FDA Warns of Type 2 Diabetes Drug Deaths

Posted by Jane Akre
Monday, August 18, 2008 11:11 PM EST
Category: Major Medical, Protecting Your Family
Tags: Pancreatitis, FDA and Prescription Drugs, Amylin Pharmaceuticals, Dangerous Drugs, Drug Products

Byetta linked to pancreatitis, two die, FDA issues warning.

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FDA Warning, August 18
Injuryboard on diabetes drugs
Injuryboard on pancreatitis
Injuryboard on Byetta
Amylin Pharmaceuticals
Byetta web site
Byetta current warning

IMAGE SOURCE: Wikimedia Commons/ development of the pancreas/ author: Jakob Suckale, Michele Solimena

Investors and patients reacted to news Monday that two patients taking the drug, Byetta, have died, apparently from damage to the pancreas.

The Food and Drug Administration is considering adding a black box warning to the drug after it received six reports of hemorrhagic or necrotizing pancreatitis (a bleeding pancreas and partial destruction of an inflamed pancreas), that required hospitalization, among patients taking Byetta for type 2 diabetes.

Two patients have died and four others are recovering.

Anyone on the drug who develops pancreatitis should discontinue its use.

Byetta is made by Amylin Pharmaceuticals and it’s jointly marketed with Eli Lilly.

Shares of both companies dropped following the news - Amylin was down 13 percent and Eli Lilly’s shares dropped 1.5 percent.

Byetta produced sales of $636 million last year in the U.S. and more than $14 million overseas.

Last October, the FDA looked at 30 cases of pancreatitis in patients taking Byetta.

The label for the Amylin drug was changed to add more information about the risk, which was not thought to be serious.

Pancreatitis, can result in toxins being released into the bloodstream, but it rarely leads to death and usually takes a week to subside.

The pancreas releases insulin which regulates blood sugar in a healthy person. In type 2 diabetes, not enough insulin is produced and as a result, blood glucose levels rise, which can damage blood vessels, arteries and organs.

Byetta is delivered twice a day by injection and it is supposed to lower blood sugar in patients with type 2 diabetes. The effort to receive two injections a day may be partially responsible for a drop-off in sales in recent months.

Amylin had planned to introduce a longer-acting delayed release form of Byetta taken once-a-week. The companies still say they will try to win approval next year.

An Eli Lilly spokeswoman reminds readers of Reuters that there’s been no link established between Byetta and pancreatitis.

The company’s web site says that when Byetta is used with a medicine that contains a sulfonylurea, low blood sugar is possible.

Other side effects include, “nausea, vomiting, diarrhea, dizziness, headache, feeling jittery, and acid stomach. Nausea is most common when first starting BYETTA, but decreases over time in most patients.” #

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Posted by Robert H Hilley IV
Wednesday, August 20, 2008 4:23 PM EST

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
hilley@schmidtandclark.com
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