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Lioresal (Baclofen Intrathecal) - Life Threatening Events - Suspected Cause - Side Effect Reports

 
 



Index of reports > Life Threatening Events (41)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Lioresal (Baclofen Intrathecal) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 41   Next >>

Possible Lioresal side effects in male

Reported by a physician from France on 2012-07-10

Patient: male

Reactions: Pancreatitis Acute, Pneumonia, Systemic Inflammatory Response Syndrome, Circulatory Collapse, Respiratory Distress, Organ Failure

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Aspirin
    Administration route: Oral
    Indication: Cerebrovascular Accident

Dipiperon
    Administration route: Oral

Diprivan
    Indication: Anaesthesia
    Start date: 2012-02-27
    End date: 2012-02-27

Lioresal
    Indication: Cerebrovascular Accident

Depakene
    Administration route: Oral
    Indication: Epilepsy
    End date: 2012-02-28



Possible Lioresal side effects in

Reported by a physician from Denmark on 2012-06-15

Patient:

Reactions: Underdose, Condition Aggravated, Muscle Spasticity, Device Leakage, Multi-Organ Failure, Overdose, Respiratory Failure, Device Connection Issue, Intracranial Hypotension

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in 12 year old male

Reported by a physician from United States on 2012-05-15

Patient: 12 year old male

Reactions: Back Pain, Mydriasis, Pyrexia, Somnolence, Overdose, Hypopnoea, Hypotonia, Bradycardia, Device Malfunction, Altered State of Consciousness, Lethargy

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in male

Reported by a physician from Australia on 2012-05-11

Patient: male

Reactions: Overdose, Cardio-Respiratory Arrest, Hypoxic-Ischaemic Encephalopathy, Lower Respiratory Tract Infection, Convulsion, Loss of Consciousness

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in 18 year old male

Reported by a physician from United States on 2012-05-07

Patient: 18 year old male

Reactions: Pneumonia Aspiration, Wrong Technique in Drug Usage Process, Vomiting, Hypotension, Device Damage, Abnormal Behaviour, Complication of Device Removal, Muscle Tightness, Implant Site Reaction, Overdose, Implant Site Fibrosis, Procedural Complication, Implant Site Induration

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Lioresal
    Indication: Muscle Spasticity

Lioresal
    Indication: Cerebral Palsy



Possible Lioresal side effects in 17 year old male

Reported by a physician from United States on 2012-05-02

Patient: 17 year old male

Reactions: Agitation, Exposure To Contaminated Device, Tonic Clonic Movements, Muscle Spasticity, Malaise, Cardio-Respiratory Arrest, Overdose, Bronchial Wall Thickening, Circulatory Collapse, Acute Respiratory Failure, Cough, Hypertonia, Scoliosis, Muscle Contracture, Drug Withdrawal Syndrome, Rash Macular, Convulsion, Urinary Tract Infection Enterococcal, Pseudomonas Test Positive, Fungal Test Positive, Meningitis Bacterial, Hypertension, Shock

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Lioresal
    Dosage: 1730 mcg/day
    Indication: Muscle Spasticity

Lioresal
    Dosage: 1730 mcg/day
    Indication: Cerebral Palsy



Possible Lioresal side effects in 31 year old female

Reported by a physician from United States on 2012-04-25

Patient: 31 year old female

Reactions: Agitation, Pruritus, Drug Ineffective, Muscle Spasticity, Device Dislocation, Malaise, Overdose, Injury, Device Connection Issue, Device Malfunction, Hypersomnia, Pain in Extremity, Drug Withdrawal Syndrome, Discomfort, Device Failure, Device Breakage

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in male

Reported by a physician from United States on 2012-04-24

Patient: male

Reactions: Blood Creatine Phosphokinase Increased, Pain, Mental Status Changes, Hypernatraemia, Pyrexia, Somnolence, Hypokalaemia, Urinary Retention, Gastrooesophageal Reflux Disease, Lethargy, Hypertonia, Hypotension, Urinary Tract Infection, Convulsion, Tremor, Flushing, Bradycardia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Lioresal
    Dosage: see b5
    Indication: Cerebral Palsy

