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Serevent Diskus (Salmeterol Xinafoate Inhalation Powder) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Adverse reactions to salmeterol are similar in nature to reactions to other selective beta2-adrenoceptor agonists, i.e., tachycardia; palpitations; immediate hypersensitivity reactions, including urticaria, angioedema, rash, bronchospasm (see WARNINGS); headache; tremor; nervousness; and paradoxical bronchospasm (see WARNINGS).

Asthma: Two multicenter, 12-week, controlled studies have evaluated twice-daily doses of SEREVENT DISKUS in patients 12 years of age and older with asthma. Table 3 reports the incidence of adverse events in these 2 studies.

Table 3. Adverse Event Incidence in Two 12-Week Adolescent and Adult Clinical Trials in Patients With Asthma
Percent of Patients
Adverse Event Placebo
(N = 152)
SEREVENT
DISKUS
50 mcg Twice Daily
(N = 149)
Albuterol
Inhalation Aerosol
180 mcg 4 Times Daily
(N = 150)
Ear, nose, and throat
Nasal/sinus congestion, pallor 6 9 8
Rhinitis 4 5 4
Neurological
Headache 9 13 12
Respiratory
Asthma 1 3 <1
Tracheitis/bronchitis 4 7 3
Influenza 2 5 5

Table 3 includes all events (whether considered drug-related or nondrug-related by the investigator) that occurred at a rate of 3% or greater in the group receiving SEREVENT DISKUS and were more common than in the placebo group.

Pharyngitis, sinusitis, upper respiratory tract infection, and cough occurred at >/=3% but were more common in the placebo group. However, throat irritation has been described at rates exceeding that of placebo in other controlled clinical trials.

Other adverse events that occurred in the group receiving SEREVENT DISKUS in these studies with an incidence of 1% to 3% and that occurred at a greater incidence than with placebo were:

Ear, Nose, and Throat: Sinus headache.

Gastrointestinal: Nausea.

Mouth and Teeth: Oral mucosal abnormality.

Musculoskeletal: Pain in joint.

Neurological: Sleep disturbance, paresthesia.

Skin: Contact dermatitis, eczema.

Miscellaneous: Localized aches and pains, pyrexia of unknown origin.

Two multicenter, 12-week, controlled studies have evaluated twice-daily doses of SEREVENT DISKUS in patients aged 4 to 11 years with asthma. Table 4 includes all events (whether considered drug-related or nondrug-related by the investigator) that occurred at a rate of 3% or greater in the group receiving SEREVENT DISKUS and were more common than in the placebo group.

Table 4. Adverse Event Incidence in Two 12-Week Pediatric Clinical Trials in Patients With Asthma
Adverse Event Percent of Patients
Placebo
(N = 215)
SEREVENT
DISKUS
50 mcg
Twice Daily
(N = 211)
Albuterol Inhalation
Powder
200 mcg
4 Times Daily
(N = 115)
Ear, nose, and throat
Ear signs and symptoms 3 4 9
Pharyngitis 3 6 3
Neurological
Headache 14 17 20
Respiratory
Asthma 2 4 <1
Skin
Skin rashes 3 4 2
Urticaria 0 3 2

The following events were reported at an incidence of 1% to 2% (3 to 4 patients) in the salmeterol group and with a higher incidence than in the albuterol and placebo groups: gastrointestinal signs and symptoms, lower respiratory signs and symptoms, photodermatitis, and arthralgia and articular rheumatism.

In clinical trials evaluating concurrent therapy of salmeterol with inhaled corticosteroids, adverse events were consistent with those previously reported for salmeterol, or might otherwise be expected with the use of inhaled corticosteroids.

Chronic Obstructive Pulmonary Disease: Two multicenter, 24-week, controlled studies have evaluated twice-daily doses of SEREVENT DISKUS in patients with COPD. For presentation (Table 5), the placebo data from a third trial, identical in design, patient entrance criteria, and overall conduct but comparing fluticasone propionate with placebo, were integrated with the placebo data from these 2 studies (total N = 341 for salmeterol and 576 for placebo).

Table 5. Adverse Events With >/=3% Incidence in US Controlled Clinical Trials With SEREVENT DISKUS in Patients With Chronic Obstructive Pulmonary Disease *
Adverse Event Percent of Patients
Placebo
(N = 576)
SEREVENT DISKUS
50 mcg Twice Daily
(N = 341)
Cardiovascular
Hypertension 2 4
Ear, nose, and throat
Throat irritation 6 7
Nasal congestion/blockage 3 4
Sinusitis 2 4
Ear signs and symptoms 1 3
Gastrointestinal
Nausea and vomiting 3 3
Lower respiratory
Cough 4 5
Rhinitis 2 4
Viral respiratory infection 4 5
Musculoskeletal
Musculoskeletal pain 10 12
Muscle cramps and spasms 1 3
Neurological
Headache 11 14
Dizziness 2 4
Average duration of exposure (days) 128.9 138.5
*Table 5 includes all events (whether considered drug-related or nondrug-related by the investigator) that occurred at a rate of 3% or greater in the group receiving SEREVENT DISKUS and were more common in the group receiving SEREVENT DISKUS than in the placebo group.

Other events occurring in the group receiving SEREVENT DISKUS that occurred at a frequency of 1% to <3% and were more common than in the placebo group were as follows:

Endocrine and Metabolic: Hyperglycemia.

Eye: Keratitis and conjunctivitis.

Gastrointestinal: Candidiasis mouth/throat, dyspeptic symptoms, hyposalivation, dental discomfort and pain, gastrointestinal infections.

Lower Respiratory: Lower respiratory signs and symptoms.

Musculoskeletal: Arthralgia and articular rheumatism; muscle pain; bone and skeletal pain; musculoskeletal inflammation; muscle stiffness, tightness, and rigidity.

Neurology: Migraines.

Non-Site Specific: Pain, edema and swelling.

Psychiatry: Anxiety.

Skin: Skin rashes.

Observed During Clinical Practice: In addition to adverse events reported from clinical trials, the following events have been identified during postapproval use of salmeterol. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to salmeterol or a combination of these factors.

In extensive US and worldwide postmarketing experience with salmeterol, serious exacerbations of asthma, including some that have been fatal, have been reported. In most cases, these have occurred in patients with severe asthma and/or in some patients in whom asthma has been acutely deteriorating (see WARNINGS no. 1), but they have also occurred in a few patients with less severe asthma. It was not possible from these reports to determine whether salmeterol contributed to these events or simply failed to relieve the deteriorating asthma.

Respiratory: Reports of upper airway symptoms of laryngeal spasm, irritation, or swelling such as stridor or choking; oropharyngeal irritation.

Cardiovascular: Arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles), and anaphylaxis.

Non-Site Specific: Very rare anaphylactic reaction in patients with severe milk protein allergy.

Drug label data at the top of this Page last updated: 2006-07-23

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