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Amylin, Lilly’s Byetta Gets Stronger Safety Warning

Amylin Pharmaceuticals Inc. and Eli Lilly & Co. said safety warnings were strengthened for their diabetes drug Byetta relating to the risks of pancreatitis and the medicine’s use by patients with severe kidney disease.

Patients with “severe kidney problems” shouldn’t take Byetta and the treatment should be “used with caution” in people who have had a kidney transplant, San Diego-based Amylin and Indianapolis-based Lilly said in a statement. The companies also said U.S. regulators approved the use of the drug as a stand-alone medication for adults with Type 2 diabetes.

Six patients taking Byetta died in August 2008 from pancreatitis, an inflamed pancreas. A safety alert was issued by the Food and Drug Administration though Amylin said no evidence directly linked the drug to the deaths. The revised language reflects the concerns raised by the FDA a year ago, according to Amylin’s medical director.


“The data still do not support a causal relationship between Byetta and pancreatitis,” Wilhelm said.

Byetta, a twice-daily injection, has been sold since April 2005 for patients also taking other diabetes medications. Amylin’s revenue from the drug fell 5 percent to $171 million in the third-quarter compared with the same period a year earlier, the company said Oct. 20 in a statement. Amylin and Lilly have been trying to gain U.S. approval for a once-weekly version of the medicine.

Regulators approved Byetta use on its own with diet and exercise to lower blood sugar in adults with Type 2 diabetes, which accounts for as much of 95 percent of all diabetes, according to the U.S. Centers for Disease Control and Prevention. Often associated with obesity, it is most common in adults older than 40 and is now being diagnosed in children and teenagers.

If you or a family member has been personally injured because of the fault of someone else: by the use of dangerous and defective drugs, bad products, or toxic injury etc then please contact the Dallas Texas Defective Drugs Product Liability Attorney Dr. Shezad Malik. For a no obligation, free case analysis, please call 817-255-4001 or Contact Me Online.

The Dr. Shezad Malik Law is currently evaluating and accepting Byetta Pancreatitis cases.

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