U.S. Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition CFSAN Adverse Event Reporting System Voluntary and Mandatory Reports on 5-Hour Energy, Monster Energy, and Rockstar Energy Drink January 1, 2004, through October 23, 2012 Introduction FDA’s Center for Food Safety and Applied Nutrition (CFSAN) Adverse Event Reporting System (CAERS) collects reports about adverse health events and product complaints related to CFSAN-regulated products, including conventional foods, dietary supplements, and cosmetics. Based on a search of CAERS, this document summarizes the adverse events reported to FDA in connection with products under the labels 5-Hour Energy, Monster, and Rockstar between January 1, 2004 and October 23, 2012. These products are currently marketed as dietary supplements. CAERS includes voluntary reports for cosmetics and conventional foods, and both voluntary and mandatory reports for dietary supplements. Mandatory reports are those required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act. Specifically, dietary supplement manufacturers, packers, and distributors must notify FDA if they receive reports about serious adverse events in connection with the use of their products. This law defines a serious adverse event as an adverse health-related event that is associated with the use of a dietary supplement and that results in death, a lifethreatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, a congenital anomaly or birth defect, or that requires, based on reasonable medical judgment, a medical or surgical intervention to prevent one of those outcomes. The requirement to report serious adverse events to FDA applies only to dietary supplements and not to beverages, other conventional foods, or cosmetics. Medical officers with the agency's Dietary Supplement Program staff review all serious adverse events reported to FDA about dietary supplements as part of the normal process of assessment and categorization. In addition to these mandatory reports, the CAERS system also contains adverse events (both serious and non-serious) that are voluntarily reported to FDA by consumers and health care providers. FDA encourages consumers and health care providers to report adverse events they believe may be related to FDA-regulated products to FDA's MedWatch Adverse Event Reporting Program (http://www.fda.gov/Safety/MedWatch/default.htm). FDA advises consumers to talk with their health care providers before using any product marketed as an “energy shot” or “energy drink.” Things You Should Know About Adverse Event Report Data Individual adverse event reports about a particular product and the total number of adverse event reports for that product in CAERS only reflect information AS REPORTED and do not represent any conclusion by FDA about whether the product actually caused the adverse events. Because CAERS is constantly updated with new information, the number of reports for a given product and the content of individual reports may change over time. Even with mandatory reporting of serious adverse events for dietary supplements, generally only a small fraction of adverse events associated with any product is reported. On the other hand, there may be duplicate reports in CAERS for the same adverse event because multiple people (such as an injured consumer and a health care provider who treated him or her) may have submitted reports. There are important limitations to making inferences based on data from adverse event reports, such as those in CAERS.  Reports to FDA do not necessarily include all relevant data, such as whether an individual also suffered from other medical conditions (such as cardiac disease) or took other supplements or medication at the same time.  Reports may not include accurate or complete contact information for FDA to seek further information about the event, or complainants may choose not to participate in the follow-up investigation. When important information is missing from a report, it is difficult for FDA to fully evaluate whether the product caused the adverse event or simply coincided with it. The fact that an adverse event happened after a person took a dietary supplement does not necessarily mean that the dietary supplement caused the adverse event. CAERS Adverse Events Reports Allegedly Related to 5 Hour Energy Search Terms: 5 Hour, Five Hour, 5Hour, FiveHour The Center for Food Safety Adverse Event Reporting System (CAERS) is a post-market surveillance system that collects reports about events or problems that are allegedly related to CFSAN regulated products. In some reports, information in the reports cannot be verified for accuracy. Furthermore, in many reports, individuals may have used other products, and many products contain multiple ingredients which further complicates the evaluation of adverse event reports. There is no certainty that a reported adverse event can be attributed to a particular product or ingredient. The number of adverse event reports in CAERS received by FDA and the adverse event report itself about a particular product only reflects information AS REPORTED and does not represent any conclusion by FDA regarding a causal relationship or association with the product or ingredient. Due to the continuous inclusion of new or updated information into the CAERS system, reports released from CAERS containing adverse event data may change over time. Each report received by CAERS regarding an individual that experiences an adverse event is assigned a unique report number (Report #). ^ Additional dates indicate receipt of additional materials on report. Report # Received Date Brand/ Product Name Symptoms Outcomes 79019 6/22/05 5 HOUR ENERGY CHASER FEELING ABNORMAL, FLUSHING NON-SERIOUS