Shortages of Key Drugs - Pharmaceutical Technology

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Shortages of Key Drugs

Pharmaceutical Technology

More Medically Significant Drugs in Short Supply?

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 date."

FDA Drug Shortage List

By date posted or updated

Product

Admin.

Posted/
Updated

Maker

Reason

Methotrexate (1-g vials)

Injection

Feb. 18, 2005

Mayne Pharma

Manufacturing Issues

American Pharmaceutical Partners (APP)

Manufacturing Issues

Trecator SC (ethionamide,  250 mg)

Tablet

Jan. 28, 2005

Wyeth

Manufacturing Issues

Methotrexate with preservative
(25 mg/mL/
2 mL vials)

Injection

 

Dec. 15, 2004

APP

Manufacturing Issues

Mayne Pharma

Manufacturing Issues

Bedford

Supply issues

Merrem i.v. (meropenem)

Injection

Sept. 30, 2004

AstraZeneca

Supply issues

Celestone Soluspan (betamethasone Injection)

Injection

Sept. 16, 2004

Schering-Plough

Manufacturing Issues

Pre-Pen (benzylpenicilloyl polylysine)

Injection

July 19, 2004

Hollister-Stier 

Manufacturing Issues

Avonex (interferon beta 1a)

Injection

May 5, 2004

Biogen Idec

Manufacturing issues

Penicillin G potassium and Penicillin G sodium

Injection

April 6, 2004

Sandoz and
Baxter have product available

Supply issues

Solu-Cortef (hydrocortisone sodium succinate)

Injection

Jan. 30, 2004

Pharmacia

Manufacturing Issues

Cytovene (ganciclovir)

Powder for Injection

Jan. 10, 2003

 Roche

Manufacturing Issues



–Douglas McCormick

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