FDA Saves "Dangerous Drug Shortage"

Leukemia drug methotrexate production will be ramped up to avert shortage

(RxWiki News) Methotrexate is the one drug children with leukemia must have in order to beat the potentially deadly disease. But it was on the brink of becoming unavailable, until the U.S. Food & Drug Administration (FDA) stepped in to - literally - save lives.

The FDA says it thinks it has averted what the agency calls a "crisis" in maintaining the supplies and availability of methotrexate, a key drug used to treat a type of childhood leukemia known as acute lymphoblastic leukemia, or ALL.

"Ask your pharmacy if any of your medications are in short supply."

What's been called a "dangerous shortage" was brought to light over the last several days with a warning from chief of oncology at the Children's Hospital of Philadelphia, Dr. Jon Maris. He said the hospital was going to run out of the drug in a matter of weeks.

"Children will die because they can't get methotrexate," Dr. Maris had told CBS News.

He explained that methotrexate plays the critical role in a cocktail of drugs that are used to treat and beat the leukemia. It's the methotrexate that keeps the leukemia from invading the spinal fluid.

The shortage of this medication is the result of a number of factors, the most prominent of which is profit. Since it is a generic drug, there are no huge profit margins to be made.

Also, there are only a few manufacturing sites that make the medicine. And one of those - Ohio-based Ben Venue Laboratories - was closed last October over quality concerns.

The shortage would have put in jeopardy the lives of some 3,500 children who are diagnosed each year with acute lymphoblastic leukemia, or ALL.

The youngsters have to undergo two to three years of grueling therapies that almost always cure the disease,  Dr. Elizabeth Raetz, a pediatric oncologist at the New York University Langone Medical Center, told the Gannett News Service.

The drug is also used to treat other diseases including arthritis, breast cancer, brain tumors, lung cancer, non-Hodgkin lymphoma, and head and neck cancers. It is one about two dozen cancer drugs that are in short supply.

For children with ALL, there are no suitable substitutions for methotrexate, according to Dr. Raetz.

To avert this crisis, the FDA worked with the three remaining manufacturers that make preservative-free methotrexate. And according to FDA spokeswoman, Shelly Burgess, all have agreed to increase production.