FDA Rejects Another Proposed Diet Pill

U.S. health officials have denied approval of the experimental weight loss drug Contrave, requesting that the manufacturer conduct more studies to address concerns about possible heart problems.

The Food and Drug Administration issued a letter Monday telling drug maker Orexigen Therapeutics that they must do a double-blind,Rift Gold placebo-controlled clinical trial of "sufficient size and duration" to demonstrate the risk of major cardiovascular events in overweight and obese subjects taking Contrave.

FDA spokeswoman Karen Riley declined to comment to AOL Health on the particular notice sent to the company,RIFT Platinum but explained that a so-called "letter of complete response" like the one issued "indicates that the review cycle for an application is complete and that the application is not ready for approval." Such a report also outlines what changes need to be made to the drug.

Riley said the FDA only approves drugs that are both "safe and effective."

Contrave contains bupropion, an antidepressant, and naltrexone, a treatment for alcohol and painkiller addiction. Previous drugs touted as weight-loss remedies have been under fire for causing heart attack and stroke in some patients.

"There continue to be concerns about the cardiovascular risk of this drug combination," Dr. Wayne Andersen, the medical director of Take Shape for Life, told AOL Health. rift gold"Contrave is a combination of two approved drugs that target different parts of the brain influencing appetite and cravings."

He said existing clinical studies on Contrave showed that it caused blood pressure and heart rate to rise among the control group, a trend that continued after weight was lost.

"[The drug] could potentially increase the risk of cardiovascular events such as angina, heart attacks or strokes," he said.

The current available weight loss medications, including Contrave, are problematic because they are combinations of older drugs that can have "long-term systemic effects on the body," according to Andersen.

"They must be used indefinitely or the weight loss is regained," he said.RIFT Platinum "Any result of the current weight loss drug would require indefinite use with the potential of dangerous side effects."

A much safer way to battle weight gain is to change diet and exercise habits, rather than take pills, Andersen said.

Orexigen said it was disappointed about the FDA's decision, but intends to address the government's concerns.

"We plan to work closely with the agency to gain more information to determine the appropriate next steps regarding the Contrave application," said company president and CEO Michael Narachi in a statement.

The drug has already been tested in several clinical trials on 4,500 patients.

"They would likely need to do an extensive,TERA Gold costly and long-term study to evaluate that the benefits of weight loss outweigh the cardiovascular risks," Andersen said, which will probably result in a years-long delay in FDA approval.

The FDA's denial is the third time the agency has tossed out a proposed diet drug since last year. The fact that the government requested another study indicates approval may be in Contrave's future, however.
Contrave has been considered to be the best of the trio of new diet pills recently submitted for the FDA green light. Four of 10 patients taking it for 12 months lost 5 percent or more of their body weight, and the drug is safer than the other two options recently offered.

The FDA has acknowledged that there is a need for better weight-loss drugs now that the obesity rate has climbed to almost 35 percent among American adults.

But cardiovascular problems have been linked to other diet pills, including the combination drug fen-phen made by Wyeth, which was taken off the market in 1997.

Abbott Laboratories pulled its weight-loss drug Meridia in October after evidence surfaced that it could raise the risk of stroke and heart attack.

There is only one prescription drug currently available to for long-term weight loss called Xenical and made by Roche.

There are a number of other generic drugs that have been approved for losing weight over the short term, among them phentermine.