By

Michelle Castillo /

CBS News/ November 15, 2012, 9:58 AM

FDA investigating 13 deaths tied to 5-hour Energy

Officials are investigating several cases including 13 deaths that may be tied to 5-hour Energy products, the Food and Drug Administration confirmed on Wednesday.

The FDA has told CBS News in a statement that cases surrounding 92 patients include 33 hospitalizations and 13 deaths are under investigation due to a possible link to 5-hour Energy, which has been labeled as a dietary supplement and marketed as an "energy shot." The FDA can pull the item off the market if is unsafe for use according to the instructions described on the labeling.

"It is important to note that, while those who voluntarily report an illness or injury (such as medical professionals, family members, or the consumers themselves) typically identify the product that they assume caused the injury or illness, FDA as a scientific public health agency must carefully investigate and evaluate all possible causes before deciding whether the product actually caused the medical problem," the FDA said in the statement.

Records that the New York Times looked into show that since 2009, more than 30 of those cases were deemed serious or life-threatening. Symptoms included heart attacks, convulsion and one case of spontaneous abortion.

"We take every adverse event report seriously," Shelly Burgess, an FDA spokeswoman, said to the Wall Street Journal.

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Burgess confirmed that the reports were filed by the company themselves.

5-hour Energy drinks are sold in 1.9-ounce containers known as shots. While they don't label how much caffeine is in their bottles, a Consumer Reports investigation claimed that it could range from 6 mg in their 5-hour Decaf bottles to 242 mg in their 5-hour Energy extra strength bottles.

This isn't the first time energy drinks have been under scrutiny from the FDA. In late October, the organization announced they were investigating five deaths and one heart attack tied to Monster Energy drinks since 2004. Around that time, the parents of 14-year-old Anais Fournier, a girl who allegedly died after drinking two Monster Energy drink beverages within 24 hours, said they were suing the drink maker for failure to label the risks of drinking their product.

Energy drinks growing popularity has some health officials concerned. The Substance Abuse and Mental Health Services Administration reported that energy drink-related emergency room visits increased tenfold from 2005 to 2009. In 2008 and 2009, there were 16,053 and 13,114 cases respectively. Two-thirds of the cases were deemed "adverse reactions."

About 52 percent of the visits were by patients between the ages of 18 to 25 who had used the energy drinks with alcohol or other drugs. Men were more likely to go to the emergency room, and their visits were more likely to be related to a combination of the energy drink with alcohol or illicit drugs. Females were more likely to visit due to a combination of energy drinks and pharmaceuticals.

The FDA pointed out that medical problems normally coupled with use of a dietary supplement may be due to the improper use of the product, prescription or over-the-counter medications, other foods and dietary supplements or pre-existing medical conditions. They cautioned that just because a certain product was used in a certain case did not mean the product in question caused the adverse episode.

However, Cleveland Clinic cardiac surgeon Dr. Marc Gillinov previously told CBSNews.com that in order to die from caffeine overdose, one would have to consume 10 grams of caffeine. For comparison, a tall cup of Starbucks brewed coffee is has about 260 milligrams of caffeine, while an average cup of tea only has 40 milligrams.

In a statement, 5-hour Energy makers Living Essentials LLC claimed that its product was a "compact-sized energy shot intended for busy adults," not an energy drink or beverage. They said that each product contains about the same amount of caffeine as a cup of premium coffee.

In addition, the company stressed the product should not be used in conjunction with alcohol, and consumers should not drink more than two bottles a day spaced several hours apart.

© 2012 CBS Interactive Inc. All Rights Reserved.
29 Comments Add a Comment
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micmac666 says:
Where are the enterprising chemists who could make and sell pure caffeine by the can, gallon jug, drum, or tanker? Obviously its legal commercially, so if folks want to explode their hearts, have at it. Adios.
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micmac666 replies:
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How about that? 'Caffeine readily available from nutritional supplement sources. "200mg 8-hour sustained release capsules". 'News to me.
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parisdakar says:
If you're that tired, how about getting some sleep instead?
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CDLady replies:
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they have other things to do..
no time for sleep..
micmac666 replies:
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'Too busy multi-tasking with the rest of the drones.
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mcneillmama5 says:
I am glad this came out tonight. I think it is unethical that this company is now using a marketing strategy of Pink Ribbon Lemonade flavor 5 Hour Energy Drink. Any woman with fibrocystic breast disease knows to stay away from caffeine. Caffeine is such a potent drug that if you go off of all caffeine products you consume on a daily basis, by the third day you will suffer a severe withdrawal headache. A debilitating headache. Caffeine is such a potent substance, hospitals use it in an IV drip to close up the puncture in the epidural space or dural space should a patient develop a spinal headache after having spinal anesthesia. The caffeine closes up the hole in the epidural space. That's how potent a vasoconstrictor it is. Now add to the mix those three states that are trying to push recreational marijuana? It is unlikely that the regulations will ever be enforced when cashiers can push 5 Hour Energy Drinks unchecked and unsupervised to little kids! The owner of the company is also dodging the questions. He doesn't even know for sure what is in the product he is selling that's killing kids and young adults? How irresponsible. He's up there right along with NECC the company that produced the tainted steroid injectables. The FDA botched up that investigation too. Can't wait until the news media covers that story and the Congressional hearing that was supposed to take place today.
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hypnotoad72 replies:
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"Personal responsibility" - it allows these companies to be unethical and get away with... murder. On top of everything else...
Not-telling replies:
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How about those of us who are under doctor orders to consume caffeine? This is the same thing as ephedra a few years ago in stacker 2. At the time the AMA recommended that be consumed by asthmatics on a daily basis as it would help prevent asthma attacks. What is good for some is not good for all but that is not a reason to say none can have. I would be dead now if it wasnt for caffeine. I am an asthmatic and caffeine helps prevents attacks and when having one can help reduce the symptoms. BTW outlawing caffeine would out law coffee which liberal love.

