Amylin's Bad Byetta News: FDA Issues Warning

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FDA issued warning on Amylin's diabetes drug Byetta as the agency found that Byetta has a potential risk for pancreatitis. FDA says 2 patients have died.

Zacks's analyist Mark Vickery realizing the implications for Amylin's stock owners immediate recommended to Sell the stock and avoid the name Amylin. You can already realize how serious is the FDA warning is on Byetta diabetes drug.

Here is what Vickery writes at Zacks.com:

"In a note received just now from Zacks senior biotechnology analyst Jason Napodano, CFA, the Food & Drug Administration [FDA] just issued a warning on Amylin's (AMLN) diabetes drug, Byetta, on a potential risk for pancreatitis.

"According to the report, there have been six reported cases, with two deaths in a recent-enough time frame that the FDA believes warnings doctors and patients is necessary. The stock is already down 10% on the news.

"From the analyst: "We have a SELL on Amylin and continue to recommend investors avoid the name."

Below is FDA's findings on Amylin's Byetta from FDA.gov.

Update 8/18/2008: Since issuing Information for Healthcare Professionals in October 2007, FDA has received reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta. Byetta is a medicine given by subcutaneous injection to help treat adults with type 2 diabetes. Of the 6 cases of hemorrhagic or necrotizing pancreatitis, all patients required hospitalization, two patients died and four patients were recovering at time of reporting. Byetta was discontinued in all 6 cases.

Byetta and other potentially suspect drugs should be promptly discontinued if pancreatitis is suspected. There are no signs or symptoms that distinguish acute hemorrhagic or necrotizing pancreatitis associated with Byetta from the less severe form of pancreatitis. If pancreatitis is confirmed, initiate appropriate treatment and carefully monitor the patient until recovery. Byetta should not be restarted. Consider antidiabetic therapies other than Byetta in patients with a history of pancreatitis.

FDA is working with the maker of Byetta, Amylin Pharmaceuticals, Inc., to add stronger and more prominent warnings in the product label about the risk of acute hemorrhagic or necrotizing pancreatitis.

The prior FDA ALERT on the topic of acute pancreatitis in patients taking Byetta is shown below.

FDA ALERT [10/2007]: FDA has reviewed 30 postmarketing reports of acute pancreatitis in patients taking Byetta, a drug used to treat adults with type 2 diabetes. An association between Byetta and acute pancreatitis is suspected in some of these cases.

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Healthcare professionals should instruct patients taking Byetta to seek prompt medical care if they experience unexplained persistent severe abdominal pain which may or may not be accompanied by vomiting. If pancreatitis is suspected, Byetta should be discontinued. If pancreatitis is confirmed, Byetta should not be restarted unless an alternative etiology is identified.

FDA has asked and the maker of Byetta, Amylin Pharmaceuticals, Inc. has agreed to include information about acute pancreatitis in the PRECAUTIONS section of the product label.

This information reflects FDA’s current analysis of data available to FDA concerning this drug. FDA is not advising practitioners to discontinue prescribing the product. FDA intends to update this sheet when additional information or analyses become available.

To report any unexpected adverse or serious events associated with the use of this drug, please contact the FDA MedWatch program and complete a form on line at http://www.fda.gov/medwatch/report/hcp.htm or report by fax to 1-800-FDA-0178, by mail using the postage-paid address form provided on line, or by telephone to 1-800-FDA-1088.

The Byetta full prescribing information will include new information in the PRECAUTIONS section about the potential for acute pancreatitis in patients taking Byetta.

Recommendations and Considerations

* Healthcare providers should be alert to the signs and symptoms of acute pancreatitis. Symptoms include persistent severe abdominal pain that can radiate to the back and may be accompanied by nausea and vomiting. Acute pancreatitis is typically confirmed by the presence of elevated levels of serum amylase and/or lipase and characteristic findings by radiological imaging.

* Discontinue Byetta if pancreatitis is suspected. If pancreatitis is confirmed, do not restart Byetta unless an alternative etiology for the pancreatitis is identified.

