"The US Food and Drug Administration (FDA) is looking into the risk for serious burns and potential permanent scarring with the use of the sumatriptan iontophoretic transdermal patch (Zecuity, NuPathe Inc) for migraine, the agency said in"...
Zecuity Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Zecuity (sumatriptan) is a transdermal system (patch) selective serotonin receptor agonist used to treat acute migraine with or without aura in adults. Common side effects of Zecuity are application site skin reactions including pain, itching, tingling, discomfort, warmth, discoloration, irritation, bruising, dermatitis (rash), skin lesions, changes in skin color, or cysts.
Zecuity delivers 6.5 mg of sumatriptan in a transdermal system (patch) over a period of 4 hours. No more than two Zecuity patches should be used in any 24-hour period. Zecuity may interact with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) such as Celexa, Cymbalta, Effexor, Pristiq, Prozac and Zoloft, and can cause a potentially life-threatening condition called serotonin syndrome. A second Zecuity patch should be used no sooner than 2 hours after activation of first. Zecuity contains metal parts and must be removed before an MRI procedure. Patients with heart disease should not use Zecuity. Patients with a history of heart disease or stroke, peripheral vascular disease, transient ischemic attack (TIA), problems with blood circulation, uncontrolled blood pressure, migraines that cause temporary paralysis on one side of the body or patients who suffer with basilar migraine, Wolff-Parkinson-White syndrome or other disturbances of heart rhythm should not use Zecuity. Zecuity should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Adverse reactions may occur in nursing infants; consult your doctor before breastfeeding.
Our Zecuity (sumatriptan) Iontophoretic Transdermal System Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Zecuity FDA Prescribing Information: Side Effects
The following adverse reactions are discussed in more detail in other sections of the prescribing information:
- Allergic Contact Dermatitis [see WARNINGS AND PRECAUTIONS]
- 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]
- Anaphylactic/anaphylactoid reactions [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.
In two long-term, open-label studies in which patients were allowed to treat multiple migraine attacks for up to 1 year, 15% (99 out of 662) withdrew from the study because of adverse reaction. The most common adverse reactions leading to withdrawal from the study were contact dermatitis (4%) and application site pain (4%).
Controlled single dose acute migraine study
Table 1 lists adverse reactions that occurred at a frequency of 2% or greater in a controlled clinical study of ZECUITY in patients with acute migraine (Study 1) [see Clinical Studies]. In that study, patients randomized to the control group used the same activated iontophoretic transdermal delivery system (TDS) as patients randomized to ZECUITY, with the only difference being the absence of sumatriptan in the drug reservoir. Therefore, patients in the control group were exposed to same TDS-related risks as patients in the ZECUITY group, minus the risks related to sumatriptan. Only reactions that occurred at a frequency of 2% or more in patients treated with ZECUITY or control are included in Table 1.
Table 1: Adverse Reactions Reported by at least 2% of
Patients in Study 1
|Adverse Reaction||Percent of Subjects Reporting|
(n = 234)
(n = 235)
|Application site pain||26%||17%|
|Application site paresthesia||9%||16%|
|Application site pruritus||8%||7%|
|Application site warmth||6%||3%|
|Application site discomfort||6%||6%|
|Application site irritation||4%||2%|
|Application site discoloration||3%||1%|
The incidence of “atypical sensations” adverse events (paresthesia, sensation warm/cold) and “pain and other pressure sensations” (chest pain/tightness/pressure/heaviness or neck/throat/jaw pain, tightness, pressure or heaviness) was 2% each in ZECUITY-treated patients, vs. 0% in the control group.
Application site bruising was reported in 2 ZECUITY-treated patients (0.9%) vs. no patient in the control group.
Subgroup analyses of age ( ≤ 41 years, > 41 years), race (Caucasian, non-Caucasian) and body mass index (BMI) ( ≤ 25.7 mg/kg2, > 25.7 mg/kg2) showed no difference between subgroups for adverse events.
Skin Irritation Examination
In Study 1, patients performed their own examination of the TDS application site at 4, 12, and 24 hours post TDS activation, and daily thereafter until resolution. Skin irritation examination scores are summarized in Table 2. The median time to “no redness” was 2.6 days for Zecuitycompared with 0.3 day in the control group.
Table 2: Subject Self-examination Skin Irritation
(n = 234)
(n = 235)
|4 hours||No or minimal redness||39%||73%|
|Intense redness with blisters/broken skin||2%||2%|
|12 hours||No or minimal redness||69%||90%|
|Intense redness with blisters/broken skin||2%||1%|
|24 hours||No or minimal redness||79%||93%|
|Intense redness with blisters/broken skin||1%||1%|
Application site reactions across clinical studies (Controlled single dose acute migraine study and long term safety studies)
In the controlled and uncontrolled clinical studies combined (n = 796 unique ZECUITY-treated subjects), the frequency of application site reactions of clinical interest is presented in Table 3.
Table 3: Application Site Reactions
|Event||Percent of Subjects Reporting
(N = 796)
Read the entire FDA prescribing information for Zecuity (Sumatriptan Iontophoretic Transdermal System)
Additional Zecuity Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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