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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 and WARNINGS AND PRECAUTIONS].

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]

Sensations of Pain, Tightness, Pressure in the Chest and/or Throat, Neck, and Jaw [see WARNINGS AND PRECAUTIONS]

Cerebrovascular Events and Fatalities [see WARNINGS AND PRECAUTIONS]

Other Vasospasm-Related Events, Including Peripheral Vascular Ischemia and Colonic Ischemia [see WARNINGS AND PRECAUTIONS]

Serotonin Syndrome [see WARNINGS AND PRECAUTIONS]

Increases in Blood Pressure [see WARNINGS AND PRECAUTIONS]

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.

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 1 0.5

The incidence of adverse events in controlled clinical trials was not affected by gender, weight, age, presence of aura, or use of prophylactic medications or oral contraceptives. There were insufficient data to assess the effect of race on the incidence of adverse events.

Adolescents

Table 2 lists the adverse reactions reported by 1% or more of AXERT®-treated adolescents age 12 to 17 years in 1 placebo-controlled, double-blind clinical trial.

Table 2: Adverse Reactions Reported by ≥ 1% of Adolescent Patients Treated with AXERT® in 1 Placebo-Controlled, Double-Blind Clinical Trial

System/Organ Class Adverse Reaction AXERT® 6.25 mg
(n=180) %
AXERT® 12.5 mg
(n=182) %
Placebo
(n=172) %
Nervous System Disorders
  Dizziness 4 3 2
  Somnolence < 1 5 2
  Headache 1 2 1
  Paresthesia < 1 1 < 1
Gastrointestinal Disorders
  Nausea 1 3 0
  Vomiting 2 0 < 1

Other Adverse Reactions Observed In AXERT® Clinical Trials

In the paragraphs that follow, the frequencies of less commonly reported adverse clinical reactions are presented. The reports include adverse reactions in 5 adult controlled studies and 1 adolescent controlled study. Variability associated with adverse reaction reporting, the terminology used to describe adverse reactions, etc., limit the value of the quantitative frequency estimates provided. Reaction frequencies are calculated as the number of patients who used AXERT® and reported a reaction divided by the total number of patients exposed to AXERT® (n=3047, all doses). All reported reactions are included except those already listed in the previous table, those too general to be informative, and those not reasonably associated with the use of the drug. Reactions are further classified within system organ class and enumerated in order of decreasing frequency using the following definitions: frequent adverse reactions are those occurring in 1/100 or more patients, infrequent adverse reactions are those occurring in fewer than 1/100 to 1/1000 patients, and rare adverse reactions are those occurring in fewer than 1/1000 patients.

Body: Frequent: Headache. Infrequent: Abdominal cramp or pain, Asthenia, Chills, Back pain, Chest pain, Neck pain, Fatigue, and Rigid neck. Rare: Fever and Photosensitivity reaction.

Cardiovascular: Infrequent: Vasodilation, Palpitations, and Tachycardia. Rare: Hypertension and Syncope.

Digestive: Infrequent: Diarrhea, Vomiting, Dyspepsia, Gastroenteritis, and Increased thirst. Rare: Colitis, Gastritis, Esophageal reflux, and Increased salivation.

Metabolic: Infrequent: Hyperglycemia and Increased serum creatine phosphokinase. Rare: Increased gamma glutamyl transpeptidase and Hypercholesteremia.

Musculo-Skeletal: Infrequent: Myalgia. Rare: Arthralgia, Arthritis, Myopathy, and Muscle weakness.

Nervous: Frequent: Dizziness and Somnolence. Infrequent: Tremor, Vertigo, Anxiety, Hypoesthesia, Restlessness, CNS stimulation, and Shakiness. Rare: Change in dreams, Impaired concentration, Abnormal coordination, Depressive symptoms, Euphoria, Hyperreflexia, Hypertonia, Nervousness, Neuropathy, Nightmares, Nystagmus, and Insomnia.

Respiratory: Infrequent: Pharyngitis, Rhinitis, Dyspnea, Laryngismus, Sinusitis, and Bronchitis. Rare: Hyperventilation, Laryngitis, Sneezing, and Epistaxis.

Skin: Infrequent: Diaphoresis, Pruritus, and Rash. Rare: Dermatitis and Erythema.

Special Senses: Infrequent: Ear pain and Tinnitus. Rare: Diplopia, Dry eyes, Eye pain, Otitis media, Parosmia, Scotoma, Conjunctivitis, Eye irritation, Hyperacusis, and Taste alteration.

Urogenital: Infrequent: Dysmenorrhea.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of AXERT® . 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.

Immune System Disorders: Hypersensitivity reactions (including angioedema, anaphylactic reactions and Anaphylactic shock)

Psychiatric Disorders: Confusional state, Restlessness

Nervous System Disorders: Hemiplegia, Hypoesthesia, Seizures

Eye Disorders: Blepharospasm, Visual impairment, Vision blurred

Ear and Labyrinth Disorders: Vertigo

Cardiac Disorders: Acute myocardial infarction, Coronary artery vasospasm, Angina pectoris, Tachycardia

Gastrointestinal Disorders: Abdominal discomfort, Abdominal pain, Abdominal pain upper, Colitis, Hypoesthesia oral, Swollen tongue

Skin and Subcutaneous Tissue Disorders: Cold sweat, Erythema, Hyperhidrosis

Musculoskeletal, Connective Tissue, and Bone Disorders: Arthralgia, Myalgia, Pain in extremity

Reproductive System and Breast Disorders: Breast pain

General Disorders: Malaise, Peripheral coldness.