FDA, do your job and warn consumers about this terrible drug

With an ally like this…

Here’s how the FDA, takes swift action to protect consumers…

When a line of weight loss products called Hydroxycut was linked to 23 reports of liver problems, including one death from liver failure, the FDA issued a warning to consumers, directing them “to immediately stop using Hydroxycut products.”

The manufacturer quickly removed all Hydroxycut products from the market.

The FDA rides to the rescue!

That was May 2009.

In August 2009, the FDA again warned consumers about another weight loss product called orlistat–you may recognize Alli as the over-the-counter brand name, and Xenical is the prescription strength product.

FDA officials noted that the Adverse Event Reporting System had received “32 reports of serious liver injury, including 6 cases of liver failure.” Hospitalization was reported in 27 of those cases. (Now, I went to public school, but I still learned that 32 > 23.)

And here’s the agency’s official instruction: “Consumers currently taking Xenical should continue to take it as prescribed and those using over-the-counter Alli should continue to use the product as directed.”

Now THERE is your FDA in action!

Potentially dangerous drug? Go right ahead and take it. Do NOT stop taking it under any circumstances.

Potentially dangerous supplement? Drop it like it’s Kryptonite.

So here we are, two years later, and orlistat is racking up an even more impressive list of serious adverse reactions. And what are we hearing from the FDA?


This drug is a train wreck

Recently, the watchdog group Public Citizen called on the FDA to remove Alli from the market.

Checking MedWatch, Public Citizen found 47 adverse reaction reports of acute pancreatitis linked with Alli or Xenical. Nearly 40 of those patients were hospitalized and one died.

Also, more than 70 cases of kidney stones were linked with the two drugs. Among those patients, 23 were hospitalized. Three patients had acute kidney failure and one died.

In a press release, Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said, “Any one of these serious risks alone would be sufficient basis for banning Xenical and Alli. These drugs have the potential to cause significant damage to multiple critical organs, yet they provide meager benefits in reducing weight loss in obese and overweight patients.”

Meager is right. When using the higher dose (Xenical) for one year, subjects in a clinical trial lost only seven pounds more than those who spent the year dieting and exercising. Other trials produced similar results.

On top of all that, orlistat works by partially blocking the absorption of fats in the intestines–including highly nutritious fats such as omega-3 fatty acids. And that fat- blocking also interferes with absorption of crucial fat-soluble vitamins such as D, E, and K.

And finally, just to add a grueling insult to this train wreck, people who use Alli or Xenical and don’t cut way back on their fat intake may experience the unexpected and embarrassing side effect of loose and oily stools.

If you know someone who’s on or even thinking of taking one of these drugs, do that one simple thing the FDA seems reluctant to do–warn them.

“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
“Weight-Loss Drugs Alli and Xenical Should Be Removed From the Market, Public Citizen Tells FDA” Public Citizen, 4/14/11, citizen.org

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