to parent drug at 2 mg/kg/day was approximately 2.5 times the exposure in humans receiving the maximum recommended human daily dose of 25 mg. A no-effect dose was not established.
6 ADVERSE REACTIONS
Serious cardiac reactions, including myocardial infarction, have occurred following the use of AXERT® (almotriptan malate) Tablets. These reactions are extremely rare and most have been reported in patients with risk factors predictive of CAD. Reactions reported in association with triptans have included coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, and ventricular fibrillation [see CONTRAINDICATIONS (4.1) and WARNINGS AND PRECAUTIONS (5.1)].
The following adverse reactions are discussed in more detail in other sections of the labeling:
Risk of Myocardial Ischemia and Infarction and Other Adverse Cardiac Events [see WARNINGS AND PRECAUTIONS (5.1)]
Sensations of Pain, Tightness, Pressure in the Chest and/or Throat, Neck, and Jaw [see WARNINGS AND PRECAUTIONS (5.2)]
Cerebrovascular Events and Fatalities [see WARNINGS AND PRECAUTIONS (5.3)]
Other Vasospasm-Related Events, Including Peripheral Vascular Ischemia and Colonic Ischemia [see WARNINGS AND PRECAUTIONS (5.4)]
Serotonin Syndrome [see WARNINGS AND PRECAUTIONS (5.5)]
Increases in Blood Pressure [see WARNINGS AND PRECAUTIONS (5.7)]
Adverse events were assessed in controlled clinical trials that included 1840 adult patients who received one or two doses of AXERT® and 386 adult patients who received placebo. The most common adverse reactions during treatment with AXERT® were nausea, somnolence, headache, paresthesia, and dry mouth. In long-term open-label studies where patients were allowed to treat multiple attacks for up to 1 year, 5% (63 out of 1347 patients) withdrew due to adverse experiences.
Adverse events were assessed in controlled clinical trials that included 362 adolescent patients who received AXERT® and 172 adolescent patients who received placebo. The most common adverse reactions during treatment with AXERT® were dizziness, somnolence, headache, paresthesia, nausea, and vomiting. In a long-term, open-label study where patients were allowed to treat multiple attacks for up to 1 year, 2% (10 out of 420 adolescent patients) withdrew due to adverse events.
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.
6.1 Commonly-Observed Adverse Reactions in Double-Blind, Placebo-Controlled AXERT® Clinical Trials
Adults
Table 1 lists the adverse events that occurred in at least 1% of the adult patients treated with AXERT®, and at an incidence greater than in patients treated with placebo, regardless of drug relationship.
Table 1. Incidence of Adverse Events in Controlled Clinical Trials (Reported in at Least 1% of Adult Patients Treated with AXERT®, and at an Incidence Greater than Placebo)
System/Organ Class
Adverse Event AXERT® 6.25 mg
(n=527)
% AXERT® 12.5 mg
(n=1313)
% Placebo
(n=386)
%
Digestive Disorders
Nausea 1 2 1
Dry mouth 1 1 0.5
Nervous System Disorders
Paresthesia 1&n |
