June 10, 2009
/24-7PressRelease/ -- FDA Alerts Consumers to Dangers of Byetta
Article provided by The Brandi Law Firm. Please visit our Web site at
http://www.brandilaw.com.
In 2008, the Food and Drug Administration (FDA) issued an update to an alert on Exenatide, a prescription drug marketed under the name Byetta. It is used to treat adults with type 2 diabetes, which is the most common form of diabetes. With type 2 diabetes the body doesn't produce enough insulin or the cells ignore the insulin produced.
The FDA received reports of six cases of pancreatitis in patients taking Byetta between October 2007 and August 2008. Two of those patients died. A few days later, Amylin Pharmaceuticals and Eli Lilly and Company, makers and marketers of the drug, said they had reported four additional deaths to the agency.
Byetta is an injectable medicine used to improve blood sugar control. Users inject themselves with regulated doses using a pen-like device twice daily before meals. A common side effect is nausea, which typically diminishes with time. The drug is perhaps best known for the weight loss it causes in users.
Dangers of Byetta
The danger for diabetics and others using the drug is the risk that Byetta will cause severe inflammation of the pancreas known as pancreatitis. The pancreas is the gland in the upper abdomen responsible for insulin production and the manufacturing of digestive enzymes. In 2007, the FDA issued an alert citing 30
reports of acute pancreatitis in patients taking Byetta, saying it suspected a link between the drug and the dangerous inflammation in some of the cases.
Symptoms of pancreatitis include pain radiating to the back, a swollen and tender abdomen, nausea and vomiting, fever and rapid heartbeat.
Off-label Use: Byetta for Weight Loss
In 2006, the New York Times ran a feature article on Byetta, focusing on its weight loss properties. "The drug seems so effective for weight loss that some nondiabetics have begun using Byetta as a diet drug," it said, "causing concern among doctors who say such use has not been medically tested and could be dangerous."
The drug slows the movement of food through the stomach, giving users a quick and prolonged feeling of fullness.
The Internet has Byetta blogs gushing about people engaging in off-label use -- meaning use of a drug for something other than FDA-approved purposes. In the case of Byetta, an unknown number of people are using it as a diet aid, though the FDA has not approved it for that use. Byetta has received FDA approval only for treatment of type 2 diabetes.
When a pharmaceutical company applies to the FDA for approval of a drug, the application states the drug's intended uses. Once FDA approval is granted, the drug can be marketed for that stated purpose only.
While off-label prescriptions are not illegal, they can be unethical or potentially dangerous. It is the FDA's position that "
f physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects."
Interestingly, in early 2009, Eli Lilly, one of the makers of Byetta, was fined $1.4 billion for its off-label marketing of another drug, Zyprexa. Included in that sum was a criminal fine of $515 million, the largest criminal fine ever imposed on a U.S. company. The FDA approved Zyprexa for treatment of bipolar disorder and schizophrenia, but in addition, Eli Lilly promoted it for use in treating sleep disorders and dementia.
If You Were Injured After Taking Byetta
Despite the dangers of acute pancreatitis in consumers of Byetta, its makers are poised to introduce a new long-acting version of the drug taken once a week rather than twice a day.
If you or a family member has taken Byetta and experienced pancreatitis, seek prompt medical treatment for your condition. In addition, an attorney may be able to advise you of potential legal claims you have.Article provided by The Brandi Law Firm. Please visit our Web site at
http://www.brandilaw.com.
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