Beware the new diet pill with stunning dangers that may soon be approved by the FDA

Big fat lie

If you’d like to lose weight without taking a pill, it can be done — I know because I’ve done it.

But from a drug company point of view, that’s ridiculous. Why work that hard when there’s a super-duper magical pill that can do the heavy lifting for you? (Pun absolutely intended.)

So the pills (and their dangers) just keep rolling down the pipeline.

Diet pills are like a box of chocolates

Remember Meridia? Fen-phen? Alli?

Each one of those weight-loss drugs came (comes) with serious safety concerns. The first two were finally removed from the market — both boosted heart risks. Alli is still with us, but it produces a very unpleasant side effect known as “orange undies,” which makes it undesirable, to say the least. (For you AND the people around you!)

So if at first, second, and third you don’t succeed…bring on another pill!

This time, the pill is called Qnexa. And if we shake the Magic 8 Ball to see if it will get FDA approval, the answer is: “Outlook is good.”

And if we give the 8 Ball another shake to see if Qnexa might cause heartache and misery and finally get pulled from market by, oh, let’s say 2020, the answer is: “Outlook is good.”

But for those who will use Qnexa, the outlook is potentially dangerous on two counts: heart issues (again!), and high risk of birth defects.

A couple of weeks ago, FDA-watchers were curious to hear the decision of an expert panel that was scrutinizing Qnexa. There wasn’t much drama expected. After all, a previous panel rejected the drug because of safety concerns.

But most people weren’t aware that this panel was a little different.

As one analyst pointed out, five experts who were on the previous panel and voted to approve Qnexa were called back for this new panel. But four members of that earlier panel who gave Qnexa a thumbs-down were not asked to return.

Well pass the smelling salts because you will never believe what happened! The new panel voted overwhelmingly (20-2) in favor of recommending approval, in spite of the drug’s serious risks.

The panel did recommend a follow-up study to track cardio events. According to Pharmalot, the panel’s briefing documents indicated that “almost every dose of Qnexa increases various cardiac events in patients with and without elevated heart rates.”

Again — I have to say it — if that same risk were created by a dietary supplement, the FDA would send in a SWAT team to shut it down.

Meanwhile, babies born to women who use Qnexa during pregnancy may be as much as two to five times more likely to have oral clefts. And no warning will be strong enough to keep these defects from happening. In one Qnexa study, rigorous contraceptive use was required, and yet more than 30 subjects became pregnant.

And here’s the kicker: Qnexa users do lose weight, but it requires modification of “diet and lifestyle.”

In other words, you have to do the three things required for any weight-loss regimen to succeed: Eat more of what’s good for you, less of what’s bad, and get off the sofa once in a while.

But if you do those three things, you don’t need a drug — especially a drug that plays Russian roulette with your heart health and puts an unborn child at risk.

Sources:
“Surprise!! FDA Panel Endorses The Vivus Diet Pill” Ed Silverman, Pharmalot, 2/22/12, pharmalot.com