3 %). Most of the adverse events showed a dose response. Tabulated list of adverse reactions In the following table, adverse reactions are listed in order of MedDRA body system organ class and frequency. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Frequency gradings are: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000). Table 1. Adverse reactions System organ class Very common Common Uncommon Rare Immune system disorders Hypersensitivity Psychiatric disorders Sleep abnormalities Confusion Hallucinations Euphoric mood Anxiety Restlessness Nervous system disorders Dizziness Incoordination Paraesthesia Hypoaesthesia Somnolence Lethargy Disturbance in attention Cognitive disorder Mental impairment Tremor Speech abnormalities Serotonin syndrome Eye disorders Visual impairment Ear and labyrinth disorders Vertigo Cardiac disorders Palpitations Respiratory, thoracic and mediastinal disorders Dyspnoea Gastrointestinal disorders Vomiting Nausea 7 Musculoskeletal and connective tissue disorders Muscular weakness Muscle spasm Limb discomfort General disorders and administration site conditions Feeling abnormal Fatigue Malaise Chest discomfort Feeling hot or feeling cold Description of selected adverse reactions Heart rate decrease In clinical pharmacology studies, lasmiditan was associated with decreases in heart rate of 5 to 10 bpm compared to a decrease of 2-5 bpm for placebo.
Incidence of bradycardia (< 50 bpm and a decrease from baseline ≥ 15 bpm) observed in lasmiditan-treated subjects was 7 % for 50 mg, 3 % for 100 mg, 4 % for 200 mg, and 1 % for placebo. Blood pressure increase Single dose administration of lasmiditan may lead to a transient increase in blood pressure.
In non-elderly healthy volunteers a mean increase from baseline in ambulatory systolic and diastolic blood pressure of approximately 2 to 3 mm Hg one hour after administration of 200 mg lasmiditan was observed, compared to an increase of about 1 mm Hg for placebo.
In healthy volunteers over 65 years of age, the mean increase from baseline in ambulatory systolic blood pressure was 7 mm Hg one hour after administration of 200 mg lasmiditan compared to a mean increase of 4 mm Hg for placebo. By 2 hours, there were no increases in mean blood pressure with lasmiditan compared to placebo.
Clinical data for the use of lasmiditan in patients with ischemic heart disease is limited. Hypersensitivity Events of hypersensitivity, including angioedema, rash, and photosensitivity reaction, occurred in patients treated with lasmiditan.
1 % of patients treated with lasmiditan compared to no patients in the placebo group; all events were mild to moderate in severity and occurred within minutes to a day after dosing with lasmiditan. If a serious or severe hypersensitivity reaction occurs, appropriate therapy should be initiated and administration of lasmiditan should be discontinued.
9 % of patients. 7 hours and a median duration of 2 hours. No accidents or injuries were reported in patients reporting dizziness. The frequency of patients reporting dizziness, and other common adverse events, typically decreases with repeat dosing.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.