Methotrexate has been reported
to cause fetal death and/or congenital anomalies. Therefore, it is
not recommended for women of childbearing potential unless there is
clear medical evidence that the benefits can be expected to outweigh
the considered risks. Pregnant women with psoriasis or rheumatoid
arthritis should not receive methotrexate. Pregnancy should be avoided if either partner is receiving methotrexate.
(See CONTRAINDICATIONS.)
Methotrexate causes hepatotoxicity, fibrosis, and cirrhosis, but generally
only after prolonged use. Acutely, liver enzyme elevations are frequently
seen. Persistent abnormalities in liver function tests may precede
appearance of fibrosis or cirrhosis in the rheumatoid arthritis population.
Methotrexate-induced
lung disease is a potentially dangerous lesion, which may occur acutely
at any time during therapy and which has been reported at doses as
low as 7.5 mg/week. It is not always fully reversible. Pulmonary symptoms
(especially a dry, nonproductive cough) may require interruption of
treatment and careful investigation.
Diarrhea and ulcerative stomatitis require interruption of therapy; otherwise,
hemorrhagic enteritis and death from intestinal perforation may occur.
Severe, occasionally fatal, skin reactions have been reported following
single or multiple doses of methotrexate. Reactions have occurred
within days of oral, intramuscular, intravenous, or intrathecal methotrexate
administration. Recovery has been reported with discontinuation of
therapy. (See PRECAUTIONS,
Organ System Toxicity, Skin.)
METHOTREXATE SHOULD BE USED ONLY BY PHYSICIANS WHOSE KNOWLEDGE
AND EXPERIENCE INCLUDES THE USE OF ANTIMETABOLITE THERAPY. PATIENTS
SHOULD BE CLOSELY MONITORED FOR BONE MARROW, LIVER, LUNG, AND KIDNEY
TOXICITIES. (See PRECAUTIONS.)
The most frequently reported adverse reactions include ulcerative
stomatitis, leukopenia, nausea, and abdominal distress. Other frequently
reported adverse effects are malaise, undue fatigue, chills and fever,
dizziness, and decreased resistance to infection. |
