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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 help you manage chronic obesity in adults with a body mass index (BMI) of more than 27, provided that they also suffer from weight-related medical issues such as Tupe2 diabestes, high cholesterol and/or hypertension (high blood pressure).Contrave can be a combination of two FDA-approved drugs, naltrexone and bupropion, in a extended-release formulation. Naltrexone is approved to treat alcohol and opioid dependence. Bupropion is eligible to treat depression and seasonal affective disorder in addition to being an aid to quitting smoking treatment.'Obesity is still 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 having a healthy lifestyle that includes a reduced-calorie eating and working out, Contrave provides another treatment option for chronic weight management for people who are obese or are overweight and also have at least one weight-related health condition.'The drug's effectiveness was evaluated in multiple numerous studies 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 showed that patients had a normal weight loss of four years old.1% as opposed to participants who were given placebos) throughout a 12- month period, while an outside study involving patients with diabetes had a typical weight loss of 2% over treatment with placebo at twelve months.
Using two separate drugs to shed pounds can be very effective there are combinations as you're watching FDA now awaiting approval. When dealing with weight reduction and the people who go through it you need to err along the side of caution and let the FDA do its job and demand some research be done so that the public recognizes the side effects and risks of the medications before we drive them. Keep in mind that drug companies are in business to generate income and that they would say everything to keep people on the medications.
Researchers found out that participants using this drug for any year, lost excess weight within a month and have kept the weight off throughout the 56 weeks with the study. Contrave can be a combination from the drugs naltrexone and bupropion, which seems to reflect a fresh trend of weight-loss drugs that are made up of many active ingredient, that might make them more potent and safer.
Combo-pilling may be the newest fad or better yet the newest in the future under scrutiny and thus it is just more publicly known in recent months, comb-pilling for weight loss has been around since the eighties. The biggest reason that utilizing a combination of pills is now popular may be the fact that by right now there are no long term prescription diet pills that have been approved by the FDA aside from orlistat. The truly disturbing part is always 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 really should not be taken in those with seizure disorders. The drug can also raise blood pressure levels and heart rate, and really should not be used in people who have a history of cardiac arrest or stroke in the earlier six months. Blood pressure and pulse should also be measured before starting the drug and throughout therapy with all the drug.
The FDA also warned that Contrave can raise blood pressure and heartbeat and must stop used in patients with uncontrolled high blood pressure level, as well as by anyone with heart-related and cerebrovascular (circulation system dysfunction impacting the brain) disease. Patients having a history of cardiac event or stroke in the last six months, life-threatening arrhythmias, or congestive heart failure were excluded from your clinical trials. Those taking Contrave needs to have their heart-rate and pulse monitored regularly. In addition, since compound includes bupropion, Contrave comes with a boxed warning to alert health care professionals and patients towards the increased likelihood of suicidal thoughts and behaviors connected with antidepressant drugs. The warning also notes that serious neuropsychiatric events are actually reported in patients taking bupropion for stop smoking.
Approving a drug using this many potentially lethal unwanted effects is inconsistent with all the mission statement from the FDA. The power with the drug manufacturing lobby is blatantly evident inside approval of countless drugs requiring 'post-marketing' studies which can be clearly significant to overall drug safety within the US.