6 ADVERSE REACTIONS
The following adverse reactions are described elsewhere in other sections of the prescribing information:
- Myocardial ischemia and myocardial infarction, and Prinzmetal's angina [see Warnings and Precautions (5.2)]
- Arrhythmias [see Warnings and Precautions (5.3)]
- Chest, throat, neck, and/or jaw pain/tightness/pressure [see Warnings and Precautions (5.4)]
- 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) and Warnings and Precautions (5.9)]
6.1 Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Among 4,597 patients who treated the first migraine headache with RELPAX in short-term placebo-controlled trials, the most common adverse reactions reported with treatment with RELPAX were asthenia, nausea, dizziness, and somnolence. These reactions appear to be dose-related.
In long-term open-label studies where patients were allowed to treat multiple migraine attacks for up to 1 year, 128 (8.3%) out of 1,544 patients discontinued treatment due to adverse reactions.
Table 1 lists adverse reactions that occurred in the subset of 5,125 migraineurs who received eletriptan doses of 20 mg, 40 mg and 80 mg or placebo in worldwide placebo-controlled clinical trials.
Only adverse reactions that were more frequent in a RELPAX treatment group compared to the placebo group with an incidence greater than or equal to 2% are included in Table 1.
|Adverse Reaction Type||Placebo|
|Flushing/feeling of warmth||2%||2%||2%||2%|
|PAIN AND PRESSURE SENSATIONS|
|Chest – tightness/pain/pressure||1%||1%||2%||4%|
|Abdominal – |
pain/discomfort/stomach pain/ cramps/pressure
|Dysphagia – throat tightness/difficulty swallowing||0.2%||1%||2%||2%|
The frequency of adverse reactions in clinical trials did not increase when up to 2 doses of RELPAX were taken within 24 hours. The incidence of adverse reactions in controlled clinical trials was not affected by gender, age, or race of the patients. Adverse reaction frequencies were also unchanged by concomitant use of drugs commonly taken for migraine prophylaxis (e.g., SSRIs, beta blockers, calcium channel blockers, tricyclic antidepressants), estrogen replacement therapy or oral contraceptives.
6.2 Postmarketing Experience
The following adverse reaction(s) have been identified during post approval use of RELPAX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.