Comments on: European Regulators To Limit Antibiotics http://www.pharmalot.com/2008/07/european-regulators-to-limit-antibiotics/ News, Comment and Conversation Fri, 10 Feb 2012 18:21:59 +0000 http://wordpress.org/?v=2.6.2 By: Justice in MI http://www.pharmalot.com/2008/07/european-regulators-to-limit-antibiotics/#comment-367765 Justice in MI Fri, 25 Jul 2008 17:41:33 +0000 http://www.pharmalot.com/?p=14805#comment-367765 I am wondering how the EMEA gets such a word out. What is the process, if anyone knows? Are there changes on packaging? Dr. Doc letters? PI? I am wondering how the EMEA gets such a word out. What is the process, if anyone knows? Are there changes on packaging? Dr. Doc letters? PI?

]]> By: Tom Lamb http://www.pharmalot.com/2008/07/european-regulators-to-limit-antibiotics/#comment-367728 Tom Lamb Fri, 25 Jul 2008 13:32:47 +0000 http://www.pharmalot.com/?p=14805#comment-367728 Where is the FDA on this Avelox - liver toxicity safety issue? The February 2008 "Dear Doctor" letter about Avelox / Avalox that Bayer sent out in Europe (only) was reportedly intended to emphasize a 2007 label change which Bayer made in Europe about, in part, severe and possibly fatal liver toxicity. Where is the corresponding letter to health care providers in the U.S. from Bayer about Avelox and its association with liver toxicity? What safety review has been done by the FDA along the lines of what EMEA has done regarding the liver toxicity issue? Where is the FDA on this Avelox - liver toxicity safety issue?

The February 2008 “Dear Doctor” letter about Avelox / Avalox that Bayer sent out in Europe (only) was reportedly intended to emphasize a 2007 label change which Bayer made in Europe about, in part, severe and possibly fatal liver toxicity.

Where is the corresponding letter to health care providers in the U.S. from Bayer about Avelox and its association with liver toxicity?

What safety review has been done by the FDA along the lines of what EMEA has done regarding the liver toxicity issue?

]]>