Lioresal
    Dosage: see b5
    Indication: Muscle Spasticity



Possible Lioresal side effects in 6 year old male

Reported by a physician from United States on 2012-04-23

Patient: 6 year old male

Reactions: Atelectasis, Metabolic Acidosis, Pneumonia, Implant Site Erosion, Hypotension, Hyperglycaemia, Hypernatraemia, Wound Infection Staphylococcal, Cardiac Disorder, Haemodynamic Instability, Respiratory Rate Decreased, Hypopnoea, Pulmonary Oedema, Staphylococcal Bacteraemia, CSF Test Abnormal

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in 6 year old male

Reported by a physician from United States on 2012-04-23

Patient: 6 year old male

Reactions: Atelectasis, Metabolic Acidosis, Pneumonia, Implant Site Erosion, Hypotension, Hyperglycaemia, Wound Infection, Hypernatraemia, Respiratory Distress, Respiratory Rate Decreased, Pulmonary Oedema, Staphylococcal Bacteraemia, CSF Test Abnormal

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in female

Reported by a consumer/non-health professional from United States on 2012-04-19

Patient: female

Reactions: Pruritus, Hypotension, Muscle Spasticity, Drug Withdrawal Syndrome, Device Occlusion, Somnolence, Device Dislocation, Implant Site Swelling, Therapeutic Response Decreased, Multiple Drug Overdose, Bradycardia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-18

Patient: male

Reactions: Contusion, Wrist Fracture, Abasia, Pain, Fear, Hand Fracture, Fall, Suicidal Ideation, Foot Fracture, Concussion, Overdose, Procedural Complication, Dysgraphia, RIB Fracture, Muscle Spasms, Medical Device Complication, Nightmare, Nausea, Anxiety, Post-Traumatic Stress Disorder, Communication Disorder, Device Infusion Issue, Insomnia, Facial Bones Fracture, Homicidal Ideation, Withdrawal Syndrome

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in male

Reported by a physician from United Kingdom on 2012-04-17

Patient: male

Reactions: Abdominal Pain, Back Pain, Hypotension

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in male

Reported by a individual with unspecified qualification from United States on 2012-04-13

Patient: male

Reactions: Medical Device Complication, Withdrawal Syndrome, Cardiac Arrest, Post Procedural Infection

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in 73 year old male

Reported by a physician from United States on 2012-04-11

Patient: 73 year old male

Reactions: Confusional State, Overdose, Coma, Headache, Device Connection Issue, Delirium, Lethargy, Implant Site Swelling

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in 12 year old male

Reported by a physician from United States on 2012-04-11

Patient: 12 year old male

Reactions: Back Pain, Mydriasis, Overdose, Hypopnoea, Hypotonia, Bradycardia, Pyrexia, Somnolence, Lethargy

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-09

Patient: female

Reactions: Agitation, Respiratory Rate Decreased, Overdose, Oedema, Loss of Consciousness, Lethargy

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in 52 year old male

Reported by a physician from France on 2012-04-06

Patient: 52 year old male

Reactions: Pancreatitis Acute, Circulatory Collapse, Respiratory Distress

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Dipiperon
    Administration route: Oral

Depakene
    Administration route: Oral
    Indication: Epilepsy
    End date: 2012-02-28

Diprivan
    Indication: Anaesthesia
    Start date: 2012-02-27
    End date: 2012-02-27

Aspirin
    Administration route: Oral
    Indication: Cerebrovascular Accident

Lioresal
    Indication: Cerebrovascular Accident



Possible Lioresal side effects in male

Reported by a physician from United States on 2012-04-05

Patient: male

Reactions: Blood Creatine Phosphokinase Increased, Pain, Mental Status Changes, Implant Site Infection, Wound Infection Staphylococcal, Hyperhidrosis, Procedural Haemorrhage, Hypertonia, Metabolic Acidosis, Dystonia, Restlessness, Urinary Tract Infection, Cognitive Disorder, Toxicity To Various Agents, Drug Withdrawal Syndrome, Blood Lactic Acid Increased, Tremor, Depressed Level of Consciousness, Infection

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in male

Reported by a physician from United States on 2012-04-05

Patient: male

Reactions: Blood Creatine Phosphokinase Increased, Implant Site Infection, Mental Status Changes, Hyperhidrosis, Wound Infection Staphylococcal, Procedural Haemorrhage, Hypertonia, Metabolic Acidosis, Blood Urine Present, Restlessness, Dystonia, Urinary Tract Infection, Cognitive Disorder, Urine Abnormality, Drug Withdrawal Syndrome, Toxicity To Various Agents, Blood Lactic Acid Increased, Tremor, Depressed Level of Consciousness, Infection

