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Stronger Label For Diabetes Drug After More Deaths Reported


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11/17/2008
Brent Adams
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Federal regulators have begun work on a stronger label for a drug widely used for the treatment of the disabling condition of diabetes manufactured by Amylin Pharmaceuticals Inc. and Eli Lilly & Co. after continued reports of deaths from the use of the drug in spite of earlier government warnings.

 

On Monday, August 18, the U.S. Food and Drug Administration reported receiving six new reports of patients who had developed a dangerous form of pancreatitis from the use of the diabetes drug Byetta. Two of the patients have died and the other four were in recovery.

 

According to the drug makers, patients who take Byetta, in rare cases, have shown reports of pancreatitis with complications or a deadly outcome. They also noted diabetics as already being at a higher risk of pancreatitis than non-diabetics.

 

An October alert regarding approximately 30 reported cases of diabetes patients developing pancreatitis after using Byetta was updated by the FDA’s announcement.

 

Regulators emphasized that patients needed to immediately cease the use of Byetta if they began to show signs of acute pancreatitis which can result in nausea, abdominal pain, and potentially fatal complications.

 

More than 700,000 patients across the world have used the injectable drug intended for type 2 diabetes sufferers since its June 2005 launch.



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