Yourlawyer.com (Byetta News)

Byetta Patients Report Kidney Problems, Label Revised

Tue, 03 Nov 2009 00:00:00 -0800

The labeling for Byetta, a drug used to treat type 2 diabetes, has been revised to include new safety information about possible kidney function problems, including kidney failure.

Byetta was approved by the Food & Drug Administration (FDA) in 2005 to help type 2 diabetics better control blood sugar when other drugs were not adequate. The twice-daily injection is a synthetic form of a lizard hormone that boosts the production of insulin. Insulin is vital to controlling blood sugar levels.

According to a notice posted on the FDA Web site, from April 2005 through October 2008, the agency received 78 cases of altered kidney function (62 cases of acute renal failure and 16 cases of renal insufficiency), in patients using Byetta. Cases of acute renal failure or insufficiency occurred as soon as 3 days and up to 2 years after initiation of Byetta. The patient ages ranged from 23 to 83 years, with an average age of 60 years.

Some cases occurred in patients with pre-existing kidney disease or in patients with one or more risk factors for developing kidney problems, the FDA said. The agency also noted that the most common Byetta side effects include nausea, vomiting, and diarrhea. These side effects may have contributed to the development of altered kidney function. Kidney malfunction can result in a build-up of waste products in the blood, leading to serious illness or life-threatening conditions.

According to the FDA, hospitalization was required in 71 of 78 (91%) patients and there were 4 deaths reported in the cases reviewed. Eighteen patients required dialysis and two patients required kidney transplantation after initiation of Byetta.

Byetta was discontinued in 63 of 78 (80%) patients, with 39 (50%) patients reporting improved signs and symptoms after discontinuation of the drug. One patient experienced recurrent altered kidney function after re-initiation of Byetta.

Due to the serious potential consequences of altered kidney function, the FDA has approved the following revisions to the drug label for Byetta to describe this risk:

Information regarding post-market reports of acute renal failure and insufficiency, highlighting that Byetta should not be used in patients with severe renal impairment (creatinine clearance <30 ml/min) or end-stage renal disease.
Recommendations to healthcare professionals that caution should be applied when initiating or increasing doses of Byetta from 5 mcg to 10 mcg in patients with moderate renal impairment (creatinine clearance 30 to 50 ml/min).
Recommendations that healthcare professionals monitor patients carefully for the development of kidney dysfunction, and evaluate the continued need for Byetta if kidney dysfunction is suspected while using the product.
Information about kidney dysfunction in the patient Medication Guide to help patients understand the benefits and potential risks associated with Byetta.

Patients taking Byetta should be aware that problems with kidney function could lead to changes in urine color, frequency of urination or the amount of urine, unexplained swelling of the hands or feet, fatigue, changes in appetite or digestion, or dull ache in mid to lower back, the FDA said. Byetta patients who experience any of these symptoms should immediately discuss them with their health care professional.

Another Byetta Delay

Tue, 09 Dec 2008 00:00:00 -0800

Federal regulators are extending a review of the diabetes drug Byetta into next year, Forbes.com is reporting. The Food & Drug Administration (FDA) is considering whether or not to approve Byetta as a stand-alone treatment for diabetes. Right now the drug, jointly marketed by Amylin Pharmaceuticals and Eli Lilly, is approved for use in combination with other diabetes medications to help people with type 2 diabetes control their blood sugar.

Byetta has been the subject of safety concerns for some time. Just last October, the FDA said that 30 people developed pancreatitis that was associated with the use of Byetta. Of those, 5 later suffered from kidney failure. Six patients experienced the onset or worsening of symptoms after their dosage of Byetta was increased from 5 milligrams twice daily to 10 milligrams twice daily. And according to the FDA, pancreatitis symptoms in 22 patients subsided or improved once they quit taking Byetta.

Then on August 18, the FDA said that Byetta had been linked to 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta since its October alert. All patients required hospitalization, two patients died and four patients were recovering at time of reporting. Byetta was discontinued in all 6 cases. Finally on August 26, Amylin announced that four additional fatalities had been confirmed in Byetta patients suffering from milder forms of pancreatitis.

Amylin and Lilly submitted an application to have Byetta approved as a stand-alone therapy in the first quarter of 2008, Forbes.com said. The companies said the FDA did not request any additional studies. According to Reuters.com, the agency is reviewing several Byetta prescribing information updates submitted by the companies, including revision of safety language.

