{"id":429235,"date":"2010-03-15T10:11:28","date_gmt":"2010-03-15T14:11:28","guid":{"rendered":"http:\/\/www.aboutlawsuits.com\/?p=8918"},"modified":"2010-03-15T10:11:28","modified_gmt":"2010-03-15T14:11:28","slug":"plavix-black-box-warning-issued-may-not-work-in-some-patients","status":"publish","type":"post","link":"https:\/\/mereja.media\/index\/429235","title":{"rendered":"Plavix Black Box Warning Issued: May Not Work in Some Patients"},"content":{"rendered":"<p>A \u201cBlack Box\u201d warning has been placed on the anti-blood clotting drug <a href=\"http:\/\/www.aboutlawsuits.com\/topics\/plavix\/\">Plavix<\/a>, alerting patients and health care professionals that the drug may not work effectively in some patients due to genetics.  This could cause serious or life-threatening injuries for individuals given the medication to reduce the risk of heart attack, unstable angina, stroke or cardiovascular death among those with cardiovascular disease.  <span id=\"more-8918\"><\/span><\/p>\n<p>The FDA announced the <a href=\"http:\/\/www.fda.gov\/NewsEvents\/Newsroom\/PressAnnouncements\/ucm204253.htm\" >Plavix boxed warning warning<\/a> on Friday, warning doctors that they should consider another anti-clotting drug for patients who are confirmed to be poor metabolizers of Plavix through genetic testing. The FDA said a genetic test is available which will determine whether patients are able to metabolize Plavix efficiently.<\/p>\n<p>The black box warning is the most stringent warning label the FDA can require on a drug.<\/p>\n<p>Plavix (clopidogrel) is a blood thinner that prevents blood platelets from sticking together to form clots. It is a blockbuster medication, generating annual sales of over $6 billion for Bristol Myers Squibb Co. and Sanofi-Aventis.<\/p>\n<p>In August 2009, researchers from the University of Maryland <a href=\"http:\/\/www.aboutlawsuits.com\/plavix-ineffectiveness-predicted-by-gene-variant-5652\/\">identified a gene variant found in about one-third of the population<\/a> that may signal a reduced effectiveness of Plavix. The people with the CYP2C19 variant have reduced functioning of a liver enzyme that is supposed to covert Plavix from its inactive form to its active form, potentially making Plavix ineffective at reducing the risk of blood clots.<\/p>\n<p>The genetic variant is found in about 30% of Caucasians and blacks, and up to 60% of Asians. Simple genetic tests using DNA from blood or saliva can identify <a href=\"http:\/\/www.aboutlawsuits.com\/plavix-ineffectiveness-may-lead-to-label-update-2229\/\">poor Plavix metabolizers<\/a>. The tests are estimated to cost about $500, however, identifying poor Plavix metabolizers\u00a0could prevent patients from being\u00a0unnecessarily exposed to risk of <a href=\"http:\/\/www.youhavealawyer.com\/plavix\/side-effects.html\">Plavix side effects<\/a>, such as an increased risk of gastrointestinal bleeding, ulcers and a possible increase in the risk of heart attacks or strokes for those with high cholesterol or high blood pressure.<\/p>\n<p>Bristol Myers Squibb Co. and Sanofi-Aventis currently face a number of <a href=\"http:\/\/www.youhavealawyer.com\/plavix\/lawsuits-class-action.html\">Plavix lawsuits<\/a> filed by plaintiffs who claim that the drug maker failed to adequately warn about problems associated with use of their drug.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>A \u201cBlack Box\u201d warning has been placed on the anti-blood clotting drug Plavix, alerting patients and health care professionals that the drug may not work effectively in some patients due to genetics. This could cause serious or life-threatening injuries for individuals given the medication to reduce the risk of heart attack, unstable angina, stroke or [&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-429235","post","type-post","status-publish","format-standard","hentry","category-news"],"_links":{"self":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/posts\/429235","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=429235"}],"version-history":[{"count":0,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/posts\/429235\/revisions"}],"wp:attachment":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/media?parent=429235"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/categories?post=429235"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/tags?post=429235"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}