Products Affected - Description

Reason for the Shortage

• Ben Venue voluntarily entered into a consent decree with FDA in late-January, 2013. The terms allow Ben Venue to continue to manufacture over 100 medications as long as they are compliant with the decree. FDA will continue to work with Ben Venue to ensure the products are being made with federal current good manufacturing practice requirements. Ben Venue supplies many multiple products for Bedford Laboratories, a division of Ben Venue.¹
• Teva had daunorubicin on shortage due to manufacturing issues.²

Available Products

Estimated Resupply Dates

• Bedford has Cerubidine 20 mg lyophilized powder for injection on back order and the company cannot estimate a release date.¹
• Bedford has daunorubicin solution for injection 4 mL and 10 mL vials on back order and the company cannot estimate a release date.¹

Implications for Patient Care

• Daunorubicin hydrochloride is an anthracycline antineoplastic antibiotic. It is labeled for the treatment of acute lymphocytic leukemia (adults, children) and for acute myelocytic leukemia (adults), usually used in combination with other antineoplastic agents.^3-5
• Daunorubicin hydrochloride is also used off-label for a variety of neoplastic diseases including chronic myelogenous leukemia (combination therapy), acute promyelocytic leukemia (combination therapy), and anaplastic large cell lymphoma (children).^3-5

Safety

• Chemotherapy agents, such as daunorubicin hydrochloride, pose additional safety risks both for patients and for healthcare workers handling these agents.^3,4
• Use additional caution when processing orders for chemotherapy drugs, especially when switching between chemotherapy agents or when processing orders for chemotherapy agents with which staff may be unfamiliar (eg, those not normally prescribed at a specific institution).^3,4

Alternative Agents & Management

• The choice of an alternative agent must be patient-specific and based on renal function, liver function, and the neoplasm type and location. No single agent can be substituted for daunorubicin hydrochloride.^3-5
• Consider evaluating the health-care system’s total supply of daunorubicin hydrochloride before beginning patients on combination chemotherapy regimens containing daunorubicin hydrochloride. If adequate supplies are not available, select an alternative regimen.
• Consult a Hematology/Oncology specialist for patient- and neoplasm-specific recommendations.
• Refer to the ASHP Guidelines on Managing Drug Product Shortages for more guidance on developing a multidisciplinary plan when the supply must be allocated.

Related Shortages

• Asparaginase Injection— No Longer Available
• Bendamustine Injection— Resolved
• Bleomycin Injection— Resolved
• Busulfan— Resolved
• Capecitabine Tablets— Resolved
• Carboplatin Solution for Injection
• Carmustine Injection— Resolved
• Cisplatin Injection— Resolved
• Cyclophosphamide Injection— Resolved
• Cytarabine Injection
• Dacarbazine Injection
• Denileukin Diftitox Injection
• Doxorubicin Injection
• Doxorubicin Liposomal Injection
• Etoposide Injection— Resolved
• Fludarabine Injection
• Fluorouracil Injection
• Gemtuzumab Ozogamicin Injection— No Longer Available
• Idarubicin Hydrochloride Injection— Resolved
• Interferon Alpha-2b, Intron A— Resolved
• Irinotecan Injection— Resolved
• Leuprolide Acetate 14-Day Kit
• Lomustine Capsules
• Mercaptopurine Tablets
• Methotrexate Injection
• Methotrexate Tablets
• Mitomycin Injection
• Paclitaxel Injection
• Pentostatin Injection
• Streptozocin For Injection— Resolved
• Thiotepa for Injection
• Tretinoin Oral Capsules— Resolved
• Vinblastine Injection
• Vincristine Injection— Resolved

1. Bedford (personal communications). January 26, February 22, March 1 and 10, April 5 and 30, May 20, June 9 and 29, July 27, August 17, and September 29, 2010; and March 1 and 29, April 25, May 11 and 20, June 1, 15, 23, and 30, July 12, August 3 and 16, September 15, October 6, 13 and 31, and November 7 and 21, and December 1 and 14, 2011; January 9, February 28, March 20, April 13, May 1 and 7, June 20, July 11, August 28, October 22, November 26, and December 17, 2012; and February 4 and March 28, 2013.
2. Teva (personal communications). January 26, February 22, March 1 and 10, April 5 and 28, May 20, June 8 and 29, July 1 and 27, August 17, and September 29, 2010; March 1 and 30, May 9 and 31, June 14, August 1, September 13, October 4 and 27, and December 14, 2011; January 17, February 27, March 20, April 12, May 9, June 18, July 12, August 28, October 22, and November 27, 2012; and February 5 and March 28, 2013.
3. Beckwith MC, Tyler LS, eds. Cancer Chemotherapy Manual. St. Louis, MO: Wolters Kluwer Health Inc. 2010.
4. Antineoplastic agents. In: McEvoy GK, ed. AHFS 2010 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2010: 902-1260.
5. Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc. September 2010.

Updated

Updated March 28, 2013 by Leslie Jensen, PharmD, Drug Information Specialist. Created September 3, 2010, by Michelle M. Wheeler, PharmD, and M. Christina Beckwith, PharmD, Drug Information Specialists. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.