Another version of Byetta - a long-acting formula - had already been delayed, partly because of the safety concerns surrounding the drug. In a filing with the Securities and Exchange Commission (SEC) last month, Amylin said data submitted for the approval of long-acting Byetta didn’t satisfy the FDA’s standards. In the filing, Amylin said that if the FDA required it to conduct an additional study, it would likely delay its plans to ask for approval by the middle of 2009.

Because of its long-acting nature, once-weekly Byetta cannot be quickly removed from the body, which would be a problem for a patient who developed pancreatitis. In most instances where Byetta patients develop pancreatitis, the problem subsides once treatment is halted. That would not likely be the case with the long-acting version.

Byetta was approved by the FDA in 2005. The twice-daily injection is a synthetic form of a lizard hormone that boosts the production of insulin. Insulin is vital to controlling blood sugar levels.

Flagging Byetta Sales Force Job Cuts at Amylin

Wed, 12 Nov 2008 00:00:00 -0800

Safety concerns surrounding the diabetes drug Byetta have slowed its sales, forcing Amylin Pharmaceuticals to cut a quarter of its work force.

Byetta, which is jointly marketed by Amylin and Eli Lilly, was approved by the Food & Drug Administration (FDA) in 2005 to help type 2 diabetics better control blood sugar when other drugs were not adequate. The twice-daily injection is a synthetic form of a lizard hormone that boosts the production of insulin. Insulin is vital to controlling blood sugar levels.

Amylin sales have been disappointing all year. Then, on August 18, the FDA said that Byetta had been linked to 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta since its October alert. All patients required hospitalization, two patients died and four patients were recovering at time of reporting. Byetta was discontinued in all 6 cases. Then, on August 26, Amylin announced that four additional fatalities had been confirmed in Byetta patients suffering from milder forms of pancreatitis.

The problems with Byetta have raised doubts about Amylin's ability to assure approval of a long-acting version of the drug. The new version of Byetta would be taken once-weekly. Because of its long-acting nature, once-weekly Byetta cannot be quickly removed from the body, which would be a problem for a patient who developed pancreatitis. In most instances where Byetta patients develop pancreatitis, the problem subsides once treatment is halted. That would not likely be the case with the long-acting version.

In a filing with the Securities and Exchange Commission (SEC) earlier this month, Amylin revealed that the FDA had rejected data from studies meant to show that new Byetta batches made by partner Alkermes were equivalent to batches made at Amylin’s Ohio facility. If Amylin has to conduct an additional study, it would likely delay its plans to ask for approval by the middle of 2009.

The layoffs announced by Amylin this week involve 340 staffers, and will leave the San Diego company with 1800 employees. Amylin says the move will save $100 million a year.

In a statement, Amylin said it expects Byetta sales to rebound, and the company is currently working with the FDA to update the drug's safety labeling. Amylin is hoping the safety update will not take the form of a black box - the FDA's toughest safety warning - which could further depress sales of Byetta.

Long-Acting Byetta Faces Approval Obstacles

Wed, 05 Nov 2008 00:00:00 -0800

A new version of Byetta, a diabetes drug made by Amylin Pharmaceuticals Inc. and Eli Lilly & Co., isn't going to be approved by the Food & Drug Administration (FDA) anytime soon. Amylin said yesterday in a regulatory filing that data for the new Byetta didn't satisfy the FDA's standards.

The original Byetta was approved by the FDA in 2005 to help type 2 diabetics better control blood sugar when other drugs were not adequate. The twice-daily injection is a synthetic form of a lizard hormone that boosts the production of insulin. Insulin is vital to controlling blood sugar levels. The new version of Byetta would be taken once-weekly.

According to Amylin's filing with the Securities and Exchange Commission (SEC),the FDA rejected data from studies meant to show that new Byetta batches made by partner Alkermes were equivalent to batches made at Amylin's Ohio facility. If Amylin has to conduct an additional study, it would likely delay its plans to ask for approval by the middle of 2009. Amylin said it is continuing discussions with the FDA.

The probable approval delay is just the latest troubling news surrounding Byetta. On August 18, the FDA said that Byetta had been linked to 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta since its October alert. All patients required hospitalization, two patients died and four patients were recovering at time of reporting. Byetta was discontinued in all 6 cases. Then, on August 26, Amylin announced that four additional fatalities had been confirmed in Byetta patients suffering from milder forms of pancreatitis.

