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FDA Approves Bydureon Pen for Once-Weekly Treatment of Adults with Type 2 Diabetes

Posted 6 Mar 2014 by Drugs.com

Monday March 3, 2014 – AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has approved the Bydureon Pen (exenatide extended-release for injectable suspension) 2 mg as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Bydureon should not be used for treatment of patients with type 1 diabetes or diabetic ketoacidosis. Bydureon is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise. Bydureon is not a substitute for insulin. The concurrent use of Bydureon with insulin has not been studied and is not recommended. Bydureon is the first and only once-weekly medicine for adults with type 2 diabetes. The Bydureon Pen is a pre-filled, single-use pen injector, eliminating the need for the patient to transfer the medication between a vial and syringe during the ... Read more

Related support groups: Diabetes, Type 2, Bydureon, Exenatide

Study Sees No Evidence Linking Diabetes Drugs With Pancreatic Cancer

Posted 26 Feb 2014 by Drugs.com

WEDNESDAY, Feb. 26, 2014 – There's no firm evidence that the type 2 diabetes medications known as incretin-based drugs cause pancreatitis or pancreatic cancer, U.S. and European health officials say. But it's too early to say there's definitely no link between the injectable drugs and pancreatitis or pancreatic cancer, according to the safety assessment by the U.S. Food and Drug Administration (FDA) and its counterpart overseas, the European Medicines Agency (EMA). "Both agencies agree that assertions concerning a causal association between incretin-based drugs and pancreatitis or pancreatic cancer, as expressed recently in the scientific literature and in the media, are inconsistent with the current data," states the report in the Feb. 27 issue of the New England Journal of Medicine. "The FDA and the EMA have not reached a final conclusion at this time regarding such a causal ... Read more

Related support groups: Victoza, Januvia, Byetta, Pancreatitis, Bydureon, Pancreatic Cancer, Onglyza, Sitagliptin, Liraglutide, Exenatide, Saxagliptin

FDA Medwatch Alert: Incretin Mimetic Drugs for Type 2 Diabetes: Early Communication - Reports of Possible Increased Risk of Pancreatitis and Pre-cancerous Findings of the Pancreas

Posted 14 Mar 2013 by Drugs.com

ISSUE: FDA is evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics. These findings were based on examination of a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes. FDA has asked the researchers to provide the methodology used to collect and study these specimens and to provide the tissue samples so the Agency can further investigate potential pancreatic toxicity associated with the incretin mimetics. BACKGROUND: Drugs in the incretin mimetic class include exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin ... Read more

Related support groups: Diabetes, Type 2, Victoza, Januvia, Byetta, Janumet, Bydureon, Tradjenta, Sitagliptin, Liraglutide, Exenatide, Linagliptin, Jentadueto, Alogliptin, Nesina, Alogliptin/pioglitazone, Kazano, Oseni, Alogliptin/metformin, Simvastatin/sitagliptin, Linagliptin/metformin

Certain Diabetes Medications May Lower Heart Failure Risk

Posted 10 Mar 2013 by Drugs.com

SUNDAY, March 10 – A newer class of diabetes drugs may offer an extra benefit: A new study suggests these medications lower the odds of suffering heart failure. Researchers from Henry Ford Hospital in Detroit found that patients taking so-called GLP-1 drugs – including brand-name medications such as Byetta, Januvia and Victoza – were more than 40 percent less likely to be hospitalized for heart failure than patients prescribed other blood sugar-lowering medications. GLP-1 diabetes drugs have been in use for only the last several years and are considered second-line treatments after well-established medications such as metformin, physicians said. "I don't think we can say this will magically prevent all heart failure deaths, but the strength of the association warrants more investigation," said study author and cardiologist Dr. David Lanfear. "Heart failure is a very common disease . ... Read more

Related support groups: Diabetes, Type 2, Victoza, Heart Failure, Congestive Heart Failure, Januvia, Byetta, Bydureon, Sitagliptin, Liraglutide, Exenatide

