Byetta Black Box Warning May Be Added

Harvey Kirk

By Harvey Kirk
Posted September 1, 2008


According to several reports, there are rumblings that the FDA may force Amylin and Eli Lilly to add a Byetta black box warning about the potential risk of pancreatitis. At least six Byetta users have died as a result of necrotizing pancreatitis or hemorrhagic pancreatitis, and there have been over 30 other reports of acute pancreatitis associated with side effects of Byetta.

>>INFORMATION: Byetta Pancreatitis Side Effects

Byetta (exenatide) is a subcutaneous injection used to treat type 2 diabetes by lowering blood sugar levels. Since it was approved by the FDA in 2005, it has been used by nearly 1 million people.

In October 2007, the FDA notified healthcare providers that they had identified a potential association between Byetta and pancreatitis, after receiving at least 30 reports of acute pancreatitis among users. At that time, the drug makers agreed to add warnings about the potential Byetta pancreatitis risk, but the language was buried in the prescription information.

On August 18, 2008, the FDA issued another alert to notify doctors about 6 more cases of severe pancreatitis, two of which had resulted in death. Following that alert, the manufacturers, Amylin and Eli Lilly, held a conference call with investors, doctors and concerned patients, where they disclosed that another four Byetta pancreatitis deaths had been reported to the FDA.

At that time, executives from Amylin and Eli Lilly confirmed that they are in talks with the FDA about the possibility of stronger Byetta warnings about pancreatitis, which could be placed more prominently on the label.

Several reports have speculated that the FDA is considering a Byetta “black box” warning that spells out the potentially fatal side effects of the diabetes drug. A “black box” warning is the strongest type of warning that can be placed on a prescription medication. However, drug makers usually oppose such a warning for consumers, since it often has a substantial negative impact on sales.


The Byetta lawyers at Saiontz & Kirk, P.A. are reviewing potential pancreatitis lawsuits for users of the diabetes drug. Cases are being investigated for users of Byetta diagnosed with pancreatitis, alleging that the drug makers failed to adequately warn about the drug’s side effects. If you, a friend or family member have suffered Byetta pancreatitis problems, request a free consultation and claim evaluation.

1 Comment • Add Your Comments

  • mike says:

    I have been on Byetta for over a year, 10mcg subquetaneously, twice a day. I have been having abdominal pain. My abdomen is hard as a rock ( a common sign and symptom of pancreatitis ) and I know my amylase and Lipase levels are elevated but my primary M.D. doesn’t seem concerned.

    Posted on September 29, 2008 at 8:49 pm

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