A shortage of a medication that has made childhood leukemia largely survivable may put hundreds or even thousands of children at risk of death, according to national cancer experts.
The drug is called methotrexate, and it treats acute lymphoblastic leukemia (ALL), a cancer that targets toddlers more than any other age group. The bone marrow produces many unformed cells called blasts that normally would develop into lymphocytes, which fight infection. The blasts do not form correctly and crowd out the normal red blood cells, white blood cells and platelets the body needs, and they particularly invade the brain and spine lining. This type of cancer is especially deadly.
Methotrexate is also used to treat rheumatoid arthritis.
According to the New York Times, Ben Venue Laboratories in Bedford, Ohio, was a major supplier of injectable, preservative-free methotrexate. The company stopped operations voluntarily in November because of "significant manufacturing and quality concerns."
Other manufacturers have not made up the difference, and cancer experts now say that shortages may impact supply as soon as within the next two weeks.
"This is a crisis that I hope the FDA's hard work can help to avert," Dr. Michael P. Link, president of the American Society of Clinical Oncology, told the New York Times. "We have worked very hard to take what was an incurable disease and make it curable for 90 percent of the cases. But if we can't get this drug anymore, that sets us back decades."
Four other American manufacturers are attempting to fill the gap by increasing production, and the U.S. Food and Drug Adminsitration is looking for a foreign supplier to meet emergency demand until those manufacturers can fill in.The FDA maintains an information page on drug shortages and listings of those that fall into that category.
Shortages of drugs, including many used to treat deadly diseases like cancer, have become a fact of life. Last May, Erin R. Fox, manager of the University of Utah drug information service, told the Deseret News the country was seeing nearly a new shortage a day. And she noted a lack of good substitutes for many of the drugs that were in short supply, including those to treat cancer, heart ailments and arthritis.
The drug information service at the U. has tracked drug shortages for the American Society of Health-System Pharmacists for more than a decade, collecting reports primarily from hospital pharmacies nationwide.
In October, noting that drug shortages often led to price gouging, the White House announced an Executive Order directing the FDA to "take action to help further prevent and reduce prescription drug shortages, protect consumers and prevent price gouging."
With shortages, some drug prices had risen 80-fold. The order also directed the Department of Justice to see if potential shortages "have led to illegal price gouging or stockpiling of life-saving medications."
The Leukemia and Lymphoma Society message boards have been active for several days with news of the leukemia drug shortage and parents expressing worries about whether their young children will receive scheduled treatment for the disease as planned.
As for methotrexate as a treatment for arthritis, About.com is advising that some patients may be able to get an oral form of the medication substituted until the shortage of injectable drug is resolved.
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