Thirteen people have died due to 5-Hour Energy shots since 2008, according to claims reported to the Food and Drug Administration that are now being investigated by the federal government, ABC News reports.
The FDA and the New York Attorney General's office are looking into nearly 90 claims that mention 5-Hour Energy, including more than 30 which involved hospitalization. Many of the instances involved convulsions, heart attacks, and one claim of a spontaneous abortion, reports The New York Times.
The caffeinated energy shot is the latest energy drink to attract unwanted attention. Last month the FDA announced it was investigating Monster Beverage Corp., for five deaths linked to its Monster energy drink. New York's attorney general is also investigating PepsiCo Inc. regarding its AMP energy drink.
On Thursday, Democratic Sens. Dick Durbin of Illinois and Richard Blumenthal of Connecticut asked FDA Commissioner Margaret Hamburg for a meeting to discuss an "action plan" to ensure the safety of energy drinks.
"Over the past year, there has been alarming evidence that energy drinks pose a potential threat to the public's health," Durbin and Blumenthal wrote. "In light of these deaths and a November 2011 report … which found a ten-fold increase in emergency room visits due to energy drinks between 2005-2009, we believe it is necessary for the FDA to take immediate action to address a serious public health issue."
The makers of 5-Hour Energy, Living Essentials LLC, reported the adverse health events to the FDA as required by law.
"Living Essentials LLC, distributor of 5-Hour Energy, takes reports of any potential adverse event tied to our products very seriously," the company said in a statement. It added the company recommends "individuals consume no more than two bottles of 5-Hour Energy shots per day, spaced several hours apart."
The drinks' main active ingredient is caffeine — the company says one of its 2 ounce shots contains "about as much caffeine as a cup of the leading premium coffee."
However, a test by Consumer Reports found that 5-Hour Energy contains 215 milligrams of caffeine, while a typical cup of coffee has 100 to 165 milligrams. According to the medical website WebMd, anything less than 400 milligrams of caffeine is considered safe for healthy adults, but higher amounts, such as those found in 5-Hour Energy, could cause serious health problems in more at-risk people such as pregnant women, children, and those with heart problems.
Like others in the energy drink industry, the beverage also contains several lesser-known ingredients such as taurine, tyrosine, and citicoline that are intended to increase alertness.
Living Essentials has had problems with the FDA before, such as with its Chaser tablets, which claimed to prevent hangovers. The FDA and the Department of Health and Human Services contacted the company in 2001, stating its claims did not meet the FDA standards and if the company intended to continue making such claims it should apply to the FDA to be regulated as a drug.
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Jason Koebler and Seth Cline are reporters for U.S. News & World Report. Follow them on Twitter @seth_cline and @jason_koebler or reach them at firstname.lastname@example.org and email@example.com.