INJURIES/ ILLNESS 97070^ 5/11/07 LIVING ESSENTIALS 5 HOUR BERRY FLAVOR ENERGY DRINK FLUSHING, LETHARGY, DIZZINESS, ANXIETY, DYSPNOEA, LIFE THREATENING, VISITED AN ER, VISITED A BLOOD PRESSURE FLUCTUATION, HEART RATE HEALTH CARE PROVIDER, REQ. INTERVENTION TO ABNORMAL, DYSPNOEA, SHOCK, CHEST PAIN, SYNCOPE, PRVNT PERM. IMPRMNT. VOMITING, DIARRHOEA, VISUAL DISTURBANCE, DEAFNESS, MOOD ALTERED, FATIGUE, PALPITATIONS, TACHYCARDIA, HEART RATE INCREASED, DEPRESSION, HEADACHE, ANAPHYLACTIC REACTION 5 HOUR ENERGY ENERGY DRINK BERRY FLAVOR HYPERVENTILATION, DYSPHONIA, DISORIENTATION, TREMOR, DYSPNOEA, CONVULSION, POISONING 10/19/07 100018 11/14/07 Page 1 HOSPITALIZATION, LIFE THREATENING, VISITED AN ER, VISITED A HEALTH CARE PROVIDER, SERIOUS INJURIES/ ILLNESS Report # Received Date 102062^ 3/10/08 Brand/ Product Name LIVING ESSENTIALS 5 - HOUR ENERGY BERRY FLAVORED VITAMIN SUPPLEMENT Symptoms Outcomes HEART RATE ABNORMAL, FAECAL INCONTINENCE, LOSS LIFE THREATENING, HOSPITALIZATION OF CONSCIOUSNESS, DIZZINESS, VOMITING, DISORIENTATION, AGGRESSION, LOSS OF CONSCIOUSNESS, LETHARGY, HEADACHE, TENDERNESS, DIZZINESS, VOMITING PROJECTILE, HEART RATE INCREASED, DRUG TOXICITY 12/17/09 102367 3/10/08 LIVING ESSENTIALS VOMITING, HEART RATE INCREASED 5 - HOUR ENERGY BERRY FLAVORED VITAMIN SUPPLEMENT 103323 4/17/08 105441 7/23/08 5 HOUR ENERGY HAEMORRHAGE NON-SERIOUS INJURIES/ ILLNESS SHOT LIVING ESSENTIALS BLOOD PRESSURE FLUCTUATION, LETHARGY, DIZZINESS NON-SERIOUS INJURIES/ ILLNESS 5 HOUR ENERGY 106752 9/29/08 INNOVATION VENTURES, LLC 5HOUR ENERGY DRINK NERVOUSNESS, NAUSEA, DIZZINESS, LOSS OF CONSCIOUSNESS, HALLUCINATION 117103 8/5/09 5 HOUR ENERGY DRINK ABNORMAL LOSS OF WEIGHT, SLEEP DISORDER, ANXIETY NON-SERIOUS INJURIES/ ILLNESS 121679^ 12/17/09 5 HOUR ENERGY SNEEZING, FALL, VOMITING, CHEST PAIN, PULSE ABSENT, VISITED A HEALTH CARE PROVIDER, DEATH HEAD INJURY 5 HOUR ENERGY DEATH DEATH 5 HOUR ENERGY ABORTION SPONTANEOUS OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) NON-SERIOUS INJURIES/ ILLNESS NON-SERIOUS INJURIES/ ILLNESS 12/30/09 3/1/10 121680^ 12/17/09 8/3/10 121681 12/17/09 Page 2 Report # Received Date Brand/ Product Name Symptoms Outcomes 121748 12/29/09 5 HOUR ENERGY DYSPNOEA, CHEST PAIN, SWELLING VISITED AN ER, HOSPITALIZATION 124601 3/16/10 5 HOUR ENERGY BERRY FLAVOR HYPERSENSITIVITY VISITED AN ER, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 124602 3/16/10 5 HOUR ENERGY BERRY MALAISE, HEART RATE INCREASED, HEAT ILLNESS VISITED AN ER, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 124603 3/16/10 5 HOUR ENERGY MYOCARDIAL INFARCTION VISITED AN ER, VISITED A HEALTH CARE PROVIDER 124605 3/16/10 5 HOUR ENERGY HOT FLUSH, HEART RATE INCREASED, ANXIETY, VISUAL IMPAIRMENT OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 124621 3/22/10 5 HOUR ENERGY HYPERHIDROSIS, HEART RATE INCREASED, ANXIETY, DIZZINESS, FEAR VISITED AN ER, NON-SERIOUS INJURIES/ ILLNESS 125698^ 4/21/10 5 HOUR ENERGY ARRHYTHMIA, SUPRAVENTRICULAR TACHYCARDIA, PALLOR, ANGINA PECTORIS VISITED A HEALTH CARE PROVIDER 9/29/10 126785 5/19/10 5 HOUR ENERGY FEAR, MALAISE LIFE THREATENING 126786^ 5/19/10 5 HOUR ENERGY CONVULSION OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 3/16/11 126994 5/14/10 5 HOUR ENERGY PALLOR, CHEST PAIN LIFE THREATENING, VISITED AN ER, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 126995 5/14/10 5 HOUR ENERGY CARDIAC ARREST LIFE THREATENING Page 3 Report # Received Date Brand/ Product Name Symptoms Outcomes 126996 5/14/10 5 HOUR ENERGY CONVULSION VISITED AN ER, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 128525 7/28/10 5 HOUR ENERGY DISORIENTATION, DIZZINESS, HEADACHE, CEREBROVASCULAR ACCIDENT, VISUAL ACUITY REDUCED DISABILITY, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS), HOSPITALIZATION 128651^ 7/26/10 5 HOUR ENERGY CONVULSION, SOMNOLENCE HOSPITALIZATION 3/16/11 129061 8/13/10 5 HOUR ENERGY 5 HOUR ENERGY VENTRICULAR ARRHYTHMIA, LOSS OF CONSCIOUSNESS, HOSPITALIZATION, DEATH PNEUMONIA, CONVULSION, ACUTE RESPIRATORY FAILURE, ANOXIC ENCEPHALOPATHY 129370 8/20/10 5 HOUR ENERGY PALPITATIONS, HYPERTENSION HOSPITALIZATION 129372 8/26/10 5 HOUR ENERGY DEATH DEATH 131692 10/28/10 5 HOUR ENERGY SOMNOLENCE DEATH 131693^ 10/28/10 5 HOUR ENERGY LEMON LIME DEHYDRATION, PARALYSIS, FEELING JITTERY, TREMOR, MUSCLE CONTRACTIONS INVOLUNTARY, BLOOD POTASSIUM DECREASED, BLOOD CAFFEINE INCREASED VISITED AN ER, LIFE THREATENING 10/28/10 5 HOUR ENERGY EXTRA STRENGTH 10/2/10 5 HOUR ENERGY GRAPE CONVULSION, BITE OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 10/2/10 5 HOUR ENERGY BERRY FLAVOR 131933^ Page 4 Report # Received Date Brand/ Product Name Symptoms Outcomes 132295 11/12/10 5-HOUR ENERGY POMEGRANA TE DYSPHAGIA, JOINT DISLOCATION, PAIN, SWELLING, BRUXISM, JAW DISORDER HOSPITALIZATION 132296 11/12/10 5-HOUR ENERGY BERRY CONVULSION OTHER SERIOUS (IMPORTANT MEDICAL EVENTS), VISITED AN ER, VISITED A HEALTH CARE PROVIDER 132297 11/12/10 5 HOUR ENERGY CONVULSION OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 133099 12/2/10 5-HOUR ENERGY RENAL FAILURE OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 133162 11/18/10 5 HOUR ENERGY DIETARY SUPPLEMENT ENERGY DRINK HEART RATE ABNORMAL, LOSS OF CONSCIOUSNESS, DIZZINESS VISITED A HEALTH CARE PROVIDER 134732 1/24/11 5-HOUR ENERGY BERRY AURA, LOSS OF CONSCIOUSNESS, CONVULSION VISITED AN ER, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 134733 1/24/11 5-HOUR ENERGY BERRY CARDIAC ARREST, CEREBROVASCULAR ACCIDENT, DIZZINESS, FEELING JITTERY, RESPIRATORY ARREST DISABILITY, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS), LIFE THREATENING, HOSPITALIZATION 134734 1/24/11 5-HOUR ENERGY POMEGRANA TE CONVULSION, PAIN, TREMOR, MUSCLE TWITCHING HOSPITALIZATION, VISITED AN