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Oseni 7 articles

Some type 2 diabetes drugs linked to heart failure

Drugs from a new class of type 2 diabetes treatments, including Onglyza, Kombiglyze XR and Nesina, have been linked to heart failure, and patients with heart or kidney disease are even more susceptible to this risk, the Food and Drug Administration (FDA) warned in a Safety Alert. The risk was seen with the drug ingredient saxagliptin (found in Onglyza and Kombiglyze XR) and alogliptin (found in the brands Nesina, Kazano and Oseni). Both saxagliptin and alogliptin are in a newer class of type 2 diabetes drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors. The new warning comes after an FDA review ... Read More

UK drug regulators close to approving risky type 2 diabetes treatments

European drug authorities are close to approving new treatments for type 2 diabetes. The European Medicines Agency (EMA) issued a favorable opinion for Takeda Pharmaceuticals drug alogliptin as a stand-alone drug, in combination with metformin, and in combination with pioglitazone. The drugs will be sold under the brand names Vipidia, Incresync, and Vipdomet, respectively. The three drugs were launched last month in the United States under the brand names Nesina, Oseni and Kazano. Alogliptin is in a class of medications known as dipeptidyl peptidase 4 (DPP-4) inhibitors. They work by slowing the inactivation of the incretin hormones that regulate blood ... Read More

Type 2 diabetes drug does not reduce risk of heart attack, stroke, death

Diabetes drug Onglyza (saxagliptin) does not reduce the risk of heart attacks, strokes or death from cardiovascular causes compared to a placebo, drug makers Bristol Myers Squibb and AstraZeneca said. The companies had conducted clinical trials to determine if the Type 2 diabetes treatment could help reduce the risk of non-fatal heart attacks and ischemic strokes and death from cardiovascular problems as well as lower blood glucose levels. Onglyza did not perform better than a placebo; however, it was not inferior to the placebo either. The clinical trials involved 16,500 people with diabetes as well as a history of heart ... Read More

Class of type 2 diabetes drugs linked to acute pancreatitis, pancreatic cancer, thyroid cancer

Concerns over the safety of a class of type 2 diabetes drugs known as incretin mimetics – glucagon-like peptide-1 (GLP-1) agonists and dipeptidylpeptidase-4 (DPP-4) inhibitors – took a sharp turn recently after an investigative report by British media revealed that it uncovered unpublished data that links the drugs to “unwanted proliferative or inflammatory pancreatic effects,” and that drug regulators in the United States and Europe have not responded quickly enough to studies that suggest these drugs are not as safe as manufacturers claim. Incretin mimetic drugs include exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, ... Read More

Lawsuits filed against makers of several type 2 diabetes drugs

Last month, the Food and Drug Administration (FDA) announced that it was investigating cases of pancreatitis and precancerous cellular changes called pancreatic duct metaplasia in patients taking a class of type 2 diabetes drugs known as incretin mimetics. Lawsuits against manufacturers of several of these drugs have been underway for years. Incretin mimetic drugs include exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni), and linagliptin (Tradjenta, Jentadueto). The FDA’s inquiry is based on unpublished findings from a group of academic researchers who examined a small number of pancreatic tissue ... Read More

FDA investigates cases of pancreatitis, precancerous pancreatic cancer with type 2 diabetes treatments

An increased risk of pancreatitis, or inflammation of the pancreas, and other precancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics is being evaluated by the Food and Drug Administration (FDA). The investigation is based on unpublished findings by a group of academic researchers who examined a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes. Incretin mimetic drugs include exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni), and linagliptin ... Read More

Newly approved type 2 diabetes drugs come with warnings, requirements

After more than five years of reviews and rejections, the dipeptidyl peptidase IV (DDP-4) inhibitor alogliptin has finally been approved by the Food and Drug Administration (FDA). The new drug was approved in three versions to improve blood sugar control in adults with type 2 diabetes. Nesina contains alogliptin as a single-agent drug; Kazano contains alogliptin with metformin; and Oseni contains alogliptin with pioglitazone. The drugs are to be prescribed in combination with diet and exercise. Alogliptin is the fourth DDP-4 inhibitor to gain FDA clearance. Others include sitagliptin, sold under the brand name Januvia; saxagliptin, sold as Onglyza; and ... Read More