Simponi (golimumab) is a human monoclonal antibody used as an immunosuppressive drug approved by the US Food and Drug Administration (FDA ) for the adult treatment of moderately to severely active psoriatic arthritis, rheumatoid arthritis, and ankylosing spondylitis. Simponi is a tumor necrosis factor inhibitor (it targets TNF-alpha).
Golimumab is sometimes taken together with methotrexate (Rheumatrex, Trexall), an antimetabolite and antifolate drug. And Simponi's efficacy in combination with methotrexate over methotrexate alone has been confirmed in large, double-blind, randomized trials.
In May 2009, the good news was tempered again, however, when the FDA published a reminder to healthcare professionals of the risk for serious fungal infections associated with the use of Simponi and other TNF-blockers. The announcement reiterates that several invasive fungal infections, including histoplasmosis, are not consistently recognized in patients taking TNF-blockers, and that this has delayed appropriate antifungal treatment in certain cases, sometimes even resulting in death.
In August 2009, the FDA then announced that it is requiring stronger warnings, including an updated boxed warning , in the prescribing information for TNF-blockers. The FDA had recently completed an analysis of reports of cancer in adolescents and children treated with TNF-blockers, which showed an increased risk of cancer after an average of 30 months of treatment. About half of the cancers were lymphomas, and some of the cancers were fatal.
Other potentially severe side effects from the use of Simponi for which medical attention should be sought immediately include:
If you or a loved one has suffered or is suffering side effects associated with the use of Simponi or other TNF blockers, you may be entitled to compensation. Contact a qualified pharmaceutical injury attorney for an evaluation of your case.