Newest Diabetes Drugs Linked to Higher Pancreatitis Risk

Posted 25 Feb 2013 by Drugs.com

MONDAY, Feb. 25 – Diabetes patients who take the latest class of drugs to control blood sugar levels are twice as likely to develop pancreatitis as those who take other medications to control blood sugar, according to a new study. The drugs Januvia (sitagliptin) and Byetta (exenatide) are glucagon-like peptide-1-based (GLP-1) therapies, which are used by millions of Americans with diabetes. Pancreatitis is inflammation of the pancreas, the organ that releases hormones such as insulin and glucagon, as well as enzymes that help digest food. Pancreatitis is a painful condition that can be dangerous if left untreated. People with diabetes are already at higher risk for pancreatitis because of the role the pancreas plays in the condition. In this study, researchers from Johns Hopkins University in Baltimore compared nearly 1,300 type 2 diabetes patients who took one of the GLP-1 drugs with ... Read more

Related support groups: Diabetes, Type 2, Januvia, Byetta, Pancreatitis, Bydureon, Sitagliptin, Exenatide

Diabetes Drug Byetta May Offer 'Modest' Weight Loss for Very Obese Teens: Study

Posted 5 Feb 2013 by Drugs.com

TUESDAY, Feb 5 – The drug Byetta, approved for adults with type 2 diabetes, appears to help severely obese teens lose some weight, a small study found. Researchers assigned 26 teens, ages 12 to 19, either to injections of Byetta (exenatide) or placebo injections twice daily. After three months, those who got the drug had a nearly 3 percent greater reduction in their body mass index (BMI, a measure of height versus weight) compared to those on placebo. However, that difference remains "modest," said researcher Aaron Kelly, assistant professor of pediatrics at the University of Minnesota Medical School and Amplatz Children's Hospital. "We are not proposing this be prescribed clinically," he said. The study was small, only lasted six months and more study is needed, he added. According to Kelly, Byetta may only be another tool to help the 4 percent to 6 percent of U.S. children and teens ... Read more

Related support groups: Obesity, Diabetes, Type 2, Byetta, Bydureon, Exenatide

New Diabetes Drugs Have Different Advantages, Study Says

Posted 7 Nov 2012 by Drugs.com

WEDNESDAY, Nov. 7 – A head-to-head comparison of two new type 2 diabetes drugs produced mixed results. In the study, liraglutide (Victoza) was somewhat better than the other drug, exenatide (Bydureon), in lowering blood sugar and weight, but Bydureon was associated with fewer side effects, researchers said. Victoza is injected daily by patients and Bydureon is injected weekly. Both drugs are classified as "glucagon-like peptide-1 receptor agonists." "These treatments are very powerful blood sugar-lowering agents that don't cause [too-low] blood sugar and are associated with weight loss," said lead researcher Dr. John Buse, a professor of medicine at the University of North Carolina at Chapel Hill. "That's a unique profile for a diabetes drug." Patients can choose between them, Buse said. A lot depends on what the person is comfortable with. "You lay this all out for patients and help ... Read more

Related support groups: Diabetes, Type 2, Victoza, Byetta, Bydureon, Exenatide, Liraglutide

Prescription Meds Can Put on Unwanted Pounds

Posted 2 Mar 2012 by Drugs.com

FRIDAY, March 2 – Medications taken by millions of Americans for mood disorders, high blood pressure, diabetes and other chronic conditions can have an unhealthy side effect: weight gain. While other choices exist for some types of drugs, adjusting medications is not simply a matter of switching, said Ryan Roux, chief pharmacy officer with the Harris County Hospital District, in Houston. In the late 1990s, Dr. Lawrence Cheskin conducted early research on prescription medicines and obesity. "Some medicines make an early, noticeable difference, causing patients to become ravenously hungry, while changes are subtle for others. A few months taking them and you've gained 10 pounds," said Cheskin, now director of the Johns Hopkins Weight Management Center, in Baltimore. To help increase awareness, Roux and his pharmacist group have compiled a list of "weight-promoting" and "weight-neutral or ... Read more

Related support groups: Bipolar Disorder, High Blood Pressure, Zoloft, Diabetes, Type 2, Wellbutrin, Prozac, Prednisone, Plan B, Seroquel, Gabapentin, Metformin, Hypertension, Paxil, Sprintec, Lamictal, Mirena, Neurontin, Metoprolol, Implanon, Provera

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