Products Affected - Description
Famotidine 10 mg/mL injection, Bedford
2 mL vial (NDC 55390-0029-10)
4 mL vial (NDC 55390-0028-10)
20 mL vial (NDC 55390-0027-01)
50 mL vial (NDC 55390-0026-01)
Famotidine 10 mg/mL Fresenius Kabi
2 mL vial (NDC 63323-0739-12)
4 mL vial (NDC 63323-0738-04)
20 mL vials (NDC 63323-0738-20)
Famotidine 10 mg/mL, Mylan Institutional
2 mL vial (NDC 00069-0121-02) - NDC discontinued
2 mL vial (NDC 67457-0433-22)
4 mL vial (NDC 00069-0125-02)
20 mL vial (NDC 00069-0126-02)
Famotidine 10 mg/mL injection, West-Ward
2 mL vial (NDC 00641-6022-25)
4 mL vial (NDC 00641-6023-25)
20 mL vial (NDC 00641-6021-10)
Reason for the Shortage
- Ben Venue has stopped production in its plant in Bedford, Ohio and will close in 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
- West-Ward states the shortage is due to manufacturing delays.2
- Oral famotidine products are not affected by this shortage.
- Pfizer launched famotidine injections in March, 2012.3
- Mylan Institutional acquired famotidine injections from Pfizer on December 6, 2013.4
Famotidine premixed bags, Baxter6
20 mg/50 mL (NDC 00338-5197-41)
Estimated Resupply Dates
- Bedford has all famotidine 10 mg/mL presentations on long term back order and the company cannot estimate a release date. Ben Venue manufactured famotidine for Bedford.1
- Fresenius Kabi has famotidine 10 mg/mL 2 mL vials and 20 mL vials on back order with a release date in mid-July 2014. Famotidine 4 mL vials are on allocation.5
- Mylan Institutional has temporarily discontinued all famotidine 10 mg/mL injection and the company cannot estimate when product will return.4
- West-Ward has famotidine 10 mg/mL 4 mL vials available on allocation. Famotidine 2 mL vials are back order and the company estimates a release date in late-July 2014. Famotidine 20 mL vials are on back order and the company estimates a release date in late-July to August 2014.2
Implications for Patient Care
Famotidine is a histamine type-2 receptor antagonist, or H2 blocker, which reduces gastric acid secretion in response to physiologic and dietary stimuli. Famotidine injection is used for patients with hypersecretory conditions, intractable ulcers, or for patients who cannot receive oral therapy.7
- Ensure patients receive an appropriate alternative based on their specific clinical indication.
- The drug interaction profile differs between the H2 blocker class and the proton pump inhibitors (PPIs). Evaluate the patient’s medication profile for drug interactions when switching between different drug classes.
Alternative Agents & Management
- Use oral H2 blocker therapy whenever possible.
- In patients who require IV therapy, ranitidine injection may be an alternative to famotidine injection. If IV H2 blockers are not available, consider therapy with an injectable proton pump inhibitor.
- Table 1 summarizes potential alternatives in selected clinical situations.
- Bedford, (personal communications). June 15, July 7 and 19, August 5, November 4, December 7, 2011; February 16 and 27, April 5, June 5, August 6, October 9, December 14, 2012; January 23, February 21, April 8, May 29, July 17, August 7 and 14, September 19, November 11, December 2, 2013; January 7, February 18, March 4 and 19, April 8, May 19 and 27, June 30, and July 2, 2014.
- West-Ward (formerly Baxter), (personal communications). June 15, July 7 and 18, August 10, 16, and 23, September 20, October 4 and 26, November 4, December 7 and 28, 2011; February 4, 24, and 27, April 3, June 14, August 6, October 5, December 14, 2012; January 23, February 21, April 5, June 7, July 26, August 16 and 30, September 23, November 11, December 4 and 6, 2013; January 7, 11, and 17, February 21 and 27, March 3 and 21, April 10, May 2, 16, and 28, June 11 and 30, and July 10, 2014.
- Pfizer, (personal communications). March 1, April 4, May 29, August 14, October 11, December 14, 2012; January 23 April 5, June 7, July 19, August 16, September 3, and 20, November 11, and December 4, 2013.
- Mylan Institutional, (personal communications). December 9, 2013; January 9 and 14, February 24, March 25, April 11 and 14, May 6, 20, and 28, and June 16, 2014.
