Tuesday, June 26, 2012

FDA: Amylin Pharma Concealed Heart Safety Risks of Key Diabetes Drug

Amylin Pharmaceuticals concealed a study from the U.S. Food and Drug Administration that raised heart safety concerns about its diabetes drug Byetta and then hindered FDA access to the data when the agency discovered its existence according to a recent report.

The review and approval of Bydureon was a "long and complicated process, in part due to Amylin's withholding of information on Byetta that FDA deemed to be important to its evaluation of the safety and effectiveness of Bydureon," according to a memo written by Mary Parks, division director of the FDA responsible for the review and oversight of diabetes drugs. Parks wrote the memo in January 2012 after Bydureon was approved 

Source:  http://www.thestreet.com/story/11595037/1/fda-amylin-pharma-concealed-heart-safety-risks-of-key-diabetes-drug.html?puc=yahoo&cm_ven=YAHOO