Qvar (Beclomethasone Dipropionate HFA) Drug Information: Side Effects and Drug Interactions

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May 27, 2012

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T or F - Asthma is "all in the mind."
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SIDE EFFECTS

The following reporting rates of common adverse experiences are based upon four clinical trials in which 1196 Patients (671 female and 525 male adults previously treated with as-needed bronchodilators and/or inhaled corticosteroids) were treated with QVAR (beclomethasone dipropionate hfa) (doses of 40, 80, 160, or 320 mcg twice daily) or CFC-BDP (doses of 42, 168, or 336 mcg twice daily) or placebo. The table below includes all events reported by patients taking QVAR (beclomethasone dipropionate hfa) (whether considered drug related or not) that occurred at a rate over 3% for either QVAR (beclomethasone dipropionate hfa) or CFC-BDP. In considering these data, difference in average duration of exposure and clinical trial design should be taken into account.

Adverse Events Reported by at Least 3% of the Patients for Either QVAR (beclomethasone dipropionate hfa) or CFC-BDP by Treatment and Daily Dose

Adverse Events		QVAR				CFC-BDP
Adverse Events	Placebo (N=289) %	Total (N=624) %	80-160mcg (N=233) %	320mcg (N=335) %	640mcg (N=56) %	Total (N=283) %	84mcg (N=59) %	336mcg (N=55) %	672mcg (N=169) %
HEADACHE	9	12	15	8	25	15	14	11	17
PHARYNGITIS	4	8	6	5	27	10	12	9	10
UPPER RESP TRACT INFECTION	11	9	7	11	5	12	3	9	17
RHINITIS	9	6	8	3	7	11	15	9	10
INCREASED ASTHMA SYMPTOMS	18	3	2	4	0	8	14	5	7
ORAL SYMPTOMS INHALATION ROUTE	2	3	3	3	2	6	7	5	5
SINUSITIS	2	3	3	3	0	4	7	2	4
PAIN	<1	2	1	2	5	3	3	5	2
BACK PAIN	1	1	2	<1	4	4	2	4	4
NAUSEA	0	1	<1	1	2	3	5	5	1
DYSPHONIA	2	<1	1	0	4	4	0	0	6

Other adverse events that occurred in these clinical trials using QVAR (beclomethasone dipropionate hfa) with an incidence of 1% to 3% and which occurred at a greater incidence than placebo were: dysphonia, dysmenorrhea and coughing.

No patients treated with QVAR (beclomethasone dipropionate hfa) in the clinical development program developed symptomatic oropharyngeal candidiasis.

If such an infection develops, treatment with appropriate antifungal therapy or discontinuance of treatment with QVAR (beclomethasone dipropionate hfa) may be required.

Pediatric Studies: In two 12-week placebo controlled studies in steroid naive pediatric patients 5 to 12 years of age, no clinically relevant differences were found in the pattern, severity, or frequency of adverse events compared with those reported in adults, with the exception of conditions which are more prevalent in a pediatric population generally.

Adverse Event Reports from Other Sources: Rare cases of immediate and delayed hypersensitivity reactions, including urticaria, angioedema, rash, and bronchospasm, have been reported following the oral and intranasal inhalation of beclomethasone dipropionate.