Methotrexate is given weekly as an intramuscular injection of 15 to 25 mg. Side effects are rare and include leukopenia and hypersensitivity interstitial pneumonitis. Hepatic fibrosis is the most severe potential sequela of long-term therapy. Patients with concomitant alcohol abuse and/or morbid obesity are more likely to develop hepatic fibrosis and therefore should not be treated with methotrexate. It is prudent to obtain a baseline chest radiograph and to monitor complete blood count, liver function and renal function every two weeks until the patient is receiving oral therapy, and every one to three months thereafter. Before methotrexate therapy is initiated, the risks of treatment and the possible need for a liver biopsy should be discussed with the patient.
A randomized, open, parallel-group multicenter safety clinical trial specifically compared the effect of ENTOCORT EC (less than 9 mg per day) and prednisolone (less than 40 mg per day) on bone mineral density over 2 years when used at doses adjusted to disease severity. Bone mineral density decreased significantly less with ENTOCORT EC than with prednisolone in steroid-naïve patients, whereas no difference could be detected between treatment groups for steroid-dependent patients and previous steroid users. The incidence of symptoms associated with hypercorticism was significantly higher with prednisolone treatment.
A study conducted by Chambers et al. in 2006 indicated that newborns whose mothers had started taking an SSRI such as Paxil after twenty weeks of becoming pregnant are six times more likely to develop PPHN than the general population. Another study by Källén et al. reported a significant relationship between the occurrence of PPHN and the use of antidepressant drugs such as Paxil during the first trimester of pregnancy. No association between the use of the SSRI drug during the third trimester of pregnancy and PPHN was found by the study conducted by Andrade et al. The FDA updated its safety warning in December 2011. As the review of more recent studies yielded additional findings that had to be taken into account, it was concluded that a final decision cannot yet be established about the relationship between the use of SSRIs and the development of PPHN.