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:

  • allergic reactions, such as rash, itching, hives, tightness in the chest, difficulty breathing, or swelling of the
  •  face, lips, mouth, or tongue
  • signs of infection, such as fever, chills, sore throat, muscle aches; red, warm, or painful skin
  • persistent pain, swelling, or redness at the injection site
  • swelling of the hands, feet, or ankles
  • muscle weakness or pain
  • new or worsening joint pain
  • numbness, pain, or tingling in the hands or feet
  • increased sensitivity to the sun
  • red, swollen, or blistered skin
  • new or worsening red, scaly patches or raised bumps filled with pus on the skin
  • open sore that does not heal
  • unusual bruising or bleeding
  • unusual lumps
  • unusually pale skin
  • jaundice (yellowing of the eyes or skin)
  • blood in the stools or urine
  • dark urine
  • frequent or painful urination
  • pale stools
  • severe or persistent stomach pain
  • diarrhea
  • butterfly-shaped rash on the cheeks or nose
  • chest pain
  • irregular or fast heartbeat
  • vision changes
  • persistent cough
  • shortness of breath
  • severe or persistent headache or dizziness
  • fainting
  • loss of appetite
  • unexplained weight loss
  • unusual tiredness or weakness
  • vomiting
  • mental or mood changes

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.