Just last October, the FDA said that 30 people developed pancreatitis that was associated with the use of Byetta. Of those, 5 later suffered from kidney failure. Six patients experienced the onset or worsening of symptoms after their dosage of Byetta was increased from 5 milligrams twice daily to 10 milligrams twice daily. And according to the FDA, pancreatitis symptoms in 22 patients subsided or improved once they quit taking Byetta.

Those safety problems could also ultimately impact the approval prospects for the new version of Byetta. Because of its long-acting nature, once-weekly Byetta cannot be quickly removed from the body, which would be a problem for a patient who developed pancreatitis. In most instances where Byetta patients develop pancreatitis, the problem subsides once treatment is halted. That would not likely be the case with the long-acting version.

New Diabetes Drugs More Expensive, But Not Always Better

Tue, 28 Oct 2008 00:00:00 -0700

A new report has found that the cost for treating diabetes has skyrocketed, despite inconclusive evidence that newer, more expensive treatments provide added benefits to patients.

In 2002, diabetes accounted for more than 10 percent of U.S. health-care expenditures, and that number is expected to increase as the number of people with type 2 diabetes grows. According to the study conducted by researchers at the University of Chicago and Stanford University, between 2001 and 2007, spending for drugs went from $6.7 billion to $12.5 billion.

"We found dramatic changes in the treatment patterns for diabetes during the past decade," study author Dr. G. Caleb Alexander, an assistant professor of medicine at the University of Chicago, told The Washington Post. "This includes a remarkable change in drugs, as well as significant increases in costs."

The study attributes much the increased treatment costs to expensive new drugs, which can be 8 to 11 times more costly than older, generic diabetes drugs. Such drugs, including Januvia, Byetta and Avandia, are marketed as being more convenient and offering better control of blood sugar than the older medicines. In many cases the new drugs are being used instead of insulin, the use of which dropped from 38 percent in 1994 to 28 percent in 2007.

However, it is not clear just how much these new drugs are actually benefiting patients. "There are some real innovations here," Alexander said. "But we don't know enough about the comparative effectiveness of these medicines compared with older medicines to make a final verdict."

In some cases, new diabetes drugs are found to have dangerous side effects after they are approved and have been prescribed to millions of people. For instance, recently the diabetes drugs Avandia and Byetta have been the subject of safety concerns. On August 18, the FDA said that Byetta had been linked to 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta since its October alert. All patients required hospitalization, two patients died and four patients were recovering at time of reporting. Byetta was discontinued in all 6 cases. Then, on August 26, Amylin announced that four additional fatalities had been confirmed in Byetta patients suffering from milder forms of pancreatitis.

Concerns about Avandia arose in 2007, after a New England Journal of Medicine revealed data linking Avandia to an increased risk of heart attack. Avandia, which has been on the market since 1999, has long carried warnings of its cardiovascular side effects, such as an increased risk for congestive heart failure and GlaxoSmithKline has known about concerns over Avandia’s heart attack risks since at least 2004; however, the heart attack risk was not mentioned in Avandia’s packaging information until November. The FDA raised existing warnings about congestive heart failure after the New England Journal’s publication triggered a congressional inquiry.

Amylin Releases Questionable Byetta Study in Attempt to Take Focus From Pancreatitis Risk

Wed, 10 Sep 2008 00:00:00 -0700

Byetta maker, Amylin Pharmaceuticals, is trying to save the diabetes drug's reputation by touting a new study that shows it to be more effective than a rival medication. But at least one drug industry analyst has characterized the research - which compares Byetta to Januvia - as a "marketing study" meant to focus attention away from Byetta's association with pancreatitis.

Byetta was approved by the Food & Drug Administration (FDA) in 2005 to help type 2 diabetics better control blood sugar when other drugs were not adequate. The twice-daily injection is a synthetic form of a lizard hormone that boosts the production of insulin. Insulin is vital to controlling blood sugar levels.

On August 18, the FDA said that Byetta had been linked to 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta since its October alert. All patients required hospitalization, two patients died and four patients were recovering at time of reporting. Byetta was discontinued in all 6 cases. Then, on August 26, Amylin announced that four additional fatalities had been confirmed in Byetta patients suffering from milder forms of pancreatitis.

