March 24, 2009. By Heidi Turner
San Diego, CA: If you have been taking Byetta for a year or more, you may have noticed a change in the drug's labeling. That is because there has been a reported link between Byetta and acute pancreatitis. In fact, some patients who took Byetta apparently developed pancreatitis and, in extreme cases, died from their Byetta pancreatitis.
So far, the number of deaths linked to Byetta complications is 6, which may not seem like that many when compared to the overall number of Byetta users. However, there is a chance that the number of Byetta-related deaths has been underreported because patients and their doctors may not have realized that their pancreatitis could be linked to the use of the diabetes drug. This means that there could be more deaths out there related to the use of Byetta that have not been properly reported to authorities.
Furthermore, there could be other hospitalizations and complications that did not result in the patient's death but are still serious. Although 4 hospitalizations were linked to Byetta, it is possible that there are more hospitalizations that were not reported. Eli Lilly warned doctors in 2007 about the potential for pancreatitis in patients, however prior to that, some doctors may not have known about the risk.
It should be noted that of the deaths and hospitalizations, there were other factors involved, including complications from a gall bladder removal. However, how those factors combined with the Byetta to create life-threatening situations is not fully know. What is known is that all the patients who died or were hospitalized were taking Byetta.
Part of the reason that patients may not realize that their pancreatitis could be linked to Byetta is that people with diabetes often have an increased risk of pancreatitis. So, they may have suffered from pancreatic problems and believed that the problem was related to their diabetes as opposed to the medication they were taking.
One clue that the pancreatitis is linked to the Byetta is that the type of pancreatitis Byetta patients experience is known as hemorrhagic pancreatitis—a disease in which pancreatic cells are actually destroyed. In normal pancreatitis, the cells are not destroyed. The number of cases of hemorrhagic pancreatitis linked to Byetta is more severe than the normal number of cases found in general.
A lawsuit has been filed against Amylin Pharmaceuticals, Inc. and Eli Lilly and Company, alleging that they did not adequately test and monitor Byetta and that they did not warn doctors or patients about the risk of pancreatitis. The plaintiff says that he was hospitalized in 2007 after he developed pancreatitis, a painful condition in which the pancreas becomes inflamed, which can lead to internal bleeding and even death.
Diabetes patients have so much to worry about already, should they really have to worry that their medication could potentially cause serious side effects like pancreatitis?
Byetta was approved for use to treat type 2 diabetes in adults by controlling the patient's blood sugar levels. In 2008, the drug's label was updated to reflect the increased risk of pancreatitis. There are critics who argue that the FDA has been too reactionary in requesting updated warnings for Byetta. They say that the FDA has become hypersensitive to medications after recent blunders such as Avandia and Vioxx.
Regardless, the FDA has requested an updated warning and patients are now concerned that they could develop pancreatitis after using Byetta. If you are concerned that you have developed any medical issues after using the diabetes drug, talk to your doctor about your medical options.
If you have suffered harm after taking Byetta, contact a lawyer to discuss your legal options.
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