On May 27th of 2009, pharmaceutical firm Centocor Ortho Biotech joined with the FDA on a Medwatch alert about adverse effects of its drug Simponi (golimumab). This medication is a TNF-a inhibitor, a drug that reduces inflammatory conditions in some autoimmune diseases such as rheumatoid arthritis and Crohn’s disease.
While Simponi is relatively new to the marketplace, Simponi functions in much the same fashion as other TNF-a blockers that have been on the market and have established a post-approval record. These medications include Remicade, Enbrel, Cimzia and Humira. What has been found in the case of these medications is that because they lower the performance of the immune system, they can leave the patient susceptible to other diseases.
In the case of these established drugs, the FDA noted that development of severe fungal infections will sometimes go undiagnosed in patients who are using them. The late diagnosis has led to severe illness and in some cases fatality. The alert that the FDA put out on Simponi is that it has the same characteristics as the older medications with regard to its ability to cause and mask fungus infections until they have reached the point that antifungal treatment is ineffective.
It is important that all adverse events potentially associated with Simponi be reported so that the adverse event profile reported in the prescribing information can be updated appropriately as post-approval experience is gathered. Centocor encourages reporting adverse events to Centocor at 1-800-457-6399 or to the FDA MedWatch program at 1-800-332-1088.
If you have had an adverse health experience while being treated with Simponi, you should also contact an attorney experienced in cases of medical maltreatment. Get in touch with us by filling out the Free Case Evaluation form on this page.