Dear Doctors column for February 19, 2007
First FDA-Approved OTC Weight-Loss Drug
Question:
What can you tell me about the new over-the-counter weight-loss drug? Can it really help me lose weight?
Answer:
In February 2007 the Food and Drug Administration (FDA) approved Alli, the first over-the-counter (OTC) medication for weight loss they have ever sanctioned. Although weight-loss products, including dietary supplements, herbal formulas, and so called “fat burning” pills, have been available in drugstores for years, they are not required to meet rigorous scientific standards. There often is no evidence beyond the anecdotal information offered by manufacturers that these products work and experts routinely question the safety of such supplements.
As the first OTC weight-loss drug given the FDA’s stamp of approval, Alli has undergone scientifically sound clinical trials showing it is safe and demonstrates some degree of effectiveness for promoting weight loss. Does that mean Alli is the long-sought magic bullet for weight loss? Unfortunately for many dieters struggling to shed excess pounds, the answer is no. The drug may help people lose a few extra pounds, but only in conjunction with a low fat, low calorie diet and exercise program. Alone, it will have little, if any, effect. And the drug can produce unpleasant side effects.
Alli is a reduced-strength version of a prescription drug called Xenical (orlistat is the generic name of both drugs). Alli is half as potent as Xenical; the OTC version is sold in 60-mg capsules, while the prescription drug comes in 120-mg doses.
Available in the United States since 1999, Xenical never became very popular with dieters or their doctors for several reasons. Xenical and Alli work the same way ─ by inhibiting enzymes that breakdown fat in the intestine. This prevents a portion of dietary fat (about 25%, according to the GlaxoSmithKline, the drug’s manufacturer) from being absorbed by the body. The unabsorbed fat is passed out the body, and this is where disagreeable side effects become a significant factor.
Both Alli and Xenical can produce greasy flatulence, diarrhea, oily and loose stools, the occasional loss of bowel control, and painful intestinal symptoms. A low fat diet can reduce these side effects. Eating high fat meals means a larger amount of fat is passed freely through the body, resulting in more severe side effects. Some experts note that the unpleasant intestinal effects create an aversion to eating high fat foods, which also may aid in weight loss.
According to GlaxoSmithKline, eating 15 grams of fat or less per meal helps limit side effects. The company also notes side effects are more likely during the first few weeks of taking the drug.
In conjunction with diet and exercise, Alli’s fat-blocking action can produce modest weight loss. In a 6-month study conducted by GlaxoSmithKline, overweight people taking the 60-mg version of orlistat and following a diet and exercise plan lost an average of 4 pounds more than those using diet and exercise alone. Longer-term studies of the prescription-strength version of orlistat show dieters tend to gain lost weight back soon after stopping the drug.
Check with your physician before starting Alli. People often need a multivitamin to supplement the drug-induced loss of fat soluble vitamins (A, D, E, K) may be required for people using Alli. In addition to blocking fat, Alli blocks the absorption these vitamins. Multivitamins that supply these essential nutrients can prevents any significant deficiency.
Some consumer groups have raised concerns about orlistat’s safety, citing studies that link Xenical with precancerous changes in the intestine. The FDA, however, states that the drug’s safety profile meets its standards.
Alli will be available in drugstores by summer 2007. It is designed to be taken three times a day with meals and will cost $1 to $2 a day, according to GlaxoSmithKline. It is intended for 6-month use in overweight and obese people 18 years and older. The company acknowledges that Alli offers only modest weight-loss benefits and that people lose weight only when they combine the drug with a low fat, reduced-calorie diet and exercise plan. Package inserts will include a fat and calorie counter, a journal for recording daily food intake, and reference guides on meal planning and eating out. The company also has launched a Web site, www.myalli.com, which allows patients to register, track their progress, and get individualized advice.