ER, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 136165 2/25/11 5 HOUR ENERGY ANAPHYLACTIC SHOCK, DYSPNOEA, CHEST PAIN LIFE THREATENING, VISITED AN ER, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 136166 2/25/11 5 HOUR ENERGY HYPOAESTHESIA, SUICIDAL IDEATION, PAIN, ACTIVITIES OF DAILY LIVING IMPAIRED OTHER SERIOUS (IMPORTANT MEDICAL EVENTS), HOSPITALIZATION 136625^ 3/8/11 5 HOUR ENERGY DRINK HYPOAESTHESIA, BLOOD CREATINE PHOSPHOKINASE MB VISITED A HEALTH CARE PROVIDER, INCREASED HOSPITALIZATION 5 HOUR ENERGY MYOCARDIAL INFARCTION, DEATH 6/27/11 137118 3/24/11 DEATH Page 5 Report # Received Date Brand/ Product Name Symptoms Outcomes 137273 3/24/11 5 HOUR ENERGY ANAPHYLACTIC SHOCK, URTICARIA, DYSPNOEA, LETHARGY, HYPERSOMNIA, ASTHENIA LIFE THREATENING, VISITED AN ER, VISITED A HEALTH CARE PROVIDER, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 138211 4/21/11 5 HOUR ENERGY EXTRA STRENGTH RENAL IMPAIRMENT, FOETAL DISTRESS SYNDROME LIFE THREATENING, CONGENITAL ANOMALY 139012 5/13/11 5 HOUR ENERGY DEATH DEATH 139013 5/13/11 5 HOUR ENERGY DEATH DEATH 139014 5/13/11 5 HOUR ENERGY EXTRA STRENGTH ACUTE MYOCARDIAL INFARCTION, DIZZINESS, LOSS OF CONSCIOUSNESS, CEREBROVASCULAR ACCIDENT HOSPITALIZATION, VISITED AN ER, LIFE THREATENING 139015 5/13/11 5 HOUR ENERGY HYPOTENSION OTHER SERIOUS (IMPORTANT MEDICAL EVENTS), HOSPITALIZATION 139016 5/13/11 5-HOUR ENERGY/ POMEGRANA TE PAIN, HYPERHIDROSIS, CHEST DISCOMFORT, HEART RATE DECREASED HOSPITALIZATION, VISITED AN ER, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 139658 5/27/11 5 HOUR ENERGY ORANGE PAIN, GENERALISED ERYTHEMA, HYPERTENSION, FEELING HOT, SWELLING FACE, HYPERSENSITIVITY, DYSPNOEA, URTICARIA, PALPITATIONS, PRURITUS, PO2 DECREASED, BREATH SOUNDS ABSENT VISITED AN ER, LIFE THREATENING 140966 6/26/11 5 HOUR ENERGY COMA, CEREBROVASCULAR ACCIDENT, HYPOAESTHESIA, HOSPITALIZATION, DISABILITY VISUAL IMPAIRMENT 140968 6/27/11 5 HOUR ENERGY VOMITING, HAEMATEMESIS, OESOPHAGEAL INJURY, INJURY OTHER SERIOUS (IMPORTANT MEDICAL EVENTS), HOSPITALIZATION 142050 8/1/11 5 HOUR ENERGY LETHARGY, ABDOMINAL PAIN, HEART RATE ABNORMAL NON-SERIOUS INJURIES/ ILLNESS 142160 7/25/11 5 HOUR ENERGY DEATH DEATH Page 6 Report # Received Date Brand/ Product Name Symptoms Outcomes 142161 7/25/11 5 HOUR ENERGY ABDOMINAL PAIN UPPER, NAUSEA, PAIN, BODY TEMPERATURE INCREASED, VOMITING, JAUNDICE, HEPATITIS, AMMONIA INCREASED, ALANINE AMINOTRANSFERASE INCREASED, BLOOD BILIRUBIN INCREASED, ASPARTATE AMINOTRANSFERASE INCREASED, BLOOD BILIRUBIN INCREASED, GAMMAGLUTAMYLTRANSFERASE INCREASED VISITED AN ER, HOSPITALIZATION 142457 8/12/11 5 HOUR ENERGY COLD SWEAT, DIZZINESS, BLOOD PRESSURE DECREASED, LOSS OF CONSCIOUSNESS, CONVULSION, MYOCARDIAL INFARCTION, DYSPNOEA HOSPITALIZATION, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS), LIFE THREATENING 142772 6/13/11 LIVING ESSENTIALS/ VOMITING, BURNING SENSATION BERRY FLAVORED 5HOUR ENERGY DRINK HOSPITALIZATION, VISITED A HEALTH CARE PROVIDER, VISITED AN ER 143074 9/1/11 5 HOUR ENERGY CEREBROVASCULAR ACCIDENT, CEREBRAL HAEMORRHAGE LIFE THREATENING, HOSPITALIZATION 143643 9/15/11 5 HOUR ENERGY LEMON LIME HYPERSENSITIVITY LIFE THREATENING 143644 9/15/11 5 HOUR ENERGY POMEGRANA TE HYPERSENSITIVITY VISITED AN ER, LIFE THREATENING 143645 9/15/11 5-HOUR ENERGY ACQUIRED IMMUNODEFICIENCY SYNDROME OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 144858 10/24/11 5 HOUR ENERGY MYOCARDIAL INFARCTION DEATH 146464 11/22/11 LIVING ESSENTIALS ABDOMINAL PAIN, ABDOMINAL PAIN UPPER 5 HOUR ENERGY POMEGRANA TE ENERGY SHOT NON-SERIOUS INJURIES/ ILLNESS 147296 12/30/11 5 HOUR ENERGY HOSPITALIZATION HOSPITALISATION Page 7 Report # Received Date Brand/ Product Name Symptoms Outcomes 147297 12/30/11 5-HOUR ENERGY DEATH DEATH 148558 2/6/12 5 HOUR ENERGY MYOCARDIAL INFARCTION OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 148559^ 2/6/12 5 HOUR ENERGY ORANGE DYSPNOEA, TREMOR, HYPOAESTHESIA, CHEST PAIN HOSPITALIZATION, VISITED AN ER, NON-SERIOUS INJURIES/ ILLNESS 2/6/12 5 HOUR ENERGY POMEGRANA TE 148696 2/10/12 5 HOUR ENERGY CEREBROVASCULAR ACCIDENT, CARDIOMEGALY, HEART OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) RATE INCREASED 148905 2/14/12 5 HOUR ENERGY VOMITING HOSPITALIZATION 149591 3/2/12 CONVULSION OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 149601 3/2/12 5 HOUR ENERGY BERRY 5 HOUR ENERGY BERRY CONVULSION OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 149603 3/2/12 5 HOUR ENERGY BERRY CONVULSION OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 149857^ 3/9/12 5 HOUR ENERGY BERRY MYOCARDIAL INFARCTION, CHEST PAIN OTHER SERIOUS (IMPORTANT MEDICAL EVENTS), HOSPITALIZATION, VISITED AN ER, VISITED A HEALTH CARE PROVIDER 4/18/12 150092 3/16/12 5-HOUR ENERGY RENAL DISORDER, JAUNDICE, TONGUE DISCOLOURATION OTHER SERIOUS (IMPORTANT MEDICAL EVENTS), HOSPITALIZATION 150093 3/16/12 5 HOUR ENERGY BERRY ANAPHYLACTIC REACTION, DYSPNOEA, URTICARIA Page 8 HOSPITALIZATION, VISITED AN ER, LIFE THREATENING Report # Received Date Brand/ Product Name Symptoms Outcomes 150422 3/23/12 5 HOUR ENERGY MYOCARDIAL INFARCTION, CIRCULATORY COLLAPSE OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 150936^ 4/6/12 5 HOUR ENERGY EXTRA STRENGTH GRAPE FATIGUE, MIGRAINE, DIZZINESS, NAUSEA, AGITATION, DEPENDENCE, MALAISE, DRUG WITHDRAWAL SYNDROME, FEELING ABNORMAL HOSPITALIZATION 4/6/12 5 HOUR ENERGY BERRY 150937 4/6/12 5 HOUR ENERGY CONVULSION OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 152471 5/15/12 FIVE HOUR ENERGY DIARRHOEA, VOMITING, CHROMATURIA, JAUNDICE, BOOSTER PRURITUS, ANOREXIA, BILIARY SPHINCTEROTOMY, CHOLESTASIS, GALLBLADDER DISORDER, PANCREATIC DISORDER OTHER SERIOUS (IMPORTANT MEDICAL EVENTS), HOSPITALIZATION 153005 6/1/12 5 HOUR ENERGY BERRY ABDOMINAL PAIN