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FDA Steps in to Meet Methotrexate Demand




Supplies of methotrexate, a drug used to treat the most common form of childhood leukemia, have not been meeting the demand in recent weeks. The FDA, with assistance from drug manufacturers, has found a temporary fix for the shortage.

Methotrexate is used to treat acute lymphoblastic leukemia (ALL), which most often affects children between the ages of 2 and 5. Physicians inject the drug directly into the spinal fluid to prevent the cancer from spreading to the lining of the spine and the brain. The drug can also be used to treat rheumatoid arthritis.

In November 2011, Ben Venue Laboratories suspended its production of preservative-free methotrexate in order “to address manufacturing-related issues at its facility.” As one of the nation’s largest suppliers of the drug, the suspension has caused serious shortages across the country.

At the urging of the FDA, Ben Venue Laboratories has recently begun accelerating its review process and releasing limited quantities of methotrexate. According to a statement from the governmental agency, Hospira, Mylan and Sandoz Pharmaceuticals, are also aiding in the supply of the critical drug.

Last October, President Obama issued an executive order that requires drug manufacturers to alert the FDA when potential problems could threaten the supply of a drug.

This month, the FDA has issued draft guidance to the pharmaceutical industry outlining the requirements for both mandatory and voluntary notifications to the agency about potential shortages. Between the FDA’s letter and President Obama’s executive order, there has been a significant increase in voluntary notifications.

In 2011, 195 drug shortages were prevented. Since the executive order was issued in October, the FDA has already prevented 114 shortages.

“A drug shortage can be a frightening prospect for patients and President Obama made it clear that preventing these shortages from happening is a top priority of his administration,” said FDA Commissioner Margaret A. Hamburg, M.D, in a statement from the federal agency. “Through the collaborative work of FDA, industry and other stakeholders, patients and families waiting for these products or anxious about their availability should now be able to get the medication they need.”


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