Feds Reject French Weight-Loss Drug

(AP)  Federal health advisers unanimously rejected a weight-loss drug Wednesday after hearing testimony that it increases the risk of suicidal thoughts, even in patients without a history of depression.

The manufacturer, Sanofi-Aventis SA, further failed to show the drug rimonabant is safe, the panel said.

The back-to-back, 14-0 votes by the expert panel made it unlikely the Food and Drug Administration will approve the drug. The agency usually follows its panel's advice, but it isn't required to do so.

"There is a reasonable suspicion we better learn some more and watch this affair more closely before we launch into massive use of this drug," said panelist Dr. Jules Hirsch, a senior physician at New York's Rockefeller University.

In studies, patients given the once-daily tablet reported twice as many psychiatric side effects, including depression, anxiety and sleep problems, than those who received sham treatment, Dr. Amy Egan, an FDA medical officer, told the advisers.

"The numbers of events are small, but in aggregate they are worrisome," Egan said.

Officials from Sanofi-Aventis suggested that patients be screened for depression before they are prescribed the drug. They also advised that patients visit their doctors five times during the first year of treatment to be reassessed to further curtail any potential problems.

"Who is the right patient to receive rimonabant? Not everybody," Sanofi-Aventis' Richard Gural told the panel of advisers earlier Wednesday. The drug is not appropriate for anyone with a history of depression or suicidal thoughts, or who has been diagnosed with depression or is taking antidepressant medication, he added.

The FDA is to make a final decision on the drug by July 27.

The company proposes selling the drug under the brand name Zimulti. Rimonabant already is sold in Europe as Acomplia.

The litany of mental problems associated with the drug clearly gave the panelists pause.

"I think this is a drug that needs further understanding with respect to what it does to people's psyche," said panelist Dr. Sid Gilman, a University of Michigan neurologist.

Even if the FDA does approve the first-in-its-class drug, the findings make it highly likely it would bear stern warnings. Company officials embraced the idea of such warnings, which could exclude FDA-approved use in some patients.

The company, FDA and panelists all agreed that Zimulti, along with diet and exercise, works to help shed weight. In yearlong studies, patients on the drug lost roughly 14 pounds. Those given dummy pills lost only about 4 pounds. However, patients regained weight when treatment was stopped after a year.

But the FDA and its outside advisers shared deep concerns that the drug's effect on the body could lead to an array of psychiatric symptoms, including anxiety, phobias, post-traumatic stress disorders and depression. No panelist felt the company had sufficiently characterized the drug's safety.

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[slim1h2o]

Yeah, kids should not get a hold of alcohol either, but they do. Just think of all the taxes that could be collected on the sale of legal marijuana. that would solve the homeless problem!
So it goes............

[mrassekh]

On the bright side, they will look nice and trim in the casket at the funeral.
Posted by incog-nito at 11:56 AM : Jun 13, 2007

Incog-nito, you are absolutely right. So what if they're dead, at least they're not, well, you know, fat. This drug seems to rank right up there with the weight loss drug that had as side effects "explosive uncontrollable bowel movements and anal leakage". Just how desperate do they think overweight people are anyway?

[rushman71]

I don't understand why the government enforces the FDA to regulate the pharmacutical products to be sold to people here in America that can cause severe psycholical or physical problems, even cause death in some cases, but will not legalize marijuana. There is absolutely no shred of evidence that mary jane causes any death or physical harm. It will make you forget what you were talking about a moment ago, hungry for some chips, and fall asleep on the couch (this I consider the only term for O.D.). Now I do understand the concept of legallized marijuana and children, and kind of see the aspects of what may come with that. But as long as our government allows lethal chemicals to be distributed as medicine and natural herbs to be outlawed and portrayed to be "bad for you", to me it seems like this is so fuqd up!!!
Come on Government, wake up!!!

[slim1h2o]

F D A do your job. Take all drugs off the market, untill you "Know" what they can or can't do.

Drug Co's are making a killing off us Lab Rats
(Americans) Legalize mary jane, at least we know how that affects us.

