Byetta to Receive New Pancreatitis FDA Warning
August 18, 2008
After receiving two reports of deaths and four other hospitalizations in Byetta users, the FDA today announced its plans to update Byetta’s warning label to include warnings about life-threatening pancreas problems linked to the type 2 diabetes drug.
The six patients at the center of the FDA announcement all had either hemorrhagic pancreatitis (inflammation of the pancreas with bleeding) or necrotizing pancreatitis (an inflamed pancreas that destroys itself). All six patients were hospitalized and their Byetta treatment was discontinued. The four survivors were still recovering from pancreatitis when the FDA announcement was made.
According to the FDA, Byetta and other suspect drugs should be promptly discontinued if pancreatitis is suspected. Additionally, Byetta should not be restarted if pancreatitis is confirmed. Byetta, which has the generic name exenatide, was approved by the FDA in 2005.
In October 2007, the FDA issued a press release stating that it had received 30 reports of acute pancreatitis, which is sudden inflammation of the pancreas, in Byetta patients. However, none of those Byetta patients had hemorrhagic or necrotizing pancreatitis, which are much more serious forms of pancreatitis.
At the time, Amylin agreed to add information about acute pancreatitis to the “precautions” section of Byetta’s label. Now, the FDA says it is working with Amylin to add additional warnings to Byetta’s label. Specifically, the FDA plans to strengthen and draw attention to warnings about acute hemorrhagic or necrotizing pancreatitis.
The companies that co-market Byetta say that pancreatitis is rare in the general public but more common among type 2 diabetics. According to these companies, there have been “rare” case reports of pancreatitis and “very rare” case reports of pancreatitis with complications or fatalities, and the proportion of complicated or fatal cases is “similar” to that observed in the general public with pancreatitis.
If you or a loved one has been injured by Byetta, you may be entitled to compensation. Please contact us today for a confidential and free assessment of your legal rights.