Product name: Jotox Botulium Toxin type A
1) Spread of toxin effects Botulinumtox can spread from innected site to other site and cause botulism sudden muscle weakness oss Orappeute, noarseness speech disturbances, stuttering loss of bladder conta dvsonea dispheoia diplopia and ptosis. Symptoms such as difficulty in breathing or swallowing can be life-threatening and there is a report of actual death. The children who have been treated for spastic cerebral palsy are in high-risk group. But it also applies to adults who have been treated for spastic cerebral palsy or for other symptoms. These side effects have been reported in similar doses to those used for cervical dystonia and low-dose therapy.
2) Hypersensitivity reactions Serious and/or immediate hypersensitivity reactions in other botulinum toxin products are rarely reported. These reactions include anaphylaxis, urticaria, soft-tissue edema, and dyspnea. One example of an anaphylaxis has been reported in which lidocaine was used as the diluent, and consequently, the causative agent was not reliably investigated. If such a reaction occurs, further injection of JOTOX should be discontinued and appropriate medical therapy immediately instituted.
3) Neuromuscular disorder Patients with peripheral motor neuropathy (e.g.,amytrophic lateral sclerosis or moto neuropathy), or neuromuscular junction disorder (e.g., myasthenia gravis or Lambert Eaton syndrome) may be at increased risk of significant systemic effects including severe dysphagia and respiratory compromise from typical doses of JOTOX. According to clinical studies conducted for the botulinum toxin preparations, severe hypersensitivity to the systemic effects of normal doses have been rarely reported when botulinum toxin is administered to patients with known or unrecognized neuromuscular disorders. In some of these cases, swallowing difficulties persist for several months, requiring use of a gastric feeding tube.
4) Dysphagia
Dysphagia is a commonly reported adverse event following treatment of cervical dystonia patients with all botulinum toxins. In these patients, there are reports of rare cases of dysphagia severe enough to warrant the insertion of a gastric feeding tube. There are also rare case reports where subsequent to the finding of dysphagia a patient developed aspiration pneumonia and died.
5) Adverse reaction in patients with cardiovascular disorders
There have been reports following the administration of botulinum toxins of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors including pre-existing cardiovascular disease.
6) Strabismus
During the administration of in other botulinum toxin products for the treatment of strabismus, retrobulbar hemorrhages sufficient to compromise retinal circulation have occurred from needle penetrations into the orbit. It is recommended that appropriate instruments to decompress the orbit be accessible. Ocular penetrations by needles have also occurred. An ophthalmoscope to diagnose this condition should be available. Inducing paralysis in one or more extraocular muscles may produce spatial disorientation, double vision or past pointing. Covering the affected eye may alleviate these symptoms.
7) Blepharospasm
Reduced blinking from other botulinum toxin products injection of the orbicularis muscle can lead to corneal exposure, persistent epithelial defect and corneal ulcers, especially in patients with Vi nerve disorders. One case of corneal perforation in an aphakic eye requiring corneal gratung has occurred because of this effect. Careful testing for corneal sensation should be conducted if there is a prior opersation history, and avoiding injection of the lower lid area may reduce the harm of ectropion. Any epithelial defect requires treatment. This may require protective drops, oinment, therapeutic soft contact lenses, or closure of the eye patching or ther mean.
8) Lack of interchangeability between botulinum toxin products The potency Units of JOTOX are not interchangeable with other preparations of botulinum toxin products and therefore units and therefore, units of biological activity of JOTOX cannot be compared to nor converted into units of any other botulinum toxin products.
9) Injection into or around anatomically weak structures Caution should be taken when iniecting into or around anatomically weak structures. Serious side effects, including fatal outcomes have been reported in patients who have injected botulinum toxin around the salivary glands, around the mouth-tongue-pharynx, esophagus, or on the stomach. Some patients had previously had difficulty in swallowing or significant debility. (The safety and efficacy of the indications including injection sites were not confirmed). Pneumothorax associated with the injection procedure was reported when injecting botulinum formulation on the thoracic region.
10) Effect of botulinum toxin in lung function of patients with respiratory disorders when used to treat upper limb stiffness or neurogenic detrusor overactivity in patients with upper limb stiffness and respiratory distress, other botulinum toxin product has been reported to be associated with a reduced pulmonary function (FVC reductions 15%) and upper airway infections have been reported more frequently than placebo when treated with botulinum toxin.
11) Bronchitis and upper airway infection in adult patients with upper limb stiffness Bronchial inflammation was more frequently reported in patients treated with other botulinum toxin when compared to placebo, in patients with reduced lung function, upper airway