Vivus is attempting FDA approval would you use it lol

eschwab855

(Reuters) - Hopes were raised slightly on Friday that U.S. health regulators could approve a weight-loss pill for the first time in 13 years, after government reviewers did not flag fresh safety risks for an experimental obesity drug from Vivus Inc.

Food and Drug Administration staff said in documents posted online that the drug Qnexa did help people lose weight, though they reiterated concerns about the risk of birth defects and heart problems.


The FDA rejected Qnexa in 2010 because of safety problems, and on Friday agency staff still seemed skeptical about the drug's long-term health effects, especially on the heart.

FDA staff will ask a panel of outside experts next Wednesday to consider whether the benefits of Qnexa for obese patients outweigh its safety risks, or if the company needs to do more studies.

Obesity, a leading cause of diabetes, heart disease and other serious health problems, has reached epidemic proportions in the United States, with about a third of the population affected.

But the FDA has set a high approval bar for weight loss drugs because such a large portion of the general population is likely to want to take them. The agency has not approved a new obesity drug since 1999.

Qnexa is one of three obesity pills up for a second round of consideration from the FDA.

"Ultimately, only a long-term, cardiovascular outcome trial can define the effect of (Qnexa) treatment on risk for major adverse cardiovascular events in an obese at-risk population," FDA reviewers said about Qnexa.

The FDA staff said they would also ask the advisers whether Vivus needs to do a heart-focused study of Qnexa before it is approved. The FDA will make its final decision by April 17.

FDA staff said patients taking Qnexa during a clinical trial had lost more weight, and kept it off for longer, than those taking a placebo, or sugar pill. The Qnexa patients also had lower levels of problems associated with obesity, such as issues with blood pressure and blood sugar.

However, the FDA staff said patients taking the drug had more safety problems, including memory loss and higher heart rates, than those on a placebo, and some of these problems could get worse over time.

They also said exposure to one of the ingredients in Qnexa has been linked to a higher rate of birth defects in other studies.


This may be old news to some it kind of surprised me the reason they say FDA has a high bar for obesity drugs is that another way of saying they don't want another fin fin fiasco with millions of people with heart valve problems. SO honestly would you take a magic pill to get thin

airlily

However, the FDA staff said patients taking the drug had more safety problems, including memory loss and higher heart rates, than those on a placebo, and some of these problems could get worse over time.

LOL "Oh wow, I looks great! What's my name, again?"

eschwab855

However, the FDA staff said patients taking the drug had more safety problems, including memory loss and higher heart rates, than those on a placebo, and some of these problems could get worse over time.

LOL "Oh wow, I looks great! What's my name, again?"

and how did i get here ? lmao