Posted in News on November 29, 2012

Billings readers who tuned into a recent discussion about concerns over Monster brand energy drinks may want to take notice of a similar investigation into fatality reports that may be related to the popular 5-Hour Energy caffeine supplement. The new investigation marks the second time in only a few weeks that highly caffeinated beverages have been implicated as potentially dangerous products.

Supercharged caffeinated liquids occupy something of a gray area when it comes to regulation and oversight by the Food and Drug Administration. Some products, like Red Bull, are marketed as beverages and are not required to notify the agency when they receive information that may link the product to harmful side effects or a fatal injury.

Other products, including the two that have come under recent scrutiny, are marketed as dietary supplements. Manufacturers of dietary supplements are required to inform the Food and Drug Administration of reported serious injuries that may involve their products.

The popular energy shot has been mentioned in approximately 90 incident reports since 2009, more than 30 of which involved potentially life-threatening events including heart attacks, convulsions and one report of a spontaneous abortion. The possibility that the product may be connected to 13 reported deaths makes it unusually suspicious since, for example, the agency received only 17 reports of injuries implicating dietary supplements in 2010.

The number of incidents reported, however, may not represent the true number of adverse events related to dietary supplements. An official with the Food and Drug Administration acknowledged that some manufacturers are probably not following the rules, and many doctors may not be aware that they can file reports when they see a patient who may have suffered dangerous side effects.

If the ongoing investigation links the energy shot to the reported injuries and fatalities, civil suits may follow seeking to hold the manufacturer liable for insufficient warnings about the product’s potentially harmful side effects.

Source: The New York Times, “Caffeinated Drink Cited in Reports of 13 Deaths,” Barry Meier, Nov. 14, 2012