"Today, the U.S. Food and Drug Administration approved Topamax (topiramate) for prevention (prophylaxis) of migraine headaches in adolescents ages 12 to 17. This is the first FDA approval of a drug for migraine prevention in this age group. The me"...
The following serious adverse reactions are described below and elsewhere in the labeling:
- Myocardial ischemia, myocardial infarction, and Prinzmetal's angina [see WARNINGS AND PRECAUTIONS]
- Arrhythmias [see WARNINGS AND PRECAUTIONS]
- Chest, throat, neck, and/or jaw pain/tightness/pressure [see WARNINGS AND PRECAUTIONS]
- Cerebrovascular events [see WARNINGS AND PRECAUTIONS]
- Other vasospasm reactions [see WARNINGS AND PRECAUTIONS]
- Medication overuse headache [see WARNINGS AND PRECAUTIONS]
- Serotonin syndrome [see WARNINGS AND PRECAUTIONS]
- Increase in blood pressure [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity reactions [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS]
- Seizures [see WARNINGS AND PRECAUTIONS]
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.
Table 1 lists adverse reactions that occurred in 2 US placebo-controlled clinical trials in migraine patients (Studies 2 and 3) following either a single 6-mg dose of IMITREX Injection or placebo. Only reactions that occurred at a frequency of 2% or more in groups treated with IMITREX Injection 6 mg and that occurred at a frequency greater than the placebo group are included in Table 1.
Table 1. Adverse Reactions in Pooled
Placebo-Controlled Trials in Patients with Migraine (Studies 2 and 3)
|IMITREX Injection 6 mg Subcutaneous
(n = 547) %
(n = 370) %
|Burning sensation||7||< 1|
|Feeling of heaviness||7||1|
|Feeling of tightness||5||< 1|
|Feeling strange||2||< 1|
|Tight feeling in head||2||< 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 reactiona||59||24|
|Neck pain/stiffness||5||< 1|
|aIncludes injection site pain, stinging/burning, swelling, erythema, bruising, bleeding.|
The incidence of adverse reactions in controlled clinical trials was not affected by gender or age of the patients. There were insufficient data to assess the impact of race on the incidence of adverse reactions.
In the controlled clinical trials assessing the efficacy of IMITREX Injection as a treatment for cluster headache (Studies 4 and 5), no new significant adverse reactions were detected that had not already been identified in trials of IMITREX in patients 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% IMITREX, 0% placebo), nausea and vomiting (4% IMITREX, 0% placebo), and bronchospasm (1% IMITREX, 0% placebo).
The following adverse reactions have been identified during postapproval use of IMITREX Tablets, IMITREX Nasal Spray, and IMITREX Injection. 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.
Read the Imitrex (sumatriptan succinate) Side Effects Center for a complete guide to possible side effects
Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. Because these effects may be additive, use of ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide) and IMITREX Injection within 24 hours of each other is contraindicated.
Monoamine Oxidase-A Inhibitors
MAO-A inhibitors increase systemic exposure by 2-fold. Therefore, the use of IMITREX Injection in patients receiving MAO-A inhibitors is contraindicated [see CLINICAL PHARMACOLOGY].
Other 5-HT1 Agonists
Because their vasospastic effects may be additive, co-administration of IMITREX Injection and other 5-HT1 agonists (e.g., triptans) within 24 hours of each other is contraindicated.
Selective Serotonin Reuptake Inhibitors/Serotonin Norepinephrine Reuptake Inhibitors And Serotonin Syndrome
Cases of serotonin syndrome have been reported during co-administration of triptans and SSRIs, SNRIs, TCAs, and MAO inhibitors [see WARNINGS AND PRECAUTIONS].This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 7/1/2015
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