Methotrexate, a drug used to treat acute lymphoblastic leukemia, the most common childhood leukemia, is now also in short supply in the USA, along with several other lifesaving drugs. According to the FDA, vital lifesaving hospital drugs have not been so scarce in ten years. Methotrexate works by slowing down the rate at which cancer cells grow.

Apart from treating childhood leukemia, methotrexate is also used for treating several autoimmune disorders, lymphoma, osteosacroma, trophoblastic neoplasms, and cancers of the neck, lung, bladder, and breast.

Methotrexate has until recently been manufactured by five drug companies, under different brand names. Some have stopped production of the injection medication altogether, while others have been producing less, says the FDA (Food and Drug Administration). Last year, Ben Venue Laboratories announced that it was shutting down production of injectable preservative-free methotrexate.

According to the industry, the current shortage has been the result of exceptionally high demand, as well as some delays in the production process.

Experts say this delay could be undermining treatment outcomes for a considerable number of children with lymphoblastic leukemia.

Dr. Michael Link, president of ASCO (American Society of Clinical Oncology) warns that several hospital pharmacies across the USA will have no supplies left within two weeks. The scarcity of the preservative-free form of the medication, which is less toxic for patients, is of particular concern. Only this form can be injected into cancer patients’ spinal fluid – it is used to stop the malignancy from spreading or recurring.

There are alternative drugs to the preservative-free form of methotrexate. However, their efficacy is inferior. Higher dose versions of methotrexate cannot be used instead.

Acute lymphoblastic leukemia, also known as ALL is a form of cancer of the white blood cells (leukemia), characterized by excess lymphoblasts (immature cells which typically differentiate to form mature lymphocytes).

The malignant, immature white blood cells multiply continuously and are produced in excess in the bone marrow. The normal cells are crowded out in the bone marrow – malignant cells spread out to other organs – the result is widespread damage and eventual death.

Most patients who develop ALL, do so during childhood (peak incidence 2-5 years of age). Some patients develop the disease in old age.

With proper treatment, 80% of children with ALL are cured; while between 45% and 60% of adults have long-term disease-free survival.

The severest shortage is currently in cancer drugs, but there is also scarcity in intravenous medications, several antibiotics, and other medications.

Dr. Link said it is unacceptable that patients, doctors and hospitals are forever dragged from one crisis to another.

Reps. John Carney (D-Del.) and Larry Bucshon (R-Ind) introduced a bill, Drug Shortage Prevention Act, at the end of January, 2012. The legislation would provide the FDA with increased powers to take into account potentially critical drug shortage issues when deciding on a new drug approval..

According to ASCO:

“(the legislation would also) provide congressional support for additional agency staff to address shortages. The bill also explores the feasibility of a national contingency plan for critical drug shortages.”

In a communiqué, ASCO quotes Dr Link as saying:

“Cancer patients continue to face shortages of critical therapies for which there are often no acceptable substitutions. Last year, the medical community experienced a record number of shortages and the situation is expected to worsen without action from Congress.

ASCO is grateful for the leadership of Reps. Carney and Bucshon and will continue to advocate for legislation that addresses the current drug shortage crisis and will prevent future shortages from occurring.”

Written by Christian Nordqvist