The first over-the-counter diet pill approved by the US Food and Drug Administration (FDA) hit US stores this weekend. The drug ‘Alli’ (generic name Orlistat) claims to help “committed dieters” lose 50 per cent more weight than they otherwise would through diet and exercise.
‘Alli’ is a pill with a plan, and people who use it have to change their eating habits to eat less fat and increase activity levels to achieve target weight loss. Priced at $50 for a four-week starter pack of 90 pills, the 60-mg ‘Alli’ is a lower-dosage version of the 120 mg prescription orlistat, which has been available in India as a prescription drug since 1999.
“‘Alli’ acts in the intestine by blocking the enzyme that metabolises fat, helping people shed up to five kg more than they would if they they just dieted and exercised. When taken in the strength of 120 mg three times a day, it causes gastrointestinal problems such as oily faecal discharged, diarrhoea and uncontrolled bowel movement,” says Dr Anoop Misra, director, department of metabolic diseases, Fortis group of Hospitals .
In clinical trials, the FDA says that people using ‘Alli’ lost an additional 2 to 3 pounds for every 5 pounds lost through diet and exercise. Though the FDA approved ‘Alli’ to be sold over the counter in February, it hit the stores on June 15.
When taken with meals, the diet drug blocks about 25 per cent of fat consumed from being absorbed in the body. It does this by attaching to enzymes that usually break down fat, thus preventing them from functioning.
That fat — about 150 to 200 calories worth — is passed out of the body, resulting in embarrassing bowel misadventures. About half of the patients in trials experienced gastrointestinal side effects, including diarrhoea and oily discharges.
“The side effects happens because the fat that is not absorbed passes out of the body, sometimes in the form of loose and frequent stools and oily discharge, which can be a social nightmare,” says Dr Misra.
Such side effects are more intense if the person taking the pill eats more fat. According to the ‘Alli’ diet plan, dieters need to have less than 15 grams of fat per meal.
Besides blocking absorption of fat, it also limits the body’s intake of fat-soluble vitamins A, D, E and K. “The pill can lead to nutritional deficiencies and everyone who takes it needs multi-vitamin supplementation,” says Dr Misra.
The pill should not be taken by pregnant and lactating women, children under 18 years, people with kidney disease and people on blood-thinners such as aspirin, which is now prescribed to people at risk of heart disease.
‘Alli’s labelling indicates that it is appropriate for anybody who is overweight, or has a body mass index of 25 or higher. A body mass index over 30 is considered obese. The recommended usage is one to three pills a day.