The Food and Drug Administration today issued an alert warning that the diabetes drug Byetta was linked to deaths in two patients with inflamed pancreases. The news sent shares of San Diego-based Amylin, one of the country’s largest biotech companies and Byetta maker, plummeting nearly 15 percent, shaving roughly $700 million off the company’s stock value, now hovering just under $4 billion.

The drug, available in the U.S. since June 2005, is Amylin’s leading product. The company agreed to warn of the risk of pancreatitis in October, after 30 milder cases were reported.

Pancreatitis is an inflammation of the pancreas, the organ that produces insulin and other hormones that regulate sugar metabolism. Hemorrhagic pancreatitis, which causes severe bleeding, or necrotizing pancreatitis, in which pancreas cells die, are potentially life-threatening conditions.

“Byetta and other potentially suspect drugs should be promptly discontinued if pancreatitis is suspected,” the FDA alert stated. There are no signs or symptoms that distinguish acute hemorrhagic or necrotizing pancreatitis from the less severe form of pancreatitis.

The FDA is working with Amylin to add “stronger and more prominent warnings” on Byetta’s risks, the agency said in the alert, posted on its website.


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