FDA Backs Diet Drug Qnexa - OMG.
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Oh. wow. That is all.
A panel of medical experts voted overwhelmingly Wednesday to endorse the controversial weight-loss drug Qnexa, clearing the way for the Food and Drug Administration to approve a new prescription obesity medication for the first time since 1999. The FDA will issue a final ruling later this year, but the agency typically follows the recommendations of its advisory committees.
The 20-2 vote in favor of Qnexa was a surprising reversal from 2010, when the same advisory committee decided that the drug's riskss outweighed its weight-loss benefits.
In a clinical trial involving 4,323 people, Qnexa — a combination of the anticonvulsant drug topiramate and the appetite suppressant phentermine led to an average loss of about 10% of total body weight in the first year of use.
According to the clinical trial data and previous studies, the risk of having a baby with a cleft lip is two to five times greater in women who took topiramate.
"The simple reality is, if you're pregnant or planning on getting pregnant, it's not the right drug for you," said Joe Nadglowski, chief executive of the Obesity Action Coalition, a patient advocacy group that supports approval of Qnexa.
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on 2/22/12 11:49 pm
My thoughts ...
The FDA approves many drugs and once in a while , they Recall them.
Because of the Obesity epidemic in this country , the FDA has reduced the minimum weight and health reqs for lap bands just last year, and it appears the FDA is perhaps making some attempt to cope with the Obesity crisis this country faces, by approving this drug. We all know being obese Increases the risks of Cancer, pre Diabetes and Diabetes. Now , they are linking Dementia to Diabetes .
Look at Medicare ... Look at the Baby Boomers using or about to start using Medicare ! Think about next generations coming of age and OBESE! What a Burden that will place on a taxed Medicare system! Medicaid has placed many cuts for those w/o insurance, WLS is one of them in some states. Obese people often pay Higher premiums for Insurance. I think the FDA may be having an " OH CRAP" moment , or Two.
We all know Obesity sucks, we all been there. The financial ramifications on the Government from an Obese Society is a FDA wake up call. The Bottom line $$$ will be staggering!
Birth defects and heart problems....
The committee today recommended that the manufacturer take a number of steps to prevent the drug from causing birth defects like cleft palate, including a possible warning label targeted toward women of childbearing years.
Critics say the risk of potentially dangerous side effects of Qnexa, whi*****lude increased heart rate, heart attacks and arrhythmias, are too great to make the drug available to millions of people, especially because long-term effects of the drug are still largely unknown.
There isn't anyway in hell that I would take the combination of these two drugs. The FDA is desperate to find something to help with weight loss.
10% weight loss over a year's period of time might be helpful for folks with a lower BMI, but for the MO, it is a drop in the bucket.
So someone taking this combo will be confused, unable to concentrate, be more irritable, have higher blood pressure, and may have numbness and tingling. Sure sounds like a winner to me (not). These are very common side effects. It will be interesting to see the amounts of each drug that are contained in Qnexa.