Alsuma (Sumatriptan) - Side Effects and Adverse Reactions

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 US placebo-controlled clinical trials in migraine subjects [Studies 2 and 3, see Clinical Studies] 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 Reported by at Least 2% of Subjects and at a Greater Frequency Than Placebo in 2 Placebo-Controlled Migraine Clinical Trials (Studies 2 and 3)The sum of the percentages cited is greater than 100% because subjects may have experienced more than 1 type of adverse reaction. Only reactions that occurred at a frequency of 2% or more in groups treated with sumatriptan injection and occurred at a frequency greater than the placebo groups are included.

	Percent of Subjects Reporting
Adverse Reaction	Sumatriptan 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 reactionIncludes injection site pain, stinging/burning, swelling, erythema, bruising, bleeding.	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 subjects. 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, see Clinical Studies], no new significant adverse reactions were detected that had not already been identified in trials of sumatriptan in subjects 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, 0% placebo), nausea and vomiting (4% sumatriptan, 0% placebo), and bronchospasm (1% sumatriptan, 0% placebo).

Adverse Reactions Observed In Association With The Administration of ALSUMA:

The safety of ALSUMA was evaluated in an open-label clinical trial evaluating the usability of ALSUMA during a migraine attack. Adverse reactions that occurred at a frequency of 5% or higher were injection site bruising (16%), injection site pain (6%), and injection site hemorrhage (6%).