Accord Healthcare resumes making methotrexate

Accord Healthcare, a London-based drugmaker, resumed manufacturing of two methotrexate solutions, according to a Nov. 7 update from the FDA. 

Methotrexate treats inflammatory arthritis, psoriasis and some cancers, and the medication has been in unsteady supply for more than a year. After the Supreme Court overruled Roe v. Wade in June 2022, access to the drug slimmed because one of its side effects is terminated pregnancy. 

By March, the American Society of Health-System Pharmacists categorized methotrexate as one of four pressing drug shortages out of nearly 300 at the time. 

Increased demand is the reason for the current supply constraints, according to the FDA's drug shortage database. Accord recently restarted production of two methotrexate injectable solutions, and three other drugmakers are reporting shortages. 

With 11 solutions in shortage and only one remaining in stock, the ASHP recommends health systems evaluate their "total supply of methotrexate before beginning patients on combination chemotherapy regimens containing methotrexate." 

Here are four other mitigation tips from the ASHP:

  • The choice of an alternative agent must be patient-specific and based on renal function, liver function, and the neoplasm type and location. No single agent can be substituted for methotrexate.

  • Reserve preservative-free methotrexate for intrathecal doses.

  • Consult a hematology/oncology specialist for patient- and neoplasm-specific recommendations and other specialists for non-oncology uses.

  • Use oral methotrexate whenever possible for non-oncology indications.

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