Bulletin

Betamethasone

06 April 2006

Products Affected - Description

Betamethasone sodium phosphate 4 mg/mL solution for injection (Celestone Phosphate), Schering-Plough -DISCONTINUED.

Reason for the Shortage

Betamethasone acetate and betamethasone sodium phosphate injection (Celestone Soluspan) was on nationwide backorder since late 2000 because of increased demand for product and a voluntary recall due to sterility concerns. ¹
Schering-Plough discontinued production of betamethasone sodium phosphate injection (Celestone Phosphate) in May 2002.¹

Estimated Resupply Dates

Schering-Plough is now shipping betamethasone acetate and betamethasone sodium phosphate injection (Celestone Soluspan) to wholesalers. The product is not longer being allocated. ¹
Betamethasone sodium phosphate 4 mg/mL injection has been discontinued.¹

Implications for Patient Care

The injectable corticosteroid suspensions are used to treat endocrine disorders, rheumatic disorders, collagen diseases, allergic states, ophthalmic diseases, gastrointestinal diseases, respiratory diseases, dermatologic diseases, hematologic disorders, neoplastic disorders, edematous states, nervous system disorders, tuberculous meningitis, and trichinosis with neurologic or myocardial involvement.⁶ Individual products have additional labeled uses, as described below.

Betamethasone acetate and betamethasone sodium phosphate injection (Celestone Soluspan) and betamethasone sodium phosphate injection (Celestone Phosphate) are labeled for use in dermatologic disorders (administered by intralesional injection) and rheumatic disorders (administered by intra-articular injection).⁷
Betamethasone acetate and betamethasone sodium phosphate injection (Celestone Soluspan) is used primarily for antenatal lung development during premature labor and delivery, although this is not an FDA-approved indication.^8,9 Although this product has also been administered epidurally for low back pain, limited clinical data are available on this route of administration and use of the product for this indication is not included in the labeling.^10-12 Because few alternatives to betamethasone injection are available, clinicians may be tempted to purchase an extemporaneously compounded product. However, there are several concerns with using an extemporaneously compounded sterile product.^13-15 Compounded preparations are not FDA-approved products.^13,15 As such, the FDA has no control over the quality or consistency of the manufacturing process. In July 2001, several patients died from bacterial meningitis after receiving betamethasone injection prepared by a compounding pharmacy.¹⁴

Alternative Agents & Management

The table below lists possible alternatives for patients who would typically receive injectable corticosteroid suspensions.

Table 1. Alternative agents for disorders commonly treated injectable corticosteroid suspensions.^7,8,10,16,19

Route of Administration	Dose of Betamethasone Acetate and Betamethasone Sodium Phosphate Injection (Celestone Soluspan)	Possible Alternative Agents and Dose
Intramuscular injection of antenatal steroids	12 mg q 24 hours x 2 doses given to mother before delivery	Dexamethasone sodium phosphate 6 mg q 12 hours x 4 doses
Intra-articular injections for disorders such as rheumatoid arthritis and bursitis	Very large joint (hip) = 12 mL Large joint (knee) = 1 mL Medium joint (elbow)= 0.5-1 mL Small joint (hand) = 0.25-0.5 mL Bursae = 0.25-1 mL	Dexamethasone sodium phosphate Large joint = 2-4 mg Small joint = 0.8-1 mg Bursae = 2-3 mg Methylprednisolone acetate (e.g., Depo-Medrol [Pharmacia]) Large joints = 20-80 mg Medium joints = 10-40 mg Small joints = 4-10 mg
Intralesional or intradermal injection for dermatologic disorders such as lichen planus and psoriatic plaques	0.2 mL injected into the lesion for every square centimeter of affected skin. A maximum of 1 mL may be administered weekly.	Dexamethasone acetate 0.8-1.6 mg Methylpredisolone acetate (e.g., Depo-Medrol [Pharmacia]) 20-60 mg
Epidural injection for low back pain or sciatica*	1-3 mL (6-18 mg) injected into the epidural space. Ideally, the procedure would be performed under fluoroscopy to confirm needle positioning.	No suitable alternative for epidural use due to preservative content. Additionally, no alternative has FDA-approved labeling for epidural use. Methylprednisolone acetate (e.g., Depo-Medrol [Pharmacia]): multiple-dose vials contain benzyl alcohol and polyethylene glycol, single-dose vials contain polyethylene glycol^8,17 *Triamcinolone acetonide (e.g., Kenalog-40 [Squibb]): contains benzyl alcohol^8,18 Triamcinolone hexacetonide (e.g., Aristospan [Fujisawa]):* contains benzyl alcohol⁸

*Currently, no clinical evidence conclusively shows that epidural corticosteroid injections are either effective or ineffective for relieving low back pain. Institutions should conserve supplies of betamethasone for more critical uses (i.e., premature labor).^10,11,15,17