- Fresenius Kabi, (personal communications). June 15, July 7, 11, and 21, August 10 and 23, September 16, October 4 and 26, November 8, December 7, 2011; January 10, February 6 and 22, April 4, June 12, August 13, October 10, December 14, 2012; January 23, February 21, April 8, June 10, July 24, August 19 and 30, September 24, November 11, December 3 and 6, 2013; January 8 and 13, February 24, March 7 and 18, April 8 and 14, May 6, 19, and 28, June 17, and July 3 and 11, 2014.
- Baxter, (personal communications). September 20, October 26, 2011; January 10, February 24, August 14, December 14, 2012; January 23, February 21, April 8, June 14, July 29, September 3, November 11, December 3, 2013; January 7, February 24, March 21, May 8, and June 16, 2014.
- McEvoy GK, ed. Antiulcer agents and acid suppressants. In: AHFS Drug Information 2011. Bethesda, MD: American Society of Health-System Pharmacists; 2011:2971-3021.
- Cooper DH, Krainik AJ, Lubner SJ, Reno HEL. Esophageal disorders. Gastroesophageal reflux disease. In: The Washington Manual of Medical Therapeutics. 32nd edition. Philadelphia, PA: Wolters Kluwer Health; 2007:444-446.
- Bajaj JS, Dua KS, Hanson K, Presberg K. Prospective, randomized trial comparing effect of oral versus intravenous pantoprazole on rebleeding after nonvariceal upper gastrointestinal bleeding: a pilot study. Dig Dis Sci. Sep 2007;52(9):2190-2194.
- Hartmann D, Eickhoff A, Damian U, Riemann JF, Schilling D. Effect of intravenous application of esomeprazole 40 mg versus pantoprazole 40 mg on 24-hour intragastric pH in healthy adults. Eur J Gastroenterol Hepatol. Feb 2007;19(2):133-137.
- Tsibouris P, Zintzaras E, Lappas C, et al. High-dose pantoprazole continuous infusion is superior to somatostatin after endoscopic hemostasis in patients with peptic ulcer bleeding. Am J Gastroenterol. Jun 2007;102(6):1192-1199.
- Zargar SA, Javid G, Khan BA, et al. Pantoprazole infusion as adjuvant therapy to endoscopic treatment in patients with peptic ulcer bleeding: prospective randomized controlled trial. J Gastroenterol Hepatol. Apr 2006;21(4):716-721.
- Rohss K, Wilder-Smith C, Kilhamn J, Fjellman M, Lind T. Suppression of gastric acid with intravenous esomeprazole and omeprazole: results of 3 studies in healthy subjects. Int J Clin Pharmacol Ther. Jun 2007;45(6):345-354.
- Armstrong D. Intravenous proton pump inhibitor therapy: a rationale for use. Rev Gastroenterol Disord. 2005;5 Suppl 2:S18-30.
- Beejay U, Wolfe MM. Acute gastrointestinal bleeding in the intensive care unit. Gastroenterology Clinics. 2000;29(2):309-336.
- Reynolds MS, Petros BA: H2-Antagonists: Continuous infusion for Stress Ulcer Prophylaxis (Drug Consult). In: Klasco RK (Ed): DRUGDEX® System (electronic version). Thomson Micromedex, Greenwood Village, Colorado, USA.
- Donnelly AJ, Baughman VL, Gonzales JP, et al. Anesthesiology and Critical Care Drug Handbook. 6th ed. Hudson, OH: Lexi-Comp; 2005.
- American Society of Health-System Pharmacists. ASHP therapeutic guidelines on stress ulcer prophylaxis. Am J Health-Syst Pharm. 1999;56:347-379.
- Leontiadis GI, Sreedharan A, Dorward S, et al. Systematic reviews of the clinical effectiveness and cost-effectiveness of proton pump inhibitors in acute upper gastrointestinal bleeding. Health Technol Assess. Dec 2007;11(51):iii-iv, 1-164.
- Sung JJ, Barkun A, Kuipers EJ, et al; Peptic Ulcer Bleed Study Group. Intravenous esomeprazole for prevention of recurrent peptic ulcer bleeding: a randomized trial. Ann Intern Med. 2009;150(7):455-464.
- GlaxoSmithKline, (personal communication). August 12, 2011.
Updated July 14, 2014 by Jane Chandramouli, PharmD, Drug Information Specialist. Created August 15, 2011 by M. Christina Beckwith, PharmD, and Jane Chandramouli, PharmD, Drug Information Specialists. Copyright 2014, Drug Information Service, University of Utah, Salt Lake City, UT.
This information is provided through the support of Novation to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Novation, ASHP, and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, which respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither Novation, ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this bulletin. Neither Novation, ASHP nor University of Utah endorses or recommends the use of any drug.
« Back to Drug Shortage Product Bulletins