Where Is Alli Diet Pills – AP file photo Public Citizen, a drug safety watchdog group, has asked the FDA to ban prescription and over-the-counter forms of orlistat, Ali’s active ingredient.
, Ohio – Ali — one of the nation’s top-selling over-the-counter weight-loss drugs — is under fire after a new study released this week found that its key ingredient increases the risk of serious kidney damage.
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Public Citizen, a drug safety group, sent a 31-page letter to the US. Food and Drug Administration on Thursday, asking the agency to immediately ban prescription and over-the-counter forms of orlistat, Ali’s active ingredient.
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The drugs, the watchdog group said, “expose patients to serious risks that greatly outweigh their minimal clinical benefits.”
When Alli was introduced in 2007, it was expected to be the next big blockbuster for drugmaker GlaxoSmithKline. It is the only non-prescription diet pill approved by the FDA. But sales did not meet expectations.
Ali works differently than most prescription and over-the-counter weight loss drugs on the market, which are largely appetite suppressants and metabolic stimulants. According to the company, Ali blocks the absorption of about 25 percent of the fat a person consumes.
To introduce Alli to consumers, GlaxoSmithKline launched an extensive marketing campaign that highlighted the clean, clear package in TV, print and online ads. The company created an online community website for users to swap nutrition stories and shop for healthy recipe ideas.
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The website also offers Alli users “a free, personalized weight loss program designed to help patients build a healthy relationship with food.” The company says customers using Ali on a low-calorie, low-fat diet can achieve “up to 50 percent more weight loss than the diet.”
Dr. Walter Cha, director of bariatric surgery at MetroHealth System, said he saw orlistat’s popularity grow when it became available over the counter.
“A person can see an ad for it on TV and then just go to a store and buy it, and more people have tried it,” Cha said. Birth control pills can be easily found in almost any drug or grocery store in the region and, as is often the case with drugs that have not been banned, will continue to be available.
For example, on Friday, popular grocery chain Giant Eagle said it has no plans to pull Alli from its shelves because its policy is to follow FDA guidelines.
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Bodies, Cha said, need a certain amount of fat for the body to function properly, and absorption of certain vitamins depends on fat absorption.
GlaxoSmithKline has known about the deficiencies of orlistat in Ali for years. In April 2006, Public Citizen called for a ban on the prescription form of Alli called Xenical because research in rats showed that orlistat caused the formation of precancerous lesions in the colon. The FDA denied the petition.
Last year, the FDA approved increased label warnings on Xenical and Alli after reviewing the side effects of orlistat and also found symptoms associated with serious liver damage.
“This drug is hurting a lot of people,” says Dr. Sidney Wolff, director of the health research group at Public Citizen. A warning on the new diet pill label advised consumers to: “Discontinue use and ask a doctor if you develop itching, yellow eyes or skin, dark urine, or loss of appetite. There have been rare reports of liver damage in people taking orlistat.”
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Public Citizen’s latest outcry comes days after a study published in the Archives of Internal Medicine found that patients taking orlistat in Ontario, Canada, for several years showed a 2 percent increase in acute kidney injury within a year of starting the drug.
This week, GlaxoSmithKline defended Ali’s safety. The company also announced that Alli is part of a list of brands it expects to sell by the end of 2011, saying it wants to focus on fast-growing brands.
If you purchase a product or register for an account through one of the links on our site, we may receive compensation. Side effects are part of the reason GlaxoSmithKline’s Alli, the first over-the-counter diet pill, works for dieters who take it. Richard Drew / AP
When Ali Fat Blocker hit drugstore shelves last June, hopeful consumers clamored for the first government-approved weight-loss drug. But it didn’t take long, and the lack of actual weight loss for some, to convince many dieters that Ali wasn’t the only answer to their weight problems.
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Besides Ali, there are about six prescription weight loss drugs on the market. Some, like Ali, block the absorption of fat in the body. Others work in the brain to suppress appetite. But the reality is, no matter how many diet pills you take, they don’t work by themselves.
“The pills we have right now don’t seem to be very effective for long-term weight loss,” says registered dietitian Ann Fletcher of Mankato, Minn. “When people go off the pill, many gain the weight back.”
Yet the pharmaceutical industry and many dieters remain convinced that pills are the answer to the nation’s growing obesity epidemic. Several new ones, including the experimental drug lorcaserin, a variant of Fen-fen. At least 30 companies are developing weight-loss drugs, and experts estimate that in the next few years there will be 10 to 15 drugs designed to help dieters in a variety of ways. Drug research firm Decision Resources expects the US obesity drug market to grow from $222 million in 2006 to nearly $2 billion in 2016.
Combined with diet and exercise, anti-obesity drugs can help someone lose about 5 to 10 percent more weight, research suggests. However, because different pills affect the body in different ways, it is possible that some people may be better suited to use one type of pill over another.
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For example, one study that looked at the differences between sibutramine (Meridia) and orlistat (Xenical and Alli) found that greater weight loss with orlistat occurred in people who could be described as “conscientious,” that is, their personalities were aligned. . -oriented or intentional. Therefore, careful monitoring of fat intake helps them. People who have difficulty controlling their eating habits have seen a greater effect with sibutramine – which affects serotonin in the brain and makes you feel full sooner when you eat.
In general, the biggest mistake people make when taking diet pills is to view them as magic bullets.
“People can’t expect a drug to do that for them,” says Gary Foster, director of the Center for Obesity Research and Education at Temple University in Philadelphia. “It’s a 50/50 partnership with the pill as half of the equation. “Exercise, what we eat and our lifestyle habits… are key to long-term success.”
When clients ask to use a weight-loss drug, Fletcher, author of “Thin for Life,” says to think of it as “one leg on a four-legged stool.”
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“Foot is a physical activity; one is diet; One is behavioral change, and the last leg can be diet pills, she says. “Remove any of the legs supporting the diet pill and the stool will fall.
From her research, Fletcher found that people who lost significant amounts of weight often took several attempts to lose weight before achieving long-term success.
“When we’re trying to change a behavior, it takes most of us a few tries to get it right,” she says.
There is no real data on how long-term the tablets are safe, especially for young people. But the Food and Drug Administration has only approved them for adults for up to two years of continuous use. According to an analysis of 30 trials of adults who took anti-obesity drugs for one to four years, about 30 to 40 percent stopped taking them after one year, although it was not clear why.
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In addition, side effects are common. Sibutramine may increase blood pressure and heart rate in some patients. Orlistat, which alters the absorption of dietary fat, can have embarrassing intestinal side effects. Rimonabant (used in Europe but awaiting approval in this country) can cause nausea, anxiety, depression and insomnia in some users.
But for the obese — people with a body mass index of 30 or higher — the benefits of prescription diet drugs may outweigh the risks, experts believe.
“The most successful are those who are willing to make a serious commitment to losing weight and who are willing to take responsibility for their actions and changes,” says Pat Baird, a dietitian and nutrition consultant for GlaxoSmithKline’s consumer health division, who works as an online moderator for people using Alli. She talks to 25 people a day and asks questions about weight loss, the program and birth control pills.
Baird admits that side effects are part of the reason Ali works for some people. When someone eats more than the prescribed 15 grams of fat per meal, they can experience not-so-pleasant digestive problems. “It helps people stay honest,” she says. Digestive health, general health care, weight management.
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