Frovatriptan adverse reactions: Difference between revisions
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The incidence of adverse events in clinical trials did not increase when up to 3 doses were used within 24 hours. The incidence of adverse events in placebo-controlled clinical trials was not affected by gender, age or concomitant medications commonly used by migraine patients. There were insufficient data to assess the impact of race on the incidence of adverse events. | The incidence of adverse events in clinical trials did not increase when up to 3 doses were used within 24 hours. The incidence of adverse events in placebo-controlled clinical trials was not affected by gender, age or concomitant medications commonly used by migraine patients. There were insufficient data to assess the impact of race on the incidence of adverse events. | ||
===Other Events Observed in Association with the Administration of FROVA | ====Other Events Observed in Association with the Administration of FROVA==== | ||
The incidence of frequently reported adverse events in four placebo-controlled trials are presented below. Events are further classified within body system categories. Frequent adverse events are those occurring in at least 1/100 patients. | The incidence of frequently reported adverse events in four placebo-controlled trials are presented below. Events are further classified within body system categories. Frequent adverse events are those occurring in at least 1/100 patients. | ||
Revision as of 17:17, 7 February 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
Adverse Reactions
The following adverse reactions are described elsewhere in other sections of the labeling:
- Myocardial ischemia, myocardial infarction, and Prinzmetal’s angina [see Warnings and Precautions (5.1)]
- Arrhythmias [see Warnings and Precautions (5.2)]
- Chest, throat, neck and/or jaw pain/tightness/pressure [see Warnings and Precautions (5.3)]
- Cerebrovascular events [see Warnings and Precautions (5.4)]
- Other vasospasm reactions [see Warnings and Precautions (5.5)]
- Medication overuse headache [see Warnings and Precautions (5.6)]
- Serotonin syndrome [see Warnings and Precautions (5.7)]
- Increases in blood pressure [see Warnings and Precautions (5.8)]
- Hypersensitivity reactions [see Contraindications (4) and Warnings and Precautions (5.8)]
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 to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
FROVA was evaluated in four randomized, double-blind, placebo-controlled, short-term trials. These trials involved 2392 patients (1554 on FROVA 2.5 mg and 838 on placebo). In these short-term trials, patients were predominately female (88%) and Caucasian (94%) with a mean age of 42 years (range 18 - 69).The treatment-emergent adverse events that occurred most frequently following administration of FROVA 2.5 mg (i.e., in at least 2% of patients), and at an incidence ≥1% greater than with placebo, were dizziness, paresthesia,headache, dry mouth, fatigue, flushing, hot or cold sensation, dyspepsia, skeletal pain, and chest pain. In a long term, open-label study where 496 patients were allowed to treat multiple migraine attacks with FROVA 2.5 mg for up to 1 year, 5% of patients (n=26) discontinued due to treatment-emergent adverse events.
Table 1 lists treatment-emergent adverse events reported within 48 hours of drug administration that occurred with FROVA 2.5 mg at an incidence of ≥2% and more often than on placebo, in the four placebo-controlled trials. The events cited reflect experience gained under closely monitored conditions of clinical trials in a highly selected patient population. In actual clinical practice or in other clinical trials, these incidence estimates may not apply, as the conditions of use, reporting behavior, and the kinds of patients treated may differ.
The incidence of adverse events in clinical trials did not increase when up to 3 doses were used within 24 hours. The incidence of adverse events in placebo-controlled clinical trials was not affected by gender, age or concomitant medications commonly used by migraine patients. There were insufficient data to assess the impact of race on the incidence of adverse events.
Other Events Observed in Association with the Administration of FROVA
The incidence of frequently reported adverse events in four placebo-controlled trials are presented below. Events are further classified within body system categories. Frequent adverse events are those occurring in at least 1/100 patients.
Central and peripheral nervous system:dysesthesia and hypoesthesia.
Gastrointestinal: vomiting, abdominal pain and diarrhea.
Body as a whole: pain.
Psychiatric: insomnia and anxiety.
Respiratory: sinusitis and rhinitis.
Vision disorders: vision abnormal.
Skin and appendages: sweating increased.
Hearing and vestibular disorders: tinnitus.
Heart rate and rhythm: palpitation.
Postmarketing Experience
The following adverse reactions were identified during post approval use of FROVA. Because these events 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.
Central and peripheral nervous system: Seizure[1]
References
- ↑ "FROVA (FROVATRIPTAN SUCCINATE) TABLET, FILM COATED [ENDO PHARMACEUTICALS INC.]". Retrieved 7 February 2014.