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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 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 Tuesday's 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, 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 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 250-mg tablets), listed Jan. 28—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
FDA Drug Shortage ListBy date posted or updated