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Phentermine/Topamax
Indication: BMI of 27 with hypertension/bad lipids. Or BMI of 30.
Anyone reading this not fall into the above?
I liked the Phen/Fen drug myself. I boffed a couple of ex-fat girls. Then they got fat again. I remember running into this girl I went to grad school with in a Manhattan Bar. I didn't even recognize her. Good time! Good time!
I hope all you youngsters benefit from this product as I did from its first iteration. Advice: start being nice to the fat girls with pretty faces. They go wild with their new bodies. Thank me later.
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FDA Panel Votes in Favor of Qnexa
By Joyce Frieden, News Editor, MedPage Today
Published: February 22, 2012
SILVER SPRING, Md. – An FDA advisory panel has voted 20-2 to recommend approval of the weight-loss drug Qnexa, but urged the agency to require a post-approval trial to monitor for cardiovascular side effects.
Members of the Endocrinologic and Metabolic Drugs Advisory Committee voting in favor of the phentermine/topiramate combination, expressed concerned about the increased risk of an elevated heartbeat and birth defects -- specifically oral clefts -- in infants born to women taking the drug, but were swayed by the fact that the drug's two ingredients are already on the market and can be prescribed off-label.
Those same concerns prompted the panel to recommend against approval in 2010 and the FDA to reject the drug shortly thereafter. Last Friday, FDA staff reviewers raised the same concerns in briefing documents prepared for Wednesday's meeting.
In the current vote, the panel seemed inclined to go with the devil they knew.
"It seems much better to come into the monitoring that's going to come with approval" of the drug, rather than have people taking it off-label with no monitoring, said panel member Erica Brittain, PhD, a statistician at the National Institute of Allergy and Infectious Diseases, in Bethesda, Md.
"It's already on the market with the potential of high-dose misuse, and, also, we can't doubt the benefit of weight loss," said panelist Jessica Henderson, PhD, of Western Oregon University, who was the committee's consumer representative.
The FDA does not have to follow the advice of its advisory committees, but often does.
The drug's maker, Vivus, is seeking approval for a once-daily pill for obese men and women with a body mass index (BMI) of 30 or higher, or for those with a BMI of 27 or higher who also have weight-related comorbidities such as hypertension, diabetes, dyslipidemia, or central adiposity.
The drug combines low doses of phentermine, an appetite suppressant that was the most widely prescribed obesity drug in 2009, and topiramate, an anti-seizure medication that increases the feeling of being full and satisfied.
During the meeting, the company presented data showing the drug was effective in helping patients lose 6% to 10% of their body weight, and also lowered blood pressure.
Cardiovascular safety is a major concern, largely because half of the combination is phentermine, a component of Fen-Phen, the popular fenfluramine/phentermine obesity drug that was found to increase the risk of valvular heart disease. Fen-Phen was pulled from the market just six months after it was approved in 1997.
Panelist Sanjay Kaul, MD, of the University of California in Los Angeles, said that "the overall evidence [on cardiovascular safety] is insufficient to adjudicate cardiovascular risk, thus necessitating a large cardiovascular outcomes trial," which could be done post approval.
For this meeting, the FDA reviewers looked at three studies that were conducted after the first advisory committee review of Qnexa. The new studies assessed the risk of major congenital malformations and oral clefts with topiramate exposure in utero.
The reviewers concluded that the three additional trials did not show an association of topiramate exposure and risk of major congenital malformations. However, they noted that topiramate monotherapy exposure in pregnancy was likely to be associated with a two- to five-fold increased prevalence of oral clefts, they said.
Several panelists expressed concerns about the adverse events, especially the heart rate increase. "[Increased heart] rate is a surrogate in the sense that it is a risk factor for cardiovascular morbidity and mortality," said committee member Almut Winterstein, PhD, of the College of Public Health and Health Professions, in Gainesville, Fla.
To address the concerns over side effects, Vivus worked with the FDA to develop a risk mitigation strategy for Qnexa.
Features of the strategy included:
Labeling stating that the drug is in Pregnancy Category X (contraindicated in women who may become pregnant) and that the drug should be discontinued if the patient becomes pregnant
Distribution of Qnexa only through 10 certified mail-order pharmacies that agree to training of their pharmacists in use of the drug and submitting to internal audits
Targeted education programs aimed at providers and patients, including a brochure on contraception and recommendations for monthly pregnancy testing
Development of a pregnancy registry to track pregnancy outcomes
Comments during the public hearing portion of the meeting were divided.
Denise Bruner, MD, of the American Society of Bariatric Physicians, urged the panel to recommend approval, noting how few options there were for obesity treatment. "Probably we could conclude that there would be a reduction in cardiovascular morbidity and mortality that would happen," she said. "Please approve Qnexa."
On the other side, Sidney Wolfe, MD, head of Public Citizen's Health Research Group, urged against an approval recommendation because of the cardiovascular issues. "Public health cannot tolerate another diet drug approved that has not been [inspected] for cardiovascular risk," he said.
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Indication: BMI of 27 with hypertension/bad lipids. Or BMI of 30.
Anyone reading this not fall into the above?
I liked the Phen/Fen drug myself. I boffed a couple of ex-fat girls. Then they got fat again. I remember running into this girl I went to grad school with in a Manhattan Bar. I didn't even recognize her. Good time! Good time!
