WebMD Medical News
Daniel J. DeNoon
Louise Chang, MD
Nov. 16, 2012 -- The FDA has posted adverse-event reports for two more energy drinks: 40 illnesses and five deaths linked to Monster Energy, and 13 illnesses and two lasting disabilities linked to Rockstar Energy.
The new reports follow this week's revelation of FDA reports linking 92 illnesses and 13 deaths to 5-Hour Energy shots. The FDA previously said it was investigating the deaths linked to Monster Energy.
These adverse-event reports (AERs) are filed by patients, families, or doctors. They simply warn that the products might have harmed someone -- but they do not prove that the product caused harm. The FDA can remove a product from the market only when investigation shows that the product causes harm when used according to the product label.
"If we find a relationship between consumption of the product and harm, FDA will take appropriate action to reduce or eliminate the risk," FDA public information officer Shelly Burgess says.
Moreover, the reports do not offer details on any underlying medical conditions that may have led to product-related illnesses.
The reports, some dating back to 2004, are not a complete inventory of all events that product users may have suffered. Most people, and many doctors, do not know how to file these reports or do not get around to filing them. And even when a product actually causes an illness, a user or doctor may not associate the product with the illness.
The new reports detail the events suffered by users of 5-Hour, Monster, and Rockstar energy drinks. These include:
All of these reports are collected by the product manufacturers. Because they market their products as nutritional supplements, they are required to submit them to the FDA.
A recent government report documented a sharp spike in the number of people who need emergency medical care after consuming energy drinks.
Living Essentials, the maker of 5-Hour Energy, said in a statement that the company "takes reports of any potential adverse event tied to our products very seriously."
But the company maintains that its products are safe when used as directed. Rockstar and Monster Energy did not respond to interview requests by publication time.
Caffeine is the main active ingredient in energy drinks, most of which also contain herbal supplements.
A recent test by Consumer Reports found that:
An 8-ounce cup of coffee has about 100 milligrams of caffeine, although that varies according to how the coffee is brewed. For example, Consumer Reports finds that 8 ounces of Starbucks coffee has 165 milligrams of caffeine.
According to Consumer Reports, safe limits of caffeine are up to 400 milligrams per day for healthy adults, 200 milligrams a day for pregnant women, and up to 45 or 85 milligrams per day for children, depending on weight.
High doses of caffeine can result in restlessness, nervousness, insomnia, and tremors. High doses can also trigger seizures and unstable heart rhythm.
SOURCES:FDA web site.Consumer Reports, December 2012.Shelly Burgess, public information officer, FDA; email exchange.Statement from Elaine Lutz, spokesperson for Living Essentials LLC.
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