SubscribeZimulti Weight Loss Drug: Suicidal Thoughts?
Rimonabant is a popular prescription weight loss drug that is currently available in 18 countries (under the name Acomplia - from Sanofi-Aventis). The drug has been before the FDA - awaiting approval for some time now.
Some time last year I wrote a large article that discussed some of the side effects of the drug.
The FDA has now released an analysis - showing why they are taking such a long time to look at Zimulti (Rimonabant).
They conclude:
Rimonabant 20 mg daily vs. placebo was associated with statistically and clinically significant weight loss. Rimonabant 5 mg daily vs. placebo was associated with statistically significant but clinically insignificant weight loss.
However, a brief look through the report (PDF) shows that adverse psychiatric events are a major issue. Anxiety, sleep disorders, and depression being the most common.
There is also extensive analysis of "suicidality" - an increase of suicidal thoughts among Rimonabant (20mg) users.
I suspect it will be sometime (if ever) until this drug is approved.
UPDATE Jun 13 2007: An FDA advisory panel of outside experts unanimously recommended that the regulatory agency not approve the novel weight-loss drug for sale in the United States.
Even knowing all the adverse side effects, I bet there'd be a significant number of people willing to risk them in order to try this pill and lose weight. If only people would be so willing to try sensible eating and mild exercise.
Brian
ReplyInteresting reading. At 20mg dosage, it does seem effective on average but the variance in percent body weight loss is gigantic. There was a large - nearly 1/2 - drop-out rate of participants, but I don't know how that compares with other studies. A re-randomization study showed that by continuing to take Rimonabant, weight contines to stay off. And, the side-effects can be pretty wild (auditory hallucinations??) but no increase in actual suicide or self-harm.
Brian, I think your comment is a bit harsh, but I understand your point. Patients using Rimonabant aren't supposed to just take the drug - it is supposed to be used in combination with an exercise and diet program. The drug is targeted for people with a BMI of at least 30 or at least 27 and some factor - say, hypertension - that may make starting an intense exercise program difficult. Putting this another way, the intended use of this drug is as a tool to help with setting up a sensible eating and mild exercise program.
I'd be willing to bet that, given it's widespread availability (Argentina, Austria, Denmark, Finland, Germany, Ireland, Norway, Sweden, Greece, and the United Kingdom) and its effectiveness, it will be approved eventually... Otherwise, it will continue to be available only via the black market and used without proper supervision. This is a drug that should be used only when being monitored...
It looks like the intended use is to take this drug forever. Sigh.
ReplyHello Quito,
Replydo you know if we can take the acomplia along with the Zoloft
I think if you have any history of depression - you would want to be careful with this drug.
ReplyI don't think it's worth the risk if ever the drug will be approved by the FDA. It's side effects are far more worse than being over weight. Most people would want to lose weight in order to feel good about their body. But it would be a waste of time if you'll only get depressed after losing weight.
ReplyThose are really high pay off just for the sake of losing weight. There are certainly lots of option for everyone to chose and most of them don't include risks like the ones mentioned.
ReplyGood information and comments. Thanks for the update.
I personally think the FDA needs to approve this drug at least for limited use - morbidly obese. I suffer from clinical depression and would never take anything that would definitely increase my feelings of depression. However, I would try Acomplia. I might quickly find myself in that 50% drop out group, but the risk would be worth it to me.
Here's my bottom line...it is incongruous that the FDA will not release Acomplia into the medical community when 1000s of obese patients are putting themselve at much greater risk with bariatric surgery. The life threatening risks from approved treatments and from doing nothing at all are much greater than the risks of side effects from taking Acomplia.
Let's get it out there on a restricted basis and see what happens. It isn't like the US is the first country to try it.
ReplyI really hope the FDA has its act together with the approval of the new Alli drug going on sale tomorrow. Whether this drug should really be available over the counter or not we will have to wait and see. Hopefully no one will report the horrific types of side effects that those poor people did who had such psychiatric problems stemming from that diet pill. Shouldn't they have figured that out before they gave it to so many people?
ReplyCraziest diet pill story ever. Spike your metabolism with a chemical used to ignite dynamite?!!
Inferno: My Week on DNP
Replyhttp://www.t-nation.com/readTopic.do?id=1035803
On second thought, I hope I wasn't being irresponsible with that last post. I meant it as a "Herein you will experience the DIE in DIEt pills!"
May this also serve as a warning:
"Jimmy Tango's Fat Busters" (classic Jim Carrey appearance on SNL)
Replyhttp://www.vidilife.com/index.cfm?f=media.play&vchrMediaProgramIDCryp=8157F90D-FC28-4749-BCC1-F
ReplyAs long as the drugs have side effects, so, as long as that is not as morbid obesity, it is not necessary to use the slimming products.
Thank you for the report!
ReplyDo you have any more updates?
I'm trying to follow the FDA