Qsymia/Qnexa – the New Weight Loss Miracle Drug.

I don’t have a lot of time for pharmaceuticals – especially for those associated with weight loss, but there’s a new one, Qnexa (which will be marketed under the brand name Qsymia), that’s about to receive FDA approval. So I thought I’d do a little bit of research and find out what all the fuss is about.

Here’s what I found out. Qnexa is manufactured by Vivus Inc. On the day the FDA panel voted 20 to 2 in favour of approval, Vivus’ stock jumped 98%.

So that’s great isn’t it?

FDA approval means it’s safe and it does what it claims it will do – doesn’t it?

And that’s got to be really good news for people struggling to lose weight – hasn’t it?

Well…

One of the things most people don’t know about pharmaceutical solutions is that all drugs have side effects. What approval means is that the benefits outweigh the side effects. Sometimes drug side effects are quite severe, but if the drug means the difference between life and death then the severe side effects can be tolerated. If it’s an over the counter preparation (OTC) available without prescription then the side effect tolerance is much lower – in theory at least. You might want to check this out for more on OTC safety

So how does this new drug work and will it really help you to lose weight?

Qnexa is a mixture of phentermine and topiramate.

Phentermine

Phentermine was a part of a diet drug marketed in the 1980’s but it was withdrawn because it damaged heart valves. It works like amphetamines and suppresses appetite. It has two sigificant side effects – tachycardia and elevated blood pressure. Interestingly, the FDA is concerned about heart risk with phentermine and is looking at the possibility of further studies – but these will only be required after approval and not before. Safety seems to me to be taking a back seat when there are billions of dollars waiting to be made.

Interestingly the appetite suppressant effect of phentermine only lasts a few weeks, so the problem will be to stop people increasing the dosage when this happens. Especially if they have enjoyed watching the pounds fall away effortlessly.

Increased dosage means increased risk.

But let’s not ignore the other drug that contributes to the magic of Qnexa – topiramate.

Topiramate

Here are some of the listed side effects:

Depression, confusion, chest pain, memory loss, difficulty breathing, concentration problems, hallucinations, difficulty with speech, fainting, mood swings, paranoia, fatigue, vision difficulty and eye pain, wanting to sleep, deep vein thrombosis, suicide, hyperglycemia, kidney stones, and allergic reactions.

42% of people taking this drug reported cognitive or mental problems.

Qnexa itself seems to be causing serious concerns relating to cardiovascular problems (just as with most other miracle weight loss drugs that had to be withdrawn) and also possible birth defects (cleft lip & cleft palate). The solution to this, suggested by the manufacturers, is adequate birth control!!!!

So it’s looking good so far.

But when we look a little deeper into this we begin to see something more than a wonder drug that benefactors Vivus are blessing humanity with.

FDA – going through the motions

Before the vote the FDA prepared a 161 page document espousing Qnexa’s benefits and strongly recommending approval. The FDA, by the way, gets most of it’s funding from the pharmaceutical industry. Isn’t that a bit like letting the criminal fraternity run the Justice System? It seems that wisdom, and the safety of those tha FDA is supposed to be protecting (the American people), fall by the wayside in the FDA’s desperate attempt to come up with an ‘easy solution’ to the obesity epidemic that the US is suffering from. And, of course, the medical mindset is that the only solution is a pharmacological one. Never mind encouraging people to do something simple and safe like eating a little less and exercising a little more.

The problem, it seems, is that there is no competition for this new drug, so everyone who wants to carry on eating and make no changes to their lifestyle sees this as an easy option. Every one will want it. Everyone wants the easy option. Even though a prescription will be required it will be available without through internet sources and Vivus will make billions of dollars.

“This drug, if approved, would likely be prescribed to millions or tens of millions of people,” said Dr. Michael Lauer, director of the division of cardiovascular sciences at the National Institutes of Health. Dr Lauer voted against the approval of this drug back in 2010, and was one of the two who voted against recently. He also says “We cannot assume that just because a drug reduces weight and improves some biomarkers that it will be safe, let alone beneficial.”

Serious Safety Concerns

The overwhelming consensus (outside of the FDA of course) is that there are potentially serious cardiovascular problems with this drug and it needs much more rigorous examination. That examination needs to take place prior to approval, not after. But the writing is on the wall and the desperate search for a magical solution to a lifestyle problem is going to ensure that profits win out over safety and the only ones who will suffer are those who trust their doctors and are desperate for help with a problem they feel powerless to impact.

 

Michael

My thanks to:
http://www.justiceforyou.com/2012/02/consequences-qnexa-side-effects-american-consumer/
http://www.forbes.com/sites/melaniehaiken/2012/02/23/new-diet-drug-qnexa-promises-10-weight-loss-at-what-price/
http://marilynmann.wordpress.com/tag/michael-lauer/
http://www.theheart.org/article/1361583.do