UPPER, VOMITING, BACK PAIN, DIARRHOEA HAEMORRHAGIC, GASTRIC DISORDER, GASTRIC HAEMORRHAGE HOSPITALIZATION, VISITED AN ER, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 154568^ 7/19/12 5-HOUR ENERGY POMEGRANA TE LOSS OF CONSCIOUSNESS, HEAD INJURY, DIZZINESS, CONCUSSION, TREMOR, CONVULSION, BRAIN OEDEMA VISITED AN ER, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 5-HOUR ENERGY GRAPE ERYTHEMA, PRURITUS, TONGUE OEDEMA, URTICARIA, OBSTRUCTIVE AIRWAYS DISORDER, DYSPHAGIA VISITED AN ER, LIFE THREATENING 8/31/12 154669^ 7/24/12 10/17/12 155222 8/7/12 5-HOUR ENERGY COELIAC DISEASE HOSPITALIZATION 155230 8/7/12 5 HOUR ENERGY COMPLETED SUICIDE DEATH Page 9 Report # Received Date 156365^ 9/10/12 Brand/ Product Name Symptoms Outcomes 5 HOUR ENERGY HOSPITALISATION HOSPITALIZATION 9/28/12 156366 9/10/12 5 HOUR ENERGY BERRY FEELING ABNORMAL, SOMNOLENCE, LOSS OF CONSCIOUSNESS, COMA, DRUG TOXICITY HOSPITALIZATION, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 156368 9/10/12 5 HOUR ENERGY HEART RATE IRREGULAR, MYOCARDIAL INFARCTION OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 157207 10/1/12 5 HOUR ENERGY SUDDEN CARDIAC DEATH, FATIGUE, LOSS OF CONSCIOUSNESS, MYOCARDIAL INFARCTION DEATH 157210 9/28/12 5-HOUR ENERGY METABOLIC ACIDOSIS, SYSTEMIC INFLAMMATORY RESPONSE SYNDROME, BRONCHOSPASM, HEPATIC ENZYME INCREASED, INSOMNIA, MYOGLOBIN BLOOD INCREASED, MANIA OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 158006 10/22/12 5-HOUR ENERGY MOTOR DYSFUNCTION, CONVULSION OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 92 Page 10 FOI 1 CAERS Reports Allegedly Related to +RXU (QHUJ\ 3URGXFWV Search Terms: Products Listed FDA's Center for Food Safety and Applied Nutrition's (CFSAN's) Adverse Event Reporting System (CAERS) is a post-market surveillance system that collects reports about adverse events and product complaints that are allegedly related to CFSAN-regulated products. These products include conventional foods (and beverages), dietary supplements, infant formulas and cosmetics. The adverse event reports about a product and the total number of adverse event reports for that product in CAERS only reflect information $6 5(3257(' and do not represent any conclusion by FDA about whether the product actually caused the adverse events. The attached reports are what have been HQWHUHG LQWR &$(56 GXULQJ WKH UHTXHVWHG GDWHV (the search date used was the CAERS entered date, as opposed to other dates such as the FDA Received Date or CAERS Received Date, etc.). The reports submitted to FDA vary in the quality and reliability of the information provided. Some reports to FDA do not necessarily include all relevant data, such as whether an individual also suffered from other medical conditions or used other products or medications at the same time. Reports may not include accurate or complete contact information for FDA to seek further information about the event, or complainants may choose not to participate in a follow-up investigation. When important information is missing from a report, it is difficult for FDA to fully evaluate whether the product caused the adverse event or simply coincided with it. There also may be duplicate reports in CAERS for the same adverse event because multiple people (such as an injured consumer and a health care provider who treated him or her) may have submitted reports. Because CAERS is constantly updated with new information, the number of reports for a given product and the content of individual reports may change over time. Report # 147296 Received Date Brand/Product Name Symptoms Outcomes 12/30/11 5 HOUR ENERGY HOSPITALISATION HOSPITALIZATION 147297 12/30/11 5-HOUR ENERGY DEATH DEATH 148558 2/6/12 5 HOUR ENERGY MYOCARDIAL INFARCTION OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) DYSPNOEA, TREMOR, HYPOAESTHESIA, CHEST PAIN HOSPITALIZATION, VISITED AN ER, NON-SERIOUS INJURIES/ ILLNESS 5 HOUR ENERGY ORANGE 148559 2/6/12 148696 2/10/12 5 HOUR ENERGY CEREBROVASCULAR ACCIDENT, CARDIOMEGALY, HEART RATE INCREASED OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 148905 2/14/12 5 HOUR ENERGY VOMITING HOSPITALIZATION 149591 3/2/12 5 HOUR ENERGY BERRY CONVULSION OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 149601 3/2/12 5 HOUR ENERGY BERRY CONVULSION OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 149603 3/2/12 5 HOUR ENERGY BERRY CONVULSION OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 3/9/12 5 HOUR ENERGY BERRY MYOCARDIAL INFARCTION, CHEST PAIN OTHER SERIOUS (IMPORTANT MEDICAL EVENTS), HOSPITALIZATION, VISITED AN ER, VISITED A HEALTH CARE PROVIDER 4/18/12 5 HOUR ENERGY BERRY MYOCARDIAL INFARCTION, CHEST PAIN OTHER SERIOUS (IMPORTANT MEDICAL EVENTS), HOSPITALIZATION, VISITED AN ER, VISITED A HEALTH CARE PROVIDER 150092 3/16/12 5-HOUR ENERGY RENAL DISORDER, JAUNDICE, TONGUE DISCOLOURATION OTHER SERIOUS (IMPORTANT MEDICAL EVENTS), HOSPITALIZATION 150093 3/16/12 5 HOUR ENERGY BERRY ANAPHYLACTIC REACTION, DYSPNOEA, URTICARIA HOSPITALIZATION, VISITED AN ER, LIFE THREATENING 5 HOUR ENERGY POMEGRANATE 149857 Page 1 Report # 150422 Received Date 3/23/12 Brand/Product Name 5 HOUR ENERGY Symptoms Outcomes MYOCARDIAL INFARCTION, CIRCULATORY COLLAPSE OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 5 HOUR ENERGY BERRY 150936 4/6/12 5 HOUR ENERGY EXTRA STRENGTH GRAPE FATIGUE, MIGRAINE, DIZZINESS, NAUSEA, AGITATION, DEPENDENCE, MALAISE, DRUG WITHDRAWAL SYNDROME, FEELING ABNORMAL HOSPITALIZATION 150937 4/6/12 5 HOUR ENERGY CONVULSION OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 152471 5/15/12 FIVE HOUR ENERGY BOOSTER DIARRHOEA, VOMITING, CHROMATURIA, JAUNDICE, PRURITUS, ANOREXIA, BILIARY SPHINCTEROTOMY, CHOLESTASIS, GALLBLADDER DISORDER, PANCREATIC DISORDER OTHER SERIOUS (IMPORTANT