[11 April 2013]
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)
Reason for the Shortage
- Ben Venue voluntarily entered into a consent decree with FDA in late-January, 2013. The terms allow Ben Venue to continue to manufacture over 100 medications as long as they are compliant with the decree. FDA will continue to work with Ben Venue to ensure the products are being made with federal current good manufacturing practice requirements. Ben Venue supplies many products for Bedford Laboratories, a division of Ben Venue.1
- West-Ward (formerly Baxter) could not provide a reason for the famotidine shortage.2
- Oral famotidine products are not affected by this shortage.
- Pfizer launched famotidine injections in March, 2012.3
Famotidine 10 mg/mL, APP4
20 mL vials (NDC 63323-0738-20)
2 mL vial (NDC 63323-0739-12)
4 mL vial (NDC 63323-0738-04)
Famotidine premixed bags, Baxter5
20 mg/50 mL (NDC 00338-5197-41)
Famotidine 10 mg/mL, Pfizer3
2 mL vial (NDC 00069-0121-02)
4 mL vial (NDC 00069-0125-02)
20 mL vial (NDC 00069-0126-02)
Famotidine 10 mg/mL injection, West-Ward2
2 mL vial (NDC 00641-6022-25)
4 mL vial (NDC 00641-6023-25)
20 mL vial (NDC 00641-6021-10)
Estimated Resupply Dates
Bedford has all famotidine 10 mg/mL presentations on long term back order and the company cannot estimate a release date.1
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.6
- 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, and April 8, 2013.
- 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, and April 5, 2013.
- Pfizer, (personal communications). March 1, April 4, May 29, August 14, October 11, December 14, 2012; January 23 and April 5, 2013.
- APP, (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, and April 8, 2013.
- Baxter, (personal communications). September 20, October 26, 2011; January 10, February 24, August 14, December 14, 2012; January 23, February 21, and April 8, 2013.
- 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 (cited: August 20, 2008).
- 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 April 11, 2013 by Megan Dryer, PharmD, Drug Information Specialist. Created August 15, 2011 by M. Christina Beckwith, PharmD, and Jane Chandramouli, PharmD, Drug Information Specialists. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.
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