Methylprednisolone and Other I.V. Glucocorticoids in Short Supply
The company has informed pharmaceutical supply companies and other customers that the plantwhich manufactures sterile methylprednisolone sodium succinate, methylprednisolone acetate, and hydrocortisone sodium succinate products for injectable usewill return to full-scale operation by the end of March. By mid-April, the company expects to have fulfilled most of its backlog of orders. [Recent correspondence from the company indicates that most of the backlog of orders will be filled by late April.]
An emergency supply of Solu-Medrol, the only injectable methylprednisolone sodium succinate product available in the United States, is available through the company's customer service center at 800-253-8600 ext. 30099. Decisions will be made on a case-by-case basis according to company-determined criteria. The company recognizes that methylprednisolone sodium succinate has been used to treat acute spinal cord injury, a use not mentioned in the package insert for Solu-Medrol.
Information about the stability of methylprednisolone sodium succinate after reconstitution can be obtained from the company's medical and drug information unit at 800-253-8600 ext. 38244. Drug Information Specialist Karl M. Wetzsteon, Pharm.D., said that his group does not advise inquirers about alternative glucocorticoid therapies, adding that "conversion potencies are in the standard texts."
Novation LLC, the supply company for VHA and University HealthSystem Consortium, advised members to consider clinical alternatives, keeping in mind each patient's needs and the biologic half-lives of the various glucocorticoids. According to the company's notice, an intravenous (i.v.) methylprednisolone dose of 40 to 80 mg could be replaced during the shortage with a dexamethasone dose of 2 to 4 mg, which takes into account the drugs' different half-lives. Also, a 125-mg dose of methylprednisolone could be replaced with a 8-mg dose of dexamethasone.
At Detroit Medical Center, Coordinator of Drug Information Services Margo S. Farber, Pharm.D., said that the pharmacy and therapeutics committee at her seven-hospital health system recently approved a conversion protocol. On the basis of a glucocorticoid equivalency table common to standard references such as AHFS Drug Information, Farber's health system will, when necessary, use 20 mg of i.v. hydrocortisone or 0.75 mg of i.v. dexamethasone in place of 4 mg of i.v. methylprednisolone.
Problems with the manufacturing process for Pharmacia & Upjohn's three corticosteroid products were noted during a September 1999 plant inspection by the Food and Drug Administration (FDA). In a Dec. 2 warning letter to Pharmacia & Upjohn, FDA stated that its investigators found "numerous significant deviations from the Current Good Manufacturing Practice Regulations" in aseptic drug manufacturing operations. The company issued a letter Jan. 27 recalling selected lots of Solu-Medrol and Solu-Cortef vials.