MEDICAL EVENTS), HOSPITALIZATION 153005 6/1/12 5 HOUR ENERGY BERRY ABDOMINAL PAIN UPPER, VOMITING, BACK PAIN, DIARRHOEA HAEMORRHAGIC, GASTRIC DISORDER, GASTRIC HAEMORRHAGE HOSPITALIZATION, VISITED AN ER, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 7/19/12 5-HOUR ENERGY POMEGRANATE LOSS OF CONSCIOUSNESS, HEAD INJURY, DIZZINESS, CONCUSSION, TREMOR, CONVULSION, BRAIN OEDEMA VISITED AN ER, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 8/31/12 5-HOUR ENERGY POMEGRANATE LOSS OF CONSCIOUSNESS, HEAD INJURY, DIZZINESS, CONCUSSION, TREMOR, CONVULSION, BRAIN OEDEMA VISITED AN ER, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 7/24/12 5-HOUR ENERGY GRAPE ERYTHEMA, PRURITUS, TONGUE OEDEMA, URTICARIA, OBSTRUCTIVE AIRWAYS DISORDER, DYSPHAGIA VISITED AN ER, LIFE THREATENING 10/17/12 5-HOUR ENERGY GRAPE ERYTHEMA, PRURITUS, TONGUE OEDEMA, URTICARIA, OBSTRUCTIVE AIRWAYS DISORDER, DYSPHAGIA VISITED AN ER, LIFE THREATENING 155222 8/7/12 5-HOUR ENERGY COELIAC DISEASE HOSPITALIZATION 155230 8/7/12 5 HOUR ENERGY COMPLETED SUICIDE DEATH 8/30/12 FIVE HOUR ENERGY EXTRA STRENGTH/ BERRY FLAVOR CAFFEINE ENERGY BOOSTER 9/10/12 5 HOUR ENERGY HOSPITALISATION HOSPITALIZATION 9/28/12 5 HOUR ENERGY HOSPITALISATION HOSPITALIZATION 156366 9/10/12 5 HOUR ENERGY BERRY FEELING ABNORMAL, SOMNOLENCE, LOSS OF CONSCIOUSNESS, COMA, DRUG TOXICITY HOSPITALIZATION, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 156368 9/10/12 5 HOUR ENERGY HEART RATE IRREGULAR, MYOCARDIAL INFARCTION OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 10/1/12 5 HOUR ENERGY SUDDEN CARDIAC DEATH, FATIGUE, LOSS OF CONSCIOUSNESS, MYOCARDIAL INFARCTION DEATH 10/31/12 5 HOUR ENERGY SUDDEN CARDIAC DEATH, FATIGUE, LOSS OF CONSCIOUSNESS, MYOCARDIAL INFARCTION DEATH 154568 154669 156247 156365 157207 NONE Page 2 Report # Received Date Brand/Product Name Symptoms Outcomes 157210 9/28/12 5-HOUR ENERGY METABOLIC ACIDOSIS, SYSTEMIC INFLAMMATORY RESPONSE SYNDROME, BRONCHOSPASM, HEPATIC ENZYME INCREASED, INSOMNIA, MYOGLOBIN BLOOD INCREASED, MANIA OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 158006 10/22/12 5-HOUR ENERGY MOTOR DYSFUNCTION, CONVULSION OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 158326 10/30/12 5-HOUR ENERGY TRANSIENT ISCHAEMIC ATTACK, VITAMIN B12 INCREASED OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 158329 10/31/12 5-HOUR ENERGY HEART INJURY DEATH 11/1/12 EXTRA STENGTH FIVE HOUR ENERGY FOUR OUNCE BOTTLE HEART RATE IRREGULAR HOSPITALIZATION 11/20/12 5-HOUR ENERGY CONVULSION VISITED AN ER, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 12/27/12 5-HOUR ENERGY CONVULSION VISITED AN ER, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 159195 11/21/12 5-HOUR ENERGY EXTRA STRENGTH BERRY HYPERHIDROSIS, NAUSEA, HEART RATE IRREGULAR, HEART RATE INCREASED, CHEST PAIN VISITED AN ER, HOSPITALIZATION 159196 11/21/12 5-HOUR ENERGY DEATH DEATH 11/21/12 5-HOUR ENERGY EXTRA STRENGTH GRAPE PALPITATIONS, ATRIAL FIBRILLATION, HEART RATE INCREASED HOSPITALIZATION, VISITED AN ER, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 11/23/12 5-HOUR ENERGY LIVING ESSENTIALS DRINK MYOCARDIAL INFARCTION, OBESITY, CARDIAC FAILURE CONGESTIVE, HYPERTENSION, BLOOD GLUCOSE DECREASED, BLOOD CHOLESTEROL INCREASED, RED CELL DISTRIBUTION WIDTH DECREASED, HAEMOGLOBIN INCREASED, WHITE BLOOD CELL COUNT INCREASED, HAEMATOCRIT INCREASED, LOW DENSITY LIPOPROTEIN INCREASED, CARBON DIOXIDE INCREASED DEATH 11/27/12 5-HOUR ENERGY LIVING ESSENTIALS DRINK MYOCARDIAL INFARCTION, OBESITY, CARDIAC FAILURE CONGESTIVE, HYPERTENSION, BLOOD GLUCOSE DECREASED, BLOOD CHOLESTEROL INCREASED, RED CELL DISTRIBUTION WIDTH DECREASED, HAEMOGLOBIN INCREASED, WHITE BLOOD CELL COUNT INCREASED, HAEMATOCRIT INCREASED, LOW DENSITY LIPOPROTEIN INCREASED, CARBON DIOXIDE INCREASED DEATH 11/23/12 FIVE HOUR ENERGY REGULAR STRENGTH URTICARIA, DYSPNOEA, VOMITING, ANAPHYLACTIC SHOCK, PANIC REACTION LIFE THREATENING 158481 159146 159197 159315 159323 Page 3 Report # Received Date Brand/Product Name Symptoms Outcomes 159324 11/23/12 5 HOUR ENERGY BACK PAIN, ACTIVITIES OF DAILY LIVING IMPAIRED, ABDOMINAL PAIN UPPER, GASTROENTERITIS, CARDIAC DISORDER, ENDOSCOPY ABNORMAL, CHEST DISCOMFORT VISITED A HEALTH CARE PROVIDER, DISABILITY 159325 11/23/12 FIVE HOUR ENERGY BLOOD PRESSURE INCREASED VISITED AN ER, HOSPITALIZATION 11/23/12 5 HOUR ENERGY CONVULSION HOSPITALIZATION, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 12/27/12 5 HOUR ENERGY CONVULSION HOSPITALIZATION, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 11/23/12 5 HOUR ENERGY MYOCARDIAL INFARCTION, THROMBOSIS, CORONARY ARTERY OCCLUSION HOSPITALIZATION, DISABILITY, LIFE THREATENING 12/27/12 5 HOUR ENERGY MYOCARDIAL INFARCTION, THROMBOSIS, CORONARY ARTERY OCCLUSION HOSPITALIZATION, DISABILITY, LIFE THREATENING 11/28/12 5 HOUR ENERGY DRINK TREMOR, CONVULSION, HYPERHIDROSIS, HEART RATE INCREASED, ELECTROCARDIOGRAM ABNORMAL, BLOOD PRESSURE ABNORMAL VISITED AN ER, HOSPITALIZATION 11/27/12 5 HOUR ENERGY MYOCARDIAL INFARCTION, CORONARY ARTERY OCCLUSION, TORSADE DE POINTES, HEART RATE DECREASED, ARTERIOSCLEROSIS CORONARY ARTERY, ANGINA PECTORIS, CORONARY ARTERY DISEASE, ARRHYTHMIA HOSPITALIZATION, LIFE THREATENING, VISITED AN ER, REQ. INTERVENTION TO PRVNT PERM. IMPRMNT., OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 12/27/12 5 HOUR ENERGY MYOCARDIAL INFARCTION, CORONARY ARTERY OCCLUSION, TORSADE DE POINTES, HEART RATE DECREASED, ARTERIOSCLEROSIS CORONARY ARTERY, ANGINA PECTORIS, CORONARY ARTERY DISEASE, ARRHYTHMIA HOSPITALIZATION, LIFE THREATENING, VISITED AN ER, REQ. INTERVENTION TO PRVNT PERM. IMPRMNT., OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 11/27/12 5 HOUR ENERGY HAEMORRHAGIC STROKE HOSPITALIZATION, VISITED AN