Tag Archives: qnexa

The 6 Miracle Diets Dr. Oz Tried to Sell Us in 2012

Many of us will never live to see a true miracle. Dr. Oz apparently found six this year alone!

Dr. Oz had another banner year on his talk show as he brought the latest and greatest health news to our living rooms each afternoon. The only rub is that some of us are questioning the good doctor and what he’s calling healthy advice these days. It seems Dr. Oz may have become more of a talk show host than a well-intentioned physician. This year, especially, the show constantly doled out miracle diet advice. While weight loss is at the top of our health concerns, it seemed the doctor derailed from prescribing trustworthy weight loss guidance to endorsements for every fad that would ultimately yield no life change, just money spent and potential side-effects.

These are the miracle diet cures (his words, not ours) that Dr. Oz unleashed on us this year. It might be more accurate to call them scams.

Raspberry Ketones

These little supplements were touted as a revolutionary metabolism booster and the compounds, typically used as food flavorings, have been purposed for weight loss supplements in Japan. Dr. Oz endorsed raspberry ketones as an effective weight loss tool as well. The theory behind the ketones is that that they alter lipid metabolism, claims found from a study in mice. The mouse with the high fat diet and the supplement gained less body fat than expected. Raspberry ketones have not yet been tested on humans. (more…)

Qsymia Approval Delivers Most Potent Weight Loss Drug on the Market

The U.S. Food and Drug Administration has approved the weight loss drug Qsymia, which went through trials as Qnexa. Dr. Oz made it popular before the approval even came, with an episode about the “the silver bullet” diet pill this spring. It’s the second diet drug to be approved by the FDA in 13 years, and the second this summer, following last month’s Lorcaserin approval. It will be the most potent weight loss drug on the market.

The drug was approved by an FDA Advisory Panel by a landslide vote of 20-2 in February, and yesterday the agency announced its final approval of Qsymia. The drug was approved for adults with a (BMI) of 30 or greater, which is categorized as obese, or adults with a BMI of 27 or greater, categorized as overweight, who have at least one obesity-related disease like high blood pressure/hypertension, type 2 diabetes, or high cholesterol.

Vivus, the creators of Qsymia, claim that just one pill a day will suppress the appetite and help obese individuals lose 10 percent of their body weight. The pill is comprised of two drugs that were already on the market in various weight loss drugs – one of which is phentermine, a type of amphetamine that stimulates the nervous system and increases heart rate and blood pressure. It’s used in weight loss drugs to suppress appetite, and is more commonly recognized as the “Phen” in the weight loss drug Fen-Phen, which was yanked from shelves by the FDA in 1997 after being deemed too dangerous for consumption. The other drug is an anti-seizure medication that helps stimulate weight loss.

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Diet Pill Belviq Approved; First New Weight Loss Drug in 13 Years

It promises to help patients lose five-to-ten percent of their weight (according to clinical trials) when combined with diet and exercise. But is this what America’s overweight patients really need?

Lorcaserin, the drug name for the prescription diet pill Belviq, was approved by the FDA today, making it the first weight loss drug to receive such approval since Orlistat (Alli) in 1999. This comes just weeks ahead of what is anticipated to be an FDA approval for Qnexa, another weight loss drug.

“In two clinical trials, Lorcaserin helped patients lose 5.8 percent of their body weight after a year. That’s about ten pounds for a 180 pound person. Big deal,” said our resident dietitian Mary Hartley, RD.

The drug works by controlling the appetite by making the brain think its fuller sooner. It’s fared well in clinical trials, and will have to undergo six more studies after its in market to ensure long-term cardiovascular health and to determine Belviq’s risk factor for heart attack and stroke. This makes the in-market patients unassuming guinea pigs, according to Hartley, and that isn’t right.