I hope all you youngsters benefit from this product as I did from its first iteration. Advice: start being nice to the fat girls with pretty faces. They go wild with their new bodies. Thank me later.
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Quick FindKeyword Search
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Medpage Today » Policy » FDA General
FDA General Latest News| Meetings| Videos
Email Print Save
FDA Panel Votes in Favor of Qnexa
By Joyce Frieden, News Editor, MedPage Today
Published: February 22, 2012
SILVER SPRING, Md. – An FDA advisory panel has voted 20-2 to recommend approval of the weight-loss drug Qnexa, but urged the agency to require a post-approval trial to monitor for cardiovascular side effects.
Members of the Endocrinologic and Metabolic Drugs Advisory Committee voting in favor of the phentermine/topiramate combination, expressed concerned about the increased risk of an elevated heartbeat and birth defects -- specifically oral clefts -- in infants born to women taking the drug, but were swayed by the fact that the drug's two ingredients are already on the market and can be prescribed off-label.
Those same concerns prompted the panel to recommend against approval in 2010 and the FDA to reject the drug shortly thereafter. Last Friday, FDA staff reviewers raised the same concerns in briefing documents prepared for Wednesday's meeting.
In the current vote, the panel seemed inclined to go with the devil they knew.
"It seems much better to come into the monitoring that's going to come with approval" of the drug, rather than have people taking it off-label with no monitoring, said panel member Erica Brittain, PhD, a statistician at the National Institute of Allergy and Infectious Diseases, in Bethesda, Md.
"It's already on the market with the potential of high-dose misuse, and, also, we can't doubt the benefit of weight loss," said panelist Jessica Henderson, PhD, of Western Oregon University, who was the committee's consumer representative.
The FDA does not have to follow the advice of its advisory committees, but often does.
The drug's maker, Vivus, is seeking approval for a once-daily pill for obese men and women with a body mass index (BMI) of 30 or higher, or for those with a BMI of 27 or higher who also have weight-related comorbidities such as hypertension, diabetes, dyslipidemia, or central adiposity.
The drug combines low doses of phentermine, an appetite suppressant that was the most widely prescribed obesity drug in 2009, and topiramate, an anti-seizure medication that increases the feeling of being full and satisfied.
During the meeting, the company presented data showing the drug was effective in helping patients lose 6% to 10% of their body weight, and also lowered blood pressure.
Cardiovascular safety is a major concern, largely because half of the combination is phentermine, a component of Fen-Phen, the popular fenfluramine/phentermine obesity drug that was found to increase the risk of valvular heart disease. Fen-Phen was pulled from the market just six months after it was approved in 1997.
Panelist Sanjay Kaul, MD, of the University of California in Los Angeles, said that "the overall evidence [on cardiovascular safety] is insufficient to adjudicate cardiovascular risk, thus necessitating a large cardiovascular outcomes trial," which could be done post approval.
For this meeting, the FDA reviewers looked at three studies that were conducted after the first advisory committee review of Qnexa. The new studies assessed the risk of major congenital malformations and oral clefts with topiramate exposure in utero.
The reviewers concluded that the three additional trials did not show an association of topiramate exposure and risk of major congenital malformations. However, they noted that topiramate monotherapy exposure in pregnancy was likely to be associated with a two- to five-fold increased prevalence of oral clefts, they said.
Several panelists expressed concerns about the adverse events, especially the heart rate increase. "[Increased heart] rate is a surrogate in the sense that it is a risk factor for cardiovascular morbidity and mortality," said committee member Almut Winterstein, PhD, of the College of Public Health and Health Professions, in Gainesville, Fla.
To address the concerns over side effects, Vivus worked with the FDA to develop a risk mitigation strategy for Qnexa.
Features of the strategy included:
Labeling stating that the drug is in Pregnancy Category X (contraindicated in women who may become pregnant) and that the drug should be discontinued if the patient becomes pregnant
Distribution of Qnexa only through 10 certified mail-order pharmacies that agree to training of their pharmacists in use of the drug and submitting to internal audits
Targeted education programs aimed at providers and patients, including a brochure on contraception and recommendations for monthly pregnancy testing
Development of a pregnancy registry to track pregnancy outcomes
Comments during the public hearing portion of the meeting were divided.
Denise Bruner, MD, of the American Society of Bariatric Physicians, urged the panel to recommend approval, noting how few options there were for obesity treatment. "Probably we could conclude that there would be a reduction in cardiovascular morbidity and mortality that would happen," she said. "Please approve Qnexa."
On the other side, Sidney Wolfe, MD, head of Public Citizen's Health Research Group, urged against an approval recommendation because of the cardiovascular issues. "Public health cannot tolerate another diet drug approved that has not been [inspected] for cardiovascular risk," he said.
Be the first to leave a comment
Rate this Article
Email Print Save
Resources (from Industry)
Video Library
Medical Education (Non-CME)
CME Spotlights
Current Survey Past Surveys »
How Do You Treat Sinusitis?
A recent study confirmed that treatment with antibiotics -- or at least amoxicillin -- is of no help in cases of acute sinusitis.
What do you usually tell patients with sinusitis?
Use a nasal spray and/or decongestant
Wait a couple weeks before we try antibiotics
See an ENT
Nothing can be done
Other
Total votes 2441 |
MedPage Today® surveys are polls of those who choose to participate and are, therefore, not valid statistical samples, but rather a snapshot of what your colleagues are thinking
Last edited:
