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 most children with acute lymphoblastic leukemia (ALL).

Unfortunately, fluorouracil (5-FU) and leucovorin are still in shortage. Read the rest of this entry »

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.

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.

Read the rest of this entry »

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 shortages are due to increased demand.  Some dosage vials are available from APP and as Camptosar from Pfizer.  Three generic manufacturers stopped making irinotecan in 2010 and another one did so in May 2011.
• Fusilev as of 6/21/11:  Although it was in shortage previously, Spectrum has announced that they have ample supplies currently and for the future.  ASHP reminds physicians and pharmacists that dosing errors can occur when substituting Fusilev (levoleucovorin) for leucovorin.

Check the links to ASHP updated sites for more detailed information about which sizes are available, reasons given for shortages, and when shortages are expected to be resolved.

Take action!

Email your Members of Congress in support of legislation that would combat future drug shortages. We make it easy in our online action center.

Leucovorin is available — but at over 3000 percent markup on the gray market.

And there is no guarantee that the drug has been handled safely, is not counterfeit or stolen, or is even leucovorin.

The gray market is taking huge advantage of  struggling health care pharmacists trying meet pressures causes by drug shortages. Read the rest of this entry »