Obviously, the news surrounding Byetta and pancreatitis does not bode well for sales of the drug, which is taken by 700,00 Americans. The side effects reports also have endangered prospects for a once-weekly, long-acting form of Byetta that Amylin had hoped would be approved by 2010. Most drug industry analysts expect that the FDA will now want more information on the new version's side effects before it makes a decision.

The bad Byetta news is taking a toll on Amylin. According to a report on Forbes.com, the company's shares have fallen 44.2% since the pancreatitis news broke in mid-August.

In an attempt to mitigate the damage done to Byetta's reputation, Amylin released a study at European Association for the Study of Diabetes in Rome on Tuesday that compared Byetta with Merck's diabetes treatment Januvia. According to Forbes.com, the study appears to show that Byetta is more potent than Januvia, which is made by Merck & Co.

One analyst told Forbes.com that the study is an attempt by Amylin to salvage its once-promising Byetta. "This is clearly a marketing study to give their reps more stuff to talk about," said Natixis Bleichroeder analyst Jon LeCroy. "You wouldn't do this study unless you knew your drug was better."

Other sources told Forbes that there are also some problems with the study. For one thing, Byetta and Januvia are very different drugs. According to Forbes.com, Januvia is a once-daily pill in the DPP-IV inhibitor class of drugs that is normally prescribed by primary care physicians to patients experiencing the earlier signs of type 2 diabetes. Byetta, a twice daily injectable of the GLP-1 class of drugs, is usually prescribed by a specialist for people with advanced cases of type 2 diabetes that need the added effects of weight loss and appetite suppression.

It also does not appear that Januvia carries the same risk of pancreatitis found with Byetta. According to Forbes.com, in a client note published late last week, Yaron Werber of Citi Investment Research said that of every 100,000 patients who took Byetta, about 6.49 developed acute pancreatitis. The rate of pancreatitis in Januvia patients was only 1.61 out of 100,000, he said. The Forbes report said Werber based this information on the total number of prescriptions written for the drugs.

Byetta Linked to More Deaths

Wed, 27 Aug 2008 00:00:00 -0700

Byetta has been implicated in six deaths, four more than federal regulators reported last week. The additional deaths were revealed late yesterday during a conference call conducted by Amylin Pharmaceuticals Inc. and Eli Lilly & Co, the co-marketers of the diabetes drugs. The companies did report the other four deaths to the Food & Drug Administration (FDA), but the agency did not make those fatalities public in last week's announcement.

No definite relationship between Byetta and the additional deaths has been proved, Amylin Chief Executive Officer Dan Bradbury said during the call yesterday. All of the deaths involved patients with pancreatitis, but according to a report in "US News and World Report", the FDA did not include the four revealed yesterday in its earlier announcement because they involved a milder form of the disorder.

Last October, the FDA said that 30 people developed pancreatitis that was associated with the use of Byetta. Of those, 5 later suffered from kidney failure. Six patients experienced the onset or worsening of symptoms after their dosage of Byetta was increased from 5 milligrams twice daily to 10 milligrams twice daily. And according to the FDA, pancreatitis symptoms in 22 patients subsided or improved once they quit taking Byetta.

Then last week, the FDA said that it had received reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta since its October alert. All patients required hospitalization, two patients died and four patients were recovering at time of reporting. Byetta was discontinued in all 6 cases.

Pancreatitis is an inflammation of the pancreas that can cause bleeding, tissue damage and infection. Severe cases of pancreatitis can lead to the release of toxins and enzymes into the blood stream that can injure the heart, lungs, kidneys or other organs. In some instances, acute pancreatitis can be fatal. Hemorrhagic pancreatitis is inflammation that involves bleeding. Necrotizing pancreatitis occurs when the inflamed pancreas destroys itself.

The FDA said last week it was working with Eli Lilly and Amylin to add stronger and more prominent warnings to Byetta's label. That could include upgrading a current precaution on pancreatitis to a warning, or changing the wording.

Byetta was approved by the FDA in 2005 to help type 2 diabetics better control blood sugar when other drugs were not adequate. The twice-daily injection is a synthetic form of a lizard hormone that boosts the production of insulin. Insulin is vital to controlling blood sugar levels.

Byetta Linked to Fatal Cases of Necrotizing or Hemorrhagic Pancreatitis

Mon, 18 Aug 2008 00:00:00 -0700

Byetta, a drug used to treat type 2 diabetes, has been linked to hemorrhagic or necrotizing pancreatitis, prompting the Food & Drug Administration (FDA) to issue a new warning about the side effect. The FDA first notified healthcare providers about Byetta's association with acute pancreatitis in October 2007, but since then, the agency has received six additional reports - two involving fatalities - of necrotizing or hemorrhagic pancreatitis linked to the drug.

