Sunday, July 14, 2013

Byetta Issues and Potential Problems

Byetta is a drug marketed for the treatment of Type 2 diabetes. While some diabetes drugs come in pill form, Byetta is a pre-filled pen which the patient injects one hour prior to the morning and evening meal. Unlike some other diabetic drugs, Byetta (exenatide) is made from a synthetic form of a hormone—exendin 4—which naturally occurs in the saliva of the Southwestern Gila monster and was discovered in 1992. The synthesized version of the hormone is nearly 50% identical to another hormone which occurs naturally in the human digestive tract—GLP-1. This GLP-1 hormone increases the insulin in the body, enabling it to balance excessively high levels of blood sugar. The body of a diabetic may lose the ability to produce the necessary levels of GLP-1, allowing blood sugar levels to rise to potentially dangerous levels.

How Byetta Works

Exenatide’s synthetic hormone remains effective for longer periods of time, effectively stabilizing blood sugar levels. Byetta has also been found to decrease the rate of the emptying of the stomach. This can lead to a decrease in appetite and, consequently, a reduction in weight. Byetta was approved by the FDA in 2005, and, like several other new diabetic drugs released around the same time, generated significant revenues for its manufacturer, Amylin. Between April, 2005 and October, 2008, Byetta was prescribed over seven million times, and by 2008 the drug had earned Amylin over $700 million dollars.

Byetta FDA Warnings

Controversy was not far behind, however. While no black box warning has been issued for the drug, Byetta FDA warnings were given beginning in 2007 following reports of adverse health effects from patients taking Byetta. Even though Byetta has actually been associated with several fatalities there remain few who advocate for a complete recall of the drug. Byetta appears to cause an increase in thyroid cancer as well as a potential increase in the risk of pancreatitis and pancreatic cancer. Overstimulation of the pancreas may lead to pancreatic problems and a study published in Gastroenterology by Dr. Peter Butler presents a link between Byetta users and the development of thyroid cancer. 

Byetta Safety Concerns

The official newspaper of the American Gastroenterology Association believes the risk of Byetta thyroid cancer among users is significantly higher than those with the same risk factors who do not use Byetta. Butler noted that “appropriate prospective studies” are required to rule out increased risks of thyroid cancer, pancreatitis and pancreatic cancer. Among thirty adverse reports presented to the FDA, six of those patients experienced substantial increases in Byetta pancreatitis symptoms when the doses were doubled and over two-thirds of the thirty patients showed significant improvement once Byetta was discontinued.  

Taking several credible studies into consideration it appears that overall Byetta users have three times the risk of developing pancreatic cancer and six times the risk of developing acute pancreatitis than those taking other diabetic drugs. In a recent report released in April, 2013, the Institute for Safe Medication Practices published findings which showed Byetta was responsible for two times the rate of thyroid tumors and thyroid cancer when compared to some other diabetic medications. While thyroid cancer is generally considered treatable, it remains a serious condition.

Print
0 Comments
Please login or register to post comments.

WARNING: Do not send any information in any email through this website if you consider the information confidential or privileged.

I understand that by submitting my contact information to Sullo & Sullo LLP for review, I consent to messages regarding this legal matter as well as marketing for other potential legal matters in the future without limitation at standard messaging and data rates unless terminated by me in writing. I further understand that my submission of any and all information in response to this website does NOT create a lawyer-client relationship between myself and Sullo & Sullo, LLP and/or its lawyers, and that any and all information submitted is NOT confidential or privileged. I further acknowledge that, unless Sullo & Sullo, LLP subsequently enters into an Attorney-Client relationship with me, any and all information I provide will NOT be treated as confidential or privileged, and any such information may be used against me and/or for the benefit of current or future clients of Sullo & Sullo, LLP. ...READ ENTIRE DISCLAIMER
Receive an Immediate Response
ANDREW SULLO IS A TOP 100 NATIONAL TRIAL LAWYER 2013 • 2014 • 2015 • 2016 • 2017 • 2018 • 2019
Obtener una Respuesta Inmediata
Andrew Sullo – 100 Mejores Abogados Nacional | 2013 • 2014 • 2015 • 2016 • 2017


4.6/5.0

STARS ON YELP
WITH OVER 400 REVIEWS*

*AS OF JANUARY 2024



Andrew Sullo has been named a

TOP 100 NATIONAL TRIAL LAWYER*
2013-2024

*BY THE NATIONAL TRIAL LAWYERS

 

CALL NOW FOR A FREE LEGAL CONSULTATION
(800) 730-7607
CALL NOW FOR A FREE LEGAL CONSULTATION (713) 839-9026 CALL NOW FOR A FREE LEGAL CONSULTATION (713) 335-9485


Andrew Sullo is a recipient of the

AVVO CLIENT'S CHOICE AWARD*
2016, 2017, 2019-2024

*GIVEN BY AVVO


Justice

Andrew Sullo is a Member of the

AMERICAN ASSOCIATION OF JUSTICE
2013-2024

*GRANTED BY THE AAJ

 

IF YOU OR A LOVED ONE WERE SERIOUSLY INJURED DUE TO THE NEGLIGENCE OF ANOTHER, CONTACT SULLO & SULLO IMMEDIATELY.
CALL NOW
(800) 730-7607
CALL NOW
(713) 839-9026
CALL NOW
(713) 335-9485

GET LEGAL HELP