Along with the alert for prescribers, this advice, targeted directly toward patients, was released by the FDA today-
Information for the Patient:
Prescribers should discuss the following information with patients and their caregivers:
* Patients treated with TNF blockers have an increased risk for infections. Some patients have had serious infections while receiving TNF blockers. In some cases, patients needed to be hospitalized for treatment. These serious infections include infections caused by viruses, fungi, or bacteria including tuberculosis (TB), including infections that have spread throughout the body. Some patients have died from these infections.
* If you have weight loss, persistent fever, sweating, cough, shortness of breath, or fatigue, promptly seek medical attention.
* Tell your doctor where you live and about recent travel in and outside the USA. The risk of some infections is greater in regions where different microorganisms (bacteria, fungi, viruses, parasites) are more common.
* Tell your doctors that you are taking a TNF blocker. A doctor may make different decisions about your medical treatment if he or she knows that you are taking a TNF blocker.
* Tell your doctor about all of your medical conditions, including if you have an infection that won't go away or a history of an infection that keeps coming back.
Background Information and Data
TNF blockers suppress the immune system by blocking the activity of TNF, a substance in the body that can cause inflammation and lead to immune system-related diseases.
There are currently four TNF blockers available in the United States: Cimzia, Enbrel, Humira, and Remicade. The TNF blockers have demonstrated benefit and are each approved to treat 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. Remicade is approved for use in children to treat Crohn's disease. Enbrel and Humira are approved for use in children to treat JIA.
Since TNF blockers are immunosuppressants, patients that take these drugs are at increased risk of serious infections, including invasive fungal infections such as histoplasmosis, coccidioidomycosis, blastomycosis, aspergillosis, candidiasis, cryptococcosis, as well as other opportunistic infections. Since the initial approval of the four TNF blockers, the prescribing information for these drugs has included information about the risk of serious infections, including fungal infections. However, based on the reports reviewed by FDA, healthcare professionals are not consistently recognizing cases of histoplasmosis and other invasive fungal infections, leading to delays in treatment. Some patients with invasive fungal infections have died.
FDA reviewed 240 reports of histoplasmosis in patients receiving Remicade (207 cases), Enbrel (17 cases), or Humira (16 cases). The majority of cases were from Histoplasma capsulatum-endemic areas in the Ohio and Mississippi River valleys. In at least 21 of the reports, histoplasmosis was initially unrecognized and antifungal treatment was delayed. Twelve of these 21 patients died. FDA has reviewed 1 reported case of histoplasmosis in a patient taking Cimzia, which was approved in April 2008. FDA has also received reports of cases, including deaths, of coccidioidomycosis and blastomycosis in patients receiving TNF blockers.
Along with the alert for prescribers, this advice, targeted directly toward patients, was released by the FDA today-
Information for the Patient:
Prescribers should discuss the following information with patients and their caregivers:
* Patients treated with TNF blockers have an increased risk for infections. Some patients have had serious infections while receiving TNF blockers. In some cases, patients needed to be hospitalized for treatment. These serious infections include infections caused by viruses, fungi, or bacteria including tuberculosis (TB), including infections that have spread throughout the body. Some patients have died from these infections.
* If you have weight loss, persistent fever, sweating, cough, shortness of breath, or fatigue, promptly seek medical attention.
* Tell your doctor where you live and about recent travel in and outside the USA. The risk of some infections is greater in regions where different microorganisms (bacteria, fungi, viruses, parasites) are more common.
* Tell your doctors that you are taking a TNF blocker. A doctor may make different decisions about your medical treatment if he or she knows that you are taking a TNF blocker.
* Tell your doctor about all of your medical conditions, including if you have an infection that won't go away or a history of an infection that keeps coming back.
Background Information and Data
TNF blockers suppress the immune system by blocking the activity of TNF, a substance in the body that can cause inflammation and lead to immune system-related diseases.
There are currently four TNF blockers available in the United States: Cimzia, Enbrel, Humira, and Remicade. The TNF blockers have demonstrated benefit and are each approved to treat 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. Remicade is approved for use in children to treat Crohn's disease. Enbrel and Humira are approved for use in children to treat JIA.
Since TNF blockers are immunosuppressants, patients that take these drugs are at increased risk of serious infections, including invasive fungal infections such as histoplasmosis, coccidioidomycosis, blastomycosis, aspergillosis, candidiasis, cryptococcosis, as well as other opportunistic infections. Since the initial approval of the four TNF blockers, the prescribing information for these drugs has included information about the risk of serious infections, including fungal infections. However, based on the reports reviewed by FDA, healthcare professionals are not consistently recognizing cases of histoplasmosis and other invasive fungal infections, leading to delays in treatment. Some patients with invasive fungal infections have died.
FDA reviewed 240 reports of histoplasmosis in patients receiving Remicade (207 cases), Enbrel (17 cases), or Humira (16 cases). The majority of cases were from Histoplasma capsulatum-endemic areas in the Ohio and Mississippi River valleys. In at least 21 of the reports, histoplasmosis was initially unrecognized and antifungal treatment was delayed. Twelve of these 21 patients died. FDA has reviewed 1 reported case of histoplasmosis in a patient taking Cimzia, which was approved in April 2008. FDA has also received reports of cases, including deaths, of coccidioidomycosis and blastomycosis in patients receiving TNF blockers.