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:
- Deaths due to heart attack or suicide linked to 5-Hour Energy
- A miscarriage linked to 5-Hour Energy
- Convulsions, life-threatening fear, deafness, and hemorrhage linked to 5-Hour Energy
- Deaths due to heart attack or loss of consciousness linked to Monster Energy drink
- Hospitalization due to irregular heartbeat, severe diarrhea, migraine, psychotic disorder, heart attack, and/or vomiting linked to Monster Energy drink
- Disability from irregular heartbeat or stroke linked to Rockstar Energy drink
- Hospitalization due to psychotic disorder, increased heart rate, or loss of consciousness linked to Rockstar Energy drink
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 Levels in Energy Drinks
Caffeine is the main active ingredient in energy drinks, most of which also contain herbal supplements.
A recent test by Consumer Reports found that:
- 5-Hour Energy contains 215 milligrams of caffeine per serving.
- 5-Hour Energy Extra Strength contains 242 milligrams of caffeine per serving.
- Monster Energy contains 92 milligrams of caffeine per serving.
- Rockstar Energy Drink, Double Strength contains 80 milligrams of caffeine per serving.
- Rockstar Energy Shot contains 229 milligrams of caffeine per serving.
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.