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in 28 year old male

Reported by a consumer/non-health professional from United States on 2012-04-04

Patient: 28 year old male

Reactions: Incision Site Infection, Meningitis, Device Breakage

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Lioresal

Other drugs received by patient: Oral Baclofen; Valium



Possible Lioresal side effects in 47 year old female

Reported by a physician from United States on 2012-04-03

Patient: 47 year old female

Reactions: Therapeutic Response Decreased, Incision Site Infection, Underdose

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Lioresal

Other drugs received by patient: Fentanyl; Hydromorphone HCL; Bupivacaine HCL



Possible Lioresal side effects in female

Reported by a physician from United States on 2012-03-15

Patient: female

Reactions: Nasopharyngitis, Device Kink, Device Damage, Drug Withdrawal Syndrome, Muscle Spasticity, Device Dislocation, Fall, Device Leakage, Poor Quality Sleep, Device Connection Issue, Urinary Retention, Hypertonia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Lioresal
    Dosage: 236 mcg/day
    Indication: Cerebrovascular Accident

Lioresal
    Dosage: 236 mcg/day
    Indication: Muscle Spasticity



Possible Lioresal side effects in 17 year old male

Reported by a physician from United States on 2012-03-15

Patient: 17 year old male

Reactions: Meningitis Bacterial, Muscle Spasticity

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Lioresal
    Dosage: 1730 mcg/day
    Indication: Cerebral Palsy

Lioresal
    Dosage: 1730 mcg/day
    Indication: Muscle Spasticity



Possible Lioresal side effects in 18 year old male

Reported by a physician from United States on 2012-03-13

Patient: 18 year old male

Reactions: Incorrect Route of Drug Administration, Pneumonia Aspiration, Hypotension, Abnormal Behaviour, Implant Site Effusion, Muscle Tightness, Device Dislocation, Accidental Overdose, Procedural Vomiting, Implant Site Induration

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Lioresal
    Dosage: see b5
    Indication: Cerebral Palsy

Lioresal
    Dosage: see b5
    Indication: Muscle Spasticity



Possible Lioresal side effects in 17 year old male

Reported by a physician from United States on 2012-02-13

Patient: 17 year old male

Reactions: Drug Withdrawal Syndrome, Device Related Infection, Muscle Spasticity, Convulsion, Urinary Tract Infection Enterococcal, Cardio-Respiratory Arrest, Respiratory Failure, Meningitis Bacterial, Hypertension, Shock

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Lioresal
    Dosage: 1730 mcg/day
    Indication: Cerebral Palsy

Lioresal
    Dosage: 1730 mcg/day
    Indication: Muscle Spasticity



Possible Lioresal side effects in female

Reported by a physician from United States on 2012-02-06

Patient: female

Reactions: Nasopharyngitis, Device Kink, Muscle Spasticity, Fall, Device Dislocation, Malaise, Insomnia, Dysuria, Withdrawal Syndrome, Hypertonia, Device Breakage

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Lioresal
    Dosage: 236 mcg/fday
    Indication: Muscle Spasticity

Lioresal
    Dosage: 236 mcg/fday
    Indication: Cerebrovascular Accident



Possible Lioresal side effects in male

Reported by a physician from United States on 2012-02-03

Patient: male

Reactions: Malaise, Cardio-Respiratory Arrest, Condition Aggravated, Muscle Spasticity, Meningitis

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Lioresal
    Dosage: 1730 mcg/day
    Indication: Muscle Spasticity

Lioresal
    Dosage: 1730 mcg/day
    Indication: Cerebral Palsy



Possible Lioresal side effects in male

Reported by a physician from United States on 2012-02-01

Patient: male

Reactions: Pyrexia, Drug Withdrawal Syndrome, Muscle Rigidity, Convulsion

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Lioresal
    Dosage: 1100 mcg/day
    Indication: Muscle Spasticity

Lioresal
    Dosage: 1100 mcg/day
    Indication: Multiple Sclerosis



Possible Lioresal side effects in male

Reported by a physician from United States on 2012-01-31

Patient: male

Reactions: Drug Dose Omission, Pneumonia, Coma, Pyrexia, Withdrawal Syndrome, Muscle Rigidity, Convulsion

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Lioresal
    Dosage: 1100 mcg/day
    Indication: Muscle Spasticity

Lioresal
    Dosage: 1100 mcg/day
    Indication: Multiple Sclerosis



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