FDA investigating deaths, possible 5-Hour Energy link

5-hour Energy is also sold in vending machines. (Christopher Seward, cseward@ajc.com)

5-Hour Energy is also sold in vending machines. (Christopher Seward, cseward@ajc.com)

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The distributor of 5-Hour Energy insists the caffeine-loaded “shot” is safe when used as directed following news that the U.S. Food and Drug Administration had received reports from the company that the product may be linked to 13 deaths in recent years.

The FDA confirmed a New York Times report that it is investigating the deaths, which occurred in the last four years. The investigation is similar to one the agency has launched targeting Monster Energy drink and reports of five possible deaths related to that product.

Elaine Lutz, a spokeswoman for Living Essentials, said the distributor is unaware of any deaths proven to have been connected to 5-Hour Energy and the NYT report acknowledges a filing to the FDA does not necessarily mean the energy shot was ultimately responsible for a death or injury.

Living Essentials is required to pass along to the FDA any reports of possible deaths or injuries  linked to its product because it is marketed as a dietary supplement. The makers of energy drinks don’t have to submit such reports.

The NYT report said, “Since 2009, 5-Hour Energy has been mentioned in some 90 filings with the F.D.A., including more than 30 that involved serious or life-threatening injuries like heart attacks, convulsions and, in one case, a spontaneous abortion.”

Lutz said 5-Hour Energy is safe if used as directed, no more than two of the 2-ounce shots a day. The two daily shots, each of which contains about as much caffeine as a cup of coffee, should not be consumed back to back, the company said.

Consumer Reports recently studied the levels of caffeine in 27 energy drinks. “The highest amount per serving was 242 milligrams of caffeine in 5-Hour Energy Extra Strength. The lowest was in 5-Hour Energy Decaf, which despite the name carries 6 milligrams of caffeine per serving.”

Living Essentials said 5-Hour Energy, which is also loaded with B vitamins, is for “hardworking adults who need an extra boost of energy,” but it’s “not an energy drink” and isn’t marketed as a beverage, the distributor said.

Monster Beverage, the maker of Monster Energy, also said its drink is safe if consumed as directed. The Substance Abuse and Mental Health Services Administration said more than 13,000 emergency room visits in 2009 were linked to energy drinks.

46 comments Add your comment

Kat

November 15th, 2012
12:25 pm

What annoys me is that commercials for this drink appear on TV on children’s programming channels. My kids wanted some, but I said no way.

Iconoclast

November 15th, 2012
12:38 pm

As with a cup of coffee or a glass of water, this product has benefits for keeping an otherwise long drive from being any more hazardous than complacency causes on the open road. Everything in moderation folks! Even too much water is bad for human health.

Herp de Derp

November 15th, 2012
12:50 pm

I’ve tried these energy shots, but they just don’t do it for me.

But chocolate-covered dark-roast coffee beans, that’s another thing. You can get ‘em at places like Starbucks, Trader Joes, pretty much anywhere foo-foo coffee or Purina Hippie Chow is sold. Just crunch ‘em up like peanuts or M&Ms, wash ‘em down with a beverage (they are kind of gritty) and presto — caffeine boost + sugar rush.

I’m not making this up; they *are* sold and they *do* work. And once you get past the notion of eating a whole coffee bean, you’ll find they’re way cheaper than the energy drinks.

JJJJJJJJJJimmy

November 15th, 2012
12:59 pm

Would be interesting to know the facts about the people who supposedly died from energy drinks….like what else was in their system. Alcohol? Drugs? Pills? etc?

scallywag

November 15th, 2012
1:24 pm

Which raises the awkward question are you happy to continue consuming a product that has been linked to such serious health issues or are you going to just shake it all off and argue that until someone takes it off the market it must by implication mean it’s still good for you? Or even worse can we even wonder if there’s a cover up….?

http://scallywagandvagabond.com/2012/11/the-5-hour-energy-drink-that-is-delicious-enough-to-kill-you-is-someone-hiding-something/

JW

November 15th, 2012
1:28 pm

I can’t believe anyone is surprised…

[...] reports of illnesses and deaths of people who took 5-Hour … – Washington Post Atlanta Journal Constitution (blog)FDA investigating reports of illnesses and deaths of people who took 5-Hour …Washington [...]

