Sumatriptan Succinate (Page 2 of 6)

5.8 Increase in Blood Pressure

Significant elevation in blood pressure, including hypertensive crisis with acute impairment of organ systems, has been reported on rare occasions in patients treated with 5-HT1 agonists, including patients without a history of hypertension. Monitor blood pressure in patients treated with sumatriptan injection. Sumatriptan injection is contraindicated in patients with uncontrolled hypertension.

5.9 Anaphylactic/Anaphylactoid Reactions

Anaphylactic/anaphylactoid reactions have occurred in patients receiving sumatriptan. Such reactions can be life threatening or fatal. In general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens. Sumatriptan injection is contraindicated in patients with a history of hypersensitivity reaction to sumatriptan.

5.10 Seizures

Seizures have been reported following administration of sumatriptan. Some have occurred in patients with either a history of seizures or concurrent conditions predisposing to seizures. There are also reports in patients where no such predisposing factors are apparent. Sumatriptan injection should be used with caution in patients with a history of epilepsy or conditions associated with a lowered seizure threshold.

6 ADVERSE REACTIONS

The following serious adverse reactions are described below and elsewhere in the labeling:

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Migraine Headache

Table 1 lists adverse reactions that occurred in 2 U.S. placebo-controlled clinical trials in migraine patients (Studies 2 and 3) following either a single 6-mg dose of sumatriptan injection or placebo. 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)

a Includes injection site pain, stinging/burning, swelling, erythema, bruising, bleeding.

Adverse Reaction Percent of Subjects Reporting
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 3 <1
Discomfort: nasal cavity/sinuses 2 <1
Injection site reactiona 59 24
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 age of the patients. There were insufficient data to assess the impact of race on the incidence of adverse reactions.

Cluster Headache

In the controlled clinical trials assessing the efficacy of sumatriptan injection as a treatment for cluster headache (Studies 4 and 5), no new significant adverse reactions were detected that had not already been identified in trials of sumatriptan injection in patients with migraine.

Overall, the frequency of adverse reactions reported in the trials of cluster headache was generally lower than in the migraine trials. Exceptions include reports of paresthesia (5% sumatriptan injection, 0% placebo), nausea and vomiting (4% sumatriptan injection, 0% placebo), and bronchospasm (1% sumatriptan injection, 0% placebo).

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