{"id":86,"date":"2008-11-29T12:57:34","date_gmt":"2008-11-29T19:57:34","guid":{"rendered":"http:\/\/cchrstl.org\/wordpress\/?p=86"},"modified":"2024-07-14T05:43:51","modified_gmt":"2024-07-14T10:43:51","slug":"fda-panel-to-review-zyprexa-side-effects-for-children","status":"publish","type":"post","link":"https:\/\/www.cchrstl.org\/wordpress\/2008\/11\/29\/fda-panel-to-review-zyprexa-side-effects-for-children\/","title":{"rendered":"FDA Panel to Review Zyprexa Side Effects for Children"},"content":{"rendered":"<p><!-- AddThis Button BEGIN --> <script type=\"text\/javascript\"> \t\t\t\t\t\taddthis_pub             = 'skmlaw';  \t\t\t\t\t\taddthis_logo_background = 'EFEFFF'; \t\t\t\t\t\taddthis_logo_color      = '666699'; \t\t\t\t\t\taddthis_brand           = 'AboutLawsuits'; \t\t\t\t\t\taddthis_options         = 'favorites, email, digg, delicious, myspace, facebook, google, live, newsvine, more'; \t\t\t\t\t\t<\/script> November 18th, 2008<\/p>\n<div class=\"postinfo\"><a href=\"http:\/\/www.aboutlawsuits.com\/fda-panel-to-review-zyprexa-side-effects-for-children-1774\/\">http:\/\/www.aboutlawsuits.com\/fda-panel-to-review-zyprexa-side-effects-for-children-1774\/<\/a><\/div>\n<div class=\"entry\">At a meeting of the FDA\u00c3\u00a2\u00e2\u201a\u00ac\u00e2\u201e\u00a2s Pediatric Advisory Committee today [11\/18\/08],  potential label changes will be considered for Eli Lilly\u00c3\u00a2\u00e2\u201a\u00ac\u00e2\u201e\u00a2s antipsychotic drug  Zyprexa. The Committee will evaluate whether new warnings are necessary about  the risk of potential Zyprexa side effects for children, such as severe weight  gain, hyperglycemia or other metabolic effects.Zyprexa (olanzapine), is an atypical antipsychotic medication that has been  used by more than 26 million people worldwide.<\/p>\n<p>It is manufactured and marketed by Eli Lilly &#038; Co., and was first  approved in the United States in 1996 for treatment of schizophrenia and bipolar  disorder in adults. It has also been widely prescribed off-label for other  unapproved uses, such as treatment of dementia and mild forms of bipolar  disorder.<\/p>\n<p>Although Zyprexa is only approved by the FDA for use by those 18 years or  older, it is commonly prescribed off-label to children, and Lilly has been  seeking approval to market the drug for children between 13 and 17 years of  age.<\/p>\n<p>In documents released in advance of the advisory meeting today, FDA staffers  suggested that new language should be considered to specifically warn about the  potential side effects of Zyprexa for children. This could include information  about the risk of weight gain and other metabolic changes that are already noted  on the label for adults.<\/p>\n<p>As a result of Lilly\u00c3\u00a2\u00e2\u201a\u00ac\u00e2\u201e\u00a2s failure to adequately warn about these side effects in  the past, the drug maker has already paid about $1.2 billion to settle over  30,000 Zyprexa lawsuits filed by users who suffered diabetes, hyperglycemia,  pancreatitis and other injuries.<\/p>\n<p>Lilly has also paid millions to settle claims over their marketing practices,  which included claims that they marketed the drug for unapproved uses and  downplayed the risk of Zyprexa side effects.<\/p>\n<p>According to the New York Times, Eli Lilly is also expected to pay at least  another $1 billion in restitution and fines to resolve federal criminal  investigations related to their marketing of Zyprexa.<\/p>\n<p>At the Pediatric Advisory Committee meeting on November 18, 2008, independent  panel of experts will also consider potential side effects of Lamisil for  children. According to the same FDA staff review documents, Novartis\u00c3\u00a2\u00e2\u201a\u00ac\u00e2\u201e\u00a2 antifungal  drug has been associated with a risk of psychiatric side effects in children,  including cases of depression, suicidal thoughts and self-harm.<\/p>\n<p>The Best Pharmaceuticals for Children Act of 2002 requires drug reviews for  all drugs recently tested in children. The FDA advisory panel consists of  outside experts who will discuss the reports and make recommendations to the FDA  about adding warnings to the drug labels about potential side effects in  children.<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"<p>November 18th, 2008 http:\/\/www.aboutlawsuits.com\/fda-panel-to-review-zyprexa-side-effects-for-children-1774\/ At a meeting of the FDA\u00c3\u00a2\u00e2\u201a\u00ac\u00e2\u201e\u00a2s Pediatric Advisory Committee today [11\/18\/08], potential label changes will be considered for Eli Lilly\u00c3\u00a2\u00e2\u201a\u00ac\u00e2\u201e\u00a2s antipsychotic drug Zyprexa. The Committee will evaluate whether new warnings are necessary about the risk of &hellip; <a href=\"https:\/\/www.cchrstl.org\/wordpress\/2008\/11\/29\/fda-panel-to-review-zyprexa-side-effects-for-children\/\">Continue reading <span class=\"meta-nav\">&rarr;<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[2,3],"tags":[],"class_list":["post-86","post","type-post","status-publish","format-standard","hentry","category-big-muddy-river-newsletter","category-press-releases"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/p6NMpC-1o","jetpack_likes_enabled":true,"_links":{"self":[{"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/posts\/86","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/comments?post=86"}],"version-history":[{"count":0,"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/posts\/86\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/media?parent=86"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/categories?post=86"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/tags?post=86"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}