United States of America — The manufacturers of Rheumatrex® (methotrexate sodium) have advised of new information concerning product labelling.
Rare reports have been received of bone and soft tissue necrosis following radiation therapy in patients receiving methotrexate. Actual risk has not been established. There have also been rare reports of painful plaque erosion in patients treated for psoriasis. Hepatotoxicity is a known potential adverse reaction associated with methotrexate therapy and concomitant use with other hepatotoxic agents may increase risk.
Most adverse reactions are reversible if detected early. When such reactions do occur the drug should be reduced or discontinued and appropriate corrective measures taken as set out in the new labelling.
Reference: Communication to WHO from US Food and Drug Administration, 1 December 1999.