389
Views
11
CrossRef citations to date
0
Altmetric
Commentary

A continuing black hole? The FDA boxed warning: An appeal to improve its clinical utility

, , , &
Pages 443-447 | Received 30 Sep 2010, Accepted 15 Feb 2011, Published online: 18 May 2011

References

  • Associated Press 2009. FDA's drug approvals flat in 2009, safety up, http://www.msnbc.msn.com/id/34708085/ns/health-more_health_news/. Accessed 23 February 2011.
  • Food and Drug Administration (FDA) 1979. 21 Code of Federal Regulations xx201.56, 201.57.
  • Food and Drug Administration (FDA) 1979. 21 Code of Federal Regulations x201.57(e).
  • Guidance for Industry Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products – Content and Format DRAFT GUIDANCE, January 2006. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075096.pdf. Accessed 23 February 2011.
  • Liang BA. FDA use of the black box warning: time for reevaluation as a safety tool. J Clin Anesth 2002; 14:561–563.
  • Wood AJ. Thrombotic thrombocytopenic purpura and clopidogrel – a need for new approaches to drug safety. N Engl J Med 2000; 342: 1824–1826.
  • Food and Drug Administration (FDA) 2009. Dr. Curtis Rosebraugh (Director of Drug Evaluation II in the Center for Drug Evaluation and Research at FDA) from the Transcript for FDA's Media Briefing on the Serious Mental Health Risks Associated with the Drugs Chantix and Zyban, 1 July 2009. www.fda.gov/downloads/NewsEvents/Newsroom/Media/transcripts. Accessed 23 February 2011.
  • Cook DM, Gurugubelli RK, Bero LA. Risk management policy and black-box warnings: a qualitative analysis of US FDA proceedings. Drug Saf 2009; 32:1057–1066.
  • Lasser KE, Allen PD, Woolhandler SJ, Himmelstein DU, Wolfe SM, Bor DH. Timing of new black box warnings and withdrawals for prescription medications. JAMA 2002; 287:2215–2220.
  • Lurie P, Sasich LD. Safety of FDA-approved drugs. JAMA 1999; 282:2297–2298.
  • 2006 Safety Alerts for Human Medical Products, FDA, U.S. Department of Health and Human Services. www.fda.gov/safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/. Accessed 23 February 2011.
  • Droperidol [package insert]. Taylor Pharmaceuticals. Decatur, IL. 2006.
  • Gan TJ. “Black box’ warning on droperidol: report of the FDA convened expert panel. Anesth Analg 2004; 98:1809.
  • Fortney JT, Gan TJ, Graczyk S, Wetchler B, Melson T, Khalil S, . A comparison of the efficacy, safety, and patient satisfaction of ondansetron versus droperidol as antiemetics for elective outpatient surgical procedures. S3A-409 and S3A-410 Study Groups. Anesth Analg 1998; 86:731–738.
  • Henzi I, Sonderegger J, Tramer MR. Efficacy, dose-response, and adverse effects of droperidol for prevention of postoperative nausea and vomiting. Can J Anaesth 2000; 47:537–551.
  • Bailey P, Norton R, Karan S. The FDA droperidol warning: is it justified? Anesthesiology 2002; 97:288–289.
  • Gan TJ, White PF, Scuderi PE, Watcha MF, Kovac A. FDA “black box” warning regarding use of droperidol for postoperative nausea and vomiting: is it justified? Anesthesiology 2002; 97:287.
  • Habib AS, Gan TJ. Food and drug administration black box warning on the perioperative use of droperidol: a review of the cases. Anesth Analg 2003; 96:1377–1379.
  • Jackson CW, Sheehan AH, Reddan JG. Evidence-based review of the black-box warning for droperidol. Am J Health Syst Pharm 2007; 64:1174–1186.
  • Kao LW, Kirk MA, Evers SJ, Rosenfeld SH. Droperidol, QT prolongation, and sudden death: what is the evidence? Ann Emerg Med 2003; 41:546–558.
