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Dysport (Botulinum Toxin Type A) - Off Label Use - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Off Label Use (7)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Dysport (Botulinum Toxin Type A) where reactions include off label use. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Dysport side effects in 81 year old female

Reported by a consumer/non-health professional from United Kingdom on 2012-07-23

Patient: 81 year old female, weighing 66.7 kg (146.7 pounds)

Reactions: Off Label Use, Fatigue, Dyspnoea, Muscular Weakness, Hypoaesthesia

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Dysport
    Dosage: 150 units (150 units, single cycle), parenteral
    Indication: Off Label Use
    Start date: 2012-04-19
    End date: 2012-04-19

Dysport
    Dosage: 150 units (150 units, single cycle), parenteral
    Indication: Head Titubation
    Start date: 2012-04-19
    End date: 2012-04-19



Possible Dysport side effects in 61 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-11

Patient: 61 year old female, weighing 46.0 kg (101.2 pounds)

Reactions: Product Quality Issue, Off Label Use, Viith Nerve Paralysis

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Dysport

Dysport

Dysport
    Dosage: 80 units (80 units, single cycle), intramuscular
    Indication: Skin Wrinkling
    Start date: 2012-03-26
    End date: 2012-03-26

Dysport
    Dosage: 80 units (80 units, single cycle), intramuscular
    Indication: Off Label Use
    Start date: 2012-03-26
    End date: 2012-03-26

Other drugs received by patient: Multivitamin; Warfarin Sodium; Aspirin; Revatio; Veletri (Eporostenol Sodium); Tiazac



Possible Dysport side effects in 61 year old female

Reported by a individual with unspecified qualification from United States on 2012-03-22

Patient: 61 year old female, weighing 58.0 kg (127.6 pounds)

Reactions: Anxiety, Off Label Use, Sensory Disturbance, Muscular Weakness, Bladder Disorder, Feeling Abnormal

Drug(s) suspected as cause:
Dysport

Other drugs received by patient: Calcium Carbonate; Wellbutrin



Possible Dysport side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-16

Patient: female

Reactions: Eyelid Oedema, Headache, Paraesthesia, Burning Sensation, Off Label Use, Hyperaesthesia, Eyelid Function Disorder, Eyelid Ptosis, Cerebral Thrombosis, Neuralgia

Drug(s) suspected as cause:
Dysport
    Dosage: not reported (not reported, single cycle), parenteral
    Indication: Off Label Use
    Start date: 2011-09-26
    End date: 2011-09-26

Dysport
    Dosage: not reported (not reported, single cycle), parenteral
    Indication: Skin Wrinkling
    Start date: 2011-09-26
    End date: 2011-09-26

Dysport

Other drugs received by patient: Unnamed Numbing Agent (Anaesthetics FOR Topical Use)



Possible Dysport side effects in 49 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-14

Patient: 49 year old female, weighing 55.8 kg (122.8 pounds)

Reactions: Off Label Use, Product Quality Issue, Wrong Technique in Drug Usage Process, Angioedema, Dizziness

Drug(s) suspected as cause:
Dysport
    Dosage: 85 units (85 units,single cycle)
    Indication: Skin Wrinkling
    Start date: 2011-08-23
    End date: 2011-08-23

Dysport
    Dosage: 85 units (85 units,single cycle)
    Indication: Skin Cosmetic Procedure
    Start date: 2011-08-23
    End date: 2011-08-23

Dysport
    Dosage: 85 units (85 units,single cycle)
    Indication: Off Label Use
    Start date: 2011-08-23
    End date: 2011-08-23

Other drugs received by patient: Fish OIL (Fish Oil); Prilosec; Multivitamins (Multivitamin / 00831701 / ); Calcium W / Vitamin D NOS (Vitacal)



Possible Dysport side effects in 44 year old female

Reported by a health professional (non-physician/pharmacist) from Australia on 2011-10-26

Patient: 44 year old female, weighing 63.0 kg (138.6 pounds)

Reactions: Back Pain, Off Label Use, Product Quality Issue, Urinary Retention, Epstein-Barr Virus Antibody Positive, Muscle Spasms, Influenza Like Illness

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Dysport
    Dosage: 300 units (300 units, single cycle), intramuscular
    Indication: Off Label Use
    Start date: 2011-08-13
    End date: 2011-08-13

Dysport
    Dosage: 300 units (300 units, single cycle), intramuscular
    Indication: Myalgia
    Start date: 2011-08-13
    End date: 2011-08-13



Possible Dysport side effects in 44 year old female

Reported by a health professional (non-physician/pharmacist) from Australia on 2011-10-05

Patient: 44 year old female, weighing 63.0 kg (138.6 pounds)

Reactions: Back Pain, Nausea, Off Label Use, Malaise, Pelvic Floor Muscle Weakness, Urinary Retention, Epstein-Barr Virus Antibody Positive, Asthenia, Muscle Spasms, Lethargy, Influenza Like Illness

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Dysport
    Dosage: 300 units (300 units, single cycle), intramuscular
    Indication: Myalgia
    Start date: 2011-08-13
    End date: 2011-08-13

Dysport
    Dosage: 300 units (300 units, single cycle), intramuscular
    Indication: Off Label Use
    Start date: 2011-08-13
    End date: 2011-08-13

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