Comments on: FDA Wants More Byetta Studies: Analyst http://www.pharmalot.com/2009/12/fda-wants-more-byetta-studies-analyst/ News, Comment and Conversation Fri, 10 Feb 2012 18:58:12 +0000 http://wordpress.org/?v=2.6.2 By: patrons99 http://www.pharmalot.com/2009/12/fda-wants-more-byetta-studies-analyst/#comment-453711 patrons99 Thu, 24 Dec 2009 23:20:17 +0000 http://www.pharmalot.com/?p=20630#comment-453711 According to an FDA Byetta Safety Update for Healthcare Professionals, “On October 30, 2009, FDA approved a Risk Evaluation and Mitigation Strategy (REMS) for Byetta. The REMS was part of an approval for a new indication of Byetta to be used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Previously Byetta was only approved for use in combination with other anti-diabetic drugs.” “Over 7 million prescriptions for Byetta have been dispensed since it was first approved by FDA in 2005. Therefore, while these adverse events are very serious, the number of reported cases of acute pancreatitis, hemorrhagic and necrotizing pancreatitis, and altered kidney function represent a small percentage of the total number of patients who have used Byetta.” “Additionally, the sponsor, Amylin Pharmaceuticals Inc, is being required to conduct six post-marketing studies (Postmarketing Requirements [PMRs]) to help further define the mechanism, incidence, and risk factors for the development of acute pancreatitis, including hemorrhagic and necrotizing pancreatitis, associated with the use of Byetta, as well as to explore a potential signal of a serious risk of thyroid cancer and pancreatic cancer.” Oh really?..."a potential signal of a serious risk of thyroid cancer and pancreatic cancer" As if hemorrhagic pancreatitis isn't a great enough risk to justify removal from the market place. Why would anyone risk prescribing this drug? According to an FDA Byetta Safety Update for Healthcare Professionals,

“On October 30, 2009, FDA approved a Risk Evaluation and Mitigation Strategy (REMS) for Byetta. The REMS was part of an approval for a new indication of Byetta to be used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Previously Byetta was only approved for use in combination with other anti-diabetic drugs.”

“Over 7 million prescriptions for Byetta have been dispensed since it was first approved by FDA in 2005. Therefore, while these adverse events are very serious, the number of reported cases of acute pancreatitis, hemorrhagic and necrotizing pancreatitis, and altered kidney function represent a small percentage of the total number of patients who have used Byetta.”

“Additionally, the sponsor, Amylin Pharmaceuticals Inc, is being required to conduct six post-marketing studies (Postmarketing Requirements [PMRs]) to help further define the mechanism, incidence, and risk factors for the development of acute pancreatitis, including hemorrhagic and necrotizing pancreatitis, associated with the use of Byetta, as well as to explore a potential signal of a serious risk of thyroid cancer and pancreatic cancer.”

Oh really?…”a potential signal of a serious risk of thyroid cancer and pancreatic cancer” As if hemorrhagic pancreatitis isn’t a great enough risk to justify removal from the market place. Why would anyone risk prescribing this drug?

]]> By: will http://www.pharmalot.com/2009/12/fda-wants-more-byetta-studies-analyst/#comment-453621 will Thu, 24 Dec 2009 16:40:53 +0000 http://www.pharmalot.com/?p=20630#comment-453621 So, the big question that seems to be on lot of folks mind is, just how big of a position does Werber hold in NVO and MRK? I'm sure the SEC is already looking in to it after his gum flapping yesterday So, the big question that seems to be on lot of folks mind is, just how big of a position does Werber hold in NVO and MRK?

I’m sure the SEC is already looking in to it after his gum flapping yesterday

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