BOTOX Contraindications
Migraine Ireland
BOTOX is contraindicated:
- In the presence of infection at the proposed injection site(s)
- In individuals with a known hypersensitivity to botulinum toxin type A or to any of the other ingredients used to form ‘Botox’
It is not advised
- During pregnancy, unless clearly necessary
- During lactation as there is no information on whether BOTOX is excreted in human milk
Note: Patients with underlying neurological disorders including swallowing difficulties are at increased risk of side effects. In this case, treatment should only be used if the benefit of treatment is considered to outweigh the risk.
Patients with neuromuscular disorders may be at an increased risk of more severe effects including acute dysphagia and respiratory compromise from typical doses of BOTOX.
Patients with a history of dysphagia (difficulty swallowing) and aspiration (inhaling foreign bodies, such as stomach contents, into the airways) should be treated with extreme caution.
Caution should be used when BOTOX is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness is present in the target muscle.
Caution should also be exercised when BOTOX is used for treatment of patients with peripheral motor neuropathic diseases.In the absence of studies, this medicinal product should not be mixed with other medicinal products.
Clinical Trials
Two clinical trials involving 1,384 adults were carried out over 60 weeks (five injection cycles).
Patients were eligible for the study if they had a history of migraine and experienced fifteen or more headache days of which at least 50% were migraine or probable migraine during a 28 day ‘baseline’ period.
Two thirds of the patients had previously been treated with at least one other headache prophylactic medication and nearly two thirds of the patients were overusing acute medications.
Patients were divided into two groups – Botox and Placebo.
At baseline, patients in the BOTOX treatment group had an average of 19.1 days with migraine. Patients in the placebo treated group had an average of 18.9 days with migraine. By week 24 BOTOX treated patients averaged 8.2 fewer migraine days. Placebo had 6.2 fewer.
47.1% of BOTOX treated patients (compared to 35.1% of placebo treated patients) achieved >50% reduction in the number of headache days at week 24. After week 56, nearly 70% of BOTOX treated patients experienced ≥50% reduction in migraine days.
Patients treated with BOTOX reported more significant improvements in their quality of life scores and a greater lessening of headache related disability compared with those on placebo.
Most adverse events reported in the trials were mild to moderate and resolved without further problems. The treatment was generally well tolerated and only 3.8% of the BOTOX group stopped treatment.