Xenical Is First Prescription Weight-Loss Treatment Approved to Treat Obesity in Adolescents

By Michael Smith, MD .. WebMD Medical News


Dec. 16, 2003 -- The FDA has approved Xenical for use as the first prescription weight-loss medication, for treating obesity in teens ages 12 to 16 years old.

"This is very good news for adolescents struggling with overweight and obesity," says Marc S. Jacobson, MD, attending physician at Schneider Children's Hospital of North Shore-Long Island Jewish Health System, in a news release.

"Obesity is an epidemic, with the number of obese adolescents doubling over the last 20 years. Physicians and parents of overweight and obese adolescents now have a safe and effective treatment option available that will help manage their child's weight." Jacobson is also director of the Center for Atherosclerosis Prevention in the division of adolescent medicine.


Obesity Puts Adolescents at Risk

Overweight and obesity have reached epidemic proportions in the U.S. Latest estimates from the CDC show that 15% of American children between the ages of 6 and 19 were overweight or obese in 2000, and the problem continues to get worse. Obesity in children is defined as having a BMI (a measure of weight for height) greater than 95% of other kids the same age.

Poor dietary habits and physical inactivity are the two main culprits contributing to this growing health problem. Adolescents who are obese are at greater risk of being obese as adults and of developing serious health problems, including type 2 diabetes and heart disease. It also puts teens at an increased risk of death.

"If a parent is concerned that their child may be overweight, it's important to talk with their physician," says Jacobson. "Combining diet, exercise, and changes in lifestyle habits with medication can help seriously overweight adolescents manage their weight and reduce their risk of serious health problems."


Xenical Drops Pounds

As part of the FDA approval process, the agency examined the results of a study on obese adolescents aged 12 to 16. About 350 teens received 120 milligrams of Xenical three times a day with meals while just more than 180 kids received a placebo -- neither the researchers nor the study participants knew which pill they were taking. Each teen also ate a reduced-calorie diet containing no more than 30% of calories from fat.

The teens treated with Xenical had an average weight of approximately 210 pounds.

After one year of treatment, adolescents treated with Xenical had a significantly reduced BMI compared with patients receiving placebo.

Among the Xenical group, 27% had a drop of at least 5% in BMI compared with 16% of those receiving placebo.

The adolescents reportedly had little trouble tolerating Xenical and side effects were generally similar to those seen in adults treated with Xenical. The most common being oily stools.


How Xenical Works

Xenical, approved for adults in 1998 and still the only drug of its type, helps promote weight loss by blocking about 30% of dietary fat from getting absorbed into the bloodstream. The long-term effects of Xenical have not been established.

Because Xenical prevents nearly one-third of the fat in the food consumed from being absorbed, patients may experience gas with oily discharge, increased bowel movements, an urgent need to have them and an inability to control them, particularly after meals containing more fat than recommended.


Xenical should not be taken if patients are pregnant, nursing, or have food absorption problems. Xenical reduces the absorption of some vitamins. Therefore, a daily multivitamin is strongly recommended.


http://my.webmd.com/content/article...0000_1000_nb_01

One pill approved, two studied for weight loss in children

December 18, 2003

BY JIM RITTER Staff Reporter, Chicago Sun Times


Kids are getting new help in the war on obesity. The government this week approved one prescription weight loss pill for adolescents, and two other drugs are under study.

The Food and Drug Administration said the label for the diet pill Xenical can include results of two clinical trials involving children aged 12 to 16. Some doctors have been legally prescribing Xenical "off label" for kids, and the new label could make the practice more common.

Xenical prevents about one-third of the fat patients eat from being digested. The undigested fat cannot be absorbed and is eliminated in bowel movements. Side effects include diarrhea, flatulence and oily leakage.

Patients can lesson side effects by reducing their fat intake. "I think it's useful for retraining people to eat a low-fat diet," said Dr. Chris Stahl of the Adolescent Weight Loss Clinic at the University of Illinois at Chicago.

Stahl has prescribed Xenical to about 10 teenagers, but only one has stuck to it. "The side effects are extremely unpopular with teens," she said.

Xenical costs about $90 per month, and many insurance companies don't cover it, Stahl said.

If a child already is exercising and eating a healthy diet, Xenical has "minimal additive benefit," Stahl said. Also, Xenical won't help teens who eat too much sugar.

Another prescription drug being studied for adolescents is the appetite suppressant Meridia. In a recent study of 82 adolescents enrolled in a behavioral weight loss program, kids who took Meridia lost an average of 17 pounds after six months. By comparison, kids who took a placebo lost an average of seven pounds. The study was published in the Journal of the American Medical Association.

Meridia's side effects include headache, dry mouth, anorexia, constipation and insomnia.

Another study is being planned to determine whether the diabetes drug Glucophage can reduce insulin intolerance and weight in heavy children aged 6 to 11.

