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View Full Version : Keep the good fight, Universal....



rev8ball
05-01-09, 1:35 pm
"FOR IMMEDIATE RELEASE - FDA
May 1, 2009

FDA Warns Consumers to Stop Using Hydroxycut Products
Dietary Supplements Linked to One Death; Pose Risk of Liver Injury

The U.S. Food and Drug Administration is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. Some Hydroxycut products are associated with a number of serious liver injuries. Iovate has agreed to recall Hydroxycut products from the market.
The FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. One death due to liver failure has been reported to the FDA. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure."


I then saw a post from the AP, and the last sentence really kicked me in the nuts:

“Dietary supplements are not as tightly regulated by the government as medications. Manufacturers don't need FDA approval ahead of time before marketing their products.”

Exactly one month ago, when we had the Animal Pak April Fool’s joke, we were talking about how the government is really putting supplements under the microscope. So, having a recall like this brings the topic of supplement regulation back to the forefront, and is the equivalent of waving a red flag in front of the FDA.

On Letting Go
05-01-09, 2:05 pm
If the goverment decides to persue further investigation in the supplement industry, supps being recalled is going to be a regular occurance. Hopefully Universal stays in the clear.

OLG

Appollonian
05-01-09, 2:14 pm
Has a clear link been made between the issues listed and the product? Surely there is a standard rate of jaundice, liver disease (up to and including transplant), rhabdomyolysis, etc. How have they determined that the people who had these diseases were not more inclined to the related issues than the average person?

Was it coincidence, or hard evidence? Hopefully due diligence has been done on the part of the investigators before the recall, because if not, no one is safe.

Aengus
05-01-09, 7:47 pm
By definition, anecdotal evidence is unreliable. With several millions of people using the supplement each year, it is not particularly indicative that a handful of people had liver issues.

Though the evidence may seem shaky at the moment, one would hope that the FDA is not simply grabbing a sensational headline.

natandrb
05-08-09, 12:02 pm
But, but, correlation directly equals causation right? That's what they taught in Bro-science 101.
There will always be scares about certain products all the time, just gotta do research and pick through the BS. I'm sorry but 23 reports out of how many thousands upon thousands of users? Even if the product did directly cause it, how many pharmaceutical products have fewer side effect rates than that? Sometimes the side effects sound worse than what the medicine is supposed to be treating.

GJN5002
05-08-09, 12:25 pm
By definition, anecdotal evidence is unreliable. With several millions of people using the supplement each year, it is not particularly indicative that a handful of people had liver issues.

Though the evidence may seem shaky at the moment, one would hope that the FDA is not simply grabbing a sensational headline.

well said. I think the media is looking for anythign to report on that isnt our crappy economy. Swine flu, hydroxycut, the octomom?

Look at the stuff the FDA approves that only comes back to bite them in the ass a year later when %80 of the people taking it are havigng heart attacks or renal failure.