Another Diet-Pill

MadeInDR022

Another pill? I mean, I guess the reason behind it is great, but I hope doctors don't just give their patients a pill and not set them up with a nurtritionist so they can also learn to eat better! Any who, I thought I'd share...thoughts?



COPY and PASTED from YAHOO!

WASHINGTON (AP) — The Food and Drug Administration has approved Arena Pharmaceutical's anti-obesity pill Belviq, the first new prescription drug for long-term weight loss to enter the U.S. market in over a decade.

Despite only achieving modest weight loss in clinical studies, the drug appeared safe enough to win the FDA's endorsement, amid calls from doctors for new weight-loss treatments.

The agency cleared the pill Wednesday for adults who are obese or are overweight with at least one medical complication, such as diabetes or high cholesterol.

The FDA denied approval for Arena's drug in 2010 after scientists raised concerns about tumors that developed in animals studied with the drug. The company resubmitted the drug with additional data earlier this year, and the FDA said there was little risk of tumors in humans.

With U.S. obesity rates nearing 35 percent of the adult population, many doctors have called on the FDA to approve new weight loss treatments.

But a long line of prescription weight loss offerings have been associated with safety problems, most notably the fen-phen combination, which was linked to heart valve damage in 1997. The cocktail of phentermine and fenfluramine was a popular weight loss combination prescribed by doctors, though it was never approved by FDA.

In a rare move, the FDA explicitly stated in a press release that Belviq "does not appear to activate" a chemical pathway that was linked to the heart problems seen with fen-phen.

The FDA says the drug acts on a different chemical pathway in the brain, which is believed to reduce appetite by boosting feelings of satiety and fullness.

Belviq is one of three experimental weight-loss drugs whose developers have been trying for a second time to win approval, after the FDA shot them all down in 2010 or early 2011 because of serious potential side effects.

Vivus Inc.'s Qnexa is thought to be the most promising of the drugs, achieving the most weight loss. But the FDA has delayed a decision on that pill until July.

Shares of San Diego-based Arena Pharmaceuticals Inc. jumped $3.03, or 34 percent, to $11.88 in trading Wednesday afternoon.

Arena's studies showed that patients taking Belviq, known generically as lorcaserin, had modest weight loss. On average patients lost just 3 to 3.7 percent of their starting body weight over a year. About 47 percent of patients without diabetes lost at least 5 percent of their weight or more, which was enough to meet FDA standards for effectiveness. By comparison, average weight loss with Qnexa is 11 percent, with more than 83 percent of patients losing 5 percent of their weight or more.

Side effects with the drug include depression, migraine and memory lapses.

In May a panel of expert advisers to the FDA voted 18-4 to recommend approval of Arena's drug, concluding that its benefits "outweigh the potential risks when used long term" in overweight and obese people.

Experts say the challenge of weight loss drug development lies in safely turning off one of the body's fundamental directives: to eat enough food to maintain its current weight.

While several drugs are available for short-term weight loss, until Wednesday there was only one FDA-approved prescription drug for long-term weight loss: Xenical from Roche, which is seldom prescribed because unpleasant digestive side effects and modest weight loss.

Other safety failures for diet pills have continued to pile up in recent years.

Four years ago Sanofi-Aventis SA discontinued studies of its highly anticipated pill Acomplia due to psychiatric side effects, including depression and suicidal thoughts. In 2010, Abbott Laboratories withdrew its drug Meridia after a study showed it increased heart attack and stroke.


http://health.yahoo.net/news/s/ap/fda-approves-first-new-weight-loss-pill-in-decade

twinmom14ek

Not a single aspect of that article makes it sound like that pill is a good idea. Only "modest weight loss," "side effects with the drug include depression, migraine and memory lapses" (I have enough issues with these on my own without a pill causing them), and the fact that the FDA believed it had "potential severe side effects" just a couple years ago.

The only thing I can guess is that someone made the case that the medical risks associated with current obesity outweigh the potential risks of future tumors/other complications from the medicine? Doesn't sound like a good thing to me...just my two cents.

MadeInDR022

I read another article and the average person loss like 6lbs in less than a year. So yes, you're very right that the only reason it got approved was because of the lack of substantial data to prove its harmful.

afwg1979

Saw this on "CBS This Morning" -- I'm going to stick to the old-fashion method = no meds!

mermx

My doc prescribed Xenical for me when I was 180lbs. I took it religiously for the 6 months, had no side effects and didn`t lose diddly squat.

I used to use Celevac tablets years ago (they are still available) they have no side effects they just make you feel full as they expand in your stomach.

But lotions and potions are not a long term solution to being a healthy weight.

So would never try any potions again MFP is the way to go.

CRSE1214

5% of 200 lbs = 10 lbs. If you cut your calories and exercise regularly 10 lbs. in a year is doable without any type of diet pill. Doesn't seem worth the added expense and medical bills.

GeritWag

I'm sticking to my regular drug called Exercise. It helps me lose up to 2 pounds per week with only a few side effects, such as soreness and hunger.