In extreme cases, surgeons are doing stomach reduction operations on teens. By some estimates, as many as 150 teens have undergone the most common technique, gastric bypass surgery, and the number is believed to be growing.

The childhood obesity epidemic has hit Chicago especially hard. Among kids aged 3 to 7 in Chicago public schools, 23 percent are overweight and 15 percent are at risk of becoming fat. By comparison, 10.4 percent of kids nationwide aged 2 to 5 are overweight, according to the Consortium to Lower Obesity in Chicago Children, based at Children's Memorial Hospital

Experts say the best way to fight obesity in kids is to prevent it in the first place. Dozens of Chicago area schools, hospitals, YMCAs and park districts are trying innovative obesity-fighting programs, a consortium spokesman said.


http://www.suntimes.com/output/heal...-nws-fat18.html

How come every time they say this concerning a low carb diet they act like this is the most important point but when it is said about some new nasty drug, they act as if it and unimportant sidenote.


Sounds like taking this stuff would be as much fun as eating lots of low carb treats filled with sugar alcohols.

Sing it with me..."Ohhh, I'm sliding into first and my pants are about to burst..."

Oh, gee, it's not like adolescents suffer enough if they are overweight, they can worry about this too!
And it sounds dangerous...the brain is still growing then, and needs essential fats to do it.

And of course we know that nothing goes better with a prom tuxedo than "...gas with oily discharge, increased bowel movements, an urgent need to have them and an inability to control them..."

That is so sad. We need to teach kids to eat proper foods not pump them full of drugs. Nor do they need to be taught that drugs are a quick fix.

I agree with chef, they need to stop touting LC as dangerous and get a grip on reality. Eating properly is the answer not popping pills. My 16 year old daughter has been watching my progress and although she still does eat some junk food she is reading labels and has lost about 20 lbs. She is now at what I believe to be almost her ideal weight. I hope that if one of her friends need to loose they will follow her lead rather than mess around with diet pills.

Not to mention it is promoting the "LOW FAT" mentality... now what do you think will take the place of the fats they will undoubtably trim out of their diets??? I'm betting on more CARBS.

See, stuff like this worries me. My daughter is 13 and lives with her dad. She is SEVERELY overweight. She weighs over 200 lbs at 13! I can see her dad taking her to the Doctor and him recommending putting her on this now that it has been approved. *sigh*

Everyday I'm leaning closer and closer to trying to get her to come live with me. : | She would benefit from LC so much. But she would have to want to do both (live with me and LC), because I won't force it on her.

I believe Xenical could be causing only a short term weight loss and may cause long term weight gain.

With time our bodies must find a way to protect themselves against such a drug. They may force us to eat more food in order to compensate for the non-absorbed fat and whenever we stop or reduce the dose we will end gaining more weight.

Well, it's ultimately an admission of failure, isn't it? Coming up with these bizarre drugs to treat symptoms, instead of addressing the causes, of illness.
My husband and I are in our forties, and we were both skinny, active children. We do not recall our preadolescent classmates having such a high incidence of overweight as we see all around us now.
There hasn't been enough time for genetics to change. It must be something else. But a drug with such potential for danger is not the answer.

OK. Some kids took Xenical and a reduced calorie/fat diet. Some other kids took a placebo and the same reduced calorie/fat diet. After one year of this regimen, 27% of the Xenical+diet kids lost 5% of BMI and 16% of non-Xenical+diet kids had the same drop in BMI.

In other words, THE DIFFERENCE BETWEEN THE PERCENTAGE OF KIDS LOSING ON XENICAL AND THE PERCENTAGE OF KIDS LOSING WITHOUT XENICAL WAS A TRULY STUPENDOUS 11%.

And in the hopes of being in that magic 11% of kids who lose 5% of BMI only by paying through the nose for Xenical, the kid gets the great side-effects listed above.

But remember, this will be handed out like candy and approved by every physician in the land, while the same quacks fulminate against the health-risks of Atkins.

Just in time for Christmas.... Anal Leakage and Oily Discharge..just what ALL kids want to get for the Holidays!!!!

These same side effects were enough to pretty much kill any chance that Olestra, that fat substitute that came out a while back, had of becoming wide-spread. I don't think anyone would be any more tempted to endure them now either. Ray Romano did a joke about the anal leakage warning on Olestra. He said that the tobacco companys should put on cigarettes: "At least we don't do that!"

A woman I work with takes dozens of different pills for high blood pressure, cholesteral, fibromyalgia, depression, arthritis and god-knows what else. Considering dietary changes that will eliminate most of her pills is not an option she will even consider. When will society realize that pills are not the answer most of the time? Using teenagers as guinea pigs by our own legislators should be illegal. And the government keeps telling us they have our best interests in mind when fighting terrorism and then pull a stunt like this (although I shouldn't be surprised if they are planning to serve irradicated meat in schools). Hypocrasy!