ER, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS), LIFE THREATENING 1/11/13 5 HOUR ENERGY HAEMORRHAGIC STROKE HOSPITALIZATION, VISITED AN ER, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS), LIFE THREATENING 1/22/13 5 HOUR ENERGY HAEMORRHAGIC STROKE HOSPITALIZATION, VISITED AN ER, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS), LIFE THREATENING 11/19/12 FIVE HOUR ENERGY BOOSTER DIARRHOEA, VOMITING, CHROMATURIA, JAUNDICE, PRURITUS, ABDOMINAL PAIN, MALAISE, PANCREATIC DISORDER, CHOLESTASIS, BLOOD BILIRUBIN INCREASED, BILE DUCT STENOSIS, ANOREXIA, LIVER INJURY, GALLBLADDER DISORDER, ALANINE AMINOTRANSFERASE INCREASED, ASPARTATE AMINOTRANSFERASE INCREASED, NAUSEA HOSPITALIZATION OESOPHAGEAL RUPTURE, BURNING SENSATION, DYSPEPSIA, DYSPNOEA OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 159326 159327 159420 159464 159492 159552 5-HOUR ENERGY BERRY 159705 12/3/12 159706 12/3/12 5-HOUR ENERGY TRANSIENT ISCHAEMIC ATTACK, MOTOR DYSFUNCTION, RESTLESS LEGS SYNDROME, VITAMIN B12 INCREASED, MUSCULAR WEAKNESS VISITED A HEALTH CARE PROVIDER, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 159795 12/7/12 5-HOUR ENERGY BERRY URTICARIA, HYPERSENSITIVITY, DYSPNOEA, OROPHARYNGEAL SWELLING LIFE THREATENING, VISITED AN ER, SERIOUS INJURIES/ ILLNESS 159796 12/7/12 5-HOUR ENERGY LOSS OF CONSCIOUSNESS, ARRHYTHMIA HOSPITALIZATION 5-HOUR ENERGY GRAPE Page 4 Report # Received Date Brand/Product Name Symptoms Outcomes 5-HOUR ENERGY MYOCARDIAL INFARCTION OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 12/7/12 5-HOUR ENERGY POMEGRANATE CONVULSION, MEAN CELL HAEMOGLOBIN DECREASED, MEAN CELL VOLUME DECREASED, WHITE BLOOD CELL COUNT INCREASED, BLOOD SODIUM DECREASED, CARBON DIOXIDE DECREASED, MONOCYTE COUNT INCREASED, LYMPHOCYTE COUNT DECREASED, BLOOD GLUCOSE INCREASED, GRANULOCYTE COUNT INCREASED, RED CELL DISTRIBUTION WIDTH INCREASED VISITED AN ER, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 3/14/13 5-HOUR ENERGY POMEGRANATE CONVULSION, MEAN CELL HAEMOGLOBIN DECREASED, MEAN CELL VOLUME DECREASED, WHITE BLOOD CELL COUNT INCREASED, BLOOD SODIUM DECREASED, CARBON DIOXIDE DECREASED, MONOCYTE COUNT INCREASED, LYMPHOCYTE COUNT DECREASED, BLOOD GLUCOSE INCREASED, GRANULOCYTE COUNT INCREASED, RED CELL DISTRIBUTION WIDTH INCREASED VISITED AN ER, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 5/24/13 5-HOUR ENERGY POMEGRANATE CONVULSION, MEAN CELL HAEMOGLOBIN DECREASED, MEAN CELL VOLUME DECREASED, WHITE BLOOD CELL COUNT INCREASED, BLOOD SODIUM DECREASED, CARBON DIOXIDE DECREASED, MONOCYTE COUNT INCREASED, LYMPHOCYTE COUNT DECREASED, BLOOD GLUCOSE INCREASED, GRANULOCYTE COUNT INCREASED, RED CELL DISTRIBUTION WIDTH INCREASED VISITED AN ER, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 159799 12/7/12 5-HOUR ENERGY CHEST PAIN, NAUSEA, MASS OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 159800 12/7/12 5-HOUR ENERGY PANCREATITIS SERIOUS INJURIES/ ILLNESS, HOSPITALIZATION 159875 12/7/12 5-HOUR ENERGY POMEGRANATE BLOOD PRESSURE INCREASED, HEART RATE INCREASED HOSPITALIZATION CONVULSION OTHER SERIOUS (IMPORTANT MEDICAL EVENTS), VISITED AN ER 159797 159798 12/7/12 5-HOUR ENERGY EXTRA STRENGTH BERRY 160030 12/12/12 160031 12/12/12 5-HOUR ENERGY BERRY DEATH, MYOCARDIAL INFARCTION DEATH 160032 12/12/12 5-HOUR ENERGY ANAPHYLACTIC SHOCK OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 160033 12/12/12 5-HOUR ENERGY HOSPITALISATION HOSPITALIZATION 5-HOUR ENERGY EXTRA STRENGTH GRAPE Page 5 Report # Received Date Brand/Product Name Symptoms Outcomes 12/12/12 5-HOUR ENERGY HYPOAESTHESIA, BLOOD PRESSURE INCREASED, PARAESTHESIA, VITAMIN B12 INCREASED, ANTINUCLEAR ANTIBODY INCREASED, ANTINUCLEAR ANTIBODY POSITIVE, MIGRAINE, CLUSTER HEADACHE OTHER SERIOUS (IMPORTANT MEDICAL EVENTS), HOSPITALIZATION 12/27/12 5-HOUR ENERGY HYPOAESTHESIA, BLOOD PRESSURE INCREASED, PARAESTHESIA, VITAMIN B12 INCREASED, ANTINUCLEAR ANTIBODY INCREASED, ANTINUCLEAR ANTIBODY POSITIVE, MIGRAINE, CLUSTER HEADACHE OTHER SERIOUS (IMPORTANT MEDICAL EVENTS), HOSPITALIZATION 3/22/13 5-HOUR ENERGY HYPOAESTHESIA, BLOOD PRESSURE INCREASED, PARAESTHESIA, VITAMIN B12 INCREASED, ANTINUCLEAR ANTIBODY INCREASED, ANTINUCLEAR ANTIBODY POSITIVE, MIGRAINE, CLUSTER HEADACHE OTHER SERIOUS (IMPORTANT MEDICAL EVENTS), HOSPITALIZATION 160556 12/27/12 5-HOUR ENERGY DEATH DEATH 160922 1/8/13 5 HOUR ENERGY DIZZINESS, VERTIGO, AUTONOMIC NERVOUS SYSTEM IMBALANCE, MALAISE, VOMITING, INNER EAR DISORDER, FEELING ABNORMAL, TREMOR, VERTIGO POSITIONAL, HYPERSENSITIVITY, MENTAL IMPAIRMENT, HYPERHIDROSIS HOSPITALIZATION, VISITED AN ER, VISITED A HEALTH CARE PROVIDER 161401 1/3/13 ORGINAL 5HOUR ENERGY DRINK FEELING OF BODY TEMPERATURE CHANGE, HEART RATE ABNORMAL, SKIN DISCOLOURATION, PARAESTHESIA, ERYTHEMA, COLD SWEAT, HEART RATE INCREASED VISITED AN ER 161688 12/10/12 5-HOUR ENERGY LEMON LIME 11/16/12 5 HOUR ENERGY DRINK CARDIOVASCULAR DISORDER, PAIN, MYOCARDIAL INFARCTION VISITED A HEALTH CARE PROVIDER, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS), HOSPITALIZATION, VISITED AN ER 3/1/13 5 HOUR ENERGY DRINK CARDIOVASCULAR DISORDER, PAIN, MYOCARDIAL INFARCTION VISITED A HEALTH CARE PROVIDER, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS), HOSPITALIZATION, VISITED AN ER 11/28/12 5 HOUR ENERGY LOSS OF CONSCIOUSNESS, FALL, HEAD INJURY, DEHYDRATION, SUBARACHNOID HAEMORRHAGE, POST CONCUSSION SYNDROME, CONVULSION, SYNCOPE HOSPITALIZATION, DISABILITY, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS), VISITED AN ER 3/1/13 5 HOUR ENERGY LOSS OF CONSCIOUSNESS, FALL, HEAD INJURY, DEHYDRATION, SUBARACHNOID HAEMORRHAGE, POST CONCUSSION SYNDROME, CONVULSION, SYNCOPE HOSPITALIZATION, DISABILITY, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS), VISITED AN ER 162637 2/22/13 5-HOUR ENERGY CARDIAC DISORDER OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 162638 2/22/13 5-HOUR ENERGY CARDIAC DISORDER VISITED A HEALTH CARE PROVIDER, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 162975 3/4/13 5 HOUR ENERGY DRINK 163354 3/14/13 5-HOUR ENERGY BERRY FLAVOR 160034 NONE 162045 162048 HOSPITALIZATION FALL, MULTIPLE INJURIES, DEHYDRATION, DISABILITY, LOSS OF CONSCIOUSNESS, BRAIN INJURY Page 6 OTHER SERIOUS (IMPORTANT MEDICAL EVENTS), DISABILITY Report # Received Date Brand/Product Name Symptoms Outcomes 163355 3/14/13 5-HOUR ENERGY (BERRY) NAUSEA, CEREBROVASCULAR ACCIDENT, DIZZINESS OTHER SERIOUS (IMPORTANT MEDICAL EVENTS), HOSPITALIZATION 163657 3/22/13 5-HOUR ENERGY MYOCARDIAL INFARCTION DEATH 3/22/13 5-HOUR ENERGY MANIA, INSOMNIA, DEPRESSED MOOD, SUICIDAL IDEATION, MEMORY IMPAIRMENT, ANXIETY, HAEMORRHAGE, PSYCHOTIC DISORDER DEATH, VISITED AN ER, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS), HOSPITALIZATION 5/6/13 5-HOUR ENERGY MANIA, INSOMNIA, DEPRESSED MOOD, SUICIDAL IDEATION, MEMORY IMPAIRMENT, ANXIETY, HAEMORRHAGE, PSYCHOTIC DISORDER DEATH, VISITED AN ER, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS), HOSPITALIZATION 3/22/13 5-HOUR ENERGY EXTRA STRENGTH BERRY CONVULSION, FOAMING AT MOUTH, GRAND MAL CONVULSION, ELECTROENCEPHALOGRAM ABNORMAL, MYOCLONIC EPILEPSY VISITED A HEALTH CARE PROVIDER, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 5/15/13 5-HOUR ENERGY EXTRA STRENGTH BERRY CONVULSION, FOAMING AT MOUTH, GRAND MAL CONVULSION, ELECTROENCEPHALOGRAM ABNORMAL, MYOCLONIC EPILEPSY VISITED A HEALTH CARE PROVIDER, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 3/28/13 5-HOUR ENERGY BERRY MYOCARDIAL INFARCTION HOSPITALIZATION, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 3/28/13 5-HOUR ENERGY BERRY PALPITATIONS, ATRIAL FIBRILLATION, DYSPNOEA OTHER SERIOUS (IMPORTANT MEDICAL EVENTS), VISITED AN ER, VISITED A HEALTH CARE PROVIDER, HOSPITALIZATION 5/24/13 5-HOUR ENERGY BERRY PALPITATIONS, ATRIAL FIBRILLATION, DYSPNOEA OTHER SERIOUS (IMPORTANT MEDICAL EVENTS), VISITED AN ER, VISITED A HEALTH CARE PROVIDER, HOSPITALIZATION 3/29/13 5 HOUR ENERGY PALPITATIONS VISITED A HEALTH CARE PROVIDER 164311 4/9/13 5-HOUR ENERGY DRINK CHEST PAIN, HEADACHE, DYSPNOEA, WHEEZING, INSOMNIA, FATIGUE, WEIGHT INCREASED, OEDEMA, MUSCLE SPASMS HOSPITALIZATION, LIFE THREATENING 165549 5/15/13 5-HOUR ENERGY VOMITING, CHOKING, ASPIRATION DEATH 167339 6/28/13 5 HOUR ENERGY BERRY LIVING ESSENTIALS, LLC CEREBROVASCULAR ACCIDENT DISABILITY, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS), LIFE THREATENING, HOSPITALIZATION 167351 6/28/13 5-HOUR ENERGY DIZZINESS, MALAISE OTHER SERIOUS (IMPORTANT MEDICAL EVENTS), HOSPITALIZATION 167846 7/10/13 5-HOUR ENERGY MYOCARDIAL INFARCTION DEATH 168025 7/18/13 5-HOUR ENERGY ORANGE NAUSEA, DEPRESSED MOOD HOSPITALIZATION, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 168029 7/18/13 5-HOUR ENERGY ORANGE NAUSEA, DEPRESSED MOOD HOSPITALIZATION 163729 163731 163852 163854 163905 Page 7 Report # Received Date Brand/Product Name Symptoms Outcomes CHEST PAIN, URINE ANALYSIS ABNORMAL, HEADACHE, ABNORMAL LOSS OF WEIGHT, APPETITE DISORDER, SYNCOPE, LETHARGY, OEDEMA, SWELLING, GAIT DISTURBANCE, BLISTER, SLEEP DISORDER, MUSCLE SPASMS, PAIN, FATIGUE, DYSPNOEA, RASH PAPULAR, CIRCULATORY COLLAPSE LIFE THREATENING, HOSPITALIZATION, VISITED A HEALTH CARE PROVIDER, VISITED AN ER, REQ. INTERVENTION TO PRVNT PERM. IMPRMNT. 168390 4/5/13 5-HOUR ENERGY 169203 8/16/13 5 HOUR ENERGY NAUSEA, PALPITATIONS, VOMITING VISITED AN ER 170296 9/18/13 5-HOUR ENERGY EXTRA STRENGTH BERRY DYSARTHRIA, CEREBROVASCULAR ACCIDENT, HYPERTENSION, AMNESIA DISABILITY, VISITED AN ER, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS), HOSPITALIZATION 170297 9/18/13 5-HOUR ENERGY PINK LEMONADE LOSS OF CONSCIOUSNESS, DYSPHAGIA, CONVULSION, DISORIENTATION, CONFUSIONAL STATE, EXOPHTHALMOS, ANOREXIA VISITED AN ER, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 170967 10/16/13 5 HOUR ENERGY DRINK CONVULSION LIFE THREATENING, HOSPITALIZATION 170969 10/2/13 5-HOUR ENERGY EXTRA STRENGTH BERRY CONVULSION, LOSS OF CONSCIOUSNESS, LOSS OF CONSCIOUSNESS, VOMITING, FOAMING AT MOUTH, MUSCULOSKELETAL STIFFNESS, TENDERNESS, DIZZINESS, SKIN LACERATION, PERFORMANCE STATUS DECREASED LIFE THREATENING, HOSPITALIZATION 170975 10/2/13 5-HOUR ENERGY BERRY LOSS OF CONSCIOUSNESS, CONVULSION, FOAMING AT MOUTH, ABDOMINAL PAIN UPPER, MUSCLE SPASMS VISITED A HEALTH CARE PROVIDER, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 170977 10/2/13 5-HOUR ENERGY COLECTOMY OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 171094 10/23/13 5 HOUR ENERGY DRINK FEELING DRUNK VISITED A HEALTH CARE PROVIDER 171143 10/15/13 5-HOUR ENERGY CONVULSION, OVERDOSE HOSPITALIZATION, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 171218 10/18/13 5-HOUR ENERGY MYOCARDIAL INFARCTION DISABILITY, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS), HOSPITALIZATION 171333 10/21/13 5 HOUR ENERGY DRINK SOMNOLENCE, VISUAL IMPAIRMENT, PARALYSIS, DYSGRAPHIA, DYSPHEMIA, CEREBROVASCULAR ACCIDENT LIFE THREATENING, HOSPITALIZATION 172173 6/25/13 5-HOUR ENERGY ORANGE FLAVORED LIQUID DIETARY SUPPLEMENT VOMITING, HEART RATE ABNORMAL, LETHARGY, LOSS OF CONSCIOUSNESS, MALAISE, BRADYCARDIA, MENTAL STATUS CHANGES, MUSCLE SPASMS HOSPITALIZATION, VISITED AN ER, REQ. INTERVENTION TO PRVNT PERM. IMPRMNT. 172193 11/14/13 5-HOUR ENERGY (BERRY) HOSPITALISATION HOSPITALIZATION 172194 11/14/13 5-HOUR ENERGY (BERRY) SOMNAMBULISM HOSPITALIZATION Page 8 Report # Received Date Brand/Product Name Symptoms Outcomes 172238 11/22/13 5-HOUR ENERGY BERRY LOSS OF CONSCIOUSNESS, MIGRAINE WITH AURA, SOMNOLENCE, SCAR HOSPITALIZATION, DISABILITY 172392 11/14/13 5-HOUR ENERGY BLOOD TEST ABNORMAL, ORGAN FAILURE, NERVE INJURY, DACRYOSTENOSIS CONGENITAL OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 172538 6/25/13 5-HOUR ENERGY ORANGE FLAVORED LIQUID DIETARY SUPPLEMENT BRADYCARDIA, MUSCLE SPASMS, MALAISE, LOSS OF CONSCIOUSNESS, VOMITING, MENTAL STATUS CHANGES, HEART RATE ABNORMAL, LETHARGY HOSPITALIZATION, VISITED AN ER, REQ. INTERVENTION TO PRVNT PERM. IMPRMNT. 