\nBlack Box Warning Should Remain on Chantix®: Panel<\/a><\/div>\nWeb<\/font><\/em>MD<\/font><\/strong><\/div>\nOctober 17, 2014<\/div>\nA black box warning about suicide risks should remain on the anti-smoking drug Chantix® until it can be reevaluated using findings from thorough scientific studies, a U.S. Food and Drug Administration panel of experts said Thursday. Chantix® has carried the FDA’s strongest warning label since 2009 after it was linked to violent or suicidal behavior among some patients taking the drug.<\/p>\n
Pfizer asked the FDA to drop the boxed warning, citing recent studies suggesting that patients taking Chantix® were not at increased risk for psychiatric problems, the Associated Press<\/em> reported. However, the 11-member FDA advisory panel voted to retain the black box warning on Chantix®. One member voting in favor of removing the warning and six favored slight changes to the label. The FDA does not have to follow the advice of its expert panels, but typically does.<\/div>\n<\/blockquote>\n\nPfizer Loses a Bet on Removing Serious Warnings From its Chantix® Pill<\/a><\/div>\nPharmalot<\/font><\/strong><\/div>\nby Ed Silverman<\/div>\nOctober 17, 2014<\/div>\n…
“I think Pfizer took quite a chance trying to get the box deleted. They obviously wouldn’t have done it if they thought they could convince people, but they failed completely,” says Diana Zuckerman, the president of the National Center for Health Research, a non-profit advocacy group.<\/p>\n“They had the best presentation money could buy – very good analyses and complicated statistics to prove their point. And the company trotted out these studies and tried to make a very strong case for why the Black Box should be deleted, but only one person voted their way."<\/font><\/strong><\/p>\n
“Pfizer took a big chance, but I think they did so because they were afraid the next study wouldn’t be so favorable and maybe they could get rid of the Black Box warning now. Remember, if it were removed, it would be hard to get it reinstated later, even if a post-marketing study showed risk.”<\/p>\n
Pfizer is not flinching. “The completion of our currently ongoing safety study will represent one more step forward in the process of accurately characterizing the neuropsychiatric safety of this important medication,” says Steven Romano, a Pfizer senior VP who heads the medicines development group.<\/div>\n<\/blockquote>\nI’ll be brief since I expect it will be all over the evening news tonight. This is one of those situations where I wonder why physicians are even in the loop. While quitting smoking is obviously an important preventive medicine maneuver, how would any single physician have any knowledge about whether a given patient should take Chantix®?<\/div>\nBut there’s something else to say. Pfizer’s sales of Chantix® are down. They obviously think it has something to do with the Black Box warning in the labeling. So they are spending tons of money trying to get the label removed – thinking more patients will "ask their doctor if…<\/em>" and that more doctors will not be afraid to prescribe it. It’s a sign of their inflated sense that they can influence and control the world if they just play their cards right. It doesn’t occur to them that maybe their sales are down because Chantix® is only for the hardy. If you’ve prescribed it yourself, you know that it does exactly what that Black Box label says it does, and maybe more often than the label suggests. They can’t change that with a label eraser<\/em> or even a piece of Robert Gibbons statistical sleight of hand [see way past time…<\/a>].<\/p>\n
It is what it is…<\/div>\n","protected":false},"excerpt":{"rendered":"Black Box Warning Should Remain on Chantix®: Panel WebMD October 17, 2014 A black box warning about suicide risks should remain on the anti-smoking drug Chantix® until it can be reevaluated using findings from thorough scientific studies, a U.S. Food and Drug Administration panel of experts said Thursday. Chantix® has carried the FDA’s strongest warning […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_topic_count_hidden":0,"_bbp_reply_count_hidden":0,"_bbp_forum_subforum_count":0,"footnotes":""},"categories":[5],"tags":[],"class_list":["post-50860","post","type-post","status-publish","format-standard","hentry","category-opinion"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/50860","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/comments?post=50860"}],"version-history":[{"count":10,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/50860\/revisions"}],"predecessor-version":[{"id":50870,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/50860\/revisions\/50870"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=50860"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=50860"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=50860"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}