Safety Alerts & Recalls

What does this mean?

TNF blockers are used to treat serious medical conditions, and most doctors are aware of link between TNF blockers and cancer. However, patients or caregivers should be aware of the possible risks associated with TNF blockers, like Golimumab, and regularly discuss the benefits and risk of treatment with their doctor. Please review the Medication Guide that is provided with your prescription of Golimumab and discuss any concerns with your doctor.

If you or someone you care for is using Golimumab, you should have a monitoring plan in place to detect early problems. Pay close attention for any signs or symptoms of cancer such as unexplained weight loss or fatigue, swollen lymph nodes in the neck, underarms or groin, or easy bruising or bleeding. If you are using Golimumab to treat psoriasis, pay close attention for any signs or symptoms of new onset psoriasis or worsening psoriasis such as red scaly patches or raised bumps on the skin that are filled with pus. If any of these signs or symptoms develop or if you have any other concerns about Golimumab, please follow up with your doctor as soon as possible. Do not stop or change Golimumab without first talking with a knowledgeable healthcare professional. Suddenly stopping certain medications can cause serious problems.

New Boxed Warning for Tumor Necrosis Factor (TNF) Blockers

The FDA is requiring the manufacturers of tumor necrosis factor (TNF) blockers to update the Boxed Warning in the prescribing information to warn of an increased risk of lymphoma and other cancers in children and adolescents treated with TNF blockers. This new Boxed Warning is an addition to the existing Boxed Warning relating to the risk of potentially fatal infections, including tuberculosis, in all patients who use TNF blockers.

The currently FDA approved TNF blockers include adalizumab (marketed as Humira), certolizumab (marketed Cimzia), etanercept (marketed Enbrel), golimumab (marketed as Simponi), and infliximab (marketed as Remicade). TNF blockers are approved for the treatment of one or more of a number of immune system diseases including juvenile idiopathic arthritis (JIA), rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, Crohn's disease, and ankylosing spondylitis.

In addition to the updated Boxed Warning, the FDA is requiring several other changes to the prescribing information for TNF blockers, including: 1) An update to the Warnings section describing reported cases of leukemia in adults, adolescents, and children

2) An update to the Adverse Events section to include information on reported cases of new-onset psoriasi

3) An update to the Medication Guide for these medications to provide this new safety information to patients who receive prescriptions for TNF blocker

This new safety information is based on the FDA's completed analysis of TNF blockers which included reports of lymphoma and other cancers in children and adolescents, post-marketing leukemia reports in all patients, as well as a post-marketing evaluation of new-onset psoriasis in patients treated with these drugs.

For more information, please visit: more information here

Source: FDA
Publication Date: 2009-08-04
Last Updated: 2009-12-05

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