Originally published February 22 2006
Effectiveness of orlistat as a weight loss drug questioned by one FDA reviewer
by Mike Adams, the Health Ranger, NaturalNews Editor
According to earthtimes.org, an anonymous report posted on the FDA's website by one reviewer calls into question the effectiveness of Xenical, also known as orlistat, for promoting weight loss over the course of six months.
GlaxoSmithKline's diet pill Xenical, generic name orlistat, may not be as effective as it is made out to be and might have risks that outweigh the benefits, a Food and Drug Administration (FDA) reviewer said ahead of the committee meeting to approve the drug to be sold over the counter (OTC).
"It is not clear to this reviewer what benefit a consumer purchasing orlistat OTC can possibly reap from six months of OTC use," a report posted on the FDA Web site said.
Clinical trials showed that obese people on Xenical lost about 5.3 to 6.2 pounds more than those who were being given placebos.
However, the reviewer warned that if the drug were made nonprescription, diabetics and those on immuno-suppressant drugs, who are not fit to take Xenical, would purchase it over the counter not knowing the side effects, thus endangering their health.
In the review study, only 35 per of diabetics were found to know that Xenical was risky for them.
Also, Xenical was found to create vitamin deficiencies in the body by preventing the absorption of fat-soluble vitamins like D, E, K and beta-carotene.
Another concern that the FDA expressed was the misuse of the drug by those with eating disorders, who already are at risk of vitamin deficiencies.
But Dr Howard Eisenson of the Duke Diet and Fitness Center in Durham felt that side effects like loose motions might prevent the misuse.
Xenical was also found to hinder the action of some drugs, like cyclosporine, which is used by those who have undergone organ transplant, thus increasing the chances of the organ being rejected.
Meanwhile, the FDA reviewer agreed that the drug did lead to significant weight loss but questioned the benefits over risks and sustainability of the weight loss.
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