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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 clinical practice.
In 4 placebo-controlled clinical trials, 1057 subjects 18 years of age and older with short ragweed pollen-induced rhinitis, with or without conjunctivitis, received at least one dose of RAGWITEK, of whom 642 (61%) completed at least 12 weeks of therapy. Of the subjects treated with RAGWITEK, 52% were male, 25% had mild asthma, and 82% were sensitized to other allergens in addition to ragweed pollen. The subject population was 83% White, 12% African American, and 2% Asian. Subject demographics in placebo treated subjects were similar to the active group. The pooled analysis includes safety data from two 28-day safety studies and safety data from the first 28 days of two 52-week safety and efficacy studies. Adverse reactions reported in ≥1% of subjects in the 28-day pooled analysis treated with RAGWITEK are shown in Table 1.
The most common adverse reactions reported in subjects treated with RAGWITEK were throat irritation (16.6% vs 3.3% placebo), oral pruritus (10.9% vs 2.0%), ear pruritus (10.4% vs 1.1%), and oral paraesthesia (10.0% vs 4.0%). The percentage of subjects who discontinued from the clinical trials because of an adverse reaction while exposed to RAGWITEK or placebo was 4.4% and 0.8%, respectively. The most common adverse reactions that led to study discontinuation in subjects who were exposed to RAGWITEK were mouth edema, swollen tongue, and dysphagia.
One subject (1/1057; 0.1%) who received RAGWITEK experienced a treatment-related severe systemic allergic reaction that led to discontinuation of RAGWITEK. The subject had local reactions starting on Day 1 of treatment with RAGWITEK. On Day 6 symptoms progressed and included swelling of the throat, dyspnea, nausea, and lightheadedness. The subject fully recovered after treatment with epinephrine (self-administered), antihistamines, and oral corticosteroids.
Table 1: Adverse Reactions Reported in ≥1% of
Subjects Treated with RAGWITEK (28-day pooled analysis)
|Ear and Labyrinth Disorders|
|Respiratory, Thoracic and Mediastinal Disorders|
|Skin and Subcutaneous Tissue Disorders|
|General Disorders and Administration Site Conditions|
The overall safety profile beyond Day 28 in the two 52-week trials was similar to that observed in the pooled 28-day analysis.
Read the Ragwitek (short ragweed pollen allergen extract tablets) Side Effects Center for a complete guide to possible side effects
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Last reviewed on RxList: 5/2/2014
This monograph has been modified to include the generic and brand name in many instances.
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