“The advisory committee decided that the benefits of the drug outweighed the risks heart value problems, but the drug manufacturer was made to conduct post-marketing studies to assess long-term cardiac events such as heart attack and stroke. That makes the patient a guinea pig. No thanks.” (more…)

Qnexa: The Dangerous ‘Silver Bullet’ Weight Loss Pill

UPDATE 7/17/12: Qnexa was approved by the FDA on July 17, 2012. This marks the second weight loss drug approval in 2012; the first weight loss drugs approved since Alli in 1999. The prescription drug will be sold as Qsymia.

Many people have inquired about ‘The Silver Bullet’ weight loss pill since we posted about its appearance on the Dr. Oz Show several weeks back. And to clarify what exactly the silver bullet pill is, it’s the controversial weight loss drug Qnexa, which has only received preliminary approval from an FDA advisory panel –  not from the FDA.

While Dr. Oz says may this be the ‘magic bullet’ America has been waiting for, we would caution consumers before buying into that thought.

Qnexa promises to suppress appetite, cut cravings and increase weight loss. But that’s because it’s comprised of two potentially dangerous drugs called topiramate and phentermine. Phentermine, a type of amphetamine that stimulates the nervous system and increases heart rate and blood pressure, has been commonly used in diet pills because it suppresses appetite. It’s most often recognized as the “Phen” in the weight loss drug Fen-Phen, which was pulled from the market by the FDA in 1997 after being deemed ‘too dangerous for consumption.’ (more…)

Potential Qnexa Users Better Off With a Salad Spinner and Walking Shoes

UPDATE 7/17/12: Qnexa was approved by the FDA on July 17, 2012. This marks the second weight loss drug approval in 2012; the first weight loss drugs approved since Alli in 1999. The prescription drug will be sold as Qsymia.

The inmates are running the asylum. Reversing an earlier decision, the medical experts on FDA’s Endocrinologic and Metabolic Drugs Panel cleared the way for approval of the new diet drug Qnexa. Qnexa (PHEN/TPM) is a combination of phentermine and topiramate (PHEN/TPM). Topiramate is used to treat seizures and prevent migraine headaches and phentermine is approved for the short-term treatment (i.e. a few weeks) of obesity. PHEN was half of PHEN/FEN, the discontinued diet drug that led to valvular heart disease and potentially fatal pulmonary hypertension, primarily in women. Qnexa is indicated for “BMI greater-than or equal to 27 kg/m2) with weight-related co-morbidities such as hypertension, type 2 diabetes, dyslipidemia, or central adiposity (abdominal obesity),” the group with the highest heart disease risk.

The panel decided that the complications of obesity outweighed the risk of heart problems. It’s hard to believe they were swayed by the research. The 2010 study published in the Lancet reported that people who took the highest dose of Qnexa (not the lower approved dose) lost at least 10% of their body weight and showed improvements in their risk cardiac factors. Clinical trials by the manufacturer showed 45% of subjects treated at the low dose lost > 5% of baseline body weight following one year of treatment. No one seems to care that we’re talking about a 10 to 15 pound weight loss on a 200 pound person. Do we need a drug for that, especially one that comes with heart disease risk? No matter because the results showed statistical significance in a placebo control study. (more…)

Diet Pill Qnexa Approved by FDA Advisory Panel

Qnexa, a diet pill created by Vivus, Inc., that claims to help dieters lose 10% of their weight when combined with diet and exercise, has been approved by the FDA advisory panel in a landslide vote of 20-2.

The panel had previously rejected the the pill due to safety concerns, which has left its opponents concerned. Since the FDA typically follows the advice of its advisory panel, the drug is likely to be approved by mid-April.

Previous concerns about the drug are still present. And if the pill does go on shelves, potential users should be aware of that. One of Qnexa’s main ingredients is phentermine, a type of amphetamine that stimulates the nervous system and increases heart rate and blood pressure. It’s commonly used in diet pills since it suppresses appetite, and was woefully recognized as the “Phen” in the weight loss drug Fen-Phen, which was yanked from the market by the FDA in 1997 after being deemed too dangerous for consumption. (more…)

FDA Requires More Testing of Weight Loss Drugs

An advisory committee to the Food and Drug Administration decided that obesity drugs must undergo clinical trials to ensure they do not cause heart attacks. The 17 to 6 vote now requires studies for all obesity drugs even if no apparent cardiovascular risk exist.

