The first question that may come to mind about Byetta is “Why we would need another diabetes medication choice with the great number of choices we have in diabetes medications today?” The second question that remains is “What did the manufacturer know about the injectible Byetta drug before they changed their box warning label in 2007?” The third question becomes “Of the 1 million Byetta users since 2005, how many have developed serious adverse reactions due to the drug?” The serious conditions that may result from the use of Byetta include:
The Physical Warning Signs of Adverse Byetta Effects • Abdominal pain�
• Back pain
• Nausea�
• Extreme Blood Pressure Levels
• Elevated Heart Rates
The Public Health Community Warnings The final question becomes “What has the public health community and the pharmaceutical manufacturer of Byetta done to protect the public?”
In August of 2007, the FDA issued an alert regarding the safety of Byetta. In December of 2007, Amylin Pharmaceutical made changes to the product label to disclose the risk of two types of pancreatitis which may be life threatening. Hemorrhagic pancreatitis may cause severe bleeding and deterioration of the blood vessels. Necrotizing pancreatitis is characterized by the release of toxins into the blood stream that may result in many organs failing and ultimate death. Amylin also sent letters of notice to approximately 100,000 physicians across the U.S. warning them about the risks associated with the drug. It is still not clear how many more people will be injured by Byetta. There have been reports that adverse conditions may not appear for months after beginning the use of Byetta. As Rachel Abrams, Attorney at Law of San Francisco explains, “People seeking legal advice because of using Byetta were unaware of the risk of pancreatitis. The physicians were unaware as well. Unfortunately the side effects may appear mild initially, but become life threatening, particularly when the symptoms are not diagnosed or treated.”
Many personal injury attorneys feel that the number of Byetta victims will continue to rise as more consumers become aware of the association between their health conditions and the drug. Some personal injury attorneys contend that Byetta lawsuits will be multi-district in nature. The verdict regarding Byetta lawsuits may not be out for some time. In the meantime, consumers need to be continued to be warned about Byetta.
Video originally created by FDA -- posted by Lawsuit.com on November 18, 2008
In October 2007, FDA warned healthcare professionals about reports of acute pancreatitis in patients taking the antidiabetic drug Byetta (exenatide). Since then, FDA has received reports of six cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta. Two were fatal.Byetta and other suspect drugs should be promptly discontinued if pancreatitis is suspected. There are no known patient characteristics that can determine whether a case of pancreatitis associated with Byetta will develop into the hemorrhagic or necrotizing forms. If pancreatitis is confirmed, it should be treated without delay and the patient should be carefully monitored until recovery. Byetta should not be restarted. Physicians should consider antidiabetic therapies other than Byetta in patients who have a history of pancreatitis.
FDA is alerting healthcare professionals that Byetta (exenatide) may be associated with acute pancreatitis in some patients. Byetta is administered subcutaneously to treat type 2 diabetes.
FDA has reviewed 30 reports of acute pancreatitis in patients taking Byetta. Twenty-one were hospitalized, five of them with serious complications. Twenty-two of the patients improved after discontinuing the drug.
Practitioners should be alert to the signs and symptoms of pancreatitis in patients taking Byetta. If pancreatitis is suspected, discontinue the drug. If the diagnosis is confirmed, do not restart Byetta unless an alternative cause for the pancreatitis is identified.
Patients taking Byetta should be cautioned to promptly seek medical care if they experience symptoms of pancreatitis, such as persistent and severe abdominal pain, possibly accompanied by vomiting.
The manufacturer of Byetta, Amylin Pharmaceuticals, has agreed to include information about pancreatitis in the Precautions section of the drug’s labeling.