MANGLER

November 15th, 2012
1:43 pm

Even if it’s 5 deaths in 4 years, it’s still a pretty small risk when compared to say, driving – but we’re not trying to ban that.

Susan

November 15th, 2012
2:05 pm

These energy drinks are very dangerous. All energy drink commercials need to add a message that labeling the side effects and they should include DEATH as a side effect. They should only sell these items behind a pharmacy counter and card everyone that buys them. They should also put warnings on the bottles.

missnadine

November 15th, 2012
2:26 pm

Herp de Derp – I LOVE those coffee beans. They also make the covered expresso beans too.

Herp de Derp

November 15th, 2012
2:46 pm

They also make the covered expresso beans too.

My wife calls those ‘93 octane beans.’

Raquel

November 15th, 2012
2:54 pm

This is sloppy journalism. There is no correlation between the deaths and 5-hour energy.

Next time, report on a REAL health issue!

Bea Kath

November 15th, 2012
2:57 pm

I have never had any problems while using 5 Hour Energy. It’s a great alternative to other energy drinks on the market and should be used correctly to prevent tragedies like this.

Fitz

November 15th, 2012
3:04 pm

It is good to see the FDA seek the truth. But, this article fails to address a significant fact. Energy shots and drinks do not solely contain caffeine. Energy shots and drinks contain numerous powerful stimulants and chemicals that work in combination. Energy shots and drinks are formulated to, and act like combination drugs. They are not tested for safety.

My own Blood Pressure was elevated and unsafe when I was using 5 Hour Energy. After I stopped drinking 5-Hour Energy, my BP dropped to normal levels. I have heard similar stories.

The pink bottle breast cancer promotion is just wrong. It is like alcohol companies making a contribution to liver cancer research.

Energy shots and drinks can be easily linked to hypertension and other cardiovascular diseases, and I expect if properly researched, we would also see a steady increase in hypertension of certain demographics over the last 5-10 years that coincides with prolonged use and the surge of energy drinks and shots sales.

You could even say “Energy drinks and shots are the nicotine of the 21st century.”

What is most distrurbing, is that you do not have to wait 10 years to see the adverse health consequences of energy shots and drinks, 13,000 ER visits and 18 deaths linked to energy shots and drinks is not a coincidence. And the costs that society will ultimately bear because of the free use and deceptive promotion of these products will be astronomical.

So, will government actually lead or act on this? Hopefully they will.

Looking back at Ephedra, until someone famous dies (and I hate to even suggest more loss of life), government, congress and the FDA will likely fail to lead and address this issue, and bring these companies to justice.

And let’s not overlook how much money these companies spends on political activities and attorneys. In America, the reality is, you can buy your freedom.

We should all pray and push our government leaders to put the public’s interest and safety first, and bring these companies to justice.

The old saying about “a few bad apples ruining it for the bunch” seems especially applicable here. The wrongful acts of a few companies is jeopardizing the future of the entire supplement industry, as well as human life.

Billy

November 15th, 2012
3:16 pm

Would rather trust coffee than a bunch of chemicals in my system. People that need this stuff don’t get enough sleep at night. That said, the people that died probably had other health issues: they didn’t just drop dead from drinking 5 hour energy folks–come on!

Herp de Derp

November 15th, 2012
3:35 pm

Would rather trust coffee than a bunch of chemicals in my system.

What do you think coffee is? It’s constituents are still chemicals. The most commonly-used preservative in the US (citric acid) is a natural substance. Strychnine, a deadly poison, is pretty much all-natural.

As Linus once said in Peanuts, “I can’t eat this! It’s full of INGREDIENTS!”

AlVane

November 15th, 2012
3:42 pm

the government should ban all of these quick energy products AsAP!–they are too dangerous and are causing deaths.

