The U.S. Food and Drug Administration on Monday strengthened warnings about the dangerous pancreas inflammation linked to the type 2 diabetes drug Byetta after receiving reports of deaths and hospitalizations in Byetta users.
The FDA got six reports of hemorrhagic or necrotizing pancreatitis requiring hospitalization, including two deaths. The cases were marked by bleeding or tissue death, the FDA said, the patients who didn't die were recovering.
Byetta and other potentially suspect drugs should be promptly discontinued if pancreatitis is suspected and not restarted if pancreatitis is confirmed, notes the FDA.
Byetta, given by injection and approved by the FDA in 2005, was thought to have wide potential use, in part because of its ability to help type II diabetes patients lose weight.
Now, the FDA is working with Byetta's maker, Amylin Pharmaceuticals, to add "stronger and more prominent warnings" about acute hemorrhagic or necrotizing pancreatitis on the product's label. It was not immediately clear if the FDA would order new so-called "black box" warnings.
Amylin and the drug company Eli Lilly & Co.collaborate on Byetta. The companies stated that pancreatitis is rare in the general public but more common among type 2 diabetes patients.
Diabetes patients have an increased risk of pancreatitis, Amylin spokeswoman Anne Erickson said in a statement, and as many as 20 percent of patients with the condition develop complications. Patients taking Byetta weren't at a greater risk for complications or death, Erickson said.
Byetta, also know by its chemical name, exenatide, is taken with other diabetes medicines to help lower blood sugar levels by regulating insulin production.
Source: Xinhua
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