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The U.S. Food and Drug Administration has approved using Contrave (naltrexone hydrochloride and bupropion hydrochloride extended-release tablets) to help manage chronic obesity in older adults with a body mass index (BMI) of more than 27, provided that they also experience weight-related health concerns such as Tupe2 diabestes, high cholesterol and/or hypertension (high blood pressure).Contrave is often a combination of two FDA-approved drugs, naltrexone and bupropion, within an 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 quitting smoking treatment.’Obesity remains a major public health concern,’ said Jean-Marc Guettier, M.D., director with 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 including a reduced-calorie eating and working out, Contrave provides another treatment selection for chronic weight management for people who are obese or are overweight and also have at least one weight-related health.’The drug’s effectiveness was evaluated in multiple clinical trials that included approximately 4,500 obese and overweight patients with and without significant weight-related conditions treated for starters year. All patients received lifestyle modification that was comprised of a reduced- calorie diet and regular exercising. Results from a clinical trial that enrolled patients without diabetes demonstrated that patients had a typical weight loss of four.1% rather than participants have been given placebos) within a 12- month period, while a separate study involving patients with diabetes type 2 symptoms had a normal weight loss of 2% over treatment with placebo at 12 months.
Using two separate drugs to shed weight can be very effective there are combinations before the FDA now awaiting approval. When dealing with weight loss and the those who go through it you should err to the side of caution and permit the FDA do its job and demand some research be done so the public recognizes the side effects and perils associated with the medications before we take them. Keep in mind that drug companies will be in business to generate income and that they would say almost anything to keep people on the medications.
Researchers discovered that participants taking this drug for any year, dropped a few pounds within four weeks and have kept the extra weight off through the 56 weeks from the study. Contrave is often a combination in the drugs naltrexone and bupropion, which seems to reflect a new trend of weight-loss drugs which might be made up of multiple active ingredient, that might make them far better and safer.
Combo-pilling will be the newest fad or in addition to this the newest to come under scrutiny and therefore it is just more publicly known in recent months, comb-pilling for losing weight has been around since the eighties. The biggest reason that by using a combination of pills is becoming popular could be the fact that as of right now there aren’t any long term prescription weightloss pills that have been authorized by the FDA other than orlistat. The truly disturbing part is that doctors are prescribing these combinations of medications however some of the combinations are actually rejected or have yet to be authorized by the FDA.
Seizures are a side effect with Contrave and mustn’t be taken in people who have seizure disorders. The drug could also raise blood pressure level and heart rate, and really should not be used in people who have a history of cardiac event or stroke in the last 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 level and heartrate and must not be used in patients with uncontrolled high blood pressure, in addition to by anyone with heart-related and cerebrovascular (circulation dysfunction impacting the mind) disease. Patients having a history of cardiac event or stroke in the previous six months, life-threatening arrhythmias, or congestive heart failure were excluded from the clinical trials. Those taking Contrave must have their heart-rate and pulse monitored regularly. In addition, since compound includes bupropion, Contrave comes using a boxed warning to alert physicians and patients on the increased probability of suicidal thoughts and behaviors linked to antidepressant drugs. The warning also notes that serious neuropsychiatric events are already reported in patients taking bupropion for smoking cessation.
“There were no signs and symptoms of depression or suicidal thoughts in trial participants,” said Fujioka.