Jan. 26, 2010 — The FDA has endorsed Victoza (liraglutide), a once-daily infusion to treat sort 2 diabetes in grown-ups.
Victoza is planning to assist lower blood sugar levels in conjunction with eat less, work out, and chosen other diabetes drugs. It isn’t suggested as the primary treatment patients attempt on the off chance that they haven’t satisfactorily controlled their diabetes with slim down and work out alone.
Victoza has a place to a lesson of drugs known as glucagon-like peptide-1 (GLP-1) receptor agonists, which offer assistance the pancreas make more affront after eating a dinner.
“Diabetes may be a driving cause of passing and incapacity, with more than 1.5 million unused cases analyzed annually,” says Mary Parks, MD, chief of the division of digestion system and endocrinology items at the FDA.
“Controlling blood sugar levels is exceptionally imperative to anticipating or decreasing the long term complications of diabetes, and Victoza offers certain patients with sort 2 diabetes a treatment alternative for controlling their blood glucose levels,” Parks says.
FDA’s Victoza Choice
The FDA endorsed Victoza based on five clinical trials including more than 3,900 individuals. In those trials, pancreatitis (aggravation of the pancreas) happened more regularly in patients who took Victoza than in patients taking other diabetes medications.
The FDA states that Victoza ought to be ceased in case patients encounter extreme stomach torment, with or without sickness and heaving, and ought to not be restarted in the event that blood tests confirm that they have pancreatitis. Victoza ought to be used with caution in individuals with a history of pancreatitis, agreeing to the FDA.
The foremost common side impacts watched with Victoza within the clinical trials were cerebral pain, sickness, and the runs. Other side impacts included allergic-like responses such as hives.
In its clinical trials, Victoza was not connected to an expanded chance of cardiovascular occasions — counting heart assault, stroke, and passing caused by heart infection — in individuals who were basically at moo hazard for such occasions. In keeping with FDA approach, Victoza will be examined encourage to check its cardiovascular security in higher-risk bunches.
Other postmarketing ponders will assess the chance of thyroid cancer and other cancer dangers, as well as the dangers of truly moo blood glucose levels (hypoglycemia), pancreatitis, and unfavorably susceptible responses.
The FDA notes that in creature considers, Victoza caused tumors of the thyroid organ in rats and mice. A few of those tumors were cancers, which were more likely in rats that got measurements of Victoza that were eight times higher than what individuals would get.
It’s not known if Victoza may cause thyroid tumors or a really uncommon sort of thyroid cancer called medullary thyroid cancer in individuals. For that reason, the FDA says Victoza ought to not be used as the primary treatment for diabetes until more ponders are done.
Victoza ought to not be utilized in individuals who are already at hazard for medullary thyroid cancer, such as those who have medullary thyroid cancer within the family, or those with a uncommon hereditary condition called numerous endocrine neoplasia disorder sort 2.
Victoza includes a hazard assessment and relief procedure to assist patients and health-care suppliers get it the drug’s dangers and to guarantee that the drug’s benefits exceed the chance of intense pancreatitis and the potential hazard of medullary thyroid cancer.
Victoza is made by the medicate company Novo Nordisk. The dispatch cost of the 1.2-milligram measurements will be $8.03 a day.