May 01, 2008 - Psoriasis Drug Can Cause Tuberculosis

May 1, 2008 - Enbrel, a drug first approved by the FDA in November of 1998 to treat rheumatoid arthritis and since approved for the treatment of psoriasis and other autoimmune disorders, will now include in its package insert a "black box" warning, the strictest type of safety labeling. The package insert with the new black box warning will also be converted to a Medication Guide. Whenever Enbrel is prescribed, the patient will be given a copy of the medication guide, which is designed to increase awareness of the possible side effects and risk factors, and to provide the patient with information concerning the proper use of the drug.

Enbrel is made with TNF, or tumor necrosis factor, a protein that appears to be present in excessive amounts in patients who have rheumatoid arthritis and other disorders of the immune system. Much like other drugs that suppress the immune system, Enbrel carries with it a risk for various infections, including sepsis, a potentially deadly blood infection. When Enbrel was initially released, healthcare providers were warned not to give Enbrel to patients suffering from sepsis. Recently, however, the drug's makers, Amgen and Wyeth observed in studies of more than 20,000 patients taking Enbrel that there were high incidences of tuberculosis, which is a bacterial infection of the lungs to which people with weakened immune systems are particularly susceptible.

Enbrel's new black box warning says that patients should be evaluated for tuberculosis risk factors and be tested for latent tuberculosis infection prior to starting and during treatment with Enbrel. In cases of latent tuberculosis infection, treatment should be initiated prior to therapy with Enbrel. The Enbrel black box warning also says some patients who tested negative for latent tuberculosis prior to receiving Enbrel have developed active tuberculosis. The black box warns physicians to monitor patients receiving Enbrel for signs and symptoms of active tuberculosis, including those patients who tested negative for latent tuberculosis infection.

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