Byetta Recall
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What is Byetta?
Approved by the Food and Drug Administration on April 2008, Byetta (exenatide) injections, according to the FDA, is intentended to improve glycemic control in patients with type 2 diabetes mellitus who have not achieved adequate glycemic control on metformin, a sulfonylurea, or a combination of metformin and a sulfonylurea.
Byetta In Detail
Exenatide is used in combination with metformin, a sulfonylurea, or a thiazolidinedione medication to treat type 2 diabetes (condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood). Exenatide is in a class of medications called incretin mimetics. It works by stimulating the pancreas to secrete insulin when blood sugar levels are high. Insulin helps move sugar from the blood into other body tissues where it is used for energy. Exenatide also slows the emptying of the stomach and causes a decrease in appetite. Exenatide is not used to treat type 1 diabetes (condition in which the body does not produce insulin and therefore cannot control the amount of sugar in the blood). Exenatide is not used instead of insulin to treat people with diabetes who need insulin.
Source: National Center for Biotechnology Information, U.S. National Library of Medicine
Byetta’s Serious Side Effects
September 2, 2009, Food and Drug Administration approved revisions to the drug label for Byetta (exenatide) to include information on post-marketing reports of altered kidney function, including acute renal failure and insufficiency.
Byetta, an incretin-mimetic, is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
From April 2005 through October 2008, FDA received 78 cases of altered kidney function (62 cases of acute renal failure and 16 cases of renal insufficiency), in patients using Byetta. Some cases occurred in patients with pre-existing kidney disease or in patients with one or more risk factors for developing kidney problems. From April 2005 through September 2008, more than 6.6 million prescriptions1 for Byetta were dispensed. Therefore, the 78 reported cases of altered renal function represent a small percentage of the total number of patients who have used the drug.
Some of the 78 patients reported nausea, vomiting, and diarrhea–the most common side effects associated with Byetta in clinical trials. These side effects may have contributed to the development of altered kidney function in the reported cases.
The revisions to the drug label allow healthcare professionals to better weigh the known benefits of Byetta with the potential risks that exist for certain patients. Changes include:
- 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.
Diabetics show higher risk of pancreas disease
Jun 1, 2011 (Reuters Health) – People with type 2 diabetes may have a heightened risk of a painful condition known as acute pancreatitis, but those odds are curbed in people on diabetes drugs, a new study suggests.
Acute pancreatitis is a sudden inflammation of the pancreas that causes upper abdominal pain – often worse after eating – as well as nausea and vomiting. Mild cases may go away without treatment, but acute pancreatitis can have serious, life-threatening complications like heart, lung or kidney failure.
The disease sends about 200,000 Americans to the hospital each year.
In the new study, researchers found that among more than 97,000 Taiwanese adults followed for up to eight years, those with type 2 diabetes had twice the rate of acute pancreatitis — almost 28 cases per 10,000 people each year, versus 14 cases for every 10,000 people without diabetes.
People with diabetes were more likely to have a number of risk factors for acute pancreatitis. Those included gallstones and heavy drinking — two of the most common causes of pancreas inflammation — as well as high triglycerides (a type of blood fat) and a history of the liver infections hepatitis B or C.
But even when those conditions were taken into account, diabetes itself was linked to an 89 percent increase in the risk of acute pancreatitis.
The findings back up earlier studies that have linked type 2 diabetes to acute pancreatitis, according to senior researcher Dr. Pei-Chun Chen, of China Medical University College of Public Health in Taiwan.
But they also add something new, Chen told Reuters Health in an email.
Among people with diabetes, the study found, those on diabetes medications had a lower risk of acute pancreatitis. And the more medications they were using, the lower the risk.
The potential benefit was seen with a range of diabetes drugs — including metformin (Glucophage); sulfonylureas, which include drugs like glimepiride (Amaryl) and glipizide (Glucotrol); thiazolidinediones, including rosiglitazone (Avandia) and pioglitazone (Actos); and alpha-glucosidase inhibitors, like miglitol (Glyset) and acarbose (Precose).
In recent years, certain other diabetes drugs — including the brand names Januvia and Byetta — have been linked to cases of pancreatitis, and warnings are included in the drugs’ prescribing information.
However, it has not been clear whether the drugs themselves cause the pancreas inflammation. The medications were not specifically analyzed in the current study.
Chen said that these latest findings cannot prove that any diabetes medication protects against acute pancreatitis. Nor do they prove that diabetes, itself, causes pancreatitis in some people, the researcher said.