Related Shortages

Fluticasone Propionate HFA Inhaler— Resolved
Hydrocortisone Sodium Succinate— Resolved
Methylprednisolone Acetate Injection— Resolved
Methylprednisolone Sodium Succinate
Prednisolone Tablets— Resolved
Triamcinolone Injection— Resolved

References

Schering-Plough, Customer Service (personal communications). October 18, 2000; January 16, April 12, May 8, June 6, 11 and 27, August 1 and 24, September 6 and 26, October 3 and 28, November 14, and December 18, 2001; and January 9 and 22, February 4 and 26, March 12 and 18, April 2 and 23, May 6 and 29, June 12, July 3 and 25, August 2 and 20, September 23, October 24, and November 21, 2002; and January 23, February 27, April 1, May 13, July 21 and 22, August 28, September 30, and November 4, 2003, January 14 , March 16, May 17, July 12, September 16 and 25, October 27, and December 2, 2004; and May 3, 2005, August 9, November 15, 2005, and February 28, and April 6, 2006.
Pharmacia, Customer Service (personal communications). January 15 and 21, February 4, 14, and 26, March 6, April 2, 18, and 23, May 21, June 4 and 11, July 3, August 2 and 20, September 24, October 24, November 21, and December 10, 2002; and January 23, February 27, April 1, and May 13, 2003.
Fujisawa, Customer Service (personal communications). February 26, July 11 and 26, August 26, September 4 and 26, November 28, and December 5, 2001; and January 9, February 4 and 26, March 29, April 23, May 14, June 12, July 3, August 2, September 24, October 24, and November 21, 2002; and January 22, May 13, and July 21, August 28, and December 3, 2003; and January 16 and March 23, 2004.
Sandoz (formerly SAB-Pharma), Customer Service (personal communications). March 23, 2004; February 25 and May 3, and November 8, 2005, and January 9, and February 28, 2006.
Bristol-Myers Squibb, Customer Service (personal communications). March 12 and 29, April 4, May 1 and 29, June 20, July 3, August 2 and 20, September 24, October 24, November 21, and December 10, 2002; and January 22, February 27, April 1, May 13, and July 21, August 28, and December 3, 2003; January 16, 2004; and February 25, 2005, February 28, March 13, and April 6, 2006.
Mosbys GenRx. The Complete Reference for Generic and Brand Drugs. 11th ed. St. Louis, MO: Mosby-Year Book; 2001.
Celestone Soluspan. In: Physicians' Desk Reference. 56th ed. Montvale, NJ: Medical Economics; 2002:3097-3099.
Glucocorticoids In: Drug Facts and Comparisons. St. Louis, MO: Facts and Comparisons; 2000:320-332.
Betamethasone (Drug Evaluation). In: Hutchison TA, Shahan DR, eds. Drugdex System. Greenwood Village, CO: Micromedex. (Edition expires June 30, 2002.)
Nelemans PJ, de Bie RA, de Vet HCW, Sturmans F. Injection therapy for subacute and chronic benign low back pain (Cochrane Review). In: The Cochrane Library, Issue 1, 2001. Oxford: Update Software.
Latham JM, Fraser RD, Moore RJ, Blumberg PC, Bogduk N. The pathological effects of intrathecal betamethasone. Spine. 1997;22:1558-1562.
El-Khoury GY, Ehara S, Weinstein JN, Montgomery WJ, Kathol MH. Epidural steroid injection: a procedure ideally performed with fluoroscopic control. Radiology. 1988;168:554-557.
American Society of Health-System Pharmacists. ASHP guidelines on managing drug product shortages. Am J Health-Syst Pharm. 2001;58:1445-1450.
Meningitis deaths linked to drug shortages. Available online at http://www.ashp.org/news/ShowArticle.cfm?cfid=21132049&CFToken=55989159&id=2425 (accessed on April 5, 2002). Bethesda, MD: American Society of Health-System Pharmacists. July 17, 2001.
Rusho WJ. Clinical issues and concerns in the use of extemporaneously compounded medications. J Pharm Care Pain Sympt Contr. 1996;4:5-20.
Tonkovich-Quaranta LA, Winkler SR. Use of epidural corticosteroids in low back pain. Ann Pharmacother. 2000;34:1165-1172.
Pharmacia, Medical Information (personal communications). March 30, 2001; and January 15 and 21, February 4, 12, and 26, and March 6, 2002.
Bristol-Myers Squibb, Medical Communications (personal communication). March 30, 2001.
Crowley P. Prophylactic corticosteroids for preterm birth (Cochrane Review). In: The Cochrane Library, Issue 4, 2000. Oxford: Update Software.

Updated

Updated April 6, 2006, by Erin R. Fox, Pharm.D, Drug Information Specialist. Created by Erin R. Fox, Pharm.D., and Shantel Mullin Pharm.D., Drug Information Specialists. Copyright 2004, Drug Information Service, University of Utah, Salt Lake City, UT.

Back to Drug Shortage Product Bulletins