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Methotrexate Update Shows Supply Slowly Increasing


Parents of children with acute lymphoblastic leukemia (ALL) who are worried about the current methotrexate shortage may get some comfort from an announcement by the American Society of Hematology (ASH). The Society has been closely monitoring the methotrexate shortage and working with the Food and Drug Administration (FDA) to help reverse the situation as soon as possible.

Limited supplies of methotrexate are ready

According to ASH, Bedford Laboratories announced on February 16 that it had limited amounts of the preservative-free form of methotrexate available. The methotrexate was to be made available to hospitals and practices that same day.

Bedford Laboratories is the facility that voluntarily stopped production of the preservative-free methotrexate in November 2011 because of concerns over production and quality.

As a result of that shutdown, higher than anticipated demand for the drug was placed on the remaining four companies (APP, Hospira Inc., Mylan Institutional, Sandoz) that also make methotrexate. Some of these companies also experienced production delays, which further exacerbated the shortage problem.

The new emergency supply of methotrexate from Bedford Laboratories is limited, and so the FDA has encouraged hospitals and practices to order only what they need to fulfill their patients’ needs at this time. To this end, the ASH has urged the FDA to make sure there is an effective drug distribution plan in place.

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Additional supplies of methotrexate are anticipated by the end of February and into March. It is hoped this emergency supply from Bedford Laboratories will be sufficient until more methotrexate becomes available.

In addition, both Hospira and Mylan Institutional have stated they expect their deliveries to resume in February and March.

Drug shortages like the one with methotrexate are, unfortunately, common events in the United States, and when those drugs are life-saving medications, like methotrexate in treatment of ALL, the situation is especially critical.

Injectable drugs are not profitable
In 2010, a total of 178 drug shortages were reported to the FDA, more than three times the number (56) reported in 2006. Among the growing number of drugs in short supply are injectable medications, like methotrexate used to treat ALL.

In a June 2011 article by CNN Money, Valerie Jensen, the FDA’s expert on drug shortages, noted the FDA is worried about the shortages of injectable drugs, which are for cancer and emergencies. “Companies have told us that these injectable drugs are older drugs and not as profitable. They’ve told us it’s a business decision to discontinue production.”

The good news appears to be that the methotrexate shortage will be easing soon as supplies slowly increase, but the outlook for this and other injectable drugs may dim again soon, given the industry’s perspective on their poor profitability.

American Society of Hematology
CNN Money