"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 adverse reactions are described elsewhere in other sections of the prescribing information:
- Myocardial Ischemia, Myocardial Infarction, and Prinzmetal Angina [see WARNINGS AND PRECAUTIONS].
- Arrthymias [see WARNINGS AND PRECAUTIONS].
- Chest and or Throat, Neck and 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].
- Risks in Patients with Phenylketonuria [see WARNINGS AND PRECAUTIONS].
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.
In a long-term, open-label study where patients were allowed to treat multiple migraine attacks for up to 1 year, 8% (167 out of 2,058) withdrew from the trial because of adverse reaction.
The most common adverse reactions ( ≥ 5% and > placebo) in these trials were neck/throat/jaw pain, dizziness, paresthesia, asthenia, somnolence, warm/cold sensation, nausea, heaviness sensation, and dry mouth.
Table 1 lists the adverse reactions that occurred in ≥ 2% of the 2,074 patients in any one of the ZOMIG 1 mg, 2.5 mg, or 5 mg dose groups in the controlled clinical trials of ZOMIG in patients with migraines (Studies 1, 2, 3, 4, and 5) [see Clinical Studies]. Only adverse reactions that were at least 2% more frequent in a ZOMIG group compared to the placebo group are included.
Several of the adverse reactions appear dose related, notably paresthesia, sensation of heaviness or tightness in chest, neck, jaw, and throat, dizziness, somnolence and possibly asthenia and nausea.
Table 1: Adverse Reaction Incidence in Five Pooled
Placebo-Controlled Migraine Clinical Trials1
|Placebo 1 mg
|ZOMIG 2.5 mg
|ZOMIG 5 mg
|Paresthesia (all types)||2%||5%||7%||9%|
|PAIN AND PRESSURE SENSATIONS||7%||13%||14%||22%|
|Chest - pain/ tightness/ pressure and/or heaviness||1%||2%||3%||4%|
|Neck/throat/jaw -pain/ tightness/pressure||3%||4%||7%||10%|
|Heaviness other than chest or neck||1%||1%||2%||5%|
|1Only adverse reactions that were at least 2% more frequent in a ZOMIG group compared to the placebo group are included.|
There were no differences in the incidence of adverse reactions in controlled clinical trials in the following subgroups: gender, weight, age, use of prophylactic medications, or presence of aura. There were insufficient data to assess the impact of race on the incidence of adverse reactions.
Less Common Adverse Reactions with ZOMIG Tablets
In the paragraphs that follow, the frequencies of less commonly reported adverse clinical reactions are presented. Because the reports include reactions observed in open and uncontrolled studies, the role of ZOMIG in their causation cannot be reliably determined. Furthermore, variability associated with adverse reaction reporting, the terminology used to describe adverse reactions, etc., limit the value of the quantitative frequency estimates provided. Adverse reaction frequencies were calculated as the number of patients who used ZOMIG tablets and reported a reaction divided by the total number of patients exposed to ZOMIG tablets (n=4,027). Reactions were further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: infrequent adverse reactions (those occurring in 1/100 to 1/1,000 patients) and rare adverse reactions (those occurring in less than 1/1,000 patients).
General: Infrequent were allergic reactions.
Neurological: Infrequent were agitation, anxiety, depression, emotional lability and insomnia; Rare were amnesia, hallucinations, and cerebral ischemia.
Adverse Reactions with ZOMIG-ZMT Oral Disintegrating Tablets
The adverse reaction profile seen with ZOMIG-ZMT oral disintegrating tablets was similar to that seen with ZOMIG tablets.
The following adverse reactions were identified during post approval use of ZOMIG. 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.
The reactions enumerated include all except those already listed in the Clinical Trials Experience section above or the Warnings and Precautions section.
As with other 5-HT1B/1D agonists, there have been reports of anaphylaxis, anaphylactoid, and hypersensitivity reactions including angioedema in patients receiving ZOMIG. ZOMIG is contraindicated in patients with a history of hypersensitivity reaction to ZOMIG.
Read the Zomig (zolmitriptan) 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 ZOMIG within 24 hours of each other is contraindicated [see CONTRAINDICATIONS].
MAO-A inhibitors increase the systemic exposure of zolmitriptan and its active N-desmethyl metabolite. Therefore, the use of ZOMIG in patients receiving MAO-A inhibitors is contraindicated [see CONTRAINDICATIONS and CLINICAL PHARMACOLOGY].
Concomitant use of other 5-HT1B/1D agonists (including triptans) within 24 hours of ZOMIG treatment is contraindicated because the risk of vasospastic reactions may be additive [see CONTRAINDICATIONS].
Selective Serotonin Reuptake Inhibitors and Serotonin Norepinephrine Reuptake Inhibitors
Cases of life-threatening serotonin syndrome have been reported during co-administration of triptans and selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) [see WARNINGS AND PRECAUTIONS].
Following administration of cimetidine, the half-life and blood levels of zolmitriptan and its active N-desmethyl metabolite were approximately doubled [see CLINICAL PHARMACOLOGY]. If cimetidine and ZOMIG are used concomitantly, limit the maximum single dose of ZOMIG to 2.5 mg, not to exceed 5 mg in any 24-hour period [see DOSAGE AND ADMINISTRATION, and CLINICAL PHARMACOLOGY].
Read the Zomig Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 10/1/2012
This monograph has been modified to include the generic and brand name in many instances.
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