4DaBirds

November 15th, 2012
3:53 pm

I’ve used 5HE for the last 2 years. One a day, 5 days a week. I’m 45 and have had no issues. I’ve had no increased heart rate and no jitters, just a refreshed and alert feeling. I get plenty of sleep at night, I have a good diet, as well as being an avid cyclist. As a person who sits at a desk all day long, I often find myself slowing down right after lunch and that’s when I usually have one. I can’t stand coffee, and soft drinks are bad for you, so it’s 5HE for me. If people died after ingesting 5HE, then chances are they were already sick with something to begin with. If you’re over weight or pregnant, then you should be watching everything you eat or drink, and anything with caffeine is probably a bad idea

Phil

November 15th, 2012
4:03 pm

As a pharmacist, I have looked over the ingredients in 5-hour Energy, and I don’t see anything that sets off flags. The only thing in it you could get too much of is vitamin b-6, and you would have to have more than two daily for a long period of time for it to be of clinical significance. The one thing I will note, is that it doesn’t give the milligrams of caffeine that it contains. If someone who only drinks caffeine occasionally drinks a full 5-Hour Energy, chances are they may shake and have a rapid heartbeat. By the same token, if that same person was to have some underlying heart condition, then we could start seeing problems. My point is that I truly don’t believe 5-Hour Energy caused the death of anyone on it’s own. There had to be more than one causative agent in these 13 deaths. I’d also like to note, that people have heart attacks after drinking coffee occasionally, but you will never see coffee or tea get the kind of attention 5-Hour Energy gets, because they are generally accepted by the public and nobody is looking to correlate their use with an individual’s death. Bottom line, caffeine is a drug and should be respected and used intelligently like any other drug.

BIrd Backer

November 15th, 2012
4:12 pm

Fitz – just curious, are you saying that 5 hour energy causes breast cancer? if not your analogy makes no sense… by the way, I wonder what the ratio of alcohol related deaths to 5 hour energy related deaths is??? It is tragic those people passed away but I think this country has bigger fish to fry in these times

the truth

November 15th, 2012
4:24 pm

In other news it was reported that cigarettes cause cancer !!!!!! People of the flock mentalility, if you think the FDA has your best interest at heart, you have your head up your a$$. If they did, why are cigarettes still available for purchase. Why? Follow the money trail..The same people that want these type drinks banned beg for the government to control their lives. Personally, I rarely use the energy shot drinks but this smell of the ban on Ephedra 10 years ago. Which was and is a SAFE and Beneficial HERBAL SUPPLEMENT ( not a drug ) if used correctly. Why did it get banned, because the FDA knew its effectiveness, but could not regulate it i.e. control it and make money from it like it does to big Pharma companies. Miss use like Corey Stringer ( if you dont know who that is, Wikipedia ) gave them the ammo to get it banned. So go ahead sheep, let the government to control your life EVEN more. Meanwhile I am going to stop on the way home, buy a case of beer, Shotgun all of them at once, die at the scene and then have my family file a wrongful death case against the alcohol companies. Grow up, grow a pair and control your own life.

kevin

November 15th, 2012
4:36 pm

If you need energy, EXERCISE. The body is an amazing thing. Use it and find out.

[...] probes if deaths were linked to energy shots – USA TODAY Atlanta Journal Constitution (blog)FDA probes if deaths were linked to energy shotsUSA TODAYThe federal government and the New York [...]

Al Dunbar

November 15th, 2012
4:59 pm

Herp de Derp, I do not believe you. It is not possible to eat coffee beans.

old timer

November 15th, 2012
5:06 pm

Watet is deadly too if you drink to much. Over 5 million people a day drink an energy shot and have had only 30 cases of serious illness or death. Sounds like an epidemic.

Dawgfan

November 15th, 2012
5:14 pm

Meth works for me.

4DaBirds

November 15th, 2012
5:16 pm

The Truth is right.

Treating 5HE like it is something dangerous is just being stupid, and insisting that the government do something about it is hilarious. 5HE had to fall under some sort of regulation before it reached the market. Meanwhile the same FDA has approved drugs that will kill you. The FDA has approved highly addictive drugs as well. For a news outlet to publish stories like this, before all of the facts are in, is just plain reckless. 5HE will lose a lot of money over this whether it’s product is proven to be bad or not.

Samantha

November 15th, 2012
5:17 pm

Why would you drink 5-Hour energy while knowingly being pregnant??

