A caffeinated energy shot that?s sold in Canada was cited as possibly linked to 13 deaths in reports received by U.S. officials over the last four years.
The disclosure of the reports about 5-Hour Energy is the second time in recent weeks that Food and Drug Administration filings citing energy drinks and deaths have emerged. Last month, the agency acknowledged it had received five fatality filings mentioning another energy drink, Monster Energy.
Since 2009, 5-Hour Energy has been mentioned in some 90 filings with the FDA, including more than 30 that involved serious injuries like heart attacks, convulsions and, in one case, a spontaneous abortion, a summary of FDA records reviewed by The New York Times showed.
The filing of an incident report with the FDA does not mean that a product was responsible for a death or an injury or contributed in any way to it.
In Canada, regular and extra strength 5-Hour Energy drinks are permitted for sale, said Health Canada spokesman Sean Upton.
The drinks are classified as natural health products and are not among the energy drinks being reclassified as food, which require a nutrition facts table.
There were 86 adverse reactions reported to Health Canada in relation to all energy drinks between 1965 and June 2012, Upton said last month. He said such reaction reports are based on suspicions as definite causes can?t be determined.
An April 2009 newsletter said Health Canada received a report of a man drinking a 5-Hour Energy drink and within an hour he ?felt his heart beating rapidly and had chest pain.?
The 55-year-old man, who went to an emergency department, was known to have a heart condition and was on multiple medications, according to the report. He released from hospital the same day.
The distributor of 5-Hour Energy, Living Essentials, said in a statement, that the product was safe when used as directed and that it was ?unaware of any deaths proven to be caused by the consumption of 5-Hour Energy.?
Monster Energy?s producer, Monster Beverage of Corona, Calif., has repeatedly said that its products are safe.
5-Hour Energy is sold in a 2-ounce bottle referred to as a shot.
In an interview Wednesday, Daniel Fabricant, the director of the FDA?s division of dietary supplement programs, said the agency was looking into the death reports that cited 5-Hour Energy.
The company does not disclose the amount of caffeine in each bottle in the U.S., but a recent article published by Consumer Reports placed that level at about 215 milligrams.
The FDA has stated that it does not have sufficient scientific evidence to justify changing how it regulates caffeine or other ingredients in energy products.
? With files from Carys Mills and Bruce Campion-Smith, news services
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