Scientists for the Food and Drug Administration have recently said that Contrave, a weight loss pill to treat obesity from Orexigen Therapeutics Inc. helped patients lose weight, though it didn’t meet all the criteria set forth by the agency. The FDA scientists linked the drug to high blood pressure and heart problems.
Contrave is the third weight loss pill to be reviewed by the FDA this year and found all three having health safety concerns.
Study: The FDA said on Friday that four studies conducted by Orexigen showed patients taking its drug lost, on an average, 4.2 percent more weight than patients taking a placebo(a sugar pill having no medicinal value; a fact patient is unaware of). However, the results did not meet an FDA guideline that there should be at least a 5 percent difference in weight loss between the groups. But Contrave did meet a second measure of effectiveness involving the number of patients who lost at least 5 percent or more of their weight.
Regarding the effects of the drug on Blood pressure and Heart; FDA came to the consclusion indirectly. FDA found that FDA found that the company enrolled few elderly patients or patients with a history of heart disease in its trials, making it difficult to determine the drug’s safety in patients at risk for heart attack and stroke; hence it linked the drug to aforementioned health problems on the basis of previous studies which had found that the two constituents of Contrave, the antidepressant bupropion and the anti-addiction drug naltrexone had higher rates of side effects, including high blood pressure, dizziness and insomnia.