5-FU Added to Drug Shortage List

Vials of FluorouracilThis 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.

According to the FDA and ASHP:

  • APP Pharmaceuticals is shipping fluorouracil intermittently as it becomes available.  They say this is due to increased demand.
  • Teva has all fluorouracil injection presentations on back order due to manufacturing delays.  They estimate releasing it in the fourth quarter of 2011.
  • Mylan Institutional has 50 ml vials on intermittent back order and is shipping them as they become available.  It is only available for drop shipment orders through wholesalers at this time.  They attribute the shortage to increased demand.

ASHP management suggestions include:

  • Consider evaluating the health-care system’s total supply of fluorouracil before beginning patients on combination chemotherapy regimens containing fluorouracil. 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.

The ASHP Guidelines for Managing Drug Product Shortages in Hospitals and Health Systems has information about managing drug shortages but also includes a good overview about how shortages arise.

It is possible to use Xeloda® (capecitabine) in place of some 5-FU and leucovorin regimens, but there are important safety concerns to think about.  Some research has found that an immediate switch from 5-FU to Xeloda may mean severe side effects. A waiting period to allow folate build-up in cells may be necessary.  Be sure your doctor is aware of this possibility.

More Information

American Society of Healthcare Pharmacists Drug Shortages: Fluorouracil

ASHP Guidelines for Managing Drug Shortages in Hospitals and Health Systems


  1. Vicki says

    It’s just not morally acceptable to play with people’s lives to make more money. It’s so not right, that I am sure people who make these awful decisions do not love someone who is suffering from these horrific diseases. People are not just dying, they are suffering. Make these drugs available to those who need them. It is a basic human right.

  2. concerned says

    How much of a demand increase? I think it’s telling that the percentage wasn’t stated. What causes delays in manufacturing too? I don’t know what is involved…is it complicated by todays standards or it is it just a matter of applying manufacturing facilities to this drug instead of more profitable lines?

    There’s lots of suspicion going around to be sure.

  3. Anon says

    This is the 4th drug that is in short supply in the past 2-3 months of the pre-chemo and chemo regimen my family member needs.

    This raises questions of root causes for shortages:
    #1 are pharmaceutical companies shrinking supplies to raise prices?
    #2 were a substantially higher number of people diagnosed and prescribed these drugs in the past 2 months than in past years?

    I have a suspicion that #1 is an underlying reason drugs that people depend on to survive are in short supply. This is totally unacceptable!

Leave a Reply

Your email address will not be published. Required fields are marked *

You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <s> <strike> <strong>