Tag Archives: leucovorin shortage

FDA Takes Action on Two Critical Cancer Drugs in Shortage

FDA Commissioner Margaret Hamburg announced yesterday during a teleconference that the FDA has arranged to meet critical needs for methotrexate and Doxil® (doxorubicin). FDA has approved temporarily importing Lipodox, which has the same active ingredient — doxorubicin — and the same concentration as Doxil. There should be enough to meet needs for Doxil treatment.  FDA has inspected and approved the foreign plants that manufacture Lipodox. APP Pharmaceuticals and Hospira both have ramped up production of methotrexate. Together they expect to be able to ship the drug immediately and have enough to meet future needs.  Methotrexate is especially needed by children with leukemia where it can produce remissions rapidly and cure

Watch our Webinar on Drug Shortages

On Wednesday night, Dr. Lindsey Poppe, the Pharmacy Clinical Manager for Oncology for the University of North Carolina hospital system talked about the alternatives and options that patients have when directly faced with the current chemo drug shortage. You can watch a recording of the webinar on our website, along with all of our past patient webinars. Webinar: What to Do When Your Doc is Out of 5-FU from Fight Colorectal Cancer on Vimeo.

Congress Probes Drug Shortages

Drug shortages in the US are a growing crisis, members of Congress were told last Friday, September 23.  And there is no single reason why this is happening and no easy solutions to the problem. Problems lie mostly in older generic versions of sterile injectable drugs, which are low-priced and complicated to manufacture made by a only a few companies manufactured in aging plants where quality is hard to maintain.

Drug Shortage Updates from ASHP

Some recent updates from the American Society of Health-Systems Pharmacists of interest to people with colon and rectal cancer: Fluorouracil (5-FU) as of 8/31/11: On back order from Teva, APP Pharmaceuticals, and Mylan Institutional.  Manufacturing delays at Teva appear to have caused increased demand from other companies. Leucovorin as of 8/31/11:   Bedford has some powderized sizes available and limited allocations of others.  Teva is importing folinic acid solution and it is available for drop shipment, but powdered leucovorin is on back order. APP is releasing powderized leucovorin as it becomes available. Irinotecan as of 8/26/11:  Teva and Sandoz have back orders of some doses because of manufacturing problems.  Hospira

Leucovorin Shortage Update: Imported Supplies Available

The FDA issued a shortage update for leucovorin on July 21, 2011. While leucovorin remains in shortage from all three US manufacturers, the FDA is temporarily allowing Teva Pharmaceuticals to import calcium folinate solution for injection from Europe. The imported solution is the same strength as  powdered leucovorin calcium for injection once water is added to the US product. In a Dear Healthcare Professional letter, Teva provides a chart comparing the two products and tells doctors and pharmacists that currently Teva is the only organization with regulatory discretion to import and distribute calcium folinate solution.

Growing Drug Shortages Cost Money, Put Patients at Risk

Shortages of prescription drugs cost the United States more than $200 million. In addition, shortages force doctors to delay or cancel treatment.  Patient safety is compromised when doctors have to use different or unfamiliar drugs when they can’t get the right ones. In the six months from July to December of 2010, 240 drugs were either in short supply or completely unavailable.  More than 400 generics were back-ordered for more than five days. Most of the medicines with shortages are necessary for emergency care, sedation, or chemotherapy — including leucovorin which is a backbone of most colorectal cancer treatment regimens.

Leucovorin Update: Teva Pushes Back Release to April 2011

Latest information from the FDA says that manufacturing delays will prevent shipments of leucovorin from Teva Pharmaceuticals until next April. Teva has leucovorin calcium lyophilized powder 100 mg and 350 mg vials on back order and the company does not anticipate release until April 2011. Bedford Laboratories also cites manufacturing delays but is “releasing product as it becomes available.” Fusilev® (levoleucovorin) continues to be available from Spectrum Pharmaceuticals.  However, special care needs to be taken with dosing.  It cannot be substituted one-to-one for leucovorin.  Patients need to be aware of its cost and the possibility that insurance may not cover its administration for colorectal cancer. Update (11/9/2010): Coalition Board member

More Leucovorin Woes

A September 2nd update from the FDA cites manufacturing delays at Bedford Laboratories and Teva Pharmaceuticals  for leucovorin shortages. Here at the Colorectal Cancer Coalition, we’re hearing from patients who are not receiving leucovorin during their chemotherapy because it just isn’t available. Bedford says that they will be releasing some 350 mg and 200 mg vials in September and are working on other presentations.  Teva is allocating 100 mg vials and says that the 350 mg vials are on back-order with an expected release date in the fourth quarter of 2010.

New Leucovorin Shortage Should Be Fixed Soon

Patients are telling C3 that they are being turned away from scheduled cancer treatment because of a new shortage of leucovorin, a drug that is commonly used in colon and rectal cancer treatment.  However, good news is on the way. TEVA Pharmaceuticals has told the Food and Drug Administration that they are shipping back orders of leucovorin now and that the drug should be in oncology clinics and doctor’s offices next week. The FDA has put leucovorin on its drugs shortages list, citing manufacturing delays as the reason.   The American Society of Health-System Pharmacists (AHSP) has additional details on the shortage.

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