Pulmonary Vascular Disease
Carrie Beach, BSN, RN-BC
The FDA has issued a safety alert regarding a clinical study that has found a 10-mg, twice-daily dose of tofacitinib increased the risk for pulmonary embolism and mortality in patients with rheumatoid arthritis.
“FDA has not approved this 10 mg twice daily dose for RA; this dose is only approved in the dosing regimen for patients with ulcerative colitis,” according to the FDA. “When the FDA first approved tofacitinib, we required a clinical trial among patients with RA to evaluate the risk of heart-related events, cancer and opportunistic infections with the medicine at two doses (10 mg twice daily and 5 mg twice daily) in combination with methotrexate in comparison to another drug called a tumor necrosis factor (TNF) inhibitor.”
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