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Kids’ cancer-drug shortage averted

The federal Food and Drug Administration says it managed to avert a “crisis” for kids with cancer by preventing a looming shortage of the lifesaving drug methotrexate, a mainstay of treatment for a type of childhood leukemia.

The shortage is the latest in a series of serious shortages of cancer medications and other drugs that have frustrated doctors and patients over the past year and a half.

Only a few days ago, cancer specialists had predicted they could run out of methotrexate by the end of next week, according to Dr. Michael Link, a pediatrict oncologist who is president of the American Society of Clinical Oncology. The shortfall arose when one of the four U.S. makers of methotrexate, Ohio-based Ben Venue Laboratories, shut down production late last year because of “manufacturing and quality concerns,” FDA spokeswoman Shelly Burgess said.

The shortage is an issue of life or death for the 3,500 kids diagnosed each year with acute lymphoblastic leukemia, or ALL. They endure two to three years of punishing therapies but are nearly always cured of their disease, says Dr. Elizabeth Raetz, a pediatric oncologist at the NYU Langone Medical Center.

Methotrexate also is used to treat bone cancers, brain tumors, lymphomas and other diseases. In some cases, doctors can find substitutes for a scarce cancer drug. For ALL, though, there’s no replacement; going without methotrexate, or even delaying it, could leave kids vulnerable to a fatal relapse, Raetz says.

The FDA worked with the three remaining manufacturers that make preservative-free methotrexate, and all have agreed to ramp up production, Burgess said.

Gannett News Service



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