[12 June 2013]
Products Affected - Description
Dexamethasone Sodium Phosphate Injection, 4 mg/mL, American Regent
1 mL single dose vial (NDC 00517-4901-25)
5 mL multiple dose vial (NDC 00517-4905-25)
30 mL multiple dose vial (NDC 00517-4930-25)
Dexamethasone Sodium Phosphate Injection, 10 mg/mL, APP2
1 mL single dose vial (NDC 63323-0506-01)
10 mL multiple-dose vial (NDC 63323-0516-10)
Dexamethasone Sodium Phosphate Injection, 4 mg/mL, Pfizer4
1 mL vial (NDC 00069-4547-02)
10 mL vial (NDC 00069-4541-02)
30 mL vial (NDC 00069-4545-02)
Reason for the Shortage
- American Regent voluntarily recalled all dexamethasone sodium phosphate due to the presence of particulate matter in the solution and discontinued manufacture of all dexamethasone 4 mg/mL presentations in March, 2011.1
- American Regent had temporarily suspended distribution of most drug products including dexamethasone in April, 2011.
- American Regent resumed manufacturing in Shirley, New York in early-May, 2011.
- APP states the dexamethasone sodium phosphate shortage was due to supply and demand issues.2
- Baxter could not provide a reason for the shortage. Baxter sold several products to West-Ward in mid-2011.3
- West-Ward had dexamethasone sodium phosphate injection on shortage due to increased demand.4
- Pfizer launched dexamethasone sodium phosphate injection in January, 2012.4
- Pfizer has dexamethasone sodium phosphate injection on shortage due to manufacturing delays.4
Dexamethasone Sodium Phosphate Injection, 4 mg/mL, APP2
1 mL single dose vial (NDC 63323-0165-01)
5 mL single dose vial (NDC 63323-0165-05)
30 mL multiple dose vial (NDC 63323-0165-30)
Dexamethasone Sodium Phosphate Injection, 4 mg/mL, Pfizer4
5 mL vial (NDC 00069-4543-02)
Dexamethasone Sodium Phosphate Injection, 10 mg/mL, West-Ward (formerly Baxter products)3
1 mL vial (NDC 00641-0367-25)
Estimated Resupply Dates
- American Regent has dexamethasone sodium phosphate 4 mg/mL products on back order and the company cannot estimate a release date.1
- APP has dexamethasone 10 mg/mL 1 mL and 10 mL vials on intermittent back order and the company is releasing product regularly.2
- Pfizer has dexamethasone sodium phosphate 4 mg/mL 1 mL and 30 mL vials on back order and the company estimates a release date of mid-June, 2013. Dexamethasone sodium phosphate 4 mg/mL 10 mL vials are on back order and the company estimates a release date of mid-July, 2013.4
Implications for Patient Care
Dexamethasone sodium phosphate injection is labeled for a variety of conditions including endocrine disorders, rheumatic disorders, collagen diseases, dermatologic diseases, allergic states, ophthalmic and otic diseases, gastrointestinal diseases, respiratory diseases, hematologic disorders, neoplastic diseases, edematous states, cerebral edema, tuberculosis meningitis, trichinosis with myocardial or neurologic involvement, as well as a diagnostic aid in testing adrenocortical function.5,6 Dexamethasone is also widely used to prevent chemotherapy-induced nausea and vomiting, as well as to prevent postoperative nausea and vomiting.5,6
Oral dexamethasone is as effective as injectable dexamethasone; however, the oral route may not be practical for all patients.6
Alternative Agents & Management
- Table 1 compares dexamethasone with other available glucocorticoid products and Table 2 lists alternatives in specific situations. If dexamethasone injection is not available, methylprednisolone may be an acceptable alternative in many situations, although there are few data that specifically address its use. When oral drug administration is possible, oral dexamethasone is the preferred alternative agent.
- There is no alternative to dexamethasone for the dexamethasone suppression test (DST). If supplies are extremely limited, institutions should consider conserving dexamethasone for DST patients until the shortage resolves.7
- Dexamethasone has been used in the past to manage intracranial pressure in head trauma patients. The Brain Trauma Foundation’s most recent evidence-based “Guidelines for the Management of Severe Traumatic Brain Injury” do not recommend corticosteroids for managing intracranial pressure in patients with severe head injury.17,18
- Methylprednisolone may be an acceptable alternative in many situations, although there are few data that specifically address its use.
