June 11 (Bloomberg) -- Sanofi-Aventis SA's weight-loss pill Acomplia isn't yet approved in the U.S. after months of delay and questions about its safety. Some Americans aren't waiting.

People are traveling to Europe or buying the medicine through foreign Web sites after the U.S. Food and Drug Administration postponed a decision three times in 16 months. A panel of advisers to the agency will meet this week to review the drug, the first of its type that blocks hunger receptors in the brain. Sanofi has predicted at least $3 billion in annual revenue, about 8.6 percent of last year's pharmaceutical sales.

``I don't have very many years to go, and I don't want to spend that time over 200 pounds,'' said Yvette Cardozo, a 62- year-old American photographer who bought six months' worth of Acomplia during a trip to London, where the medicine is already sold. ``This is the only thing that's ever worked for me.''

The FDA panel must decide whether Acomplia's benefits -- reducing weight, cholesterol and blood sugar -- outweigh its risks. Clinical tests show the drug, which acts on the brain, can cause anxiety and depression. Analysts say the panel may be cautious about approving it without seeing more studies.

Once approved, Acomplia may be used by millions who want to shed just a few pounds, says Nick Turner, an analyst at Mirabaud Securities Ltd. in London. As a result, side effects not revealed in patient trials may arise, he says.

``The major issue with Acomplia appears to be the neurological or mood disorders,'' said Turner, who has a neutral rating on the stock. ``People won't take this drug because it helps their diabetes, they'll take it because somebody promises them that they'll become slim.''

Suicidal Thoughts

The drug may raise the risk of suicide and suicidal thoughts, FDA staff said in documents posted today. The FDA noted two suicides in clinical trials of volunteers testing the drug.

The documents also said 20 milligrams, the highest dose, did result in statistically and clinically significant weight loss.

Shares of Sanofi, the world's third-largest drugmaker, fell 5 cents to 67.52 euros at the close of trading in Paris. The stock has dropped 3.5 percent this year. The ratings tracked by Bloomberg show 24 analysts recommend buying the stock, 14 advise holding it and five suggest a sale. Sanofi's U.S. depositary shares, each equal to half an ordinary share, fell 36 cents to $45.14 at 4:02 p.m. in New York Stock Exchange composite trading.

Sanofi executives say the drug, which will be sold as Zimulti in the U.S., isn't for those trying to fit into a party dress. It belongs to a new class of compounds called CB1 antagonists, which block receptors that regulate hunger and food intake in the brain, as well as interacting directly with fat cells.

`Not Cosmetic'

``Acomplia is not a cosmetic product,'' Chief Executive Officer Gerard Le Fur told shareholders at the Paris-based company's annual meeting May 31.

The French drugmaker needs the medicine to sell in the U.S., where a third of the population is considered obese, as older best-sellers like the sleeping pill Ambien lose patent protection. The company's profit fell in the first quarter.

The panel of doctors scheduled to meet June 13 will make a recommendation to the FDA, which will issue a decision by late July, according to Sanofi. The FDA's Web site warns consumers that drugs bought abroad or on the Internet may be unsafe.

The ``panel meeting may not result in immediate approval,'' Alexandra Hauber, an analyst at Bear Stearns in London who rates the shares ``underperform,'' said in a note to clients last month. ``The FDA may request further clinical data'' because some patients experienced anxiety or depression in tests, an unusual number dropped out, and concerns about other products have made regulators more cautious.

The FDA has come under pressure in recent weeks after a study showed a diabetes drug approved in 1999, GlaxoSmithKline Plc's Avandia, raised the risk of heart attacks.

`Glacial Speed'

Sanofi had expected Acomplia to be approved last year. The FDA demanded more information in February 2006. The company completed its submission in October and said in December a decision would come in April. In February, Sanofi said the FDA would need until July to complete its review.

Neither side will say what's causing the delay, though Hauber, Turner and Kevin Scotcher of HSBC Securities, who rates the stock ``overweight,'' say the questions are probably about safety and side effects. Turner also said the FDA may not be convinced that the weight loss caused by Sanofi's drug is significantly more than other anti-obesity treatments.

Weight Loss

Patients given the highest dose of the drug lost an average 5.3 kilograms (11.7 pounds) over a one-year period compared with a weight loss of 1.4 kilograms among patients given a control pill. Acomplia significantly lowered the level of HbA1c, a measure of blood sugar, to within a safe range, the study found.

The medicine may be the first blockbuster weight-loss pill approved in the U.S. since Wyeth's fen-phen combination was pulled in 1997 because of heart and lung problems.

Cardozo, the photographer who traveled to London to buy Acomplia, says she has lost 20 pounds since restarting treatment after participating in Sanofi clinical trials five years ago. She lost 30 pounds during the tests. She says Acomplia is the only drug that helps her shake the excess weight that's plagued her since her teens.

``If I have a drug that's gone through clinical trials and is not poison, and it works for me, then I'm happy to take it,'' says Cardozo, who's 5 feet 7 inches tall and weighs 190 pounds.

To contact the reporter on this story: Angela Cullen in Frankfurt at acullen8@bloomberg.net

Last Updated: June 11, 2007 16:29 EDT