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admin | Supplements To Gain Muscle | 19.11.2013
In September 2014, the Food and Drug Administration (FDA) approved the weight loss drug Contrave.
The JAMA study sheds light on some of the potential issues wrought by a new approval process adopted by the FDA in recent years. The FDA also requires that trials for approval be blinded, so that researchers and the people in the studies are not aware of whether they are taking the drug or a placebo. It also requested an entirely new study to continue evaluating the drug’s heart safety and shut down the existing trial. Given the widespread publicity over the preliminary results that showed benefit, however, doctors began prescribing the drug and many people participating in the trial dropped out so they could get the medication from their own physicians. For now, the question of whether people taking Contrave are exposed to a higher risk of heart events is still unanswered. The use of software that blocks ads limits our ability to provide you with the journalism you enjoy. Consider turning your Ad Blocker off so that we can continue to provide the world class journalism you have become accustomed to.
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It’s a combination of naltrexone and bupropion, an antidepressant, that together work to lower appetite. Early research about Contrave suggested the drug was good for heart health, a message that made its way to the public. The only thing for certain is that it doesn’t double the risk of heart events compared to people taking placebo. When you proceed to the checkout page, the Seller Discount will be automatically calculated. But bupropion is also linked to high blood pressure and increased heart rate, and two previous weight loss drugs with similar effects on the heart had already been removed from the market.
The problem, according to the new study, is that as the trial continued, that benefit didn’t hold up.
Normally, accumulating data about side effects like heart attacks, strokes, even death can take five years or more. In Contrave’s case, the early finding that the drug was linked to a 41% lower risk of heart events was shared with more than 100 people. Orexigen is now funding a new trial that will deliver a more definitive answer on the heart safety of its drug, which Nissen will lead.


Now, in order to speed drugs to patients faster, the agency can approve drugs before the full study on its side effects is complete—as long as certain criteria are met. And because the results meant it met that agreed-upon threshold for safety, the FDA approved the drug. In fact, there was almost no significant difference in heart events among the people taking the drug and those taking a placebo. The FDA, the drug maker and the scientists doing the trial must agree on a pre-specified threshold of safety that the drug has to meet.
In this case, all parties agreed that the study would have to show that the drug didn’t more than double the number of negative heart-related outcomes.



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