FDA Finds Pharmaceutical Companies to Replace Supply of Pediatric Cancer Drug

COMMENTARY | As if pediatric cancer patients with acute lymphocytic leukemia (ALL) aren’t suffering enough already, they have recently been burdened with a shortage in a potentially life-saving drug. While methotrexate is used to combat many types of cancer and other diseases, preservative-free methotrexate is a necessary component of therapy for pediatric ALL as it is injected into the fluid surrounding the brain and spinal cord. It then works to slow the growth of cancer cells, giving these children a better chance of survival.

The shortage of methotrexate began when Bedford/Ben Venue decided to close their plant. The largest manufacturer of the drug, Bedford/Ben Venue’s decision left doctors all across the country with the task of trying to come up with another way to treat their patients. This may not be such a big deal if more was being done to find new treatments for childhood cancer.

The National Cancer Institute’s annual budget is roughly $4.6 billion, but pediatric cancer research gets less than 3.5 percent. Thanks to this ridiculous statistic, only one new drug has been approved for treatment of childhood cancers since 1980. Unfortunately, pediatric cancer kills more children every year than asthma, diabetes, cystic fibrosis, and pediatric AIDS combined, making it the number one killer of children by disease. The fact that more isn’t being done to find new treatments is beyond me.

Following the shut-down of Bedford/Ben Venue and an immense amount of demand from doctors and patients’ families, the U.S. Food and Drug Administration made the replacement of the supply of methotrexate a priority. APP Pharmaceuticals, who already produced methotrexate with preservatives, will take over the majority of the production, with the preservative-free drug expected to be available in four to six weeks.

Pharmaceutical company Hospira has taken on the job of making 31,000 vials of methotrexate available immediately, bridging the gap between now and when the rest of the drug will be available from APP next month. They are also ensuring that there will be enough produced in the coming weeks to supply doctors with enough for the rest of the year, easing the minds of these young patients and their families.


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