In a tale of two weight-loss aids, the FDA reveals its true colors

True Colors

In a startling moment of honesty, an FDA spokesperson recently made this announcement: “The FDA obviously has a friendly relationship with drug companies compared to our relatively cool relationship with supplement makers. So of course we’re likely to apply more lenient standards to drug companies while pretty much sticking it to supplement companies.”

I’m actually indulging in some wish fulfillment here – that statement was never made. Not in so many words, anyway. But if you read between the lines, all is revealed.

Let’s compare…

EXHIBIT ONE: Free pass for giant drug companies

Last month, FDA officials announced a safety information review for orlistat, a weight-loss aid. You probably know this drug by the brand name Alli, made by GlaxoSmithKline. It’s also sold at higher dosage as a prescription drug called Xenical, made by Roche.

At issue are 32 reports of “serious liver injury,” which include six cases of liver failure and 27 cases of hospitalization.

The FDA press release states: “FDA is not advising healthcare professionals to change their prescribing practices with orlistat.” The agency also advises consumers to continue taking Alli and Xenical as directed.

EXHIBIT TWO: Getting tough with a supplement maker

This past May, the FDA issued a consumer warning about several (but not all) Hydroxycut weight-loss products. All of these are non-drug items, available over-the-counter.

At issue are 23 reports of liver problems, ranging from jaundice and elevated liver enzymes (indicators of potential liver injury) to one death due to liver failure.

The FDA warning stated: “The U.S. Food and Drug Administration is warning consumers to immediately stop using Hydroxycut products.”

There, in a nutshell, is your FDA.

Dangerous blockage

Obviously, liver damage is a huge issue, but it’s just part of the orlistat side effect picture. In fact, it’s a relatively small part compared to the fact that this drug works by partially blocking absorption of dietary fats, which would include sources of omega-3 fatty acids. Add to that, orlistat also interferes with absorption of fat- soluble vitamins, such as D, E and K, and the precursor of vitamin A, beta carotene.

Block these vitamins at your peril. No exaggeration – with reduced absorption of these vitamins and omega-3s, you’ll also reduce your defenses against cancer, heart disease, type 2 diabetes, Alzheimer’s, AMD, osteoporosis…just for starters.

If you or someone you care about is taking Alli, you can read about other drawbacks of this drug in the e-Alert “Expert Tease” (7/31/06).

Sources:
“Early Communication about an Ongoing Safety Review Orlistat (marketed as Alli and Xenical)” Food and Drug Administration, 8/24/09, fda.gov
“Warning of Hydroxycut Products” Food and Drug Administration, 5/1/09, fda.gov