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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ISSUE: FDA is evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis and pre-cancerous cellular changes called pancreatic duct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, Oseni, Alogliptin, Nesina, Alogliptin/pioglitazone, Kazano, Juvisync, Metformin/Sitagliptin, Alogliptin/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, Plan B, Prozac, Prednisone, Gabapentin, Seroquel, Metformin, Hypertension, Sprintec, Paxil, Lamictal, Mirena, Implanon, Provera, Metoprolol, Neurontin

Certain Diabetes Drugs Might Aid Weight Loss

Posted 11 Jan 2012 by Drugs.com

TUESDAY, Jan. 10 – A class of newer diabetes drugs that includes exenatide (Byetta, Bydureon) might also be used to help the obese lose weight, Danish researchers report. That's because weight loss and lowered cholesterol are often side effects of these drugs, called "glucagon-like peptide-1 receptor agonists" (GLP-1), the team noted. "If you use this treatment for 20 weeks, you have a positive effect on body weight," said lead researcher Dr. Tina Vilsboll, head of the Diabetes Research Division at Gentofte Hospital of the University of Copenhagen. "The hope is that we have a new class of treatment for obesity, and not just for type 2 diabetes." "It's not a wonder drug," Vilsboll stressed. "It doesn't make everyone normal weight, but it's a way of changing your lifestyle." And she does not recommend using these drugs as a standalone treatment for weight loss. "Not right now, we need ... Read more

Related support groups: Obesity, Byetta, Exenatide

Byetta Approved for Use with Insulin Glargine in the U.S.

Posted 30 Oct 2011 by Drugs.com

SAN DIEGO and INDIANAPOLIS, Oct. 19, 2011 /PRNewswire/ – Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced that the U.S. Food and Drug Administration (FDA) has approved a new use for Byetta (exenatide) injection. Byetta is now approved as an add-on therapy to insulin glargine, with or without metformin and/or a thiazolidinedione (TZD), in conjunction with diet and exercise for adults with type 2 diabetes who are not achieving adequate glycemic control on insulin glargine alone. "This expanded use for Byetta is important for clinical care, in that it provides a new option for the many patients with type 2 diabetes who are not achieving treatment goals," said John Buse, M.D., Ph.D., professor of medicine, director of the Diabetes Care Center and chief of the Division of Endocrinology at the University of North Carolina School of Medicine in Chapel Hill. "Byetta is ... Read more

Related support groups: Byetta

Popular Diabetes Drugs May Raise Pancreatic Cancer Risk, Study Suggests

Posted 22 Sep 2011 by Drugs.com

THURSDAY, Sept. 22 – People with type 2 diabetes taking the drugs Januvia or Byetta might have an increased risk of developing pancreatitis and pancreatic cancer, a preliminary study suggests. The study also found that Byetta (exenatide) may raise the risk of thyroid cancer. Although the links aren't conclusive, they merit further investigation, the researchers noted. "We have raised concern that there may be a link, but we haven't confirmed it," said lead researcher Dr. Peter Butler, director of the Larry L. Hillblom Islet Research Center at the University of California, Los Angeles. "We need to do more work to figure out whether this is real or not." Both drugs help control blood sugar levels by encouraging production of a hormone called glucagon-like peptide 1 (GLP-1). Januvia (sitagliptin) and Byetta, an injectable drug, are a new way of treating type 2 diabetes, and they ... Read more

Related support groups: Diabetes, Type 2, Januvia, Byetta, Pancreatitis, Pancreatic Cancer

FDA Asks for Risk Plan Info on Diabetes Drug

Posted 15 Mar 2010 by Drugs.com

From Associated Press (March 15, 2010) SAN DIEGO – Amylin Pharmaceuticals Inc. said Monday it received a Food and Drug Administration request for information on manufacturing and a risk mitigation plan for a potential once-weekly diabetes treatment. Amylin, along with partners Eli Lilly & Co. and Alkermes Inc., are not being asked to conduct additional studies on the much anticipated drug. The FDA request focuses on product labeling for Bydureon, which is the proposed trade name for exenatide, along with risk mitigation and manufacturing information. The FDA response does not contain requests related to a December preapproval inspection of a manufacturing facility in Ohio. Amylin said it is "working diligently" to submit a response to the FDA in the next few weeks. Bydureon, or exenatide, is a once-weekly version of the injectable treatment Byetta, which is currently taken twice daily. ... Read more

Related support groups: Byetta, Exenatide

Byetta Approved for Expanded Use as First-Line Treatment for Type 2 Diabetes

Posted 2 Dec 2009 by Drugs.com

SAN DIEGO and INDIANAPOLIS, Oct. 30, 2009 /PRNewswire-FirstCall/ – Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Byetta (exenatide) injection. Byetta is now approved for use as a stand-alone medication (monotherapy) along with diet and exercise to improve glycemic control in adults with type 2 diabetes. Previously, it was approved for use only in patients who were also taking other common diabetes medications and had not achieved adequate glycemic control. "The expanded indication gives physicians the option to prescribe Byetta as a first-line treatment, increasing the number of patients who may benefit from the medication and providing an opportunity to treat patients with Byetta earlier in the disease," said Orville G. Kolterman, M.D., senior vice president of research ... Read more

Related support groups: Diabetes, Type 2, Byetta

FDA Issues Warning for Diabetes Drug

Posted 1 Dec 2009 by Drugs.com

TUESDAY, Nov. 3 – Reports about possible kidney problems, including renal failure, in people taking the diabetes drug exenatide (Byetta) have prompted changes to the drug's prescribing information, the U.S. Food and Drug Administration said Monday. From April 2005 to October 2008, the FDA received 78 reports of kidney function problems in patients taking Byetta. Most of the problems occurred in patients with pre-existing kidney disease or one or more risk factors for developing kidney problems. Byetta is prescribed for type 2 diabetes; 7 million prescriptions were filled between April 2005 and September 2008, according to the agency. "Health-care professionals and patients taking Byetta should pay close attention to any signs or symptoms of kidney problems," Dr. Amy Egan, of the Division of Metabolism and Endocrinology Products at the FDA's Center for Drug Evaluation and Research, said ... Read more

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FDA Medwatch Alert: Byetta (exenatide)

Posted 18 Aug 2008 by Drugs.com

[UPDATED 08/18/2008] 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 ... Read more

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Diabetes Drug Byetta May Aid Weight Loss in Obese Patients

Posted 11 Jun 2009 by Drugs.com

THURSDAY, June 11 – Exenatide (Byetta), a drug normally used to treat diabetes, may also help non-diabetic obese people lose weight when combined with diet and exercise, new research has found. Researchers divided 152 obese men and women (with a body-mass index of greater than 30 and an average weight of 241 pounds) into two groups. About 25 percent of the study participants had impaired glucose tolerance, which can be a precursor to diabetes. One group received 10 micrograms of exenatide twice a day, while the other received a placebo. Both groups were put on a diet and exercise program for 24 weeks, according to the study authors. After six months, those taking exenatide lost three times more weight than those taking the placebo, the researchers found. Participants taking exenatide lost an average of 11 pounds, while those in the placebo group lost 3.5 pounds on average. Some 9.6 ... Read more

Related support groups: Obesity, Byetta

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