders, or to those 5ublnikthg hcornpiete sweys. Respo~lsients may have felt their participation in the srervey would result in their e-mail identity being prolnulgated,

CONCLUSION Among those EPs replying to this survey, use of droperidol decreased dramatically as a result of the FDA warning. Over half the suwey resporsdenks feel the FDA w ~ l ~ g is u~~jusdfied and are copzcerned by the pote~~tial loss or h11311er rest~jction of drope~dol in the United States. Many of the d~xegs listed by EPs as alternatives to droperidol, such as hitloperidol, cMor- promazine, rispesidone, and dsIase&on also have risk of QT intenla9 prolongation. Beca~rse of limited alter- native therapies, as well as tlaeir side effect profile and expense, many EPs ,and anestl~esiologists ques- tion the FDRs action.

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Resident/Student Corner

Training in emergency medicine is full of fascinating encounters. Over the course of medical school and residency we will amash a h~age body of inta~agible experience. Much of this we share with our i m e d i - ate peers, residents, and classmates, as a para of our own coping and cahloguing mecl~misms. However, much of it is also an important part of our learning process. I cannot begin to relay how much Y have learned, not from books (I will never read as much as my residency director would like me to) bent from the experience of my fellow residents. Not only have 1 leafned about the practice of medicine, but about the practice of life as a medical professional.

This E S 21 new section for this journal, As it starads there are no official boursdaries. Wc (the colh"ective reiidentisaudent population) can fill it as we see fit. There are many o~atlets for statishcalgy s~gniii'icant rm- domized, Minded, meta-prospective studie5 about vasiable dosing of phenytoin in post-ictd rats. Hsw- ever, these are very few place$ to share on a wider front, the more nebulous. but nor necessarily less irn- portant experiential aspects of our training. (Pva,7c>w. that sorinds abit hew-agey.') HopefuUy tkis will spark some interesting disc~rssio~~ and we can l e m aad laugh a little in the process.

Submissio~~s of any kind (interesting stories, poems, prose, f k t , fiction, and outside-the-box research pro- posals) nnay be sent 'so Jason Quinn jquirm@hghed~com,