Byetta is made by Amylin Pharmaceuticals Inc. The drug was approved by the FDA in 2005 to help type 2 diabetics better control blood sugar when other drugs were not adequate. The twice-daily injection is a synthetic form of a lizard hormone that boosts the production of insulin. Insulin is vital to controlling blood sugar levels.

Pancreatitis is an inflammation of the pancreas that can cause bleeding, tissue damage and infection. Severe cases of pancreatitis can lead to the release of toxins and enzymes into the blood stream that can injure the heart, lungs, kidneys or other organs. In some instances, acute pancreatitis can be fatal.

Last October, the FDA said that 30 people developed pancreatitis that was associated with the use of Byetta. Of those, 5 later suffered from kidney failure. Six patients experienced the onset or worsening of symptoms after their dosage of Byetta was increased from 5 milligrams twice daily to 10 milligrams twice daily. And according to the FDA, pancreatitis symptoms in 22 patients subsided or improved once they quit taking Byetta.

At that time, the FDA said that Amylin had agreed to include information about acute pancreatitis in the PRECAUTIONS section of the Byetta label, but that information has yet to be added.

Today, the FDA said that it had received reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta since its October alert. All patients required hospitalization, two patients died and four patients were recovering at time of reporting. Byetta was discontinued in all 6 cases.

The FDA alert said that 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, doctors should initiate appropriate treatment and carefully monitor the patient until recovery. Byetta should not be restarted. Doctors should consider antidiabetic therapies other than Byetta in patients with a history of pancreatitis, the FDA said.

The FDA also said that 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.

The FDA said it is working with Amylin to add stronger and more prominent warnings in the product label about the risk of acute hemorrhagic or necrotizing pancreatitis.

Byetta to Get New Side Effects Warnings Following Pancreatitis Reports

Wed, 17 Oct 2007 00:00:00 -0700

The makers of Byetta have agreed to include new side effects warnings on its label following reports that link the diabetes drug to the development of acute pancreatitis. According to the Food & Drug Association (FDA), the sometimes fatal Byetta side effect has been reported in dozens of patients taking the drug and some of those have gone on to develop other complications like kidney failure.

Pancreatitis is an inflammation of the pancreas that can cause bleeding, tissue damage and infection. Severe cases of pancreatitis can lead to the release of toxins and enzymes into the blood stream that can injure the heart, lungs, kidneys or other organs. In some instances, acute pancreatitis can be fatal    According to the FDA, 30 people have developed pancreatitis that has been associated with the use of Byetta. Of those, 5 later suffered from kidney failure.   Six patients experienced the onset or worsening of symptoms after their dosage of Byetta was increased from 5 milligrams twice daily to 10 milligrams twice daily. And according to the FDA, pancreatitis symptoms in 22 patients subsided or improved once they quit taking Byetta.

Byetta is marketed jointly by Amylin Pharmaceuticals Inc. and Eli Lilly & Co. The drug was approved by the FDA in 2005 to help type 2 diabetics better control blood sugar when other drugs were not adequate. The twice-daily injection is a synthetic form of a lizard hormone that boosts the production of insulin.   Insulin is vital to controlling blood sugar levels.

The changes to the Byetta side effects warnings will say that the drug has been associated with the development of pancreatitis. The FDA is also urging physicians and patients to be alert to warning signs for the disorder, including persistent and severe abdominal pain that can radiate to the back. The pain can be accompanied by nausea and vomiting. Some of these symptoms are themselves common side effects of Byetta, but the FDA said that the symptoms of pancreatitis would be much more severe and persistent. The FDA said that patients who develop pancreatitis should stop taking Byetta immediately.

Amylin and Eli Lilly agreed to update the Byetta side effects labeling at the FDA’s request. According to the companies, information about pancreatitis had already been included on the Byetta label.   But the new Byetta side effects information will be more detailed and will give clear advice on what signs and symptoms doctors and patients need to be aware of.

Byetta is one of the fastest growing diabetes drugs on the market, and has been used by about 700,000 patients in the US since it was first introduced.

