FDA again "black box warning" the risk of adding two kinds of TNF inhibitors

Source: on September 7, 2011, MedWatch, the US FDA's safety information and adverse event notification system, announced that FDA changed the label of TNF (tumor necrosis factor) inhibitor again The black box warning added two infection risk warnings of Legionella and listeriosis TNF inhibitors are used to treat immune system diseases Currently, TNF inhibitors listed in the United States include REMICADE (infliximab / infliximab), Enbrel (etanercept / etanercept), Humira (adalimumab / adamumab), cimzia (certolizumab pegol) and simponi (golimumab) Among them, REMICADE was approved for the treatment of Crohn's disease in children, Enbrel and Humira were approved for the treatment of juvenile idiopathic arthritis Cimzia (available in 2008) and simponi (available in 2009) are not approved for children It is understood that the main producers of the above drugs are Humira of Abbott, REMICADE of Johnson & Johnson and Enbrel of Amgen More than 30 species of Legionella have been found in this increase, at least 19 of which are the pathogens of human pneumonia, a very serious and sometimes fatal pneumonia Listeria is widespread and can be found in most foods, but serious poisoning can cause blood and brain tissue infection After infection, the main manifestations are septicemia, meningitis and monocytosis Many countries have taken measures to control Listeria in foods, and formulated corresponding standards According to FDA reports, cancer patients may die when they are treated with TNF inhibitors due to the increased risk of serious infection by bacteria, mycobacteria, fungi, viruses, parasites and other pathogens In fact, this is the second time the FDA has warned about TNF inhibitors In 2008, the FDA first warned that TNF inhibitors were associated with increased cancer risk in children and adolescents, and added the warning to the drug's instructions in 2009 The warning of hepatosplenic T cell lymphoma (HSTCL) in young people has been included in the instructions of infliximab and adalimumab, and will be updated in the instructions of azathioprine and mercaptopurine TNF inhibitors have been warned of similar side effects in other countries In early 2010, the Australian Medical Products Agency (TGA) released information in the Australian adverse reactions bulletin that TNF inhibitors may induce systemic lupus erythematosus The State Food and Drug Administration reported the risk information in the second issue of pharmacovigilance express 2010 (total issue 79) According to the reporter of "daily economic news", there are only two enterprises with TNF inhibitor production qualification in China Yisaipu of Shanghai CITIC Guojian Pharmaceutical Co., Ltd was developed and listed in 2005, and the other one is Shanghai SAIJIN biomedical Co., Ltd.