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The U.S. Food and Drug Administration has approved the application of Contrave (naltrexone hydrochloride and bupropion hydrochloride extended-release tablets) to aid manage chronic obesity in adults with a body mass index (BMI) of more than 27, so long as they also have problems with weight-related health concerns such as Tupe2 diabestes, high-cholesterol and/or hypertension (high blood pressure levels).Contrave is a combination of two FDA-approved drugs, naltrexone and bupropion, in the extended-release formulation. Naltrexone is eligible to treat alcohol and opioid dependence. Bupropion qualifies to treat depression and seasonal affective disorder so when an aid to smoking cessation treatment.'Obesity remains a major public health concern,' said Jean-Marc Guettier, M.D., director of the Division of Metabolism and Endocrinology Products in FDA's Center for Drug Evaluation and Research. 'When used as directed in combination using a healthy lifestyle that includes a reduced-calorie eating and working out, Contrave provides another treatment selection for chronic weight reduction for people who are obese or are overweight and possess at least one weight-related health.'The drug's effectiveness was evaluated in multiple many studies that included approximately 4,500 obese and overweight patients with and without significant weight-related conditions treated for one year. All patients received lifestyle modification that was comprised of a reduced- calorie diet and regular physical activity. Results from a clinical trial that enrolled patients without diabetes indicated that patients had the average weight loss of four years old.1% instead of participants who have been given placebos) within a 12- month period, while an outside study involving patients with type 2 diabetes had the average weight loss of 2% over treatment with placebo at twelve months.
Using two separate drugs to lose weight can be very effective you'll find combinations as you're watching FDA now awaiting approval. When dealing with weight loss and the individuals who go through it you need to err to the side of caution and let the FDA do its job and demand some research be done so your public understands the side effects and perils associated with the medications before we drive them. Keep in mind that drug companies have been in business to make money and that they would say everything to keep people on the medications.
Researchers found out that participants investing in this drug to get a year, dropped a few pounds within a month and have kept the body weight off through the 56 weeks from the study. Contrave is a combination from the drugs naltrexone and bupropion, which seems to reflect a brand new trend of weight-loss drugs which are made up of multiple active ingredient, which can make them more efficient and safer.
Combo-pilling could be the newest fad or also the newest in the future under scrutiny and for that reason it is just more publicly known in recent months, comb-pilling to lose weight has been around since the eighties. The biggest reason that by using a combination of pills has become popular could be the fact that as of right now there aren't long term prescription diet pills that have been authorized by the FDA other than orlistat. The truly disturbing part is doctors are prescribing these combinations of medications and some of the combinations happen to be rejected or have yet to be licensed by the FDA.
Seizures can be a side effect with Contrave and shouldn't be taken in people who have seizure disorders. The drug may also raise blood pressure levels and heart rate, and shouldn't be used in those with a history of heart attack or stroke in the previous six months. Blood pressure and pulse should also be measured prior to starting the drug and throughout therapy while using drug.
The FDA also warned that Contrave can raise blood pressure and heartbeat and must not used in patients with uncontrolled high blood pressure, along with by a person with heart-related and cerebrovascular (circulation dysfunction impacting the mind) disease. Patients having a history of cardiac arrest or stroke in the previous six months, life-threatening arrhythmias, or congestive heart failure were excluded in the clinical trials. Those taking Contrave must have their heart-rate and pulse monitored regularly. In addition, since the compound includes bupropion, Contrave comes which has a boxed warning to alert medical professionals and patients for the increased risk of suicidal thoughts and behaviors connected with antidepressant drugs. The warning also notes that serious neuropsychiatric events happen to be reported in patients taking bupropion for smoking cessation.
"There were no warning signs of depression or suicidal thoughts in trial participants," said Fujioka.