[texas468]

I took Phen-Phen for 2 months back in 1999. Will NEVER take another prescription diet drug AGAIN! Yea, I lost some weight, but the fact that I have a hard time remembering things from time to time is aggravating. (*NOTE - before taking the drug, was able to finish New York Times crossword puzzles - Now? Much more difficult......) I simply started watching my diet, cutting back on the starches, and MOVING! I even had reconstructive ACL surgery, and STILL found a way to get moving 2 months after. Just get off your fannies...I know it's tough sometimes, but America is so inundated with fast food and junk, smart food choices are so important!!! Just say no to the diet drugs, and I hope all of you that are on this medication the best for a change!! :O)

[toldyouso21]

gramto11 at 07:55 AM : Jun 13, 2007

Please understand that when it comes to medicine, your doctor is about as in the dark as you are. The major difference is that a sales person from the drug manufacturer, has sent your doctor brochures, taken him to lunch or dinner and shared information with him also found in the PDR--then he may or may not have been offered incentives to get patients on the product. Incentives can be anything from discounts on other products to bonuses or even discounts or rebates on medical equipment that can amount to hundreds of thousands of dollars.

So here's a clue--no Doctor is God--they are only as good as the information that is pitched to them and the source it comes from, AND never trust anyone who stands to get incentives from pushing a product to have your personal best interest at heart. I spent almost 2 decades as an auditor and investigator for the Pharm and Biologics industry--and can say that most doctors can only rely on what sales reps from pharm. companies tell them. There is no panacea for weight loss. Eat less, exercise more or go under the knife--if you take pills, you may have temp. success--but you trade one set of bad circumstances for another. Never forget Phen Phen. There is no substitute for you helping yourself instead of hoping someone creates a pill have you do what you won't do for yourself.

[gramto7]

At least one person here realizes that perhaps some of us have a clinical reason for weight gain and inability to lose weight. My physician let me know months ago that this med was in the pipeline and we had hoped it would become available by May. I guess I will continue to wait until the FDA and many other bureaucrats decide whether I can or cannot follow the advice of my doctor. This medication has been in use in other countries for years with few problems. Considering the number of people who have been on the med, the percentage who have problems is quite infintessimal. Granted, those that have problems need to QUIT taking the med, but for the others it can be a life-saver!

[jetlizhan]

not that i can't believe the fda would approve this drug for consumption - but where's the concern for people? this is getting so scary and ridiculous - our pet foods, our drugs - JUST FOR THE ALMIGHTY DOLLAR!! as that guy said in the movie "i'm mad as h-ell and i won't take it anymore!" this is what all of us americans (and others) need to stand up and say. boycott all this stuff and when 'they' are no longer making a buck, maybe something will be done. we're killing ourselves.

[toldyouso21]

Okay. so now the FDA no longer protects us from bad drugs, they just give a heads up? So I wonder whose pocket the FDA is in now?

[toldyouso21]

really feel extremely worried because I am taking this drug for 2 weeks now and already had signs of depresion and anxiety. What can I do to firmly protest and set the spot on the Laboratory and the doctors who are prescripting these medicins using us as testing rats. I am seriously upset with this.

Please let me know if I can demand these people.

Thank you

Ada Palaci
Argentina


You might want to start with STOP taking the drug. Nothing sends a stronger message to drug companies than the loss of sales.

Why would you take something that already has you depressed? Why not look at diet alternatives like Protein focused diets or Carb managed diets? Pills are not the answer because a diet is not something you do to lose weight. "Diet" means the way you eat--and whether that is healthy or not, it is forever. If you use pills or shakes to lose weight--then when you stop them, the weight will rebound back. The reason is, you will only have used an artificial means to affect your weight. So when you stop, all the weight comes back plus some more.

I'd stop the pills, make a schedule to take a walk, even if it is only for 10 minutes each day, then make it longer and longer as you get stronger. Change my diet to one focused on veggies and meat and less on starches, corn or wheat. Lower the sugar and see how that works for a while. It may be slower--but it probably will not depress you or make you want to kill yourself.