FDA sanctions first over-the-counter weight loss drug

The US Food and Drug Administration today approved the first officially sanctioned weight-loss drug that will be sold without a prescription.

Orlistat, to be marketed under the name Alli by GlaxoSmithKline is expected to become available to consumers this summer. The drug is the first government-approved alternative to unproven over-the-counter weight loss remedies.

The anti-obesity drug also known as tetrahydrolipstatin works by reducing the gut's ability to absorb fat from the human diet, thereby reducing caloric intake.

Designed and developed for use in conjunction with a "reduced calorie, low fat diet, and exercise program," the drug will not work on its own, Dr. Charles Ganley, FDA's head of nonprescription drug products specified.

Marketed by GlaxoSmithKline as the brand Alli, the drug will be available for adults over 18 years of age in 60 mg capsule form to be taken up to 3 times a day with meals. The drug would retail at $2 to $3 for a day's dose.

However, the drug should not be consumed by people who have undergone an organ transplant. Also, if one is under medication for diabetes, thyroid or is on blood thinners, the use of the drug should be restricted, FDA cautions.

The primary side effect of the drug is gastrointestinal-related, Dr. Adrienne Youdim, a weight loss specialist at Cedars-Sinai Medical Center said.

As Orlistat prevents dietary fat from being absorbed, it is excreted in the feces causing it to be greasy and loose. Increased flatulence is also common. Bowel movements may become frequent and urgent. However these effects can be reduced by intake of a low fat diet, FDA marks.

Also, as the absorption of fat-soluble vitamins and other fat-soluble nutrients are inhibited by the use of orlistat, a multivitamin tablet is to be taken once a day, at least 2 hours before or after taking the drug, Youdim added.

Meaniwhile, Orlistat should not be consumed if one is not overweight, FDA warns. A Body Mass Index (BMI) of 27 kg per metre squared or above is defined as overweight by the National Institutes of Health.

With nearly 130 million Americans overweight, and about 50 percent of those obese, GlaxoSmithKline expects around 6 million users of the drug during its first year.

There are currently no plans to launch drug in Europe.