  • Lischke V, Behne M, Doelken P, Schledt U, Probst S, Vettermann J. Droperidol causes a dose-dependent prolongation of the QT interval. Anesth Analg 1994; 79:983–986.
  • Smith SW, Martel M, Biros M. QT lengthening after parenteral droperidol administration. Acad Emerg Med 2002; 9:374–375.
  • Mieckowski A, Burns M. Droperidol and the Blackbox. Clin Toxicol (Phila) 2005; 40:669–670 (abstract).
  • Habib AS, Gan TJ. The use of droperidol before and after the Food and Drug Administration black box warning: a survey of the members of the Society of Ambulatory Anesthesia. J Clin Anesth 2008; 20:35–39.
  • Nuttall GA, Eckerman KM, Jacob KA, Pawlaski EM, Wigersma SK, Marienau ME, . Does low-dose droperidol administration increase the risk of drug-induced QT prolongation and torsade de pointes in the general surgical population? Anesthesiology 2007; 107:531–536.
  • Methadone-associated Deaths and Efforts to Prevent Them. Government Accountability Office Report to Congressional Requesters: GAO-09-341; March, 2009.
  • Paulozzi LJ, Logan JE, Hall AJ, McKinstry E, Kaplan JA, Crosby AE. A comparison of drug overdose deaths involving methadone and other opioid analgesics in West Virginia. Addiction 2009; 104: 1541–1548.
  • Sims SA, Snow LA, Porucznik CA. Surveillance of methadone-related adverse drug events using multiple public health data sources. J Biomed Inform 2007; 40:382–389.
  • Wysowski DK. Surveillance of prescription drug-related mortality using death certificate data. Drug Saf 2007; 30:533–540.
  • Fredheim OM, Moksnes K, Borchgrevink PC, Kaasa S, Dale O. Clinical pharmacology of methadone for pain. Acta Anaesthesiol Scand 2008; 52:879–889.
  • Li Y, Kantelip JP, Gerritsen-van SP, Davani S. Interindividual variability of methadone response: impact of genetic polymorphism. Mol Diagn Ther 2008; 12:109–124.
  • Weschules DJ, Bain KT, Richeimer S. Actual and potential drug interactions associated with methadone. Pain Med 2008; 9: 315–344.
  • Andrews CM, Krantz MJ, Wedam EF, Marcuson MJ, Capacchione JF, Haigney MC. Methadone-induced mortality in the treatment of chronic pain: role of QT prolongation. Cardiol J 2009; 16:210–217.
  • Ehret GB, Desmeules JA, Broers B. Methadone-associated long QT syndrome: improving pharmacotherapy for dependence on illegal opioids and lessons learned for pharmacology. Expert Opin Drug Saf 2007; 6:289–303.
  • Maremmani I, Pacini M, Cesaroni C, Lovrecic M, Perugi G, Tagliamonte A. QTc interval prolongation in patients on long-term methadone maintenance therapy. Eur Addict Res 2005; 11:44–49.
  • Pearson EC, Woosley RL. QT prolongation and torsades de pointes among methadone users: reports to the FDA spontaneous reporting system. Pharmacoepidemiol Drug Saf 2005; 14:747–753.
  • Methadone [package insert]. Roxane Laboratories, Inc. Columbus, OH.
  • Bronstein AC, Spyker DA, Cantilena LR Jr., Green JL, Rumack BH, Giffin SL. 2008. Annual Report of the American Association of Poison Control Centers’ National Poison Data System (NPDS): 26th Annual Report. Clin Toxicol (Phila) 2009;47:911–1084.
  • Litovitz TL, Klein-Schwartz W, White S, Cobaugh DJ, Youniss J, Omslaer JC, . 2000. Annual report of the American Association of Poison Control Centers Toxic Exposure Surveillance System. Am J Emerg Med 2001; 19:337–395.
  • Krantz MJ, Rowan SB, Schmittner J, Bucher BB. Physician awareness of the cardiac effects of methadone: results of a national survey. J Addict Dis 2007; 26:79–85.
  • Dershwitz, M. There should be a threshold dose for FDA black-box warning on droperidol. Anesth Analg. 2003; 97:1542–1543; author reply 1543.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.