FDA Backs Diet Drug Qnexa - OMG.

M M
on 2/22/12 11:14 pm, edited 2/22/12 11:15 pm
 

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Oh. wow.  That is all.

Via LA Times -

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.

 
Neal R.
on 2/22/12 11:27 pm - Wylie, TX
That's kind of sad. The ironic part is that there will be people who take this with the risks for an average of a 10% weight loss who will bad mouth WLS because it's too dangerous or cheating.

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M M
on 2/22/12 11:44 pm
 Or people like me who had WLS and will take a drug like this anyway.  LOL.
(deactivated member)
on 2/22/12 11:49 pm
 MM
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!     
MyLady Heidi
on 2/23/12 12:18 am
Can I take 2014 as when the first lawsuits will start over whatever horrible side effect this is gonna have?  Because it will and then the lawyers will go nuts.
M M
on 2/23/12 12:21 am
 
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.

(deactivated member)
on 2/23/12 1:57 am
Once upon a time  the FDA  approved  "Phen Phen"  along with  many other RX"s  that have been taken off the  US market after initial FDA  approval . Hind sight  has a way of being 20/20. 
loverofcats
on 2/23/12 12:34 am
The side effect profile for these two drugs separately is horrendous. I don't know what the combo will do. Phenteremine is known to increase heart rate, increase blood pressure, increase irritability for starters. Topirarmate is an anticonvulsant medication that can cause concentration and memory problems, increased risk of kidney stones, numbness and tingling for starters.

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.
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M M
on 2/23/12 12:38 am
Topiramate ... also often mood issues and sleepiness... It's good times...
loverofcats
on 2/23/12 1:38 am
Yes, it can be helpful for mood issues and sleepiness, but otoh, it can also contribute to increased risk of kidney stones, lack of concentration and memory problems, as well as numbness and tingling. Sometimes the side effects are dose related, but I wouldn't take this combo of drugs.
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