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The Food and Drug Administration has received reports of 13 deaths and 92 medical events among people who have used 5-hour Energy, federal officials confirmed Thursday.
The incidents, first reported Wednesday by the New York Times, range from heart attacks and convulsions to one case of spontaneous abortion.
According to the FDA, 5-hour Energy manufacturer Living Essentials has submitted 13 fatality reports since 2009, following a law requiring supplement companies to notify the regulatory agency when they become aware of a death or injury possibly related to their product.
An FDA spokeswoman said the agency is investigating the reports, which include 33 hospitalizations.
"FDA assesses the relationship, if any, between a product or ingredient and the reported adverse event. If we find a relationship between consumption of the product and harm, FDA will take appropriate action to reduce or eliminate the risk," spokeswoman Shelly Burgess said.
The submission of reports to the FDA does not mean 5-hour Energy caused the medical conditions or deaths or even contributed to them. Instead, it means consumers, physicians, medical facilities or the company itself notified FDA of a medical problem that occurred either during or after consumption of 5-hour Energy.
In May, a Living Essentials spokeswoman told Military Times that 5-hour Energy has an "exemplary profile" and is "subject to adverse reporting requirements imposed by FDA."
She did not disclose the number or nature of any FDA reports when asked directly if the company was aware of any illness reports related to 5-hour Energy.
"There has never been any causal relationship found in any of these serious adverse events reported to FDA and 5-hour Energy," spokeswoman Elaine Lutz said Thursday. "I stand by my previous statements."
She added the company is "unaware of any deaths proven to have been caused by the consumption of 5-hour Energy. It is important to note that submitting a serious adverse event report to the FDA, according to the agency itself, is not construed by FDA as an admission that the dietary supplement was involved, caused or contributed to the adverse event being reported."
The reports on 5-hour Energy come in the wake of other reports last month linking five deaths to consumption of Monster Energy drink. The parents of a 14-year old Maryland girl who died in December after drinking two 24-ounce Monster Energy drinks have filed a wrongful death lawsuit against the company.
Monster Energy maintains its products are used safely by millions and "is unaware of any fatality anywhere that has been caused by its products," the beverage company said in a statement.
Consumer safety advocates are becoming increasingly alarmed by what they see as an unregulated dietary supplements industry.
Sens. Dick Durbin, D-Ill., and Richard Blumenthal, D-Conn., have called for improved labeling and closer FDA scrutiny of supplements.
On Thursday, they requested a meeting with FDA Commissioner Margaret Hamburg asking her agency to investigate the health risks of caffeine and stimulants in 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. "We request a meeting with you on the steps FDA is taking regarding highly caffeinated energy drinks and to ensure they are safe for their intended use and in combination with other energy drink ingredients."
Energy drinks, and 5-hour Energy in particular, are immensely popular with U.S. troops. In 2011, sales of 5-hour Energy topped $9.2 million across the military exchanges — almost 1 percent of 5-hour Energy's $1 billion in total sales. That does not include what troops buy in commissaries, where 5-hour Energy sales reached nearly $1 million in the first seven months of fiscal 2012.
Last year, in an effort to understand the health consequences of energy shots on the cardiovascular system, the Air Force launched a study of 5-hour Energy on the blood pressure, heart rate and heart rhythm of 18- to 40-year olds.
Lead researcher Sachin Shah, a cardiovascular pharmacologist at the University of the Pacific, said little is known about the product's effects on the heart's electrical cycle.
"The FDA requires new drugs coming on the market to have a thorough QT study," he said, referring to the electrical cycle intervals. "The herbal market, the nutraceutical market, are not monitored as closely."
Energy shots are the only food supplement classified as "high risk" by the Defense Department Human Performance Resource Center, part of the Uniformed Services University of the Health Sciences in Bethesda, Md.
The HPRC says it places energy shots in the category because insufficient data exists to determine a recommendation.
A 2-ounce shot of 5-hour Energy contains twice the amount of caffeine as a regular cup of brewed coffee and 200 times the daily recommended dose of Vitamin B12.