How about people use the product as directed. I one time drank 2 32 ounce monsters back to back and my heart felt like it was going to jump out of my chest. So i didn't do that again. I still drink them i just do it the right way. Same thing with Four Loco dont drink 4 of them and you wont have a problem. No one ever blames the person who over consumed OD for not stopping. Now if just one did something then you might have a case.

I love it when people go "what about the children?" which is the battle cry of the ignorant. Who dont have a real argument that would stand up otherwise. I remember when i was a child i wasnt as stupid as people think. That probably because my parents thought me how to think for myself and not be a drone who blindly follows orders. But proper parenting doesnt seem to be something people want to blame for their kids doing stupid things. A 14 year old girl died, when i was 14 i worked at mcdonalds and the manager would go on break and leave me in charge of the store. So because this 14 year old was stupid the rest of us should be punished by having something we enjoy taken away?
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bobnjersey says:
[While they don't label how much caffeine is in their bottles, a Consumer Reports investigation claimed that it could range from 6 mg in their 5-hour Decaf bottles to 242 mg in their 5-hour Energy extra strength bottles.]
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it's not about caffeine ... it has somewhere around 3000 times the daily required amount of 'b' vitamins in it.

it's a massive dose of 'b' vitamin ... which may be an issue for some people's system.
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hypnotoad72 replies:
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Caffeine can be a factor (increased heart rate near or at (or above) maximum, and for excessive, uncontrolled periods of time...

Some people have compromised systems that necessitates the need for B-series vitamin supplements, but the reason why the "energy" drink is fortified with them is because the main ingredient, caffeine, is a diuretic - that and vitamins cannot be absorbed into the body while the body is preparing to urinate (think "diuretic" again).

Still, if you think caffeine isn't a problem, go drink 10 cups of coffee all at once. Let us know what happens. If you feel palpitations, then "I told you so" might be what I say.

Still, regulations are bad. Then again, who cares if a bunch of people die from drinking it, right?
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Joefortruth says:
Yes lets hound five hour energy that cruel business killing our kids. This is the problem with liberalism, they expect government to protect them from everything and take care of them. Where is personal repsonsibility? What happened to being reponsible? It's not governments job to protect you from energy drinks.
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hypnotoad72 replies:
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Okay, where was the personal responsibility of the company that decided to do the cruel thing that's harming and killing people?

IT WORKS BOTH WAYS, SO STOP IT WITH YOUR ONE-SIDED CLAPTRAP.

THANK YOU.
hypnotoad72 replies:
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Liberals expect everyone to act ethically, and that starts from the top down. I'm sorry if you want to side with crooks, swindlers, and murderers, but that's your choice.

So, along with your one-dimensional thinking, you also take what Liberals say, spin it, dilute it, and make it fit your myopic, parochial beliefs.
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rwsmith29456 says:
There is some part of the population walking around with heart trouble that don't know it and what would be harmless to most people can be deadly in others.
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hypnotoad72 replies:
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So spend $200+ for a quack visit, with relevant heart tests, before drinking.

Personal responsibility - the companies that make and sell products don't need to engage in it, but everyone else had better to so. (One day, the people who spew "personal responsibility" beyond the realm of common sense will be eating their own words, unfortunately... )
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daddycrc-2009 says:
This just asw bad as when they took davacet a pain killer off the market that had been onthere since 1937, over 37 trillion scrips written, the fda stated 167 deaths causaed by the drug, ONLY 167 deaths after 37 trillion scripps, Not to bad odds, Also it wasnt addictting like the other crap out there..
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wildemanne says:
this garbage needs to be removed & banned some people are so desperate to get that extra buzz they will take any sort of speed or upper stick with good old STRONG COFFEE a safer bet
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Nate650 says:
This stuff is junk:

Other Ingredients: Purified Water, Natural and Artificial Flavors, Sucralose, Potassium Sorbate, Sodium Benzoate and EDTA (to protect freshness).
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hypnotoad72 replies:
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When they get around it by saying "natural and artificial flavors", then you know they're doing something shady. Not everybody would automatically be so paranoid, and most customers are under the impression that companies do things for peoples' benefit.

Which includes the sheer bulk of the "personal responsibility" folks, who are the most ignorant (and ironic!) of the bunch.
Nate650 replies:
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I'm definitely more cautious than the average person. I don't even trust "natural flavors." Certain companies really do care and are making a difference, such as Numi Tea, which emphasizes the use of only real ingredients. And because of that they have my business. :)
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jmerring says:
I have had Red Bull and 5 hour energy. Neither one did what it claimed ( I fell asleep wathing TV, 2 hours after 5 hr energy. The Red Bull, tasted lke carbonated cough syrup. I guess the Wiings they reference are those of an angel; a conclusion drwan from this article.
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