Rozerem (Ramelteon) - Adverse Event Reports - Life Threatening Events

Legal Problem (1),  Drug Hypersensitivity (1),  Drug Interaction (1),  Amnesia (1),  Impaired Driving Ability (1),  Homicide (1),  Palpitations (1),  Suicide Attempt (1),  Imprisonment (1),  Feeling Abnormal (1)

Adverse event in 54 year old male receiving Rozerem (Ramelteon)

Reported by a physician from United States on 2007-10-02

Patient: 54 year old male, weighing 104.3 kg (229.5 pounds)

Adverse reactions / side effects: Impaired Driving Ability, Legal Problem, Drug Interaction, Imprisonment, Amnesia, Feeling Abnormal

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Cymbalta
    Dosage: 30 mg, qhs
    Indication: Pain

Hydrocodone Bitartrate

Lortab
    Dosage: 10/500, q12-24 hrs
    Indication: Pain

Methadone HCL
    Dosage: 10 mg, 2 in 1 d, per oral
    Administration route: Oral

Rozerem
    Dosage: per oral
    Administration route: Oral
    Indication: Insomnia
    Start date: 2007-07-18
    End date: 2007-07-24

Other drugs received by patient: Aleve; Omega 3 Fish OIL (Fish Oil); Decadron

Adverse event in 52 year old female receiving Rozerem (Ramelteon)

Reported by a health professional (non-physician/pharmacist) from United States on 2007-06-04

Patient: 52 year old female, weighing 99.8 kg (219.5 pounds)

Adverse reactions / side effects: Heart Rate Decreased, Palpitations

Adverse event resulted in: life threatening event

Suspect drug(s):
Rozerem
    Dosage: 8 mg once hs po
    Administration route: Oral
    Indication: Insomnia
    Start date: 2007-04-26

Rozerem
    Dosage: 8 mg once hs po
    Administration route: Oral
    Indication: Insomnia
    Start date: 2007-04-27

Adverse event in 67 year old male receiving Rozerem (Ramelteon)

Reported by a consumer/non-health professional from United States on 2007-05-22

Patient: 67 year old male

Adverse reactions / side effects: Homicide, Suicide Attempt

Adverse event resulted in: life threatening event

Suspect drug(s):
Ambien

Cymbalta
    Indication: Depression

Rozerem
    Dosage: per oral
    Administration route: Oral

Other drugs received by patient: Lunesta

Adverse event in 32 year old female receiving Rozerem (Ramelteon)

Reported by a consumer/non-health professional from United States on 2007-04-09

Patient: 32 year old female, weighing 59.0 kg (129.7 pounds)

Adverse reactions / side effects: Pruritus, Drug Hypersensitivity, Throat Tightness

Adverse event resulted in: life threatening event

Suspect drug(s):
Rozerem (Ramelteon)