'Children Will Die': Panic in US Over Methotrexate Supplies

Zosia Chustecka

February 14, 2012

February 14, 2012 — Although there have been shortages of several cancer drugs in the United States for a while now, a sudden drop in the supplies of one particular product is causing a panic among pediatric oncologists.

Supplies of preservative-free methotrexate have fallen so low that "institutions will run out of the drug in a matter of days to weeks," according to the American Society of Clinical Oncology (ASCO).

"This drug is critical to the treatment of children with acute lymphoblastic leukemia [ALL]," ASCO president Michael Link, MD, explains in a letter signed jointly by the presidents of the Children's Oncology Group and the American Society of Pediatric Hematology Oncology.

ALL affects about 3500 children and teenagers in the United States each year. The cure rates for ALL are close to 90%, but without preservative-free methotrexate, "patients are at a dramatically heightened risk of dying," the officials note.

"It is not an understatement to say that this is creating a panic in the childhood cancer community," they stress.

The letter was sent yesterday to 2 manufacturers: APP Pharmaceuticals in Schaumburg, Illinois; and Sandoz in Princeton, New Jersey. Both companies have been working with the US Food and Drug Administration to address the situation.

"We implore you to take the necessary steps to rapidly increase access to preservative-free methotrexate," the 3 society presidents write. "We are hoping that your responsiveness at this critical time will mitigate the crisis and avoid the tragedy of not being able to deliver curative therapy to children and families facing this horrible disease."

Over the past 2 months, the crisis escalated very quickly to the point of panic.

"Children will die because they can't get methotrexate," said John Maris, MD, chief of oncology at the Children's Hospital of Philadelphia in Pennsylvania. He told CBS News that his hospital has only a 2-month supply of the drug remaining, and children usually take the drug for 3 years.

"This is a real, real crisis," Dr. Maris said. "Unless something dramatic changes in the next few weeks, myself and other physicians and nurses on this very unit will have to look patients in the eye and explain that we don't have methotrexate and that the substitute is not as good."

Dr. Maris recently spoke about the ongoing cancer drug shortages on a Medscape videoblog.

Dwindling Supplies

Methotrexate is used for many other cancers and in the treatment of rheumatoid arthritis, but many preparations contain preservatives. For the treatment of ALL, preparations must be preservative-free because the drug is administered intrathecally; therefore, the presence of preservatives can lead to problems such as paralysis.

Supplies of preservative-free methotrexate have been dwindling in the United States since last November, the New York Times reports, when the largest manufacturer of this product, Ben Venue Laboratories, voluntarily suspended operations in Bedford, Ohio, because of "significant manufacturing and quality concerns," according to the company.

A number of other cancer drugs are in short supply in the United States, as previously reported by Medscape Medical News, and the shortages have been getting worse over the past few years, prompting action from many quarters, even from President Obama. Despite these action, the shortages in cancer drugs are continuing and are affecting patient care. A recent survey of oncologists reported that in some cases the shortages are speeding cancer deaths.

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