Byetta Lawyer Pancreatitis l.Side Effects

Wed, 17 Oct 2007 00:00:00 -0700

Byetta Pancreatitis Lawyers

Keywords: Byetta Lawyer Pancreatitis Side Effects

The lawyers and attorneys at our firm are currently offering free case evaluations to the victims of Byetta side effects. Byetta has been linked to the onset of acute pancreatitis, as well as hemorrhagic and necrotizing pancreatitis. At least two people have died as a result of Byetta-associated pancreatitis. If you or a loved one were diagnosed with pancreatitis while taking Byetta for type 2 diabetes, please contact one of our Byetta pancreatitis lawyers as soon as possible to protect your rights.

Byetta is made by Amylin Pharmaceuticals Inc, and marketed jointly by Amylin and Eli Lilly, & Co. The drug was approved by the Food & Drug Administration (FDA) in 2005 to help type 2 diabetics better control blood sugar when other drugs were not adequate. The twice-daily injection is a synthetic form of a lizard hormone that boosts the production of insulin.

More than 700,000 patients worldwide have used Byetta since it was launched. While diabetics are more vulnerable to developing pancreatitis than those without the disease, it is becoming apparent that this drug increases that risk. Our Byetta pancreatitis lawyers will work hard to make sure that these companies are held accountable for their negligence.

In August 2008, the FDA said it was working with Amylin to add stronger and more prominent warnings on the product label about the risk of acute hemorrhagic or necrotizing pancreatitis. However, the FDA did not indicate if such warnings would take the form of a "black box", the agency's most urgent safety alert. Our Byetta pancreatitis lawyer believe that Amylin should have added such a warning much earlier, when the drug's association with pancreatitis became apparent.

FDA Byetta Warnings

Since October 2007, the FDA has issued two warnings regarding Byetta and acute pancreatitis, as well as hemorrhagic and necrotizing pancreatitis. Pancreatitis is an inflammation of the pancreas that can cause bleeding, tissue damage and infection. Severe cases of pancreatitis can lead to the release of toxins and enzymes into the blood stream that can injure the heart, lungs, kidneys or other organs. In some instances, pancreatitis can be fatal.

In October 2007, the FDA issued a health alert after it received 30 reports of Byetta patients who developed acute pancreatitis. Of those, 5 later suffered from kidney failure. Six patients experienced the onset or worsening of symptoms after their dosage of Byetta was increased from 5 milligrams twice daily to 10 milligrams twice daily. And according to the FDA, pancreatitis symptoms in 22 patients subsided or improved once they quit taking Byetta.

Acute pancreatitis comes on suddenly, and is characterized by mild to severe pain in the upper abdomen that may radiate to the back and occasionally to the chest. The pain can be nearly constant for hours or days, and will become worse if a patient drinks alcohol or eats. Bending forward or curling into a fetal position may provide temporary relief. The Byetta pancreatitis lawyers at our firm know how serious and debilitating acute pancreatitis is, and we will make sure that the victims of this dangerous drug receive the compensation they deserve.

At the time of the 2007 alert, the FDA said that Amylin had agreed to include information about acute pancreatitis in the PRECAUTIONS section of the Byetta label. However, as of August 2008, that information still was not included on the Byetta package insert.

In August 2008, the FDA issued its second pancreatitis warning for Byetta. At the time, the agency said that it had received reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta since its October alert. All patients required hospitalization, two patients died and four patients were recovering at time of reporting. Byetta was discontinued in all 6 cases.

Hemorrhagic pancreatitis is inflammation that involves bleeding. Necrotizing pancreatitis occurs when the inflamed pancreas destroys itself. There are no signs or symptoms that distinguish hemorrhagic or necrotizing pancreatitis associated with Byetta from the less severe form of pancreatitis.

The FDA alert said that Byetta should be discontinued if pancreatitis is suspected. The FDA also said doctors should consider antidiabetic therapies other than Byetta in patients with a history of pancreatitis. Patients taking Byetta should seek prompt medical care if they experience unexplained persistent severe abdominal pain which may or may not be accompanied by vomiting.

Legal Help Byetta Pancreatitis Victims

If you or a loved one suffered from acute pancreatitis, necrotizing pancreatitis or hemorrhagic pancreatitis that may have been caused by Byetta, you have valuable legal rights. Please fill out our online form or call 1-800 LAW INFO (1-800-529-4636) to discuss your case with an experienced Byetta pancreatitis lawyer.