Tagged Articles

acute pancreatitis 180 articles

Obesity treatment balloons linked to serious adverse events

The Food and Drug Administration (FDA) is alerting doctors that it has received several dozen adverse event reports with fluid-filled intragastric balloons used to aid in weight loss of obese patients. Doctors are being advised to closely monitor patients with these devices for adverse events and submit reports to the agency so that investigators can better understand any complications associated with the use of obesity treatment devices. The first type of adverse event involves the fluid-filled gastric balloon over-inflating with air or with more fluid, a condition known as spontaneous hyperinflation, while in the patient’s stomach, leading to the premature removal ... Read More

SGLT2 inhibitors linked to acute pancreatitis

A painful inflammation of the pancreas called acute pancreatitis is a potential new safety issue identified with the new class of type 2 diabetes treatments known as SGLT2 inhibitors. The side effect was identified through the Food and Drug Administration (FDA) adverse event tracking database, which identifies potential hazards with drugs each quarter. The FDA identifies potentially harmful side effects with medications to determine if further action – such as additional or strengthened warnings – are required. The agency said it is currently evaluating the need for regulatory action regarding the link between SGLT2 inhibitors and acute pancreatitis. SGLT2 inhibitors ... Read More

Large analysis of three clinical trials links diabetes drugs gliptins to acute pancreatitis

An analysis of three large clinical trials looking at the cardiovascular safety of three type 2 diabetes drugs known as gliptins has found that the medications significantly increase the risk of acute pancreatitis. The study, conducted by Ivan Tkac, M.D., Ph.D., from Pasteur University Hospital in Kosice, Slovakia, and Itamar Raz, M.D., from Hadassah Hebrew University Hospital in Jerusalem, combined incidence of acute pancreatitis from randomized controlled trials. The trials included SAVOR-TIMI 53, involving the medication Onglyza (saxagliptin); EXAMINE, involving the drug Nesina (alogliptin); and TECOS, involving the drug Januvia (sitagliptin). Combined, the studies involved 18,238 gliptin-treated patients and 18,157 ... Read More

New labels warn of new risks for diabetes drugs Nesnia, Onglyza

The safety labels for the type 2 diabetes drugs Nesnia (alogliptin) and Onglyza (saxagliptin) have been updated to include new warnings for pancreatitis and heart failure. Nesnia and Onglyza are in a newer class of type 2 diabetes drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors. Other drugs in this class include Januvia (sitagliptin) and Tradjenta (linagliptin). The “Warnings and Precautions” section for both Nesnia and Onglyza now include a warning that in post-marketing settings and/or randomized clinical trials, patients have been diagnosed with acute pancreatitis. Pancreatitis is a painful inflammation of the pancreas that can increase the risk for more ... Read More

FDA to review new combination diabetes drugs

French drugmaker Sanofi plans to redeem a fast-track voucher to gain accelerated regulatory review of its experimental combination diabetes drug Lixilan, a once-daily injectable treatment that combines its blockbuster insulin Lantus with Lyxumia, a Type 2 diabetes medication currently marketed in Europe. Lyxumia is not yet approved in the United States but is currently under review by the Food and Drug Administration (FDA). It is in a class of type 2 diabetes drugs known as GLP 1 receptor agonists. Other drugs in this class include the brand names Byetta and Victoza. Sanofi hopes to give Lixilan the edge over competitor ... Read More

Type 2 diabetes drug Januvia increases risk of acute pancreatitis

People who take type 2 diabetes medications such as Januvia have a small but statistically significant increased risk of developing a painful inflammation of the pancreas known as acute pancreatitis, according to a new meta-analysis from three major clinical trials. Januvia, know chemically as sitagliptin, was approved by the Food and Drug Administration in 2006, becoming the first in a new class of type 2 diabetes drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors. Since then, several other DPP-4 inhibitors have hit the market including Janumet, Onglyza, Tradjenta and Nesnia. DPP-4 inhibitors are a subclass of diabetes drugs called incretin mimetics. ... Read More

Weekly, daily versions of diabetes drugs have similar risk-benefit profile

Once-weekly versions of a popular class of type 2 diabetes drugs carry a similar risk-benefit profile as daily-dose versions of drugs in the same class, a new study has found. The study involved type 2 diabetes drugs known as glucagon-like peptide-1 receptor agonists, or GLP1 agonists. The drugs are designed to improve blood sugar control, but also carry the attractive side effect of weight loss. Obesity and being overweight are risk factors for type 2 diabetes. All are administered by injection. GLP1 agonists include the brand names Byetta (exenatide) and Victoza (liraglutide), which are administered once or twice daily; and ... Read More

Victoza claims better efficacy than Invokana

Novo Nordisk is taking great efforts to stretch the profit-earning potential of its blockbuster type 2 diabetes drug Victoza. The company won approval to market the drug as an obesity treatment under the brand name Saxenda, and has launched clinical trials to test the drug as a treatment for nonalcoholic fatty liver disease, one of the most common causes of chronic liver disease. Now the company is taking aim at its competitors in the lucrative diabetes market, rolling out a new meta-analysis showing that Victoza was superior at reducing blood sugar metric HbA1c (a more accurate test for diabetes control) ... Read More

Pancreatitis rate dramatically increasing in recent years

Pancreatitis, a painful inflammation of the pancreas, is the most common cause of hospitalization for patients with a gastrointestinal disorder. The number of those afflicted with the condition has nearly doubled in the past two decades, with more than 40-60 new cases per 100,000 diagnosed each year. Researchers say the cause for the increase in pancreatitis is likely linked to the growing problem of obesity, which is strongly related to gallstones, as well as increasing amounts of alcohol consumption. Pancreatitis can be acute, meaning it occurs suddenly and usually resolves within days if treated in a timely manner, or chronic, ... Read More

Novo Nordisk could reap billions from experimental diabetes pill

Drug maker Novo Nordisk has enjoyed booming profits from its injectable diabetes treatment Victoza, thanks to winning approval for a potent version of the drug, marketed as Saxenda, as an obesity treatment. But it’s new oral version of a diabetes drug from the same class as Victoza could send profits as high as $20 billion per year. In the pharmaceutical industry, drugs that reap annual profits of at least $1 billion are called blockbusters. There is a special term for a drug that exceeds $10 billion in sales – super-blockbuster, says Seeking Alpha. These drugs are few and far between, ... Read More