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Shortages of Key Drugs
The chemotherapy drug methotrexate (injection) in 1-g vials is the most recent entry on the ten-product FDA Current Drug Shortages List. The US Food and Drug Administration listed the product on Feb. 18, citing unspecified manufacturing delays at Mayne Pharma (Paramus, NJ, www.us.maynepharma.com) and American Pharmaceutical Partners (APP, Schaumburg, IL, www.appdrugs.com).
Overall, the FDA listattributes 77% of the shortages to manufacturing issues, includingplant capacity restrictions, with the remaining 23% caused by supply interruptions. The figures continue to grab public attentioneven as Tuesday's Wall Street Journalheadlined the recent shortages of methotrexate andhighlighted what the agency has called an increase in the number ofmedicallysignificant medicines in short supply. (Amy Dockser Marcus, "CriticalCancer Drug Faces Shortage," WallStreet Journal, March 15, 2005, p.D1. Subscription required.)
Another methotrexate formulation—made by Mayne, APP, and Bedford Laboratories (Bedford, OH,www.bedfordlabs.com)—had already joined the shortage list lastDecember. The American Society of Health-System Pharmacists' (ASHSP,Bethesda,MD, www.ashp.org) index of "DrugProducts with Limited Availability" cites "manufacturing delays" atall three manufacturers, which have put current requests for theproduct onback-order.
The other recent entry on the FDA list—Wyeth's "Trecator SC"(ethionamide 250-mg tablets), listed Jan. 28—is the only solid oralformulation said to be in short supply. The tuberculosis treatment isscarce because of unspecified manufacturing issues; FDA indicates thatnormal distribution should resume this month.
According to ASHSP, "For unknown reasons, Wyeth has limited suppliesof ethionamide tablets (NDC 00008.4130.01). The product is short-datedand expires July 2005. The company is allocating a single 100-countbottle per patient, for use in patients currently receiving ethionamideor for patients initiating therapy. Product is available by dropshipment to wholesalers or by direct order through Wyeth CustomerService (800-666-7248). When ordering ethionamide, the purchasing agentmust specify the number of patients being treated and the date eachpatient started therapy. The company will not estimate a releasedate."
By date posted or updated
Methotrexate (1-g vials)
Feb. 18, 2005
American Pharmaceutical Partners (APP)
Trecator SC (ethionamide, 250 mg)
Jan. 28, 2005
Methotrexate with preservative
Dec. 15, 2004
Merrem i.v. (meropenem)
Sept. 30, 2004
Celestone Soluspan (betamethasone Injection)
Sept. 16, 2004
Pre-Pen (benzylpenicilloyl polylysine)
July 19, 2004
Avonex (interferon beta 1a)
May 5, 2004
Penicillin G potassium and Penicillin Gsodium
April 6, 2004
Baxter have product available
Solu-Cortef (hydrocortisone sodium succinate)
Jan. 30, 2004
Powder for Injection
Jan. 10, 2003