Although an abortifacient, methotrexate is mostly used to treat autoimmune conditions and—at much higher doses—cancer. Methotrexate can also be used to manage ectopic pregnancies.
Recommendations
The injectable methotrexate shortage seems to be disappearing. However, patients currently receiving the injectable form could be switched to oral methotrexate or, potentially, leflunomide, which works similarly to methotrexate, or to another csDMARD they have not yet tried or that has not previously failed to work for them—if they have no contraindications for use.
Leflunomide is a dihydroorotate dehydrogenase inhibitor approved in September 1998.7,8
These patients could also be switched to subcutaneous methotrexate, provided it is available.
To help patients get their methotrexate prescriptions filled, the Arthritis Foundation has set up a hotline: (800) 283-7800.6
And the FDA is working with manufacturers to identify temporary importation solutions to help meet patients’ needs until the approved manufacturers can meet the demand.
These next few months will most likely give us some insight into the future of methotrexate availability. The ACR is closely monitoring the drug shortage and working with the FDA and will continue to provide updates as they become available.
The FDA is seeking information about how rheumatology patients are being affected by the shortage. Share your experiences by sending an email to [email protected].
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
References
- Treatments: Methotrexate (Rheumatrex, Trexall, Otrexup, Rasuvo) American College of Rheumatology. 2023.
- Weinblatt ME. Methotrexate in rheumatoid arthritis: A quarter century of development. Trans Am Clin Climatol Asso. 2013;124:16–25.
- Methotrexate sodium. National Cancer Institute. 2023 Mar 22.
- Methotrexate injection. ASHP drug shortages list. American Society of Health-Systems Pharmacists. 2023 May 26.
- Becker Z. After shutting down, Akorn recalls its 70-plus products nationwide. Fierce Pharma. 2023 Apr 26.
- Arthritis Foundation statement on methotrexate access. Arthritis Foundation. 2022 Jun 24.
- Leflunomide FDA approval letter. U.S. Food & Drug Administration. 1998 Sep 10.
- Leflunomide FDA labeling. U.S. Food & Drug Administration. 1998 Sep 10.
Get the Background
Warmflash DM. 75 years: A look back on the fascinating history of methotrexate and folate antagonists. Medscape. 2023 Jan 25.
