Qnexa is the third diet pill to be rejected by the FDA

Qnexa is the latest in a long line of quick fix diet pills aimed at combating obesity.  The combination drug is manufactured by Vivux Inc. of California and their test pills easily passed the FDA’s requirements.

The FDA rules that anti-obesity drugs must cause at least a 5% body weight loss in a third of its test subjects to be considered for release as a prescription drug, something which Qnexa easily managed.  Despite meeting the requirements the FDA rejected the drug over concerns about safety, citing risks to the heart and other major organs as the reason for their decision.

The setback for Vivus and their wonder pill Qnexa comes at a time when the FDA has tightened its belt over such drugs, Qnexa being the third this month.  Vivus were confident that the combination of Phentermine  (a weight loss stimulant) and Topiramate (an anti-convulsant drug used in epilepsy treatment) would yield great results in the nation’s battle against increasing obesity cases.

An alternative to drug assisted weight loss is a change of diet and exercise.  Although most diets require a good level of commitment, there are many proven, healthy diets for people to try such as 50% raw vegan which can be supplemented by organic meat products.

Food manufacturing, in the US especially, is big business and a quick scan of the ingredients on any frozen food package or ‘junk’ food carton will give you a good idea as to why there is so much obesity these days.  That’s before looking at fast food ingredients.

Most products are full of chemicals as indicated by E numbers and sugars which the body is unable to break down leaving fatty deposits which obviously leads to weight gain.  On the other hand raw and organic food steers away from such things, leaving foods in their natural state meaning that the nutrients, friendly bacteria and enzymes remain intact which is far more beneficial to the body.

Combine that healthier calorific intake with an hour long walk everyday or yoga three times per week and you’ve found yourself a drug free combination for improving health and losing weight.  It may take longer to see the results but once the weight is lost it tends to stay gone.

Anti-convulsants or fresh air and organic food?  Let us know your opinion by leaving a comment.

Read about celebs who have lost weight such as Anthony Hopkins, Kelly Osbourne, 50 cent – or look at our Yoga selections like Bikram, Kundalini, Iyengar and Ashtanga Vinyasa.

images: www.sxc.hu

36 thoughts on “Qnexa is the third diet pill to be rejected by the FDA

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  20. The relatively benign CRL for Qnexa is not really surprising. VVUS is an FDA/Wall St./media darling.

    David Orloff had been promoting the concept of combination therapies since at least 2004 while he was still at the FDA. When he suddenly resigned from the FDA in the middle of controversy over questionable drug approvals in his office, he was fortunate to get a job at Medpace.

    While at Medpace, Dr. Orloff oversaw clinical trials of Qnexa and “crafted” the Qnexa NDA, which was reviewed at the FDA by Eric Colman, the person who Orloff had supervised and worked closely with while at the FDA.

    The fact that Qnexa does not meet the requirements for combination therapies based on the component efficacies does not matter. The fact that the advisory committee panel requested additional clinical trials for cardiovascular concerns does not matter. The fact that topiramate causes cognitive problems and birth defects does not matter.

    This drug was a foregone decision that has been in the works at FDA since at least 2004, where it was discussed by the theraputics subcommittee at the FDA obesity working group.

    An FDA official tainted by scandal, leaving to test a drug already being discussed by FDA, and submitting the application for approval back to the same office where he worked, for review by his former associate, reeks of cronyism.

    Cheers to your good news today VVUS shareholders! Qnexa will be approved soon, but as a citizen I am sadly disappointed in our FDA drug approval process.

    The relatively benign CRL for Qnexa is not really surprising. VVUS is an FDA/Wall St./media darling.

    David Orloff had been promoting the concept of combination therapies since at least 2004 while he was still at the FDA. When he suddenly resigned from the FDA in the middle of controversy over questionable drug approvals in his office, he was fortunate to get a job at Medpace.

    While at Medpace, Dr. Orloff oversaw clinical trials of Qnexa and “crafted” the Qnexa NDA, which was reviewed at the FDA by Eric Colman, the person who Orloff had supervised and worked closely with while at the FDA.

    The fact that Qnexa does not meet the requirements for combination therapies based on the component efficacies does not matter. The fact that the advisory committee panel requested additional clinical trials for cardiovascular concerns does not matter. The fact that topiramate causes cognitive problems and birth defects does not matter.

    This drug was a foregone decision that has been in the works at FDA since at least 2004, where it was discussed by the theraputics subcommittee at the FDA obesity working group.

    An FDA official tainted by scandal, leaving to test a drug already being discussed by FDA, and submitting the application for approval back to the same office where he worked, for review by his former associate, reeks of cronyism.

    Cheers to your good news today VVUS shareholders! Qnexa will be approved soon, but as a citizen I am sadly disappointed in our FDA drug approval process.

  21. Judging on what i am reading here about the Qnexa pill, I would not be surprised if the FDA approves it eventually with strict labeling on it, due to its high effectiveness.

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