The track record of weight loss drugs has not been stellar. Though the new testing requirement will require much more time and money and ultimately impede drug production, the majority felt strongly about their decision.

“Given the checkered history of weight loss drugs, I think it is better to be prudent and err on the side of caution,” Dr. Sanjay Kaul, a cardiologist at Cedars-Sinai Medical Center in Los Angeles.

Those who oppose the vote feel a much needed treatment will now be difficult to administer.

“If the F.D.A. follows through with this vote, you’ve just added another big disincentive for the drug companies to come up with obesity drugs, and we desperately need new drugs,” said Dr. Ed J. Hendricks, an obesity specialist in Sacramento.

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Qnexa’s Side Effect Profile has Critics Concerned

With the obesity epidemic on a collision course with no stop in sight, the FDA and drug developers are feeling the pressure to approve and develop weight loss drugs at a fast clip. Qnexa could be approved by the FDA by April but some people are wondering how this could happen when it was initially rejected by the FDA advisory committee a couple years ago.

Qnexa, which is a combination drug of phentermine and topiramate, was initially brought to the FDA advisory committee’s attention in 2010. The committee basically told the drug maker Vivus to go back to the drawing board and give them more concrete data about the phentermine portion of Qnexa would not lead to cardiac events like heart attacks even with its side effect of increased blood pressure. The committee also wanted a plan in place to prevent women of childbearing age from being exposed to topiramate’s birth defect potential if they became pregnant while on Qnexa.

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Qnexa is One Step Closer to FDA Approval

If, at first, you don’t succeed try, try again. That’s what Vivus, the makers of a diet drug called Qnexa did by resubmitting their drug approval application to the FDA advisory committee and it is now one step closer to being approved. The initial application was rejected because of two main concerns: risk of cardiac events like heart attacks and risk to women of child bearing age and women who may be pregnant.

Qnexa is a combination drug of phentermine and topiramate. Both these drugs are currently available by prescription which makes the approval process a little bit easier for Qnexa because there already are a lot of clinical trials and data available about these drugs. Phetermine increases metabolism while topiramate is used for seizures, migraine prevention and as an adjunct therapy for conditions like bipolar disorder. Weight loss for topiramate is really more of a glorified side effect that is believed to be caused by an increase in energy for the patient and increased feeling of fullness after eating because the digestive tract is slowed down.

Qnexa is a capsule made up of immediate release phentermine and extended release topiramate which would have a longer duration of action and is taken once daily. Vivus is currently studying the use of a low, moderate and high dose combination. Qnexa is indicated for people who have a BMI of 30 or higher or overweight patients with a BMI greater than 27 who have other conditions like hypertension, type 2 diabetes, high cholesterol, and fat that is most prominent on the abdomen also known as belly fat. The most common side effects of this combination drug include a prickling or tingling sensation, dry mouth, constipation, and headache.

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Safety of Qnexa Diet Pill Still Concerns FDA

vivus pharmaceuticals logoThe small pharmaceutical company Vivus is preparing to resubmit its diet pill Qnexa for approval from the FDA, however federal officials still have concerns. The FDA initially rejected the weight loss medication in October of 2010, due to concerns that taking the drug could increase the risk possible birth defects and heart problems.

Qnexa is a drug that combines two existing the appetite suppressant Phentermine and the anti-convulsant Topiramate. Vivus has gone through several rounds of research in the process of resubmitting its request to the FDA, and succeed in lifting the contraindication for women of child-bearing age, although the FDA is still worried about a possible link between Qnexa and cleft lip defects. The drug has also been shown to increase blood pressure and cause higher heart rates in some patients.

The FDA will hold a public meeting on Wednesday with experts to try to resolve these concerns.  The panel of doctors will also decided if any additional research is required, and will take a vote on Qnexa’s safety, and the FDA is expected to make its final ruling in April. Vivus will offer to conduct a long-term follow-up study to monitor patients for heart events.

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