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 18 February, 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 list attributes 77% of the shortages to manufacturing issues, including plant capacity restrictions, with the remaining 23% caused by supply interruptions. The figures continue to grab public attention even as the Wall Street Journal headlined the recent shortages of methotrexate and highlighted what the agency has called an increase in the number of medically significant medicines in short supply. (Amy Dockser Marcus, "Critical Cancer Drug Faces Shortage," Wall Street Journal, 15 March 2005, p. D 1.)
Another methotrexate formulation-made by Mayne, APP, and Bedford Laboratories (Bedford, OH, www.bedfordlabs. com)--had already joined the shortage list last December. The American Society of Health-System Pharmacists' (ASHSP, Bethesda, MD, www.ashp.org) index of "Drug Products with Limited Availability" cites "manufacturing delays" at all three manufacturers, which have put current requests for the product on back-order.
The other recent entry on the FDA list-Wyeth's "Trecator SC" (ethionamide 250mg tablets), listed 28 January--is the only solid oral formulation said to be in short supply. The tuberculosis treatment is scarce because of unspecified manufacturing issues; FDA indicates that normal distribution should resume this month.
According to ASHSP,"For unknown reasons, Wyeth has limited supplies of ethionamide tablets (NDC 00008.4130.01). The product is short-dated and expires July 2005. The company is allocating a single 100-count bottle per patient, for use in patients currently receiving ethionamide or for patients initiating therapy. Product is available by drop shipment to wholesalers or by direct order through Wyeth Customer Service (800.666.7248). When ordering ethionamide, the purchasing agent must specify the number of patients being treated and the date each patient started therapy. The company will not estimate a release date."
FDA drug shortage list by date posted or updated.
Product Admin. updated
Methotrexate Injection 18 Feb. 2005
Trecator SC (ethionamide, Tablet 28 Jan. 2005
Methotrexate with preservative Injection 15 Dec. 2004
(25 mg/mL2 mL vials)
Merrem i.v. (meropenem) Injection 30 Sept. 2004
Celestone Soluspan Injection 16 Sept. 2004
Pre-Pen (benzyl-penicilloyl Injection 19 July 2004
Avonex (interferon beta 1 a) Injection 5 May 2004
Penicillin G potassium and Injection 6 April 2004
Penicillin G sodium
Solu-Cortef (hydrocortisone Injection 30 Jan. 2004
Cytovene (ganciclovir) Powder for 10 Jan. 2003
Product Maker Reason
Methotrexate Mayne Manufacturing
(1-g vials) Pharma issues
Trecator SC (ethionamide, Wyeth Manufacturing
250 mg) issues
Methotrexate with preservative APP Manufacturing
(25 mg/mL2 mL vials) issues
Merrem i.v. (meropenem) AstraZeneca Supply issues
Celestone Soluspan Schering- Manufacturing
(betamethasone Injection) Plough issues
Pre-Pen (benzyl-penicilloyl Hollister- Manufacturing
polylysine) Stier issues
Avonex (interferon beta 1 a) Biogen Idec Manufacturing
Penicillin G potassium and Sandoz and Supply issues
Penicillin G sodium Baxter have
Solu-Cortef (hydrocortisone Pharmacia Manufacturing
sodium succinate) issues
Cytovene (ganciclovir) Roche Manufacturing