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Adverse Experiences

Information on the incidence of adverse events in clinical investigations conducted in the U.S. was obtained from 33 controlled and 15 uncontrolled clinical studies in which 2499 patients received acrivastine and 2631 patients received acrivastine plus pseudoephedrine hydrochloride for treatment periods ranging from one day to one year. The majority of patients in clinical trials were exposed to acrivastine or acrivastine plus pseudoephedrine for less than 90 days. Acrivastine dosage ranged from 3 to 96 mg/day; 1336 patients received dosages equal to or greater than acrivastine 24 mg/day. Acrivastine plus pseudoephedrine hydrochloride dosages ranged from acrivastine 8 to 48 mg/day plus pseudoephedrine hydrochloride 60 to 240 mg/day. A total of 2335 patients received three or four daily doses of acrivastine 8 mg plus pseudoephedrine hydrochloride 60 mg.

In controlled clinical trials, only 12 spontaneously elicited adverse events were reported with frequencies greater than 1% in the acrivastine plus pseudoephedrine hydrochloride treatment group (see table).

TABLE 1: ADVERSE EVENTS REPORTED IN CLINICAL TRIALS* (PERCENT OF PATIENTS REPORTING)†

  Controlled Studies
Placebo
(n= 1767)
Acrivastine
(n= 1935)
Pseudo-ephedrine (n= 887)
Acrivastine plus Pseudo-ephedrine
(n= 1650)
CNS
   Somnolence‡ 6 12 8 12
   Headache 18 19 19 19
   Dizziness 2 3 3 3
   Nervousness‡ 1 2 4 3
   Insomnia‡ 1 1 6 4
MISCELLANEOUS
   Nausea 2 3 3 2
   Dry Mouth‡ 2 3 5 7
   Asthenia 2 3 2 2
   Dyspepsia 1 1 2 2
   Pharyngitis 2 1 1 3
   Cough Increase 1 2 1 2
   Dysmenorrhea 1 2 3 2
*Includes all events regardless of casual relationship to treatment.
†Includes all adverse events with a reported frequency of > 1% for the acrivastine plus pseudoephedrine treatment group.
‡SEMPREX-D (acrivastine and pseudoephedrine) demonstrates a statistically higher frequency of events than placebo, p ≤ 0.05.

The nature and overall frequencies of adverse events from international clinical trials (35 studies involving approximately 1600 patients) were similar to the results obtained in the U.S. studies.

Post-marketing clinical experience reports with acrivastine and acrivastine plus pseudoephedrine have included rare serious hypersensitivity reactions manifested by anaphylaxis, angioedema, bronchospasm, and erythema multiforme. No deaths associated with use of acrivastine or acrivastine plus pseudoephedrine have been reported.

Pseudoephedrine may cause ephedrine-like reactions such as tachycardia, palpitations, headache, dizziness, or nausea (see WARNINGS and OVERDOSAGE).