5-Hour Energy, Monster, Rockstar cited in FDA report for deaths, hospitalizations
Rockstar Inc.'s energy drinks, distributed in most of the U.S. by PepsiCo Inc., were named in 13 adverse event reports dating to 2006, according to the Food and Drug Administration. No deaths were cited.
The events in some cases involved increased heart rate, abdominal pain and nausea, and included four hospitalizations, according to a list posted Thursday on the FDA's website. The incidents are voluntarily reported and are deemed allegations with no conclusion drawn until investigations are completed.
Living Essentials LLC's 5-Hour Energy was cited in 92 reports, including 33 hospitalizations and 13 deaths, according to the data covering Jan. 1, 2004, to Oct. 23, 2012. Monster Beverage Corp. products were in 40 reports, with 20 hospital stays and five deaths. The FDA hasn't yet made public reports for other drinks such as Red Bull and PepsiCo's AMP Energy.
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"It takes time to go through these reports and get the information ready and redacted," Shelly Burgess, a spokeswoman for the FDA said by telephone. "We're making this information available as we can."
The Monster and 5-Hour energy reports involving deaths had been made public before Thursday.
Energy drinks are the target of some lawmakers, including U.S. Sen. Dick Durbin. The Illinois Democrat is seeking to impose caffeine limits on the beverages after emergency room visits involving such drinks jumped 10-fold from 2005 through 2009.
Monster and competitors such as Red Bull aren't bound by the FDA guidelines for caffeine in sodas, because energy drinks are often sold as dietary supplements. Soda typically can have as many as 71 milligrams of caffeine per 12 ounces for the FDA to consider it safe. The FDA may require companies to prove caffeine levels are safe if they exceed the guideline.
Caffeine in energy drinks often ranges from 160 milligrams to 500 milligrams a serving, the FDA said in an August letter responding to Durbin's call for greater regulation of the industry.
Monster is the largest U.S. energy drink maker by sales volume, with about $1.6 billion from such drinks last year, the majority of the Corona, Calif.-based company's revenue, according to data compiled by Bloomberg.
Coca-Cola Co., the world's largest soft-drink maker, distributes almost half of Monster Beverage's U.S. volume. Anheuser-Busch InBev NV, the biggest brewer, distributes about the same amount, with a few small vendors making up the balance.
"Over the past year, there has been alarming evidence that energy drinks pose a potential threat to the public's health," the senators wrote. "It is necessary for the FDA to take immediate action to address a serious public health issue."