Pending Methotrexate Shortage May Affect Thousands of Patients
MONDAY, Feb. 13, 2012 — Developed in the 1940s, methotrexate is one of the most commonly prescribed rheumatoid arthritis drugs. It's also prescribed for lupus and other autoimmune conditions, and in an injectable, preservative-free version, methotrexate is used to treat acute lymphoblastic leukemia (ALL), a type of cancer most often seen in young children. But following the suspension of manufacturing by one of the country's largest suppliers of preservative-free methotrexate, both patients and health care advocates are up in arms about a potential shortage.
As reported in the New York Times, one key manufacturer of methotrexate, Ben Venue Laboratories, suspended operations at its Bedford, Ohio plant last November due to what the company said were "significant manufacturing and quality concerns." The U.S. Food and Drug Administration (FDA) has also stated that the four other companies that produce methotrexate have also either slowed or stopped manufacturing the drug, according to ABC News. As a result, many fear that supplies of methotrexate are in danger of running out within a matter of weeks.
The potential shortfall is of greatest concern to patients with ALL and their families, since methotrexate injection into spinal fluid can keep the cancer from spreading or recurring. The preservative-free form is considered less toxic and thus preferable for this method of administration.
But people living with rheumatoid arthritis are also expressing concern via social media: @thejuicyjoint tweeted, "Has anyone heard anything about methotrexate running out? Should I be worried?" And in comments on the blog Rheumatoid Arthritis Guy, one reader wrote, "I do take [methotrexate], however, I am not letting this bother me. Stress acts as a trigger for RA and, for me, can bring on more pain and fatigue."
Considered a disease-modifying antirheumatic drug (DMARD), methotrexate helps rheumatoid arthritis by reducing inflammation and slowing the progression of the disease. Besides the injectable form, the drug can also be taken as tablets or as a liquid.
Valerie Jensen, associate director of the FDA's drug shortages program, told the Times that the agency is looking for a foreign supplier to provide emergency imports of methotrexate until domestic manufacturers can meet the demand. “We’re working on many fronts, and will keep this a priority,”