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| − | About two years ago I wrote concerning the two newest weight reduction drugs rejected by the FDA. Among these drugs was Qnexa a mixture pill made up of two effectively established drugs, phentermine and topiramate (Topamax). At that time the FDA felt there was not adequate info concerning the possible cardiac risks with the drug to let its promoting within the U.S. Now the same drug, produced by precisely the same business, Vivus, has recently been authorized by the FDA below a different name, Qsymia. Certainly one of the terms of approval is the fact that the enterprise will conduct on-going surveillance studies on the cardiovascular threat of making use of this drug.
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| − | The FDA prescribing suggestions for Qsymia are surprisingly lenient, requiring only that an otherwise wholesome patient possess a BMI of 30 or more. or for a person with underlying illnesses such as diabetes, a BMI of 27 or a lot more. As an example, at five foot 5 inches a person having a BMI of 27 will weigh 165 lb and for the identical height a BMI of 30 is 180 lb.
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| − | Qsymia is composed of two drugs with long-standing FDA approval. Topiramate was authorized in 1996 for therapy of epilepsy and phentermine has been available because 1959. Both drugs are recognized to suppress appetite and are connected with fat reduction. In Qsymia, a long acting version of topiramate and phenteramine are combined in a ratio of six:1. Within a 1 year study performed by Vivus, obese subjects taking the higher dose of Qsymia lost on typical an impressive 9% of their weight.[http://www.youtube.com/user/phen375q Qsymia reviews]
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| − | In 2010, I predicted it would take 10 years for drugs like Qsymia to get acceptance by the FDA. Clearly I was wrong by eight years but I wonder what happened in the past 2 years. The primary concern expressed by the FDA in 2010 was potential for cardiovascular complications of utilizing this drug combination. I've not been able to discover any substantial research supplying reassurance about this possible complication. The FDA is requiring on-going surveillance studies to detect these challenges but how will that function for all those who take the drug now and are at prospective danger?
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| − | I believe it can be sensible to be skeptical of drug firm sponsored research. Talk about conflict of interest! Nonetheless the risk of these drugs is well-known in light with the extended history of use by both up till now. One especially strong warning from Vivus is that females at danger of becoming pregnant need to not obtain this drug. This warning has been in location considering that initial approval in 1996 of the topiramate element.
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| − | A further condition of approval for Qsymia by the FDA should be to limit the pharmacies allowed to dispense the drug and for physicians to finish a very simple education program just before being permitted to prescribe it. I'm eager to see how this operates out. Painful recollections of your Fen-Phen debacle 15 years ago, creates a degree of anxiety for many experienced physicians when pondering of prescribing a brand new weight-loss drug. Offered the restricted quantity of obtainable alternatives for treating those with obesity who're at risk for complications of diabetes, hypertension, arthritis and so on.
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Текущая версия на 22:25, 26 декабря 2025
