In response to the ongoing leucovorin shortage crisis, Fight Colorectal Cancer has created a Frequently Asked Questions document for patients.

The Fight CRC Answer Line (1-877-427-2111) has fielded over 100 calls from patients who were told they could not receive leucovorin due to a manufacturing shortage in the United States. Many patients, worried and confused, have had trouble determining their options if faced with this issue.

The FAQ addresses issues such as “What choices do I have if my doctor doesn’t have leucovorin?” and “Why is there a leucovorin shortage?”. It also directs patients to the Fight CRC online action center, where they can weigh in on the issue with their Members of Congress.

View and download the FAQ.

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. Read the rest of this entry »

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. Read the rest of this entry »

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 Nancy Roach was quoted in an article on ReporterNews.com about this issue

Previously: 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. Read the rest of this entry »