Lowdawg

November 15th, 2012
5:18 pm

i farted and somebody died .. does that mean too much of my gas is a bad thing?

JD in Marietta

November 15th, 2012
5:21 pm

I drank 2 of these while driving from Atlanta to Tunica MS via Nashville-Memphis and I stayed up for at least 12 hours after drinking them…It is powerful stuff.

Herp de Derp

November 15th, 2012
5:34 pm

Herp de Derp, I do not believe you. It is not possible to eat coffee beans.

It’s absolutely possible.

http://en.wikipedia.org/wiki/Chocolate-covered_coffee_bean

You can get them at Starbucks, Trader Joes, Amazon and even Wal-Mart now. All sorts of places carry them.

http://www.walgreens.com/store/c/ferrara-pan-dark-chocolate-covered-espresso-beans/ID=prod4267522-product

Herp de Derp

November 15th, 2012
5:39 pm

Phamacist Phil, if you ingested too much Vitamin B-6, wouldn’t you just eliminate it in your urine? Aren’t the B vitamins all water-soluble?

Al Dunbar

November 15th, 2012
5:39 pm

Anybody can create a wikipedia page, and everybody knows coffee beans are poisonous!

BIG RON

November 15th, 2012
5:54 pm

I’m a trucker that has driven over 1.75 million miles over the road and have tried just about every energy drink out there.I have’nt had any problems with any of them,and I must say that 5 hr is one of the best,and that it did’nt affect my heart rate,or blood pressure.also I mite add that i’m 58 yrs old and has some health issues,but they are from being overweight so that’s what I have to work on,and not worry about getting energy drinks banned.

Judy

November 15th, 2012
6:38 pm

My husband died last month and I believe this drink was a contributing factor. The story is too log for me to go into, but he ended up with a massive heart attack. I have since talked to others that this drink caused them to have a rapid heart beat. Only wish I could have my husband back.

Annie

November 15th, 2012
9:04 pm

@ Al Dunbar… OMG! Are you serious? I have eaten coffee beans for years. They are delicious and give a natural “high”!! You better do your homework before commenting with such confidence!!

Morgan

November 15th, 2012
9:15 pm

Yes those are ALL bad. If you want an alternative try Arbonne Fizz Sticks. As much caffeine as a cup of coffee but formulated with green tea. Has all you B vitamins, tastes amazing and has as much anti oxidants as 4 cups of green tea! Arbonne.com #19119467–plus you get a 45 day money back guarantee.

evelyn

November 16th, 2012
4:10 am

I wonder what else these 13 people were consuming. According to webmd 5 hour has 207 to 214 mg of caffine which is a safe amount. Its when you drink coffee and green teas and cola with it that adds on to the 207 mg. I don’t think 5 hour is to blame it comes down to accountablility – if you can’t tolerate caffine then why are you taking energy supplements?

Herp de Derp

November 16th, 2012
9:44 am

Anybody can create a wikipedia page

True.

and everybody knows coffee beans are poisonous!

False.

http://www.traderjoes.com/fearless-flyer/article.asp?article_id=355

StevenCee

November 16th, 2012
11:22 am

Can someone explain to me how a shot, the equivalent of the caffeine in one cup of coffee (at a far higher cost), “gives” you more energy than just drinking a cup, or two of coffee?

StevenCee

November 16th, 2012
11:22 am

Can someone explain to me how a shot, the equivalent of the caffeine in one cup of coffee (at a far higher cost), “gives” you more energy than just drinking a cup, or two of coffee?

Richard

November 16th, 2012
3:44 pm

This is the reason i only drink all natural energy drinks! The Monsters and Rockstars etc are so bad for your health.

http://www.revvnrg.com/rivera87

Vera

November 17th, 2012
6:53 am

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Zang

November 17th, 2012
10:17 am

Vera, post about the article and not about some crap advertising.

[...] Getting tired and feeling sleepy during the day is a common problem. Many of us resort to several cups of joe per day and some even try energy drinks, which are now reported as deadly. [...]

zan zang

November 20th, 2012
2:59 pm

you want a scary statistic? 100% of people who consume water die.