- American Regent, Customer Service (personal communications). March 21, July 22, August 4, September 29, October 26, November 22, 2011; January 10 and 31, February 28, April 10, May 21, June 21, August 8, November 7, 2012; January 11 and 23, March 20 and 29, April 11, May 3, and June 12, 2013.
- American Pharmaceutical Partners, Customer Service (personal communications). March 21 and 24, April 4 and 20, May 11 and 23, June 23, August 4 and 18, September 27, October 26, November 22, 2011; January 10 and 31, February 28, April 10 and 17, May 21, June 18, August 7, November 7, 2012; January 14 and 19, March 17 and 29, April 11, May 3, and June 10, 2013.
- West-Ward (formerly Baxter Anesthesia), Customer Service (personal communications). March 21 and 24, April 4 and 18, May 11 and 23, June 21, September 30, October 26, November 22, 2011; January 5, 13, 18, and 31, February 6 and 27, April 6, May 23, June 21, August 6, November 9, 2012; January 14 and 21, March 15 and 29, April 11 and 22, 2013, and June 7, 2013.
- Pfizer, Customer Service (personal communications). January 13 and 31, February 27, April 10, May 21, June 15, August 6, November 7, 2012; January 14, March 15 and 29, April 11, May 2, and June 12, 2013.
- Dexamethasone Sodium Phosphate. In: Mosby’s Drug Consult. St. Louis, MO. Mosby Inc., 2005: 763-766.
- McEvoy GK, Snow EK, Kester L, Miller J, Welsh OH, Litvak K, eds. AHFS 2005 Drug Information. Bethesda, MD: American Society of Health-System Pharmacists; 2005.
- Klasco RK, ed. Drugdex System. Greenwood Village, CO: Thomson Micromedex. (Edition expires 12/2005).
- Glucocorticoids. In: Drug Facts and Comparisons. St. Louis, MO: Facts and Comparisons; 2005: 320-332.
- American Society of Health-System Pharmacists. ASHP therapeutic guidelines on the pharmacologic management of nausea and vomiting in adult and pediatric patients receiving chemotherapy or radiation therapy or undergoing surgery. Am J Health-Syst Pharm. 1999;56:729-764.
- Herrstedt J, Aapro MS, Smyth JF, Del Favero A. Corticosteroids, dopamine antagonists and other drugs. Support Care Cancer. 1998;6(3):204-214.
- Beckwith MC, Tyler LS. Methylprednisolone. In: Beckwith MC, Tyler LS, eds. Cancer Chemotherapy Manual. St. Louis, MO: Wolters Kluwer Health; 2010:445-446.
- American Society of Clinical Oncology; Kris MG, Hesketh PJ, Somerfield MR, et al. American Society of Clinical Oncology guidelines for antiemetics in oncology: update 2006. J Clin Oncol. 2006;24(18):2932-2947.
- Gebbia V, Testa A, Valenza R, et al. Oral granisetron with or without methylprednisolone versus metoclopramide plus methylprednisolone in the management of delayed nausea and vomiting induced by cisplatin-based chemotherapy. A prospective randomized trial. Cancer.1995;76(10):1821-1828.
- Levin VA, Leibel SA, Gutin PH. Neoplasms of the central nervous system. In: DeVita VT, Hellman S, Rosenberg SA, eds. Cancer Principles and Practice of Oncology. 6th ed. Philadelphia, PA: Lippincott Williams and Wilkins;2001:2100-2160.
- Bjerre JS. Effect of glucocorticoids on ICP in patients with a cerebral tumour. Acta Neurol Scand. 1997;96:167-170.
- McCrea JB, Majumdar AK, Goldberg MR, et al. Effects of the neurokinin1 receptor antagonist aprepitant on the pharmacokinetics of dexamethasone and methylprednisolone. Clin Pharmacol Ther. 2003;74(1):17-24.
- Boucher BA, Phelps SJ, Timmons S. Acute management of the head injury patient. In: DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey LM, eds. Pharmacotherapy: A Pathophysiologic Approach. 6th ed. Stamford, CT: Appleton & Lange;2005:1061-1074.
- Brain Trauma Foundation. Guidelines for the Management of Severe Traumatic Brain Injury. J Neurotrauma. 2007;24:S1-106.
Updated June 12, 2013 by Kristen Jefferies, PharmD, Drug Information Specialist. Created March 20, 2001, by Erin R. Fox, PharmD, Drug Information Specialist, and Linda S. Tyler, PharmD, Drug Information Specialist. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.
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