DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Toviaz (Fesoterodine Fumarate) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Clinical Trials Experience

The safety of Toviaz was evaluated in Phase 2 and 3 controlled trials in a total of 2859 patients with overactive bladder, of which 2288 were treated with fesoterodine. Of this total, 782 received Toviaz 4 mg/day, and 785 received Toviaz 8 mg/day in Phase 2 or 3 studies with treatment periods of 8 or 12 weeks. Approximately 80% of these patients had >10 weeks exposure to Toviaz in these trials.

A total of 1964 patients participated in two 12-week, Phase 3 efficacy and safety studies and subsequent open-label extension studies. In these two studies combined, 554 patients received Toviaz 4 mg/day and 566 patients received Toviaz 8 mg/day.

In Phase 2 and 3 placebo-controlled trials combined, the incidences of serious adverse events in patients receiving placebo, Toviaz 4 mg, and Toviaz 8 mg were 1.9%, 3.5%, and 2.9%, respectively. All serious adverse events were judged to be not related or unlikely to be related to study medication by the investigator, except for four patients receiving Toviaz who reported one serious adverse event each: angina, chest pain, gastroenteritis, and QT prolongation on ECG.

The most commonly reported adverse event in patients treated with Toviaz was dry mouth. The incidence of dry mouth was higher in those taking 8 mg/day (35%) and in those taking 4 mg/day (19%), as compared to placebo (7%). Dry mouth led to discontinuation in 0.4%, 0.4%, and 0.8% of patients receiving placebo, Toviaz 4 mg, and Toviaz 8 mg, respectively. For those patients who reported dry mouth, most had their first occurrence of the event within the first month of treatment.

The second most commonly reported adverse event was constipation. The incidence of constipation was 2% in those taking placebo, 4% in those taking 4 mg/day, and 6% in those taking 8 mg/day.

Table 1 lists adverse events, regardless of causality, that were reported in the combined Phase 3, randomized, placebo-controlled trials at an incidence greater than placebo and in 1% or more of patients treated with Toviaz 4 or 8 mg once daily for up to 12 weeks.

Table 1: Adverse events with an incidence exceeding the placebo rate and reported by ≥1% of patients from double-blind, placebo-controlled Phase 3 trials of 12 weeks treatment duration
System organ class/Preferred term Placebo
N=554
%
Toviaz
4 mg/day
N=554
%
Toviaz
8 mg/day
N=566
%
ALT = alanine aminotransferase; GGT = gamma glutamyltransferase
Gastrointestinal disorders
  Dry mouth 7.0 18.8 34.6
  Constipation 2.0 4.2 6.0
  Dyspepsia 0.5 1.6 2.3
  Nausea 1.3 0.7 1.9
  Abdominal pain upper 0.5 1.1 0.5
Infections
  Urinary tract infection 3.1 3.2 4.2
  Upper respiratory tract infection 2.2 2.5 1.8
Eye disorders
  Dry eyes 0 1.4 3.7
Renal and urinary disorders
  Dysuria 0.7 1.3 1.6
  Urinary retention 0.2 1.1 1.4
Respiratory disorders
  Cough 0.5 1.6 0.9
  Dry throat 0.4 0.9 2.3
General disorders
  Edema peripheral 0.7 0.7 1.2
Musculoskeletal disorders
  Back pain 0.4 2.0 0.9
Psychiatric disorders
  Insomnia 0.5 1.3 0.4
Investigations
  ALT increased 0.9 0.5 1.2
  GGT increased 0.4 0.4 1.2
Skin disorders
  Rash 0.5 0.7 1.1

Patients also received Toviaz for up to three years in open-label extension phases of one Phase 2 and two Phase 3 controlled trials. In all open-label trials combined, 857, 701, 529, and 105 patients received Toviaz for at least 6 months, 1 year, 2 years, and 3 years, respectively. The adverse events observed during long-term, open-label studies were similar to those observed in the 12-week, placebo-controlled studies, and included dry mouth, constipation, dry eyes, dyspepsia, and abdominal pain. Similar to the controlled studies, most adverse events of dry mouth and constipation were mild to moderate in intensity. Serious adverse events, judged to be at least possibly related to study medication by the investigator and reported more than once during the open-label treatment period of up to 3 years, included urinary retention (3 cases), diverticulitis (3 cases), constipation (2 cases), irritable bowel syndrome (2 cases), and electrocardiogram QT corrected interval prolongation (2 cases).

Post-marketing Experience

The following events have been reported in association with fesoterodine use in worldwide post-marketing experience: Eye disorders: Blurred vision; Cardiac disorders: Palpitations; General disorders and administrative site conditions: Hypersensitivity reactions, including angioedema with airway obstruction, face edema; Skin and subcutaneous tissue disorders : Urticaria, pruritus.

Because these spontaneously reported events are from the worldwide post-marketing experience, the frequency of events and the role of fesoterodine in their causation cannot be reliably determined.



REPORTS OF SUSPECTED TOVIAZ SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Toviaz. The information is not vetted and should not be considered as verified clinical evidence.

Possible Toviaz side effects / adverse reactions in 83 year old female

Reported by a physician from United States on 2011-10-05

Patient: 83 year old female weighing 75.8 kg (166.7 pounds)

Reactions: Hepatic Enzyme Increased

Suspect drug(s):
Toviaz
    Dosage: 8mg daily oral
    Administration route: Oral
    Indication: Urinary Incontinence
    Start date: 2010-11-23
    End date: 2011-04-05

Toviaz
    Dosage: 8mg daily oral
    Administration route: Oral
    Indication: Urinary Incontinence
    Start date: 2011-06-07
    End date: 2011-08-21

Other drugs received by patient: Citalopram Hydrobromide; Boniva; Dicyclomine; Doxazosin Mesylate; Lisinopril; Omeprazole; Sucralfate; Acetaminophen and Hydrocodone Bitartrate; Bupropion HCL



Possible Toviaz side effects / adverse reactions in 74 year old male

Reported by a consumer/non-health professional from Switzerland on 2011-10-11

Patient: 74 year old male

Reactions: Mania, Drug Interaction

Suspect drug(s):
Toviaz

Other drugs received by patient possibly interacting with the suspect drug:
Toviaz
    Dosage: 4 mg, 1x/day
    Administration route: Oral
    Start date: 2011-08-08
    End date: 2011-08-22

Toviaz
    Dosage: 8 mg, 1x/day
    Administration route: Oral
    Start date: 2011-08-24
    End date: 2011-08-29

Seroquel
    Dosage: 75 mg, 1x/day
    Administration route: Oral
    Indication: Bipolar Disorder

Other drugs received by patient: Depakene; Venlafaxine; Aspirin; Antabuse; Acidum Folicum Streuli; Diovan HCT; Lescol



Possible Toviaz side effects / adverse reactions in 67 year old female

Reported by a consumer/non-health professional from Netherlands on 2011-10-18

Patient: 67 year old female

Reactions: Bacterial Infection, DRY Skin, Erythema

Suspect drug(s):
Toviaz

Other drugs received by patient: Micardis; Acetylsalicylic Acid; Thyrax



See index of all Toviaz side effect reports >>

Drug label data at the top of this Page last updated: 2012-04-06

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017