th a history of epilepsy or conditions associated with alowered seizure threshold.
5.11 Local Irritation
Local irritative symptoms were reported in approximately 46% of patients treated withTOSYMRA in an open-label trial which allowed repeated use of TOSYMRA over the course of6 months. Of these, the most common local irritative symptoms were application site reaction(36%), dysgeusia (21%), and throat irritation (5%). Approximately 0.5% of the cases werereported as severe.
6 ADVERSE REACTIONS
The following serious adverse reactions are described below and elsewhere in thelabeling:
Myocardial Ischemia, Myocardial Infarction, and Prinzmetal’s Angina [see Warningsand Precautions (5.1)]
Arrhythmias [see Warnings and Precautions (5.2)]
Chest, Throat, Neck, and/or Jaw Pain/Tightness/Pressure [see Warnings andPrecautions (5.3)]
Cerebrovascular Events [see Warnings and Precautions (5.4)]
Other Vasospasm Reactions [see Warnings and Precautions (5.5)]
Medication Overuse Headache [see Warnings and Precautions (5.6)]
Serotonin Syndrome [see Warnings and Precautions (5.7)]
Increase in Blood Pressure [see Warnings and Precautions (5.8)]
Hypersensitivity Reactions [see Contraindications (4), Warnings and Precautions(5.9)]
Seizures [see Warnings and Precautions (5.10)]
Local Irritation [see Warnings and Precautions (5.11)]
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction ratesobserved in the clinical trials of a drug cannot be directly compared with rates in the clinicaltrials of another drug and may not reflect the rates observed in practice.
Adverse Reactions in Placebo-Controlled Trials with Sumatriptan Injection Table 1 lists adverse reactions that occurred in 2 placebo-controlled clinical trials in patients withmigraine (Studies 2 and 3) following either a single 6-mg dose of sumatriptan injection orplacebo. Only reactions that occurred at a frequency of 2% or more in groups treated with sumatriptan injection 6 mg and that occurred at a frequency greater than the placebo group are
included in Table 1.
Table 1: Adverse Reactions in Pooled Placebo-Controlled Trials in Patients with Migraine
(Studies 2 and 3)
Adverse Reaction
Sumatriptan Injection
6 mg Subcutaneous
(n = 547)
%
Placebo
(n = 370)
%
Atypical sensations 42 9
Tingling 14 3
Warm/hot sensation 11 4
Burning sensation 7 <1
Feeling of heaviness 7 1
Pressure sensation 7 2
Feeling of tightness 5 <1
Numbness 5 2
Feeling strange 2 <1
Tight feeling in head 2 <1
Cardiovascular
Flushing 7 2
Chest discomfort 5 1
Tightness in chest 3 <1
Pressure in chest 2 <1
Ear, nose, and throat
Throat discomfort
Discomfort: nasal cavity/sinuses
3
2
<1
<1
Miscellaneous
Jaw discomfort 2 0
Musculoskeletal
Weakness 5 <1
Neck pain/stiffness 5 <1
Myalgia 2 <1
Neurological
Dizziness/vertigo 12 4
Drowsiness/sedation 3 2
Headache 2 <1
Skin
Sweating 2 1
The incidence of adverse reactions in controlled clinical trials was not affected by gender or ageof the patients. There were insufficient data to assess the impact of race on the incidence ofadverse reactions.
Adverse Reactions in Studies with TOSYMRA
In an open-label study that was designed to eva luate the local tolerability of TOSYMRA,repeated u |
