FDA Reports Possible Link Between 5-Hour Energy Shots and 13 Deaths
NEW YORK -- Federal officials received reports of 13 deaths during the past four years that were possibly connected to the consumption of the energy shot 5-Hour Energy, according to U.S. Food and Drug Administration (FDA) records and an interview with an agency official, reported the New York Times.
Additionally, 5-Hour Energy was mentioned in approximately 90 incident report filings with the FDA, including more than 30 involving serious or life-threatening injuries such as heart attacks or convulsions, according to the report. However, the filing of an incident report does not mean that a product was necessarily responsible for or contributed to a death or injury.
5-Hour Energy distributor Living Essentials stated that it was unaware of any deaths proven to be caused by consumption of the energy shot.
"In direct contrast to other products on the market, 5-Hour Energy is not marketed for use with alcohol, nor do we condone its consumption with alcoholic beverages," said Elaine Lutz, spokeswoman for Living Essentials, in a statement. "When consumed according to our recommended use guidelines, 5-Hour Energy is an effective dietary supplement, although individual results may vary."
Unlike some energy drinks, 5-Hour Energy is sold in a small, two-ounce bottle.
Daniel Fabricant, director of the FDA's division of dietary supplements, stated during an interview yesterday that the agency is looking into the death reports that cite 5-Hour Energy, according to the Times. He noted that medical information in the reports could rule out a link to the energy shot, while other reports may not contain enough information to determine whether the product played a part in the incidents, or if it played a role at all.
All 13 of the fatality reports that mentioned 5-Hour Energy were submitted to the FDA by Living Essentials, Fabricant added.
Dietary supplement producers have been required to notify the agency when they are made aware of a death or serious injury potentially related to their products since 2008, according to the report. Companies that market energy drinks as beverages, not dietary supplements, are not required to make such reports, although they may do so voluntarily.
The report comes just weeks after other FDA filings indicated five people died after drinking Monster Energy during the last three years. Those reports also did not prove a direct link between the deaths and the caffeinated energy drink. Monster defended the safety of its products and resolved to "vigorously defend" against a related lawsuit, as CSNews Online reported.