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Leucovorin Shortage Threatens Colorectal Cancer Treatment

The Food and Drug Administration is reporting shortages of leucovorin calcium, used to enhance the effectiveness of 5-FU (fluorouracil) in treating colorectal cancer.  The reason the FDA gives for the shortage is “Manufacturing Delays.” Leucovorin is supplied by Teva Pharmaceuticals and Bedford Laboratories, and the FDA directs consumers to contact them for more information.

According to a bulletin from the American Society of Health System Pharmacists (ASHP), “Leucovorin calcium lyophilized powder is on back order and the company cannot estimate a release date.” In addition, ASHP has been told, The manufacturers will not provide a reason for the shortage.” ASHP updated their information with personal communications with the manufacturers on December 8, 2008.

Calls from to the FDA, Teva, and Bedford from patient advocates on December 12 provided no new information about what was causing the problem or when it might be resolved.

The shortage not only affects thousands of colon and rectal cancer patients who are being treated with 5-FU and leucovorin, it impacts over one hundred clinical trials in the United States where leucovorin is part of treatment protocols. 

It may be necessary to stop enrolling new patients in those trials and to make difficult and time-consuming changes to trial treatment plans.  This would result in  serious delays in finding new treatments for colon and rectal cancer and answering important questions for patients living with the disease.

For patients not on clinical trials, oral Xeloda® (capecitabine) is being substituted by some oncologists.  While Xeloda has shown equal effectiveness to 5-FU and leucovorin in some clinical situations, patients and their doctors need to be aware of the possibility of serious side effects when patients are switched from 5-FU/leucovorin to Xeloda.  Recently a clinical trial designed to test patient preferences for either 5-FU/leucovorin or Xeloda was stopped when patients being switched to Xeloda experienced excessive toxicity.  Costs of Xeloda and patient copays are also issues in changing treatment.

Another alternative is off-label use of Fusilev® (levoleucovorin) a different formulation of folinic acid.  Fusilev was approved by the FDA in May, 2008 to manage serious side effects from methotrexate chemotherapy.   However, Spectrum Pharmaceuticals, the manufacturer of Fusilev, has only limited supplies of the drug and probably cannot meet the increased demand for its use for colorectal cancer.  ASHP also points out the danger of dosing errors when Fusilev is interchanged with for leucovorin calcium.  The dose of Fusilev is half that of leucovorin.

Leucovorin is available as oral tablets but patients would need to take a very large number of pills to equal to IV dose, something that is difficult to do.

The FDA tells the public to call the manufacturers for more information:

  • 1-888-TevaUSA
  • Bedford Customer Service 1-440-232-3320

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One Comment;

  1. Sandra Shroy said:

    Funny, I did contact TEVA and they told me that the FDA has put a halt on their production of Calcium Leucovorin. Maybe the FDA would like to explain WHY to those with colorectal cancer and soon! It’s not like cancer patients all have time on their side!!

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