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U.S. health officials warned doctors and patients on Tuesday that Amylin Pharmaceuticals Inc's and Eli Lilly and Co's diabetes drug Byetta may be linked to acute pancreatitis in some patients.

The U.S. Food and Drug Administration said it has reviewed 30 reports of pancreatitis in patients being treated with Byetta, one of the most successful new diabetes medicines in recent years.

"An association between Byetta and acute pancreatitis is suspected in some of these cases," an FDA alert said.

Amylin has agreed to add information about acute pancreatitis to the precautions section of Byetta's label, the FDA said. Amylin spokeswoman Alice Bahner said the company would send a letter to doctors about the issue shortly.

Shares of Eli Lilly and Amylin were off 1.5 per cent and 3.9 per cent, respectively, in afternoon trading after the FDA alert. Shares of Alkermes Inc, the drug-delivery technology of which is being used to develop a long-acting version known as Byetta LAR, were down about 3 per cent.

Pancreatitis, or inflammation of the pancreas, usually develops quickly and subsides quickly, according to the Merck Manual of Medical Information, but can destroy the function of the vital organ when it goes untreated.

Twenty-seven of 30 patients who reportedly developed pancreatitis had at least one other risk factor such as gallstones and alcohol use, the FDA said. Twenty-one patients were hospitalized, and five developed serious complications.

Lilly spokeswoman Kindra Strupp said the risk of pancreatitis was included in Byetta's label late last year.

"What you're seeing today is a clarification of language to show that severe and persistent abdominal pain could be a sign of something serious like pancreatitis" and require medical attention, Ms. Strupp said.

The pancreatitis cases were "rare", given the fact the drug has been taken by 700,000 people worldwide, Ms. Strupp said.

"People were asking questions about this a year or so ago and management dismissed it, so I'm surprised it has come back," said Andrew Forman, an analyst at WR Hambrecht & Co.

"Given the FDA's very cautious stance on side effects, it's not a surprise that the stock reacted negatively right away, but I think this is probably a buying opportunity because Byetta is such an effective treatment for diabetes," he said.

Byetta, which is known generically as exenatide, was launched in the United States in mid-2005 for treating type II diabetes. Its success has been due in part to the drug's ability to help patients shed weight.

Indianapolis-based Lilly records 50 per cent of gross profit from U.S. sales of the medicine, which is given by injection twice daily, and pays Amylin a royalty on foreign sales.

Cowen and Co has predicted Byetta's annual sales will grow to $4.18-billion (U.S.) by 2012. Amylin and Lilly are developing the Byetta LAR once-weekly formulation, which could further boost sales if it were approved.

"One of the concerns is that any problems with Byetta could lead to a delay or slow approval of Byetta LAR. Right or wrong, that's how the market is going to react," said Scott Henry, an analyst with Oppenheimer & Co.

The FDA said doctors should tell patients taking Byetta to seek prompt medical care should they develop unexplained, persistent severe abdominal pain, which might or might not be accompanied by vomiting.

Byetta should be discontinued should pancreatitis be suspected, the FDA said. Should pancreatitis be confirmed, Byetta should not be restarted unless an alternative cause is identified, the agency advised.