The Food and Drug Administration has released the first government-approved nonprescription diet pill. Orlistat, which is available by prescription, will now be sold over the counter in a reduced strength version.
The new version, known as “Alli,” is being sold by GlaxoSmithKline PLC.
In an article for USA Today, Dr. Charles Ganley, the FDA’s director of nonprescription products, stressed that the pill is intended for people 18 and older and should be used along with a low-fat diet and regular exercise.
“Using this drug alone is unlikely to be beneficial,” Ganley said.
According to Ganley, this drug is the first approved by the agency for weight-loss and is unlike other supplements that claim the same thing. When used in trials, Ganley said that “for every five pounds people lost through diet and exercise, those using orlistat lost an additional two to three pounds.”
“I think this will have a big effect because of the amount of people who struggle with weight-loss in this country,” Susan Fitzgerald, the coordinator of health services, said.
Like Ganley, Fitzgerald said that because the pill doesn’t do anything for the fat on people’s bodies the only way it will be beneficial is if it is used along with diet and exercise. Fitzgerald also stated that it is not something that necessarily has to be used forever.
The pill does have side effects. According to the FDA, the most common of these is a change in bowel habits. These include loose stool and oily spotting. However, it was said that a low-fat diet would reduce the chances of these side effects.
The effects that the pill will have is just one of the vital concerns that the release of this drug might raise. Now that the pill is available over the counter, the potential for abuse and possible addiction may increase among people with eating disorders. This is according to an article on USNews.com.
“There’s potential for abuse in any kind of medication,” Fitzgerald said. “I would encourage everyone to check with their physician before trying it.”
“The approval of this drug is the height of recklessness,” Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said in the same article in USA Today.
Wolfe has called for a withdrawal of the prescription version due “to studies that have associated it with precancerous lesions of the colon.”
When asked if they would consider using the diet pill, most Cabrini students answered in the negative. They said that the side effects alone were enough to make them wary of trying it.
The price has yet to be set, but the nonprescription version is expected to cost $1 to $2 a day. This means it could cost $30 to $60 a month. The company estimated that 5 million to 6 million Americans a year will buy this drug over the counter.