Two more highly caffeinated energy drinks —marketed as dietary supplements—are being linked to serious injuries or deaths in reports to federal regulators.

In the last four years, the Food and Drug Administration has received reports of 13 deaths that cited possible involvement of 5-Hour Energy, according to a report in The New York Times. The article said that since 2009, 5-Hour Energy has been mentioned in some 90 filings with the FDA, including more than 30 that involved serious or life-threatening injuries such as heart attacks, convulsions and spontaneous abortion.

In October, the FDA said it had received five reports of deaths possibly involving another popular energy drink, Monster Energy.  The publicity about that product led the FDA to release a detailed summary of adverse incidents involving three products—5-Hour Energy, Monster energy drink and Rockstar. The FDA summary included 13 previously undisclosed injury reports that mentioned consumption of Rockstar energy drink.

It’s important to note that the filing of an adverse event report does not mean a product or drug had anything to do with an injury or death. Such reports can be incidental. But a number of similar reports about a product may reveal a possible pattern, prompting federal regulators to open an investigation into the safety of a food or drug.

Daniel Fabricant, director of the FDA’s division of dietary supplements, said the agency is looking into the death reports that cited 5-Hour Energy. Living Essentials of Farmington Hills, Mich., the distributor of 5-Hour Energy, submitted the reports. Since 2009, producers of dietary supplements have been required to notify the FDA when they become aware of a death or serious injury that may be linked to their product.

Sold as a dietary supplement in 2 oz. “shot” bottles, 5-Hour Energy is marketed to boost energy and heighten alertness. It contains about 215 milligrams of caffeine, while another version, 5-Hour Energy Extra Strength, packs about 242 milligrams of caffeine, according to Consumer Reports. An 8 oz. cup of coffee contains from 100 to 150 milligrams of caffeine, depending on how it’s made.

When someone consumes multiple bottles of an energy drink, they are getting astronomical amounts of caffeine, and that’s when side effects may occur, Dr. Sean Patrick Nord, a toxicologist at the University of Southern California, told ABC news.

Living Essentials said in a prepared statement that 5-Hour Energy is safe when used as directed. The product’s label and website say that consumers should drink no more than two bottles of 5-Hour Energy a day, spaced several hours apart; and people sensitive to caffeine should talk to their doctors first.

Manufacturers of foods and drugs do have a legal responsibility to make and market products that are safe when used as intended. They also have a duty to warn of known dangers. They should be held accountable when they put profits ahead of consumer safety.

The lawyers of The Driscoll Firm, LLC, are committed to helping people who have been harmed by unsafe products. We have helped thousands of clients nationwide receive full and fair compensation from manufacturers, pharmaceutical companies and medical device manufacturers whose products cause harm. If you suspect that you or a loved one has been harmed by an unsafe product, contact us at 314-932-3232 or use our online contact form for a free case review.