It’s possible, according to Chen, that something else about people with diabetes — such as high rates of obesity — account for the connection.
The researchers also lacked information on study participants’ smoking habits, and smoking is linked to an increased risk of pancreatitis.
More studies are needed, according to Chen’s team, to confirm that diabetes does contribute to pancreatitis, and that medications — or at least certain medications — are protective.
For now, Chen advised that people with diabetes be aware of the symptoms of acute pancreatitis, and call their doctor immediately if they experience them. That may be especially important, Chen noted, for diabetics with alcohol problems or hepatitis C infection.
In this study, alcoholism and hepatitis C were each stronger risk factors than diabetes for pancreatitis. And both appeared to further boost the risk linked to diabetes.
The study was funded by the Taiwanese government and China Medical University. None of the researchers reports any financial conflicts of interest.
FDA September 2009 Healthcare Professionals Revision Notice
FDA notified healthcare professionals of revisions to the prescribing information for exenatide (Byetta) to include information on post-marketing reports of altered kidney function, including acute renal failure and insufficiency. Exenatide, an incretin-mimetic, is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
FDA: Byetta drug label is revised
November 2, 2009 (UPI) — The U.S. Food and Drug Administration says it has approved a Byetta drug label revision to include information about possible kidney function problems.
Byetta (exenatide) is a drug used to treat Type 2 diabetes.
The FDA said it received 78 reports between April 2005 through October 2008 about kidney problems in patients taking Byetta.
The most common side effects associated with Byetta include nausea, vomiting, and diarrhea, but the FDA said those side effects might have contributed to the development of altered kidney function.
“Healthcare professionals and patients taking Byetta should pay close attention to any signs or symptoms of kidney problems,” said Dr. Amy Egan of the FDA’s Center for Drug Evaluation and Research. “Patients also 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.”
Patients experiencing any of those symptoms should immediately discuss them with their health care professional.
Diabetes drug Byetta tied to kidney problems, says FDA
November 4, 2009 (Health.com) — People with type 2 diabetes who are taking the blood-sugar-lowering drug Byetta may be at increased risk for kidney problems, including kidney failure, the U.S. Food and Drug Administration reported this week.
The drug’s label will be updated to warn doctors and patients about this possible side effect.
Byetta (exenatide) is a relatively new drug and was approved to treat type 2 diabetes in 2005. It’s known as an incretin mimetic and is a synthetic version of a compound found in the venom of a Gila monster, a lizard in the southwestern United States.
Doctors wrote almost 7 million Byetta prescriptions between 2005 and 2008. The drug is injected, and patients and doctors tend to like it because it’s easier to inject than insulin and can promote weight loss in some people.
In 2007, Byetta was linked to a higher risk of acute pancreatitis, a potentially life-threatening inflammation of the pancreas. The symptoms are severe abdominal pain that is sometimes accompanied by nausea and vomiting.
In general, side effects of Byetta can include diarrhea, nausea, and vomiting, which may contribute to changes in kidney function, says Dr. Richard Hellman, the past president of the American Association of Clinical Endocrinologists, and a clinical professor at the University of Missouri–Kansas City School of Medicine.
“It is thought that the main reason nausea occurs is the effects of Byetta on the stomach,” he says. “If someone starts vomiting, they can lower the volume of fluid in their body. If it gets to dangerously low levels, their kidneys could be damaged and kidney failure could take place.”
The FDA received 78 reports of kidney problems related to Byetta, including kidney failure, between April 2005 and October 2008. Some patients already had kidney disease before they started the drug, but others developed kidney problems after taking Byetta. Overall, 91 percent of patients were hospitalized, 18 required dialysis, two had kidney transplants, and four died. Eighty percent stopped taking Byetta, and half of those patients had an improvement in kidney function after stopping the drug.
“The 78 cases represent a small percentage of the total number of patients using the drug to control blood sugar (glucose) levels,” according to the FDA.
People with type 2 diabetes should always be aware of the signs of kidney damage, as high blood sugar is a leading cause of kidney disease.
Although kidney problems sometimes cause no symptoms at all, the symptoms can include changes in urine color, swelling that starts in the feet and legs, fatigue, nausea or vomiting, and trouble sleeping. Patients with any of these symptoms should talk to their doctor. If left untreated, kidney damage can worsen and turn into kidney failure, which can have serious affects on the heart, brain, and bones.
“Before any patient takes Byetta, they should ask their physician whether they have decreased function of their kidneys,” Hellman says, “and whether their kidneys are functioning well enough that taking Byetta would not be hazardous to their health.”
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