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The pending release of the over-the-counter weight loss medication Xenical is causing unrest in the medical field. The product, which will be marketed under the name Alli, was favored in an 11-3 vote by an FDA advisory panel on Monday, for release as an over-the-counter diet pill.

Xenical operates by preventing consumed fat from being absorbed into the body, and instead passing it through the stool, which may be oily or loose. Side effects may include the inability to absorb important vitamins such as beta-carotene, D, E, and K as well. Pharmaceutical distributor of the drug, GlaxoSmithKline has commented that they will include a recommendation in the medication that patients take a multivitamin supplement while using Xenical.

Expressed worries regarding the release of the drug however seem to cover broader reasons than the irksome side effects. “I do not see grave danger in making orlistat [Alli] over the counter. But I do see cause for concern, and little reason to expect significant benefit,” commented Dr. David L. Katz, director of the Prevention Research Center at Yale University School of Medicine.

The primary concerns associated with the release of the medication for over the counter availability, seems to be the lack of doctor supervision and guidance. Alli may cause serious complications for people taking blood thinning medications or the drug cyclosporine that is used to prevent organ-transplant rejection, as well as for those with diabetes. Without supervision of a prescribing doctor, the risk of people being unaware of these potentially fatal complications is substantially greater.

GlaxoSmithKline, the pharmaceutical company responsible for the distribution of the Xenical, has commented, “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”.

Though the new drug may successfully initiate weight loss during use, trial experiments of the drug suggest that most participants gained the weight back with discontinuation of Xenical. The FDA has commented on the issue that, “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 manifest by being overweight.”

Historically in the U.S., over-the-counter weight loss drugs such as ephedrine and Fen-Phen have proven to pose greater health risks than benefits.