Risks appear greater than the benefit. A review of several thousand adverse event reports from the Food and Drug Administration associated with orlistat—the active ingredient in the over-the-counter OTC weight-loss drug Alli and the prescription drug Xenical--has further strengthened our earlier advice: Skip this drug. The reports, obtained through a Freedom of Information Act request we filed with the FDA earlier this year, show a pattern of adverse events submitted to the agency since Jan. Those reports don't prove that orlistat is to blame; but only that those conditions are associated in the reports with the use of Alli and Xenical.
To date, a clear link between the use of the drug and a majority of those side effects has not been firmly established. Of the several thousand reports submitted to the FDA, Charles Bennett, director of the Research on Adverse Drug Events and Reports RADAR group, which also reviewed the reports said "this safety concern is heightened when one considers that only an estimated 1 percent to 10 percent of all adverse events that occur are ever reported to the FDA. Orlistat is a powerful medication meant for people who are overweight or obese. Both Alli and Xenical are specifically approved to be taken only while also adhering to a low-calorie diet and exercise program.
Orlistat works by blocking enzymes in the gut that normally digest fat, thus preventing its absorption. During our review of the latest information one of our medical consultants commented that "fat malabsorption," as the condition is known, is actually a disease. But that lack of absorption can lead to a number of adverse effects. In clinical trials of Xenical, during the first year of use, 27 percent of people experienced oily underwear staining, 24 percent had gas with involuntary discharge of stool, 22 percent experienced fecal urgency, 11 percent had an increased number of bowel movements, and 8 percent suffered fecal incontinence.
Virtually everyone who takes orlistat experiences diarrhea, at least, occasionally. Most people can reduce the frequency and severity of those unpleasant side effects by cutting the amount of fat in their diets to 30 percent or less. But even then they must make other nutritional adjustments, since orlistat also hinders the absorption of fat-soluble vitamins, notably beta-carotene vitamin A , vitamin D, vitamin E, and vitamin K. In addition, the prescription version Xenical includes warnings on its label about the possibility of pancreatitis inflammation of the pancreas. The benefits.
Even when orlistat is combined with exercise and nutritional changes, it produces only a modest 5 percent to 10 percent decline in body weight. Three studies done before the approval of orlistat measured weight loss over a one-year period in obese patients with and without type 2 diabetes. They had a BMI body mass index over 28 and were on a reduced-calorie diet. At the beginning of the trials, the patients weighed an average of 220 pounds. Pooled data show that the average weight loss with orlistat was about 19 pounds vs. Orlistat inhibits the work of lipase. When you take the drug with a meal, about 25 percent of the fat you consume isn't broken down and is eliminated through bowel movements.
How much weight could I lose using Alli? Alli may help you lose weight, but the weight loss will likely be modest — perhaps just a few pounds more than you would lose with diet and exercise alone. More than 40 percent of people taking Alli while following a calorie-restricted diet and increasing physical activity lost 5 percent or more of their body weight within a year. Clinically meaningful weight loss — enough weight loss to begin lowering the risk of cardiovascular disease, diabetes and other diseases — is generally defined as 5 percent or more of body weight. People who ate a calorie-restricted diet, exercised regularly and took Alli lost an average of 5.
How is Alli taken? One 60-milligram Alli pill is taken within an hour of a fat-containing meal up to three times a day. Daily fat intake should be distributed over the three main meals and should be no more than 30 percent of total calories. The manufacturer recommends a fat intake of about 15 grams a meal. If you eat a meal that contains no fat, then you don't need a dose of Alli.
If you eat a meal that contains no fat, then you don't need a dose of Alli. If you take Alli with a high-fat meal, you will likely experience more-severe gastrointestinal side effects. Alli can reduce the absorption of fat-soluble nutrients, including beta carotene and vitamins A, D, E and K. Take a multivitamin at bedtime and at least two hours after your last dose of Alli. Does Alli have side effects? The active ingredient in Alli, orlistat, causes gastrointestinal side effects related to undigested fats passing through your digestive system. They generally subside over time and with appropriate use of the medication. These side effects include: Send this info to a friend To: Check this box if you wish to have a copy mailed to you.
The reports, obtained through a Freedom of Information Act request we filed with the FDA earlier this year, show a pattern of adverse events submitted to the agency since Jan. Those reports don't prove that orlistat is to blame; but only that those conditions are associated in the reports with the use of Alli and Xenical. To date, a clear link between the use of the drug and a majority of those side effects has not been firmly established. Of the several thousand reports submitted to the FDA, Charles Bennett, director of the Research on Adverse Drug Events and Reports RADAR group, which also reviewed the reports said "this safety concern is heightened when one considers that only an estimated 1 percent to 10 percent of all adverse events that occur are ever reported to the FDA.
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