<레미케이드>인하대 병원 송정수 선생님 답변

Remicade 시판후조사 (PMS)에서 밝혀진 사실인 것 같습니다. USFDA와 Remicade 제조회사인 Centocor가 함께 발표한 것을 보면 신빙성이 있습니다. 다만 이러한 부작용이 발생되는 고위험군을 미리 알 수 없기때문에 사용 중에 혈액학적, 신경학적 이상이 나타나고 발열이 생기면 즉시 사용을 중단하고 이에 대한 적절한 대응을 해야 한다고 합니다. 이에 따라 Remicade의 사용상 주의점이 추가되었네요. 제가 사용한 환자들 중에는 아직 이런 부작용이 난 경우는 없었고 많은 경우에서 발생된 부작용이 아니기 때문에 무조건 금기될 것은 아닌 것 같고 다만 더욱 조심하고 신경을 써야 할 것으로 생각합니다. 인하대병원 송정수 드림. FDA issues new infliximab warnings Aug 25, 2004 Janis Kelly The US Food and Drug Administration (FDA) and Centocor this week warned physicians that new hematologic adverse events, some fatal, have been identified in postmarketing surveillance of patients taking infliximab (Remicade, Centocor) for treatment of rheumatoid arthritis (RA) or Crohn's disease [1]. The labeling for Remicade has been revised to include these problems [see sidebar] in addition to previously recognized risks such as reactivation of latent tuberculosis associated with this and other TNF inhibitors. Caution urged if prior history of hematologic problems Although no high-risk group(s) has been identified, caution should be exercised in patients being treated with Remicade who have ongoing or a history of significant hematologic abnormalities. In an August 11 "Dear Healthcare Professional" letter, Dr Daniel Everitt (Centocor's vice president for clinical pharmacology and global pharmacovigilance) writes, ""Although no high-risk group(s) has been identified, caution should be exercised in patients being treated with Remicade who have ongoing or a history of significant hematologic abnormalities. All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (eg, persistent fever) while on Remicade." The Centocor statement notes that postmarketing data on Remicade include reports of leukopenia, neutropenia, thrombocytopenia, and pancytopenia, "some with a fatal outcome." Rare cases of systemic vasculitis presenting with central nervous system (CNS) symptoms have also been reported. Other adverse events identified in postmarketing surveillance include pericardial effusion and both systemic and cutaneous vasculitis. According to the Wall Street Journal, Centocor says that 580 patients taking the drug have died over a 6-year period, but whether deaths were due to the underlying disease or related to the drug is unknown [2]. More than 508 000 patients have taken infliximab during that time. Remicade is marketed by Johnson & Johnson in the US, by Tanabe Seiyaku in Japan and parts of the Far East, and by Schering-Plough in all other countries. New information added to Remicade prescribing information Hematologic events Cases of leukopenia, neutropenia, thrombocytopenia, and pancytopenia, some with a fatal outcome, have been reported in patients receiving REMICADE. The causal relationship to REMICADE therapy remains unclear. Although no high-risk group(s) has been identified, caution should be exercised in patients being treated with REMICADE who have ongoing or a history of significant hematologic abnormalities. All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (eg, persistent fever) while on REMICADE. Discontinuation of REMICADE therapy should be considered in patients who develop significant hematologic abnormalities. Neurologic events Infliximab and other agents that inhibit TNF have been associated in rare cases with optic neuritis, seizure, and new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disorders, including multiple sclerosis and CNS manifestation of systemic vasculitis. Prescribers should exercise caution in considering the use of REMICADE in patients with preexisting or recent onset of central nervous system demyelinating or seizure disorders. Discontinuation of REMICADE should be considered in patients who develop significant central nervous system adverse reactions. Adverse reactions The following adverse events have been reported during postapproval use of REMICADE: neutropenia, interstitial pneumonitis/fibrosis, idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura, pericardial effusion, systemic and cutaneous vasculitis, Guillain-Barr?syndrome, transverse myelitis, and neuropathies (additional neurologic events have also been observed). Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to REMICADE exposure. Patient information Heart failure. If you have been told that you have a heart problem called congestive heart failure and you are currently being treated with REMICADE, you will need to be closely monitored by your doctor. If you develop new or worse symptoms that are related to your heart condition, such as shortness of breath or swelling of your ankles or feet, you must contact your doctor immediately. Blood problems. In some patients the body may fail to produce enough of the blood cells that help your body fight infections or help you stop bleeding. Some patients have died from this failure to produce blood cells. If you develop a fever that doesn't go away, bruise or bleed very easily, or look very pale, call your doctor right away. Your doctor may decide to stop your treatment Nervous system disorders. There have been rare cases where people taking REMICADE or other TNF blockers have developed disorders that affected their nervous system. Signs that you could be having a problem include: changes in your vision, weakness in your arms and/or legs, and numbness or tingling in any part of your body. Sources FDA. 2004 Safety Alerts for Drugs, Biologics, Medical Devices, and Dietary Supplements. August 24, 2004; Available at: http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#remicade Dooren JC. FDA, J&J's Centocor issue Remicade warning. Wall Street Journal August 24, 2004; Available at: http://online.wsj.com/article/0,,SB109337535919299863,00.html Related links Adverse events with infliximab: fibrosing alveolitis and coccidioidomycosis [Rheumawire > News; Jun 30, 2004] New details of adverse events with TNF inhibitors [Rheumawire > News; Nov 13, 2003] FDA Arthritis Committee finds TNF inhibitors add no lymphoma risk but might worsen CHF [Rheumawire > News; Mar 6, 2003]