Five people may have died over the past three years after drinking Monster Energy, a popular energy drink that is high in caffeine, according to incident reports recently released by the Food and Drug Administration.
The reports, like similar filings made with the FDA in cases connected with drugs or medical devices, do not prove a link between Monster Energy and the deaths or health problems. The records were recently obtained under the Freedom of Information Act by the mother of a 14-year-old Maryland girl who died in December from a heart arrhythmia after drinking large cans of Monster Energy on two consecutive days.
Last week, Wendy Crossland, the mother of that teenager, filed a lawsuit against Monster Beverage, a publicly traded company in Corona, Calif., that used to be known as Hansen Natural. The lawsuit charges that Monster failed to warn about the risks of its energy drinks; a spokeswoman for the company said last week that its products were safe and not the cause of the teenager’s death.
That spokeswoman, Judy Lin Sfetcu, added that Monster was ‘‘unaware of any fatality anywhere that has been caused by its drinks.’’
Monster Beverage’s stock ended the day down more than 14 percent after the FDA filings were reported.
In an interview, an FDA spokeswoman, Shelly Burgess, said the agency had received reports of five deaths possibly linked to the drink as well as a report of a nonfatal heart attack. The reports cover a period of 2004 to June of this year, but all the deaths occurred in 2009 or later. Additional incident reports referred to other adverse events such as abdominal pain, vomiting, tremors, and abnormal heart rate.
The reports do not make clear whether the incidents involved other factors, like alcohol or drugs. However, the number of reports that the FDA receives about any product it regulates usually understates by a large degree the actual number of problems.
The release of the filings about Monster Energy may increase congressional calls for greater regulation of the energy products industry.
In a statement, Burgess said it was the responsibility of energy drink manufacturers to investigate accusations of death or injuries associated with them. She said the FDA was still looking into the cases but had yet to establish a causal link between the deaths and the drink.
Under current FDA rules, companies do not need to disclose caffeine levels in their beverages and can choose to market them as drinks or as dietary supplements. Those categories have differing labeling and ingredient rules.