The FDA Says a Dallas-Made Bodybuilding Supplement May Be Causing Hepatitis

Categories: Healthcare

OxyElitePro.png
Here's the good news for customers of Dallas-based USP Labs. Its dietary supplements are no longer linked to fatal heart attacks. The FDA made sure of that this summer when it made the company destroy $8 million worth of product containing dimethlyamylamine, or DMAA, a compound that had been linked to 86 reports of illness and death.

And here's the bad news. The FDA thinks USP Labs may have replaced DMAA with a new active ingredient: hepatitis.

The federal agency issued a warning on Wednesday linking the company's bodybuilding supplement OxyElite Pro to an outbreak of non-viral hepatitis in Hawaii. Of 29 patients hospitalized with acute heptatitis so far, the state's health department says that two dozen had used the powder. Two of those have required liver transplants. One has died.

See also: FDA Makes Dallas Supplement Maker Destroy $8 Million Worth of Bodybuilding Powder

The public health investigation is ongoing, and officials have found no definitive evidence linking OxyElite Pro to the hepatatis outbreak. Nevertheless, the initial findings have been suggestive enough that the FDA recommends that "consumers stop using any dietary supplement product labeled as OxyElite Pro while the investigation continues."

In a statement to WFAA, USP Labs says it "stands by the safety of all of its products."

"The cluster of liver issues in Hawaii is a complete mystery and nothing like this has ever been associated with OxyELITE Pro in all of the years are products have been on the market," it said. "We know of no credible evidence linking OxyELITE Pro to liver issues."

Nevertheless, the company has stopped distribution of the product pending the outcome of the investigation.


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7 comments
roger190
roger190

I just wish the government would start caring about prevention from the get-go instead of getting caught up in debates regarding cost of treatment when there is already an epidemic.  It is much more cost effective to make sanitization a priority to prevent the spread of viruses.  There are products out there like SaniGuard sold by ER Distributing <a href="http://erdistributing.com">http://erdistributing.com</a> that can kill these viruses on contact.  Unfortunately, prevention doesn't put money into the pockets of the big pharmaceutical companies

Myrna.Minkoff-Katz
Myrna.Minkoff-Katz topcommenter

Probably the dosage was too high.  Acute hep can occur with too much Tylenol as well.

s.aten
s.aten

Thank Orin Hatch for that legislation.

ThePosterFormerlyKnownasPaul
ThePosterFormerlyKnownasPaul topcommenter

Just remember folks, this was part of the wave of deregulation under both the Clinton and Bush presidencies.  "Food supplements" are not reviewed by the FDA nor are the health claims, if any, evaluated by FDA for efficacy.


RTGolden1
RTGolden1 topcommenter

@s.aten Sorry buddy-o.  Orrin Hatch sponsored the bill, which was co-written by Sen. Tom Harkin (D-IA), who, incidentally was a recipient of fairly large campaign contributions from Herbalife.  You can try to paint this as a Republican debacle, but you'll fail.  It passed the Senate with a voice vote, the amended version passed the House with NO objections, and Pres Bill Clinton signed it into law.

If you really want to thank someone for idiotic legislation like the DSHEA, thank all the clueless voters who still think our 'Two party system' actually means there are two distinct parties.  There isn't.  There is one party, called the Politicians, and their goal is to keep the public complacent and stupid so they can continue to control the reins of power.

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