Antoaneta Sawyer, PhD
The FDA Endocrinologic and Metabolic Drug Advisory Committee (July 15, 2010) failed to endorse the new obesity drug Qnexa® (Phentermine/ Topiramate) of Vivus Inc. for a final approval, due to concerns of its safety. In a final 10-6 vote, the FDA Advisory Panel concluded that they were concerned that Qnexa was too experimental. (Source, FDA and ChicagoTribune)
Most, if not all members agreed that Qnexa® is very effective drug- a combination of two separate drugs working in obvious synergism in inducing sensible weight loss. The drug alters the taste of food and boosts human metabolism, by cutting a person's body weight up to 15 percent. (Source, Vivus)
Despite their agreement on the efficacy of the drug, a number of side effects (e.g. depression, anxiety, insomnia, attention deficit/ hyperactivity disorder,metabolic acidosis, tachycardia, language and cognitive disorders, suicidal thoughts and teratogenicity) postponed the final Advisory Committee approval. It is obvious that the benefits of Qnexa® did not outweigh its potential risks.
Abraham Thomas, MD, MPH (Whitehouse Chair of Endocrinology at Henry Ford Hospital, Detroit, MI) agreed, "Qnexa® is far superior to anything else on the market. But our concerns are with safety. These have to be addressed, and I think it's best if these are addressed before approval." He especially was concerned about the metabolic acidosis that may occur with its use, reflecting young individuals bone health.
Some of the members proposed further pharmacodynamic studies and longer period of a follow-up (five years), while emphasizing on the increasing necessity of new anti-obesity drugs, due to the pandemic rate of obesity in U.S. The short follow-up of one year, was the major reason for casting a negative vote, for some of the panel members.
Michael Rogawski, MD, PhD (Chair of Neurology at the UC,Davis, Sacramento, CA) agreed, "Clearly we need more information about this medication, but the type of information we need, particularly with respect to teratogenicity, cannot be gained in a clinical trial setting, it can only be gained once the drug is on the market and large numbers of individuals are exposed to it."
Michael Proschan, PhD (Statistician from the National Institutes of Health, Bethesda, MD), explained his negative vote with the following statement, "A lot of these potential problems are brain related — depression, anxiety, memory, cognitive, and that always makes me worry a little more than with other kinds of problems. I don't think we have enough data to be able to say whether they are serious issues or not. I think if we had had longer follow-up I probably would have voted the other way but I just don't feel comfortable with 1-year follow-up."
Jessica Henderson, PhD (Acting Consumer Representative on the panel) voted in favor of Qnexa® approval, although she agreed that long-term safety data are missing. She concluded, "As a consumer representative, I put a lot of credence into quality of life and the pursuit of life, liberty, and happiness and a patient's right to those things."
Kenneth Burman, MD – (Acting Chair and endocrinologyst at Washington Hospital Center in Washington, DC) finally concluded, "We know that obesity is a major health problem and all efforts to address this issue should be lauded. Qnexa® does meet or exceed the agency's requirement for efficacy. On the other hand the medication has serious potential adverse effects, including potential teratogenicity, increased suicidal ideation, cognitive issues, tachycardia, and possible renal stones. Some of these side effects are serious and could be life threatening, and they have to be weighed against the potential of a relatively modest weight loss and its long-term health benefits."
Most, if not all members agreed that Qnexa® is very effective drug- a combination of two separate drugs working in obvious synergism in inducing sensible weight loss. The drug alters the taste of food and boosts human metabolism, by cutting a person's body weight up to 15 percent. (Source, Vivus)
Despite their agreement on the efficacy of the drug, a number of side effects (e.g. depression, anxiety, insomnia, attention deficit/ hyperactivity disorder,metabolic acidosis, tachycardia, language and cognitive disorders, suicidal thoughts and teratogenicity) postponed the final Advisory Committee approval. It is obvious that the benefits of Qnexa® did not outweigh its potential risks.
Abraham Thomas, MD, MPH (Whitehouse Chair of Endocrinology at Henry Ford Hospital, Detroit, MI) agreed, "Qnexa® is far superior to anything else on the market. But our concerns are with safety. These have to be addressed, and I think it's best if these are addressed before approval." He especially was concerned about the metabolic acidosis that may occur with its use, reflecting young individuals bone health.
Some of the members proposed further pharmacodynamic studies and longer period of a follow-up (five years), while emphasizing on the increasing necessity of new anti-obesity drugs, due to the pandemic rate of obesity in U.S. The short follow-up of one year, was the major reason for casting a negative vote, for some of the panel members.
Michael Rogawski, MD, PhD (Chair of Neurology at the UC,Davis, Sacramento, CA) agreed, "Clearly we need more information about this medication, but the type of information we need, particularly with respect to teratogenicity, cannot be gained in a clinical trial setting, it can only be gained once the drug is on the market and large numbers of individuals are exposed to it."
Michael Proschan, PhD (Statistician from the National Institutes of Health, Bethesda, MD), explained his negative vote with the following statement, "A lot of these potential problems are brain related — depression, anxiety, memory, cognitive, and that always makes me worry a little more than with other kinds of problems. I don't think we have enough data to be able to say whether they are serious issues or not. I think if we had had longer follow-up I probably would have voted the other way but I just don't feel comfortable with 1-year follow-up."
Jessica Henderson, PhD (Acting Consumer Representative on the panel) voted in favor of Qnexa® approval, although she agreed that long-term safety data are missing. She concluded, "As a consumer representative, I put a lot of credence into quality of life and the pursuit of life, liberty, and happiness and a patient's right to those things."
Kenneth Burman, MD – (Acting Chair and endocrinologyst at Washington Hospital Center in Washington, DC) finally concluded, "We know that obesity is a major health problem and all efforts to address this issue should be lauded. Qnexa® does meet or exceed the agency's requirement for efficacy. On the other hand the medication has serious potential adverse effects, including potential teratogenicity, increased suicidal ideation, cognitive issues, tachycardia, and possible renal stones. Some of these side effects are serious and could be life threatening, and they have to be weighed against the potential of a relatively modest weight loss and its long-term health benefits."
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Photo credit: Flickr (Colros)
Photo credit: Flickr (Colros)
Courtesy: Youtube.com (LoCiceroMedicalGroup)
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