Information for the patient: Physicians who prescribe Byetta should discuss with their patients:

Byetta is a medicine given by injection to help treat adults with type 2 diabetes. Commonly reported side effects of Byetta include nausea, vomiting, diarrhea, indigestion and upper abdominal discomfort. However, the presence of unexplained, severe abdominal pain, with or without nausea and vomiting, raises the suspicion of acute pancreatitis, a potentially serious condition that requires prompt medical attention. Therefore, patients taking Byetta should promptly seek medical care if they experience unexplained severe abdominal pain with or without nausea and vomiting.

Background Information and Data

FDA has reviewed 30 postmarketing reports of acute pancreatitis in patients treated with Byetta. Twenty-seven of the 30 patients had at least one other risk factor for acute pancreatitis such as gallstones, severe hypertriglyceridemia, and alcohol use. In six patients the symptoms of pancreatitis began or worsened soon after the dose of Byetta was increased from 5 micrograms twice daily to 10 micrograms twice daily. Twenty-one patients were hospitalized. There were no reports of hemorrhagic or necrotizing pancreatitis. However, five patients developed serious complications including dehydration and renal failure; suspected ileus; phlegmon; and ascites. Twenty-two of the 30 reports indicated that the patients improved after discontinuing Byetta.

Details in three reports indicated that the symptoms of acute pancreatitis returned when Byetta was restarted. Nausea and vomiting returned in two patients when Byetta was restarted. In a third patient, abdominal pain returned when Byetta was restarted and abated after Byetta was permanently discontinued.

FDA has asked and the maker of Byetta, Amylin Pharmaceuticals, Inc. has agreed to include information about acute pancreatitis in the Precautions section of the product label.

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Amylin Pharmaceuticals Diabetes Drug Byetta® the Focus of California Lawsuit Moore Labriola LLP and The Schmidt Firm, LLP represent Virginia man who developed pancreatitis; FDA seeks more stringent warnings SAN DIEGO--(BUSINESS WIRE)--A Virginia man yesterday filed what is believed to be the first personal injury lawsuit stemming from injuries associated with the use of Byetta®, an injectable medication for diabetes. Victor Deleon alleges in a lawsuit filed in San Diego Superior Court (Case No. 37-2008-00090003-CU-PL-CTL) that the manufacturer of the drug, San Diego-based Amylin Pharmaceuticals, Inc., and the drug’s co-marketer, Eli Lilly and Company, failed to adequately test and monitor the side effects of Byetta®, and didn’t warn doctors or patients of the risk of developing pancreatitis. Deleon was hospitalized in December of 2007 after developing the condition, which causes inflammation of the pancreas and can lead to bleeding and death. Deleon’s lawsuit comes two days after the Food and Drug Administration (FDA) announced that it has received six reports of hemorrhagic or necrotizing pancreatitis in patients taking Byetta® since October of 2007. Two of the six patients died. In a press release, the FDA said it is“working with the maker of Byetta®” to add “stronger and more prominent warnings” to the product’s label. Deleon’s lawsuit alleges that Amylin “failed to adequately warn prescribing physicians of the risk of pancreatitis, of measures needed to properly assess the appropriateness of prescribing the drug to certain categories of patients, and of measures doctors and patients could and should take to minimize the risk.” In the fall of 2007, Amylin agreed to add information about pancreatitis to the “precautions” section of the Byetta® label after the FDA reported 30 post-marketing reports of acute pancreatitis associated with the drug. “It is pretty obvious that the label change in 2007 was not adequate,” said Thomas M. Moore of Moore Labriola LLP in Newport Beach, who jointly represents Mr. Deleon with Michael Schmidt of The Schmidt Firm, LLP in Dallas, TX. “We believe that Amylin possessed data prior to the 2007 label revision that justified a stronger and more prominent warning than the precaution language that Amylin ultimately negotiated with FDA,” Moore added. Contacts Schmidt & Clark, LLP Robert H Hilley IV (866) 588-0600 [email protected] http://www.schmidtandclark.com/Byetta/