Originally published Oct 4, 2013 See updates below
Healthy adults trying to lose weight or gain muscle have experienced acute hepatitis or liver failure possibly from a dietary supplement. The federal shutdown is hampering efforts to investigate the cause.
Hawaii News Now has learned that the number of cases of acute hepatitis linked to a weight loss supplement has tripled in the last week.
There were 7 original cases but HNN sources say that number has gone up significantly since the weekend. They range from acute hepatitis to complete liver failure. At least one patient has already had a transplant, several more are on the list for a transplant and many more are being evaluated.
More cases were reported after an alert went out. The suspect is Oxy Elite Pro. A woman is on the brink of death after taking the pills for several weeks.
OxyElite Pro isn’t the only supplement that the patients took before getting sick. There is at least one other, but the Department of Health won’t reveal the name of that supplement.
And it’s unclear if an ingredient in the supplements is to blame or a combination of factors.
Another mystery, why the cases are only in Hawaii. Did Hawaii get a bad batch? These are all questions the health department and the FDA are looking into. The investigation could take weeks, even months and slowing things down, the government shutdown. The FDA is experiencing delays because of it.
It’s a mystery why this particular trend is only showing up in Hawaii.
Oxyelite Pro is a fat-burning pill with stimulanants. Ingredients include caffeine, Bacopa monnieri, a substance which increases a thyroid hormone, Bauhinia purpurea, which supposedly reacts with the thyroid hormone resulting in increased fat burning, Rauwolfia, which purportedly blocks fat storage and
Cirsium oligophyllum, which prevents fat gain. Finally, Geranium, said to be a stimulant.
But since these supplements are not regulated as are drugs, we don’t know WHAT ELSE is in them or if they have been examined for safety or efficacy. As long as the government shutdown continues, I don’t expect to see a ban on this product. If there is a serious issue with the product, it could mean more harm. The FDA issued a warning about this product already. But there was no mention of connection with liver problems.
UPDATE (9-Oct-2013) The FDA is investigating. This just reached wide circulation.
Steven Immergut, a spokesman for the FDA, said the agency has recalled “a couple” of technical experts who had been furloughed due to the government shutdown. The CDC said it had already begun responding to the situation at the time of the shutdown and has not had to change its staffing.
(10-Oct-2013) Hawaii officials are asking stores to stop selling Oxyelite Pro. This is the CRITICAL POINT for all dietary supplements right here:
OxyElite Pro is sold nationwide. Because it is a dietary supplement, it did not have to be approved by the FDA before going to market.
But the law allows the FDA no teeth in this matter. There is likely counterfeit drugs (yes, DRUGS) on the market that could be the cause of the problem. But the regulations are so lax on these products that this problem is hard to get a handle on and control. Shame on the lawmakers that allow this to nonsense to occur by giving these manufacturers exemptions from the law that governs health-related USEFUL drugs.
Tip: Joy Harris