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2000-12-19 12:29:25 , Á¶È¸:
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2000³â 12¿ù 8ÀÏ FDA Talk Papers¿¡ ½Ç¸° ³»¿ë.
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http://www.fda.gov/bbs/topics/ANSWERS/ANS01060.html
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T00-67 Print Media: 301-827-6242
December 8, 2000 Broadcast Media: 301-827-3434
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FDA APPROVES NEW TREATMENT FOR ECZEMA
FDA´Â ¾ÆÅäÇǼº ÇǺο°ÀÇ »õ·Î¿î Ä¡·áÁ¦¸¦ ½ÂÀÎ
The Food and Drug Administration (FDA) today approved a new treatment for atopic dermatitis (eczema) - a non-contagious skin condition that can cause redness, itching and oozing lesions.
FDA´Â ¿À´Ã ¾ÆÅäÇǼº ÇǺο°-È«¹ÝÀ̳ª °¡·Á¿ò µîÀ» ÀÏÀ¸Å³ ¼ö ÀÖ´Â ºñÀü¿°¼ºÀÎ ÇǺλóÅÂ-¿¡ ´ëÇÑ »õ·Î¿î Ä¡·áÁ¦¸¦ ½ÂÀÎÇß´Ù.
The drug is Protopic (tacrolimus) Ointment (0.1% and 0.03% for adults and 0.03% for children 2 years and older). The drug is for patients with moderate to severe eczema, for whom standard eczema therapies are deemed inadvisable because of potential risks, or who are not adequately treated by or who are intolerant of standard eczema therapies.
ÀÌ ¾àÀº Protopic¿¬°í·Î¼ ¼ºÀÎÀ» À§ÇÑ 0.1% ¹× 0.03% ÇÔ·®, ¸¸ 2¼¼ ÀÌ»ó ¾î¸°À̸¦ À§ÇÑ 0.03%ÇÔ·®ÀÌ ÀÖ´Ù. ÀÌ ¾àÀº °æÁõº¸´Ù ½ÉÇÑ(moderate to severe) ¾ÆÅäÇÇ È¯ÀÚµéÀ» À§ÇÑ °ÍÀ¸·Î ÀáÀçÀû À§Ç趧¹®¿¡ ÀϹÝÀûÀÎ ¾ÆÅäÇÇ Ä¡·á °úÁ¤ÀÌ Àû´çÇÏÁö ¾ÊÀº ȯÀÚµéÀ̳ª ÀÌ·¯ÇÑ ÀϹÝÀûÀÎ ¾ÆÅäÇÇ Ä¡·á °úÁ¤À» °ßµðÁö ¸øÇϴ ȯÀڵ鿡°Ô ÀûÇÕÇÏ´Ù.
FDA based its approval on the results of three 12- week studies which indicated that 28-37% of patients using Protopic experienced greater than or equal to 90% improvement of their skin condition, as measured by physicians, and two one year studies that indicated that the drug is safe for intermittent long term use.
FDA´Â ½ÂÀÎÀÇ ±Ù°Å·Î¼ ¼¼°³ÀÇ 12ÁÖ°£ ÀÓ»óÀÚ·á°á°ú(ÀÓ»óÀǵéÀÌ ÆǺ°ÇßÀ¸¸ç ÀÌ ¿¬°í¸¦ »ç¿ëÇÑ È¯ÀÚµé Áß 28-37%°¡ ±×µéÀÇ ÇǺλóÅ¿¡ ºñÇØ 90%ÀÌ»ó È£ÀüµÇ¾ú½¿)¿Í µÎ°³ÀÇ 1³â°£ ÀÓ»óÀÚ·á°á°ú(ÀÌ ¿¬°í´Â ¿À·£ ±â°£ °£ÇæÀûÀ¸·Î »ç¿ëÇصµ ¾ÈÀüÇÏ´Ù´Â °á°ú)¸¦ Á¦½ÃÇß´Ù.
