Shortages of Key Drugs

March 17, 2005
Pharmaceutical Technology Editors
Pharmaceutical Technology

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."

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 mLvials)

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 Gsodium

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