The first over-the-counter medication for the treatment of obesity in adult patients has been approved by the US Food and Drug Administration.
The medication, called alli (orlistat), is created to be used only along with a reduced-calorie, low-fat diet by overweight adult patients over the age of eighteen. According to the producer of the drug, GlaxoSmithKline, the medication helps people lose 50 per cent more weight than dieting alone.
"This is the only FDA-approved, non-prescription weight-loss medical product," Dr Charles J. Ganley, the FDA’s director of the Division of Over-The-Counter Drug Products, said in the course of a teleconference. "There are some products, primarily dietary supplements, that make weight-loss claims and those are not FDA-approved, even though they are allowed to make these claims."
The medication will soon be available in 60 milligram capsules. It needs to be taken three times daily with meals containing fat. The company explained that the medication works by "blocking around 25 per cent of the fat in food a person consumes. Due to the way it works, alli needs to be used in conjunction with a reduced-calorie, low-fat diet comprising around 15 grams of fat per meal."
According to the FDA, having a meal with too much fat whilst taking the medication can lead to bowel changes like loose stools. Such side effects usually appear in the first weeks of treatment, they are not harmful, and can be managed by following the suggested diet of around 15 grams of fat per meal, GlaxoSmithKline informed.
Moreover, it is suggested that patients should take a multivitamin once a day, at bedtime, due to the fact the medication can interfere with the absorption of several vitamins, GlaxoSmithKline said.
People who have had a transplantation of organ should not take the medication. And anyone taking blood-thinning drugs or being treated for diabetes or thyroid disease should consult a healthcare professional before using this medication, the FDA warned.
To be taken with weight loss program
"This medication is only going to be successful if it is used together with a weight-loss program," Ganley explained. "That means a reduced-fat diet, lowered calories and an exercise program."
"If somebody uses the medication without a weight-loss program, it is not going to be very successful," he added. Since 1999, a higher dose of orlistat (120 milligram capsules) has been marketed as the prescription medicine Xenical in the United States.
Safety questioned
Whilst the company claims that Xenical’s security has been proven by nine years of worldwide use in 146 countries, last year the consumer-advocacy group Public Citizen petitioned the FDA to remove Xenical from the American market.
Public Citizen contended that the higher-dose medication might increase the risk of aberrant crypt foci, which are widely thought to be causes to colon cancer.
Late Wednesday, a statement criticizing the FDA’s approval of the non-prescription version of the drug was made out by the advocacy group. "When colon cancer is a major cause of death and illness in the United States, the Food and Drug Administration’s decision to approve, for non-prescription use, a diet medication that clearly leads to precancerous lesions of the colon is the height of recklessness and shows a profound lack of concern for the public’s health," Dr Sidney M. Wolfe, director of Public Citizen’s Health Research Group, said in the statement.
Not successful for most
One obesity specialist is not sure if the new OTC medication will be successful for the majority of people.
"The medication is perhaps safe," explained Dr Raj Padwal, an assistant professor of general internal medicine at the University of Alberta. "Nevertheless, I’m not sure the half-strength dosage will have much effect."
Full-strength dosage decreases weight by less than 3 kilograms (6.6 pounds), approximately, Padwal explained. "People may only lose 1 to 2 kilograms (2.2 to 4.4 pounds) on this half-strength dose. If that is worthwhile is questionable. The occasional patient may experience some benefits, but majority of patients may not. For those patients who require additional incentive to adhere to a low-fat diet, the medication may be helpful," Padwal added.
Pills not the answer?
Padwal and his team have lately published an article in The Lancet that noted precious little evidence exists proving weight-loss medications like orlistat in fact lower the risks of heart attack, stroke and diabetes connected with being overweight or obese.
The FDA’s approval of the first non-prescription medication for weight loss comes as the United States and other western countries are fighting with an unprecedented epidemic of obesity.
According to the US National Centre for Health Statistics, thirty per cent of American adult citizens over the age of twenty - more than 60 million people - are obese. And another 36 per cent are considered overweight.
Limited good, limited harm
Generally, this medication is probably to be restricted in the direct harm that it causes, but also in the good that it brings, said Dr David L. Katz, an associate professor of public health and director of the Prevention Research Centre at Yale University School of Medicine. "It is a relatively unproductive weight-loss aid," he explained. "If availability of the medication distracts people from the tried-and-true approach to weight control, eating well and being physically active, then the FDA decision could prove more harmful than helpful, despite good intentions."
