Products Affected – Description

Reason for the Shortage

• Ben Venue has stopped production in its plant in Bedford, Ohio and will close in early 2014. Ben Venue supplies multiple sterile injectable products for Bedford Laboratories. Supplies of product that has already been manufactured will continue to be released until inventory is depleted. Bedford Laboratories has a small number of products manufactured elsewhere that are not affected by this closure.1
  
• Teva temporarily discontinued norepinephrine in June 2010.2
  
• Hospira had Levophed on shortage due manufacturing delays.3

Available Products

Estimated Resupply Dates

• Bedford has norepinephrine 1 mg/mL 4 mL vials on long-term back order and the company cannot estimate a release date. Ben Venue manufactured norepinephrine for Bedford.1
  
• Teva has temporarily discontinued norepinephrine and the company does not expected product before the 4th quarter of 2016.2

Implications for Patient Care

• Norepinephrine is a vasopressor used to correct hypotension due to shock and to adjunctively manage hypotension during cardiac arrest.5,6
  
• No single agent may be substituted for norepinephrine for all patients. Base choice of therapy on specific  patient characteristics.

Alternative Agents & Management

• No other vasopressor has the same pharmacologic profile, although alternative agents may be used to manage patients typically treated with norepinephrine.
  
• Guidelines published in 2008 (Surviving Sepsis Campaign: International Guidelines for Management of Severe Sepsis and Septic Shock)7 recommend using norepinephrine or dopamine as an initial vasopressor of choice.
  
• Low dose vasopressin has been suggested in early septic shock.8
  
• The table below compares the pharmacologic action of norepinephrine with other potential alternative vasopressors.6

Table. Vasopressor comparison6

*Norepinephrine is currently in short supply.

Related Shortages

• Epinephrine Injection — Current

1. Bedford (personal communications and website). November 19, December 7 and 29, 2010; January 12, 19, and 31, May 20, June 29, July 20, October 6 and 26, December 2, 2011; February 2, March 27, April 20, May 21, June 18, August 9, October 22, December 21, 2012; February 22, May 8, July 23, September 9, October 21, and December 17, 2013.
   
2. Teva (personal communications).July 8, 2010; March 8, June 8, and August 2 and 31, and October 4, 2011; January 4, March 27, May 7, October 24, 2012; May 7, July 23, and November 6, 2013.
   
3. Hospira (personal communications and website). November 18, December 7 and 29, 2010; January 12 and 18, February 1, 2, 8, 10, and 25, March 2 and 8, April 1 and 28, May 23, June 6, July 20, August 2 and 31, September 15, October 6, November 1, 2011; January 4 and 30, March 27, April 20, May 7 and 22, June 28, August 13, October 24, December 21, 2012; February 21, May 9, July 23, September 13, November 4, 2013; and January 7, 2014.
   
4. Claris (personal communications). April 30, July 23, September 13, November 5, 2013; and January 6, 2014. 
   
5. Norepinephrine Bitartrate. In: McEvoy GK, Snow EK, Miller J, Kester L, Welsh OH, eds. AHFS Drug Information. Bethesda, MD: American Society of Health-System Pharmacists; 2011:1388-1391.
   
6. Vasopressors Used in Shock. In: Wickersham RM, Horenkamp JR, McCarron SM, Polley MM, Schweain SL eds. Drug Facts and Comparisons (updated monthly). St. Louis, MO: Wolters Kluwer Health; 2010: 550-565.
   
7. Dellinger RP, Levy MM, Carlet JM, Bion J, Parker MM, Jaeschke R, et al. Surviving Sepsis Campaign: International Guidelines for Management of Severe Sepsis and Septic Shock: 2008. Intensive Care Med. 2008;34(1):17-60.
   
8. Russell JA, Walley KR, Singer J, Gordon AC, Hebert PC, et al. Vasopressin versus norepinephrine infusion in patients with septic shock. N Engl J Med 2008;358:877-87.

Updated

Updated January 7, 2014 by Michelle Wheeler, PharmD, Drug Information Specialist. Created March 2, 2011, by Erin Fox, PharmD, Director, Drug Information Service, and Michelle M. Wheeler, PharmD, Drug Information Specialists. Copyright 2014, Drug Information Service, University of Utah, Salt Lake City, UT.