FDA Filings Reveal 5 Hour Energy Mentioned With Incidents Including Heart Attacks and 13 Deaths

(Image: 5-Hour Energy)

You might have seen the commercial for 5-Hour Energy with a woman stating that more than 3,000 doctors have reviewed and 73 percent can attest to the safety of the vitamin and “energy blend” infused substance. She challenges viewers to ask their own doctor. But a look at records maintained by the U.S. Food and Drug Administration might also provide some insights on the energy shot.

The New York Times reported that in its review of records from the FDA it found 90 filings mentioning 5-Hour Energy with 30 that involved incidents of heart attacks, convulsions and a spontaneous abortion since 2009. It noted that 5-Hour Energy, distributed by Living Essentials, might have had involvement in 13 deaths, but this does not mean the substance was actually the cause of death.

FDA Filings Reveal 5 Hour Energy Mentioned With Incidents Including Heart Attacks and 13 Deaths

5-Hour Energy ingredients label. (Image: 5-Hour Energy)

The product label does caution that the substance is not recommended for pregnant women or children under 12 years of age.

Here’s what the agency had to say about its investigation into these cases, according to the Times:

In an interview Wednesday, Daniel Fabricant, the director of the agency’s division of dietary supplement programs, said the agency was looking into the death reports that cited 5-Hour Energy. He said that while medical information in such reports could rule out a link with the product, other reports could contain insufficient information to determine what role, if any, a supplement might have played.

Mr. Fabricant said that the 13 fatality reports that mentioned 5-Hour Energy had all been submitted to the F.D.A. by Living Essentials. Since late 2008, producers of dietary supplements are required to notify the F.D.A. when they become aware of a death or serious injury that may be related to their product.

Earlier this month, the FDA launched an investigation into another energy drink — Monster — and five deaths that might be related to it.

The agency acknowledged the adverse reports Monday, but FDA spokeswoman Shelly Burgess said they don’t prove that the drinks caused the deaths.

One of the most recent cases involved a wrongful death suit filed by the parents of a 14-year-old, Hagerstown, Md., girl who died after drinking two, 24-ounce Monster Beverage Corp. drinks in 24 hours.

An autopsy concluded she died of cardiac arrhythmia due to caffeine toxicity. She had an inherited disorder that can weaken blood vessels.

Monster says it doesn’t believe its products caused any deaths.

Read more about the 5-Hour Energy filings looked into by the New York Times here.

The Associated Press contributed to this report. 

(H/T: Yahoo! News)