Byetta Makers Refute Claims of Increased Heart Problems

The makers of the controversial diabetes drug Byetta say the medication does not increase the risk of heart problems, despite recent studies finding such a link.

Byetta is a twice-daily injection for treating type 2 (also called adult onset) diabetes, but San Diego-based Amylin Pharmaceuticals Inc. and Eli Lilly and Co. are now seeking Food and Drug Administration approval of a once-a-week injection of the same drug. The FDA has not yet ruled on whether to approve the extended-release form of Byetta.

Because of heart problems associated with Avandia and other popular diabetes drugs, the FDA is now requiring the makers of the drugs to withstand increased scrutiny before the drugs are approved for consumers. Those new guidelines call for more extensive testing of the drugs on patients deemed high risk. In the past, some critics have accused drug companies of cherry picking test only the healthiest patients for clinical studies, which can skew the results to be more positive.

The drug companies say an analysis of previous clinical study data found no link between Byetta and increased risks of heart attack and that further studies are planned to better determine the safety of the drug.

However, Byetta still faces FDA scrutiny for a link to a potentially life-threatening pancreatic condition.

Byetta Linked to Deadly Pancreas Inflammation

Earlier this year, the FDA warned of an increased risk of deadly pancreatic disease in people taking Byetta. Dozens of Byetta patients have developed hemorrhagic pancreatitis, also called inflammation of the pancreas, which resulted in death or serious injuries.

In 2008, the FDA ordered Byetta’s packaging to carry stronger warnings to users about the risks of injury.

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