[01 November 2013]
Products Affected - Description
Papaverine injection, American Regent3
30 mg/mL, 2 mL single dose vial (NDC 00517-4002-25)
30 mg/mL, 10 mL vial (NDC 00517-4010-01)
Reason for the Shortage
- Bedford and Sandoz have discontinued their papaverine presentations.1,2
- American Regent, the sole supplier of papaverine injection, had temporarily suspended distribution of all drug products in April, 2011.
- American Regent resumed manufacturing in Shirley, New York in early-May, 2011.
No presentations are available.
Estimated Resupply Dates
American Regent has papaverine 30 mg/mL 2 mL and 10 mL vials on back order and the company cannot estimate a release date.3
Implications for Patient Care
- Papaverine hydrochloride is an unapproved drug. It is a phosphodiesterase inhibitor that relaxes smooth muscle of the vascular system (eg, large blood vessels), bronchial musculature, and the gastrointestinal, biliary, and urinary tracts. Papaverine is labeled for the management of smooth muscle spasm including vascular spasm from acute myocardial infarction, angina pectoris, pulmonary or peripheral embolism, peripheral vascular disease with vasospasm, and some cerebral angiospastic states, and visceral spasm such as ureteral, biliary or gastrointestinal colic.4-7
- Unlabeled uses for papaverine include intracavernous injection for the treatment of erectile dysfunction, and topical administration in the perioperative setting to prevent spasm during coronary artery bypass grafting or arterial reconstruction.5,7-12
Alternative Agents & Management
- Papaverine is used by Cardiothoracic and Vascular Surgeons perioperatively to prevent vasospasm and relax vascular grafts. It is a component of irrigation solutions or “vein bath” solutions. Consult with the surgeons at your institution for their recommendations on alternatives to papaverine. Other vasodilators, such as nitroglycerin, have been used and may be a suitable alternative.7-12
- Reserve papaverine injection for intraoperative use. Use alternative agents for the treatment of erectile dysfunction.5
- Bedford Laboratories (personal communications). April 21, 2011.
- Sandoz (personal communications). April 22, 2011.
- American Regent (personal communications and website). April 21, May 6, July 22, September 14, October 3, 11, and 20, November 8, December 5, 2011; January 10 February 3, March 29, May 24, August 1, October 16, November 8, December 4 and 19, 2012; January 24, March 8, May 31, June 24, July 18 and 31, September 19, and October 31, 2013.
- American Regent. Papaverine hydrochloride injection [product information]. Shirley, NY: American Regent; January 2009.
- McEvoy GK, Snow EK, Kester L, Litvak K, Miller J, Welsh OH, eds. AHFS DI (Lexi-Comp Online). Bethesda, MD: American Society of Health-System Pharmacists; 2011.
- Wickersham RM, Novak KK, managing eds., eds. Drug Facts and Comparisons (eFacts). St. Louis, MO: Wolters Kluwer Health, Inc.; 2011.
- Anon. Drug Evaluation: Papaverine. In: Hutchison TA, Shahan DR, Anderson ML, eds. Drugdex System [internet database]. Greenwood Village, CO: Thomson Healthcare; 2011. Updated periodically.
- Rosenfeldt FL, He GW, Buxton BF, Angus JA. Pharmacology of coronary artery bypass grafts. Ann Thorac Surg. Mar 1999;67(3):878-888.
- Attaran S, John L, El-Gamel A. Clinical and potential use of pharmacological agents to reduce radial artery spasm in coronary artery surgery. Ann Thorac Surg. Apr 2008;85(4):1483-1489.
- Owens CD. Adaptive changes in autogenous vein grafts for arterial reconstruction: clinical implications. J Vasc Surg. 2010; Mar;51(3):736-746.
- Roubos N, Rosenfeldt FL, Richards SM, Conyers RA, Davis BB. Improved preservation of saphenous vein grafts by the use of glyceryl trinitrate-verapamil solution during harvesting. Circulation. Nov 1 1995;92(9 Suppl):II31-36.
- Adcock OT, Jr., Adcock GL, Wheeler JR, Gregory RT, Snyder SO, Jr., Gayle RG. Optimal techniques for harvesting and preparation of reversed autogenous vein grafts for use as arterial substitutes: a review. Surgery. Nov 1984;96(5):886-894.
Updated November 1, 2013 by Michelle Wheeler, PharmD, Drug Information Specialist. Created May 3, 2011, by Jane Chandramouli, PharmD, Drug Information Specialist and Michelle Wheeler, PharmD, Drug Information Specialist. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.
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