Tags: fda | cites | leukemia | drug | shortage

FDA Cites Leukemia Drug Shortage

Monday, 13 Feb 2012 03:41 PM




A crucial drug used to treat childhood leukemia is in such short supply that hospitals across the country may exhaust their stores within the next two weeks, federal health officials said.
The shortage could leave hundreds and perhaps thousands of children at risk of dying from a largely curable disease, according to the U.S. Food and Drug Administration in an alert posted on the agency’s website.
"This is dire," said Valerie Jensen, associate director of the FDA's drug shortages program.
One of the largest producers of the drug, Ben Venue Laboratories, voluntarily ceased production of the drug – methotrexate -- in November over quality and production concerns, FDA said.
The shutdown, along with production delays or higher than anticipated demand at the other companies -- APP, Hospira Inc., Mylan Institutional, Sandoz -- have placed parents of children with [leukemia] as well as hospitals and physicians on alert, the agency noted.
The drug is used to treat acute lymphoblastic leukemia, which most often strikes children from 2 to 5 years of age. Each year, nearly 3,000 children and adolescents under age 20 are diagnosed with it, according to the National Cancer Institute. Eighty percent of children are successfully treated.
The FDA officials said they are attempting to find foreign supplier of the drug to provide an emergency import supply until the approved domestic ones can meet demand.

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Manufacturers of methotrexate, used to treat childhood leukemia, are not keeping up with demands.
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2012-41-13
Monday, 13 Feb 2012 03:41 PM
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