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