ADVERSE REACTIONS
The safety of Sanctura was evaluated in Phase 2 and 3 controlled clinical trials in a total of 2975 patients, who were treated with Sanctura (N=1673), placebo (N=1056) or active control medications (N=246). Of this total, 1181 patients participated in two, twelve-week, Phase 3, U.S., efficacy and safety studies and a 9-month open-label extension. Of this total, 591 patients received Sanctura 20 mg twice daily. In all controlled trials combined, 232 and 208 patients received treatment with Sanctura for at least 24 and 52 weeks, respectively.
In all placebo-controlled trials combined, the incidence of serious adverse events was 2.9% among patients receiving Sanctura 20 mg BID and 1.5% among patients receiving placebo. Of these, 0.2% and 0.3% were judged to be at least possibly related to treatment with Sanctura or placebo, respectively, by the investigator.
Table 4 lists treatment emergent adverse events from the combined 12-week U.S. safety and efficacy trials that were judged to be at least possibly related to treatment with Sanctura by the investigator, were reported by at least 1% of patients, and were reported more frequently in the Sanctura group than in the placebo group.
The 2 most common adverse events reported by patients receiving Sanctura 20 mg BID were dry mouth and constipation. The single most frequently reported adverse event for Sanctura, dry mouth, occurred in 20.1% of Sanctura treated patients and 5.8% of patients receiving placebo. In the two Phase 3 U.S. studies, dry mouth led to discontinuation in 1.9% of patients treated with Sanctura 20 mg BID. For the patients who reported dry mouth, most had their first occurrence of the event within the first month of treatment.
Table 4. Incidence (%) of adverse events judged at
least possibly related to treatment with Sanctura,
reported in >/= 1% of all patients treated with Sanctura
and more frequent with Sanctura (20 mg BID) than
placebo in Studies 1 and 2 combined.
| Adverse Event |
Placebo (N=590) |
Sanctura 20 mg BID (N=591) |
| Gastrointestinal disorders |
|
Dry mouth
Constipation
Abdominal pain upper
Constipation aggravated
Dyspepsia
Flatulence
|
34 (5.8)
27 (4.6)
7 (1.2)
5 (0.8)
2 (0.3)
5 (0.8) |
119 (20.1)
57 (9.6)
9 (1.5)
8 (1.4)
7 (1.2)
7 (1.2) |
| Nervous system disorders |
|
Headache
|
12 (2.0) |
25 (4.2) |
| General Disorders |
|
Fatigue
|
8 (1.4) |
11 (1.9) |
| Renal and Urinary Disorders |
8 (1.4) |
11 (1.9) |
|
Urinary retention
|
2 (0.3) |
7 (1.2) |
| Eye Disorders |
|
Dry eyes NOS
|
2 (0.3) |
7 (1.2) |
|
Abbreviations: BID=twice daily, NOS=not otherwise specified.
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Other adverse events from the Phase 3, U.S., placebo-controlled trials judged possibly related to treatment with Sanctura by the investigator, occurring in >/=0.5% of Sanctura-treated patients, and more common with Sanctura than placebo are: tachycardia NOS, vision blurred, abdominal distension, vomiting NOS, dysgeusia, dry throat, and dry skin.
During controlled clinical studies, one event of angioneurotic edema was reported.
POSTMARKETING SURVEILLANCE
Additional spontaneous adverse events, regardless of relationship to drug, reported from marketing experience with trospium chloride include: gastritis, palpitations, supraventricular tachycardia, chest pain, Stevens-Johnson syndrome, anaphylactic reaction, syncope, rhabdomyolysis, vision abnormal, hallucinations and delirium, and "hypertensive crisis".
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