Manufacturer Releasing Emergency Supplies of Methotrexate
Article date: February 16, 2012
By Stacy Simon
A maker of the cancer drug methotrexate, Bedford Laboratories, has advised the US Food and Drug Administration (FDA) that it will release emergency supplies of preservative-free methotrexate to meet patients’ needs. This form of the drug is used to treat a form of childhood leukemia as well as several other cancers. It has been in short supply because of a voluntary shutdown of a Bedford facility in November 2011.
In a statement, the FDA said, “The issue of methotrexate is and has been of the highest priority for FDA, and we’ve been working hard to make sure that patients continue to get the medicine they need when they need it.”
The emergency supply of the drug was produced before the shutdown. The FDA says Bedford worked to ensure that the problems that led to the shutdown did not affect this batch. The new supplies are expected to be available by the end of February.
Over the past several years, reports of drug shortages in the U.S. have increased. There are currently hundreds of drugs on the list, and they include a couple of dozen cancer drugs.
Last September, the American Cancer Society's advocacy affiliate, the American Cancer Society Cancer Action Network (ACS CAN) announced its support of a bill that would require drug companies to give the FDA advance notice of issues that could lead to shortages, in hopes of allowing officials to prepare and respond. Currently, there is no requirement that drug manufacturers formally give notice of an expected shortage.
In his blog post, J. Leonard Lichtenfeld, MD, MACP, Deputy Chief Medical Officer for the American Cancer Society, calls for better communication, and more efficient manufacturing processes to bring about a long-term solution to the problem.
Reviewed by: Members of the ACS Medical Content Staff
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