Common side effects associated with this drug include temporary stinging or burning sensations where the drug is applied, which may lessen if the diseased skin heals. There was evidence from an animal study that Protopic Ointment may accentuate the adverse effects of ultraviolet light on the skin. Therefore, it is important that patients avoid sunlight and sun lamps, tanning beds, and treatment with UVA or UVB light. Patients who need to be outdoors after applying Protopic should wear loose fitting clothing that protects the treated area from the sun. In addition, patients should ask their health care providers what other type of protection from the sun to use.
ÀÌ ¾à°ú °ü·ÃÇÑ ÀϹÝÀûÀÎ ºÎÀÛ¿ëÀ¸·Î´Â ÀϽÃÀûÀÎ Àڱذú Ȳö°Å´Ï¸¦ Çö»óÀ̸ç ÀÌ·¯ÇÑ Áõ»óÀº ÇǺΰ¡ °³¼±µÇ¸é¼ °¨¼ÒµÈ´Ù. µ¿¹°½ÇÇè°á°ú·ÎºÎÅÍ ÀÌ ¾àÀº Àڿܼ±ÀÇ ºÎÀÛ¿ëÀ» Áõ°¡½ÃŲ´Ù´Â Áõ°Å°¡ È®º¸µÇ¾ú´Ù. ±×·¯¹Ç·Î Àڿܼ±A, B¸¦ ÀÌ¿ëÇÑ Ä¡·á³ª ÇÞºû, ¼±ÅÄ´× µîÀº ÇÇÇÏ´Â °ÍÀÌ Áß¿äÇÏ´Ù. ¶ÇÇÑ ÀÌ ¾àÀ» µµÆ÷ÇÑ ÈÄ ¾ß¿ÜÈ°µ¿À» ÇؾßÇϴ ȯÀÚµéÀº ¹Ýµí½Ã ÀûÀýÇÑ ¿ÊÀ» ÀÔ¾î¼ Å¾çÀ¸·ÎºÎÅÍ µµÆ÷µÈ ºÎÀ§¸¦ °¡·Á¾ßÇÑ´Ù. ¾Æ¿ï·¯ ȯÀÚµéÀº ´Ù¸¥ ÇüÅÂÀÇ Àڿܼ± Â÷´Ü ¼ö´Üµµ ¾Ë¾Æº¸¾Æ¾ß ÇÒ °ÍÀÌ´Ù.
The drug should not be used by patients who are allergic to its active ingredient, tacrolimus, or to its inactive ingredients. Women who are breastfeeding should also avoid using this drug. Women who are pregnant or who are planning to become pregnant should check with their physicians before using this product.
ÀÌ ¾àÀº ÀÌ ¾àÀÇ À¯È¿¼ººÐÀÎ tacrolimus ȤÀº ºñÀ¯È¿ ¼ººÐ¿¡ ¾Ë·¯Áö ¹ÝÀÀÀ» ³ªÅ¸³»´Â ȯÀÚµéÀÌ »ç¿ëÇؼ´Â ¾ÈµÈ´Ù. ¸ðÀ¯¸¦ ¼öÀ¯ÇÏ´Â ¿©¼ºµéµµ ÀÌ ¾àÀÇ »ç¿ëÀ» ÇÇÇؾßÇϸç ÀÓ½ÅÇ߰ųª °ð ÀÓ½ÅÇÒ °èȹÀ» °®´Â ¿©¼ºµéÀº ±×µéÀÇ ´ã´çÀǻ翡°Ô ÀÌ ¾àÀ» »ç¿ëÇϱâÀü ¹Ýµå½Ã »óÀÇÇØ¾ß ÇÑ´Ù.
Protopic will be marketed by Fujisawa Healthcare Inc. of Deerfield, Ill.
ÀÌ ¾àÀº Fujisawa Healthcare»ç¿¡ ÀÇÇØ ÆÇ¸ÅµÉ °ÍÀÌ´Ù.
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