Tag Archives: drug shortages

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.

The White House Addresses the Drug Shortage Issue

President Barack Obama signed an Executive Order yesterday addressing the drug shortage issue. As we have reported extensively on www.FightColorectalCancer.org, the current drug shortages have impacted colorectal cancer patients who have been unable to get 5-FU, leucovorin or on occasion, irinotecan. The Executive Order does not change the law, and it will not help patients who cannot get their drugs today, but it does reinforce the powers of the Food and Drug Administration to take steps that would ease the burden by: Broader reporting of when a manufacturer has stopped producing a drug that could lead to a shortage. Increased effort to review drug suppliers and manufacturing sites and changes.

How the FDA Is Addressing Drug Shortages

If you missed the FDA Webinar on Drug Shortages last Friday, you can Watch a video of the entire presentation, including questions. Download the webinar slides. The webinar, led by Captain Valerie Jensen, R.Ph., Associate Director for the FDA’s Drug Shortage Program, discusses how the FDA responds to drug shortages and what they are doing to try to prevent shortages of medically necessary drugs.

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.

House Energy and Commerce Subcommittee Holds Hearings on Drug Shortage

Quick update Fight Colorectal Cancer is watching the House Energy and Commerce Subcommittee on Health hearing Examining the Increase in Drug Shortages. The hearing began at 9:30 this morning, September 23, 2011, and will continue after a recess. You can watch it with us on UStream Live. Testimony already from Howard K. Koh, Assistant Secretary for Health, Department of Health and Human Services, who was accompanied by Dr. Sandra L. Kweder from the FDA.  Both answered questions from Subcommittee Members.  

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

5-FU Added to Drug Shortage List

This morning the FDA added fluorouracil to its drug shortage list. The American Society of Healthcare Pharmacists (ASHP) has also reported a shortage of fluorouracil (5-FU), a common backbone drug for colorectal cancer chemotherapy. Two manufacturers have some doses of the drug on intermittent back order and are shipping it as it becomes available.  A third has all dose vials on back order and estimates shipping sometime in the fourth quarter of 2011.

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.

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