TUESDAY, Jan. 24, 2006 (HealthDay News) -- Although the prescription weight-loss medication known as Xenical may soon be available over the counter, some doctors are questioning the drug's value.
Those experts include some officials at the U.S. Food and Drug Administration who say there is insufficient evidence that Xenical (orlistat) actually works in the long term. And one critic believes the drug could be unsafe in an over-the-counter setting.
Late Monday, an FDA advisory panel voted 11-to-3 in favor of making Xenical available without a prescription under the trade name Alli. The application for over-the-counter use of the drug was made by GlaxoSmithKline, although Roche actually makes the prescription version of the medication. The FDA typically follows the recommendation of its advisory panels.
"We are excited about the potential opportunity to provide consumers with an FDA-approved over-the-counter option that promotes gradual yet meaningful weight loss," said George Quesnelle, president of GlaxoSmithKline Consumer Healthcare North America, the Associated Press reported.
Xenical acts by keeping about 25 percent of the fat a person consumes from being absorbed; this fat is passed from the body in stools that can be loose or oily. Other side effects include the inability to absorb fat-soluble vitamins such as D, E, K and beta carotene.
"This drug doesn't work," said Dr. Sidney M. Wolfe, director of Public Citizen Health Research Group. "There is no evidence that, in the long term, this drug improves morbidity or mortality related to obesity."
Wolfe noted in his testimony before the panel on Monday that the drug can also have serious side effects, especially for people taking the blood thinner Coumadin or the drug cyclosporine, used to prevent organ-transplant rejection. While the prescription version of the drug makes it necessary for doctors to monitor patients who take Xenical, that safeguard wouldn't exist in an over-the-counter setting.
The bottom line, Wolfe said, is that the drug companies are more concerned with profit and saving a struggling drug than with patient safety. The sales of the Xenical have dropped 60 percent, Wolfe said. "They obviously don't like that, so Roche, the maker of the drug, has gotten together with GlaxoSmithKline to push this stuff over the counter."
But Deborah Fisher, a nurse from the Baltimore area, told the FDA panel: "We need this new solution to losing weight and keeping it off."
"Eat less, move more: It sounds pretty simple, doesn't it? Well, as my kids say, not!" said Fisher, adding that she's dieted for 45 of her 52 years, the AP reported.
Another expert thinks that, on balance, the FDA panel made the wrong decision.
"Orlistat is not a particularly dangerous drug, in part because the main side effects relate to bowel control, and that limits the dose anyone is willing to use," said Dr. David L. Katz, director of the Prevention Research Center at Yale University School of Medicine.
But there are other concerns, Katz noted. "Any weight-loss product offers the public an opportunity to pursue a goal that generally should be about lifestyle, by taking a pill instead. When that pill is available over the counter, a potentially useful dialogue with a health-care provider is avoided. I am concerned that some people, who would benefit from professional guidance toward sensible and sustainable weight control, will now just opt for a pill."
"I do not see grave danger in making orlistat available over the counter," Katz said. "But I do see cause for concern, and little reason to expect significant benefit. If the decision were based on the ratio of likely benefit to potential risk, I would be inclined to part company with the FDA, and vote no."
If the FDA follows the lead of its advisory panel and allows Xenical to be sold over the counter, GlaxoSmithKline has said it will recommend patients take multivitamins when using the medication. Whether that would happen is unclear since at least 47 percent of the people involved in trials of the drug did not take multivitamins as recommended, according to the FDA.
In those trials, obese people who took Xenical for six months lost an average 5.3 pounds to 6.2 pounds more than those who were given a placebo, according to the FDA. However, they gained the weight back once they stopped taking the drug.
Even though the proposed over-the-counter dose of 60 milligrams three times a day shows statistically significant weight loss, "there is no evidence presented that a modest, transient weight loss due to orlistat will afford any long-term clinical benefit through either a change in behavior or a reduced risk of serious clinical diseases manifested by being overweight," the FDA found.
GlaxoSmithKline plans to limit sales of Alli to adults; it expects women to account for 80 percent of its market. Alli will cost $12 to $25 a week, according to the AP.
GlaxoSmithKline told the wire service it plans to package Alli as part of an overall diet-and-fitness program. The program would emphasize eating a lower-fat diet, both to cut calories and lessen the drug's effect on patients' stools.
More information
To learn more about Xenical, visit Drug Digest.
