{"id":420707,"date":"2010-03-12T09:47:11","date_gmt":"2010-03-12T14:47:11","guid":{"rendered":"http:\/\/www.aboutlawsuits.com\/?p=8899"},"modified":"2010-03-12T09:47:11","modified_gmt":"2010-03-12T14:47:11","slug":"winrho-sdf-linked-to-intravascular-hemolysis-and-death-fda","status":"publish","type":"post","link":"https:\/\/mereja.media\/index\/420707","title":{"rendered":"WinRho SDF Linked to Intravascular Hemolysis and Death: FDA"},"content":{"rendered":"<p>A \u201cblack box\u201d warning has been added to Baxter Healthcare and Cangene Corporations\u2019 platelet deficiency drug, WinRho SDF, after the FDA determined the drug has caused a condition in some patients that led to lethal cases of anemia and multi-organ failure. <span id=\"more-8899\"><\/span><\/p>\n<p>The FDA, Cangene and Baxter <a href=\"http:\/\/www.fda.gov\/Safety\/MedWatch\/SafetyInformation\/SafetyAlertsforHumanMedicalProducts\/ucm203739.htm\" >alerted health care professionals on Wednesday<\/a> that some patients being treated for immune thrombocytopenic purpura (ITP) have died after taking WinRho SDF due to complications from intravascular hemolysis (IVH). <\/p>\n<p>IVH can cause severe anemia, failure of the kidneys and other organs, and respiratory distress. WinRho SDF side effects have proven lethal in some patients, particularly those over the age of 65 with other life-threatening conditions.<\/p>\n<p>ITP is a syndrome in which the patient has a decreased number of blood platelets due to the immune system attacking them with antibodies, which can lead to bleeding, easy bruising, or the leaching of blood from capillaries into the skin and mucous membranes. WinRho SDF was first approved in the U.S. by FDA in 1995, and is made from human plasma.<\/p>\n<p>The black box warning, the most stringent labele warning that the FDA can mandate for a drug, warns health care professionals that patients should be closely monitored in a health care setting for at least eight hours after being put on the drug. It also recommends several urine analyses be performed over several hours.<\/p>\n<p>The warning also includes a list of symptoms that patients should be aware of, which could indicate the onset of IVH, including:<\/p>\n<ul>\n<li>Back pain<\/li>\n<li>Shaking and chills<\/li>\n<li>Fever<\/li>\n<li>Discolored urine\u00a0\u00a0<\/li>\n<\/ul>\n<p>If symptoms arise, a battery of post-laboratory tests should be performed. A lack of symptoms in the first few hours does not mean that IVH will not occur at a later time. The drug carried a warning against IVH previously, but now that warning will be placed prominently on the label with a black border on all WinRho SDF packaging.<\/p>\n<p>If symptoms arise, a battery post-laboratory tests should be performed. A lack of symptoms in the first few hours does not mean that IVH will not occur at a later time. The drug carried a warning against IVH previously, but now that warning will be highlighted by a black border on all WinRho SDF packaging.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>A \u201cblack box\u201d warning has been added to Baxter Healthcare and Cangene Corporations\u2019 platelet deficiency drug, WinRho SDF, after the FDA determined the drug has caused a condition in some patients that led to lethal cases of anemia and multi-organ failure. The FDA, Cangene and Baxter alerted health care professionals on Wednesday that some patients [&hellip;]<\/p>\n","protected":false},"author":3957,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[],"class_list":["post-420707","post","type-post","status-publish","format-standard","hentry","category-news"],"_links":{"self":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/posts\/420707","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/users\/3957"}],"replies":[{"embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/comments?post=420707"}],"version-history":[{"count":0,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/posts\/420707\/revisions"}],"wp:attachment":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/media?parent=420707"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/categories?post=420707"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/tags?post=420707"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}