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Frova

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Migraine is a serious, potentially life-threatening neurological disease that affects nearly 32 million Americans, the majority of whom are women. The hallmark symptom of migraine is an escalating, often "...

Frova

Side Effects
Interactions

SIDE EFFECTS

The following adverse reactions are described elsewhere in other sections of the labeling:

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.

Table 1 : Treatment-Emergent Adverse Events Reported within 48 Hours (Incidence ≥ 2% and Greater Than Placebo) of Patients in Four Pooled Placebo-Controlled Migraine Trials

Adverse events FROVA 2.5 mg
(n=1554)
Placebo
(n=838)
Central & peripheral nervous system
Dizziness 8% 5%
Headache 4% 3%
Paresthesia 4% 2%
Gastrointestinal system disorders
Dry mouth 3% 1%
Dyspepsia 2% 1%
Body as a whole – general disorders
Fatigue 5% 2%
Hot or cold sensation 3% 2%
Chest pain 2% 1%
Musculo-skeletal
Skeletal pain 3% 2%
Vascular Flushing 4% 2%

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.

Read the Frova (frovatriptan succinate) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Ergot-containing Drugs

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 FROVA within 24 hours of each other is contraindicated [see CONTRAINDICATIONS].

5-HT1B/1D Agonists

Because their vasospastic effects may be additive, co-administration of FROVA and other 5-HT1 agonists (e.g., triptans) within 24 hours of each other is contraindicated [see CONTRAINDICATIONS].

Selective Serotonin Reuptake Inhibitors / Serotonin Norepinephrine Reuptake Inhibitors and Serotonin Syndrome

Cases of serotonin syndrome have been reported during combined use of triptans and SSRIs, SNRIs, TCAs, and MAO inhibitors [see WARNINGS AND PRECAUTIONS].

Read the Frova Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 10/28/2013
This monograph has been modified to include the generic and brand name in many instances.

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Frova - User Reviews

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