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Injectable methotrexate shortage may last into the new year

First posted Dec. 17, 2004

Psoriasis and psoriatic arthritis patients who use injectable methotrexate may face difficulty in receiving this treatment for the next few months. Injectable methotrexate is in a shortage because the primary manufacturers (American Pharmaceutical Partners and Mayne Pharmaceuticals) of the product are facing production issues. American Pharmaceutical Partners and Bedford Laboratories, a manufacturer of preservative-free injectable methotrexate, both expect to resume their production schedule in the first quarter of 2005.

Methotrexate is often prescribed for severe plaque psoriasis, erythrodermic psoriasis and acute pustular psoriasis. In addition, the drug can be used to treat psoriatic arthritis, a psoriasis-related condition similar to rheumatoid arthritis. Methotrexate can be highly effective in reducing the painful symptoms of psoriatic arthritis and, in some cases, slows the progression of joint destruction.

Methotrexate is most commonly used in the pill form, but patients sometimes use injectable methotrexate because it is usually less expensive and may have fewer side effects than the oral form.

American Pharmaceutical Partners, the largest manufacturer of injectable methotrexate, has all injectable methotrexate products on back order. The back order is due to the opening of a new facility in Switzerland that needs to comply with U.S. Food and Drug Administration requirements. The company estimates that production will be resumed in March of 2005. Patients and health care professionals who have specific questions can contact the medical information line at 800.551.7176.

Mayne Pharmaceuticals is still on back order for all doses of injectable methotrexate. There have been manufacturing delays which the FDA and Mayne are working together to address. There is no estimated date of release for their preservative-free injectables. If you have specific questions you can contact Mayne Pharmaceutical's medical information line at 888.606.2245.

Bedford Laboratories had been serving the market through their preservative-free methotrexate, but now anticipates a shortage through at least the first quarter of 2005. The company is currently backordered on all dosage sizes (50 mg, 100 mg, 200 mg and 250 mg) and expects intermittent releases of various dosage sizes beginning on Dec. 30, 2004 and continuing through January and February of 2005. For questions, call the product ordering line at 800.562.4797.

Patients who use injectable methotrexate should talk with their doctor about other methods of treatments until the shortage is resolved.


Posted on Dec. 17, 2004
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