173345 12/27/13 5-HOUR ENERGY CONVULSION OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 102 Page 9 FOI 15-1828 CAERS Reports Allegedly Related 5-Hour Energy Products Search Tenns: Products Listed Center for Food Safety and Applied Nutrition's (CFSAN's) Adverse Event Reporting System (CAERS) is a post-market surveillance system that collects reports about adverse events and product complaints that are allegedly related to CFSAN-regulated products. These products include conventional foods (and beverages), dietary supplements, infant formulas and cosmetics. The adverse event reports about a product and the total number of adverse event reports for that product in CAERS only re?ect information AS REPORTED and do not represent any conclusion by FDA about whether the product actually caused the adverse events. The attached reports are what have been entered into CAERS during the requested dates (the search date used was the CAERS entered date, as opposed to other dates such as the FDA Received Date or CAERS Received Date, etc). The reports submitted to FDA vary in the quality and reliability of the information provided. Some reports to FDA do not necessarily include all relevant data, such as whether an individual also suffered from other medical conditions or used other products or medications at the same time. Reports may not include accurate or complete contact information for FDA to seek further information about the evant, or complainants may choose not to participate in a follow-up investigation. When important information is missing from a report, it is dif?cult for FDA to fully evaluate whetherthe product caused the adverse event or simply coincided with it. There also may be duplicate reports in CAERS for the same adverse event because multiple people (such as an injured consumer and a health care provider who treated him or her) may have submitted reports. - Because CAERS is constantly updated with new information, the number of reports for a given product and the content of individual reports may change over time. Report Received it Date anleroduct Name Outcomes 174340 2128,14 ENERGY EXTRA PARAESTHESIA, HYPERSENSITIVITY, ERYTHEMA, THROAT TIGHTNESS, VISITED AN ER, LIFE THREATENING THROAT TIGHTNESS STRENGTH 5 HOUR ENERGY OTHER SERIOUS (IMPORTANT MEDICAL EVENTS), 174752 3111/14 POMEGRANATE LOSS OF CONSCIOUSNESS, CONVULSION HOSPITALIZATION 174763 3mm 5 HOUR ENERGY ATRIAL OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 5 HOUR ENERGY 174881 11T20I13 SHOT NONE EXTRA STRENGHT 5? HOUR ENERGY GRAPE JAUNDICE, LIVER FUNCTION TEST ABNORMAL, ABDOMINAL PAIN 175076 3723714 EXTRA VOMITINGI GALLBLADDER DISORDER PAIN AN ER, STRENGTH 5- HOUR ENERGY SOUR APPLE 4116/14 5 HOUR ENERGY HEADACHE, PAIN, NAUSEA, CHEST PAIN, HEART RATE OTHER SERIOUS (IMPORTANT MEDICAL EVENTS), 175855 HEART RATE IRREGULAR, HYPERHIDROSIS HOSPITALIZATION 518,14 5 HOUR ENERGY HEADACHE, PAIN, NAUSEA, CHEST PAIN, HEART RATE INCREASED, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS), HEART RATE IRREGULAR, HYPERHIDROSIS 5 HOUR ENERGY HOSPITALIZATION, VISITED AN ER, OTHER SERIOUS 175856 4/16/14 ORANGE TRANSIENT ISCHAEMIC ATTACK, DIZZINESS, (IMPORTANT MEDICAL EVENTS) 5 HOUR CHEST PAIN, CARDIAC ARREST, LOSS OF CONSCIOUSNESS, 177372 6l24l14 ENERGY DEATH, HOSPITALIZATION 5 - HOUR CHEST PAIN, CARDIAC ARREST, LOSS OF CONSCIOUSNESS, 7124/14 ENERGY DEATH, HOSPITALIZATION Page 1 Report Received anleroduct Outcomes Date Name 177400 178714 gag PALPITATIONS, MYOCARDIAL INFARCTION OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 5-HOUR HOSPITALIZATION, OTHER SERIOUS (IMPORTANT MEDICAL 177730 777714 EN ERGY REVERSIBLE POSTERIOR LEUKOENCEPHALOPATHY EVENTS LIFE THREATENING 5-HOUR 177785 7/9714 ENERGY (LIVING HEPATIC DRUG OTHER SERIOUS MEDICAL EVENTS), DEATH TOXICITY ESSENTIALS) 178475 818(14 5 HOUR ENERGY VASCULITIS, HAEMORRHAGE DISABILITY, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) 5-HOUR ENERGY BERRY LETHARGY, DEHYDRATION, DIARRHOEA, ABDOMINAL PAIN UPPER, 178844 811414 VOMITING, STAPHYLOCOCCAL INFECTION, CONDITION VISITED AN ER, HOSPITALIZATION ENERGY EXTRA IMPROVED, BLOOD POTASSIUM DECREASED, INFLAMMATION STRENGTH BERRY 179114 914114 gag MYOCARDIAL INFARCTION OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) COMA, DISSEMINATED INTRAVASCULAR COAGULATION, METABOLIC LIVING ACIDOSIS, RENAL FAILURE, RHABDOMYOLYSIS, ACUTE HEPATIC ESSENTIALS 5 FAILURE, ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED, BLOOD BILIRUBIN INCREASED, BLOOD CREATINE PHOSPHOKINASE 179710 1071114 ENERGY INCREASED, ASPARTATE AMINOTRANSFERASE VISITED A HEALTH CARE PROVIDER, LIFE THREATENING STRENGTH PROTHROMBIN LEVEL INCREASED, LOSS OF CONSCIOUSNESS, BODY TEMPERATURE DECREASED, ALANINE AMINOTRANSPERASE INCREASED LIVING 10l8114 ESSENTIALS 5? ANGINA PECTORIS, CHEST PAIN VISITED AN ER, HOSPITALIZATION HOUR ENERGY 179981 LIVING 12723714 ESSENTIALS 5? ANGINA PECTORIS, CHEST PAIN VISITED AN ER, HOSPITALIZATION HOUR ENERGY CONVULSION, TROPONIN INCREASED, BLOOD CREATINE LIVING PHOSPHOKINASE INCREASED, HEPATIC ENZYME INCREASED, 180334 10mm ESSENTIALS 5- AGITATION, BLOOD PRESSURE INCREASED, MUSCLE CONTRACTIONS HOSPITALIZATION, VISITED AN ER, REQ. INTERVENTION TO HOUR ENERGY INVOLUNTARY. HEART RATE INCREASED, ANION GAP INCREASED, PERM. ORIGINAL BLOOD LACTATE DEHYDROGENASE INCREASED, MYOGLOBIN BLOOD INCREASED, ASPARTATE AMINOTRANSFERASE INCREASED 17 Page 2