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Brovana (Arformoterol Tartrate Inhalation) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Long-acting beta 2 -adrenergic agonists increase the risk of asthma-related death [see BOXED WARNING and WARNINGS AND PRECAUTIONS].

6.1 Beta-Agonist Adverse Reaction Profile

Adverse reactions to BROVANA Inhalation Solution are expected to be similar in nature to other beta2-adrenergic receptor agonists including: angina, hypertension or hypotension, tachycardia, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, muscle cramps, nausea, dizziness, fatigue, malaise, hypokalemia, hyperglycemia, metabolic acidosis and insomnia.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in 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.

Adults with COPD in Short-Term Trials (12 weeks)

The safety data described below for adults ≥35 years of age are based on 2 clinical trials of 12 weeks. In the 2 trials of 12 weeks duration, 1456 patients (860 males and 596 females, ages 34 to 89 years old) with COPD were treated with BROVANA Inhalation Solution 15 mcg twice daily, 25 mcg twice daily, 50 mcg once daily, salmeterol 42 mcg twice daily, or placebo. The racial/ethnic distribution in these two trials included 1383 Caucasians, 49 Blacks, 10 Asians, and 10 Hispanics, and 4 patients classified as Other. Among the 1,456 COPD patients in two 12-week, placebo-controlled trials, 288 were treated with BROVANA Inhalation Solution 15 mcg twice daily and 293 were treated with placebo. Doses of 25 mcg twice daily and 50 mcg once daily were also evaluated.

Table 1 shows adverse reaction rates among patients from these two trials where the frequency was greater than or equal to 2% in the BROVANA Inhalation Solution 15 mcg twice daily group and where the rate in the BROVANA Inhalation Solution 15 mcg twice daily group exceeded the rate in the placebo group. The total number and percent of patients who reported adverse events were 202 (70%) in the 15 mcg twice daily and 219 (75%) in the placebo groups. Ten adverse events demonstrated a dose relationship: asthenia, fever, bronchitis, COPD, headache, vomiting, hyperkalemia, leukocytosis, nervousness, and tremor.

Table 1: Number of Patients Experiencing Adverse Events from Two 12-Week, Double-Blind, Placebo-Controlled Clinical Trials

* Reported terms coded to “Lung Disorder” were predominantly pulmonary or chest congestion.

BROVANA Inhalation Solution
15 mcg
twice daily
Placebo
n (%) n (%)
Total Patients 288 (100) 293 (100)
Pain 23 (8) 16 (5)
Chest Pain 19 (7) 19 (6)
Back Pain 16 (6) 6 (2)
Diarrhea 16 (6) 13 (4)
Sinusitis 13 (5) 11 (4)
Leg Cramps 12 (4) 6 (2)
Dyspnea 11 (4) 7 (2)
Rash 11 (4) 5 (2)
Flu Syndrome 10 (3) 4 (1)
Peripheral Edema 8 (3) 7 (2)
Lung Disorder* 7 (2) 2 (1)

Adverse events occurring in patients treated with BROVANA Inhalation Solution 15 mcg twice daily with a frequency of <2%, but greater than placebo, were as follows:

Body as a Whole: abscess, allergic reaction, digitalis intoxication, fever, hernia, injection site pain, neck rigidity, neoplasm, pelvic pain, retroperitoneal hemorrhage

Cardiovascular: arteriosclerosis, atrial flutter, AV block, congestive heart failure, heart block, myocardial infarct, QT interval prolonged, supraventricular tachycardia, inverted T-wave

Digestive: constipation, gastritis, melena, oral moniliasis, periodontal abscess, rectal hemorrhage

Metabolic and Nutritional Disorders: dehydration, edema, glucose tolerance decreased, gout, hyperglycemia, hyperlipemia, hypoglycemia, hypokalemia

Musculoskeletal: arthralgia, arthritis, bone disorder, rheumatoid arthritis, tendinous contracture

Nervous: agitation, cerebral infarct, circumoral paresthesia, hypokinesia, paralysis, somnolence, tremor

Respiratory: carcinoma of the lung, respiratory disorder, voice alteration

Skin and Appendages: dry skin, herpes simplex, herpes zoster, skin discoloration, skin hypertrophy

Special Senses: abnormal vision, glaucoma

Urogenital: breast neoplasm, calcium crystalluria, cystitis, glycosuria, hematuria, kidney calculus, nocturia, PSA increase, pyuria, urinary tract disorder, urine abnormality.

In these trials, the overall frequency of all cardiovascular adverse events was 6.9% in BROVANA Inhalation Solution 15 mcg twice daily and 13.3% in the placebo group. There were no frequently occurring specific cardiovascular adverse events for BROVANA Inhalation Solution (frequency ≥1% and greater than placebo). The rate of COPD exacerbations was also comparable between the BROVANA Inhalation Solution 15 mcg twice daily and placebo groups, 12.2% and 15.1%, respectively.

Adults with COPD in Long-Term (52-week) Safety Trial

BROVANA Inhalation Solution was evaluated in one 52 week double-blind, randomized, placebo-controlled, safety trial conducted in patients with moderate to severe COPD. The primary endpoint was time to either respiratory death or first COPD exacerbation-related hospitalization, whichever occurred first. The event had to be a death or hospitalization for which the patient's respiratory status was predominant and/or inciting contributor, as determined by the clinical investigator. The objective of the trial was to demonstrate that the risk of respiratory death or COPD exacerbation-related hospitalization for patients treated with BROVANA Inhalation Solution was not greater than 40% more than the risk for patient treated with placebo. A total of 841 patients (479 males and 361 females, ages 41 to 94 years old) with COPD were randomized: 420 to BROVANA Inhalation Solution 15 mcg twice daily and 421 to placebo. Of the randomized patients, 255 (61%) in the BROVANA Inhalation Solution group and 211 (50%) in the placebo group, completed one year of treatment. The trial objective was met demonstrating that COPD patients treated with BROVANA Inhalation Solution are not at an increased risk of respiratory death or COPD exacerbation-related hospitalizations compared to placebo.



REPORTS OF SUSPECTED BROVANA SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Brovana. The information is not vetted and should not be considered as verified clinical evidence.

Possible Brovana side effects / adverse reactions in 77 year old female

Reported by a consumer/non-health professional from United States on 2011-10-28

Patient: 77 year old female

Reactions: Blood Pressure Increased, Malaise, Dyspepsia, Heart Rate Increased, Chest Pain

Suspect drug(s):
Brovana
    Indication: Dyspnoea
    End date: 2011-04-25

Nasonex

Astepro

Advair Diskus 100/50
    Indication: Product Used FOR Unknown Indication

Spiriva

Albuterol
    Indication: Product Used FOR Unknown Indication

Allegra
    Dosage: 180mg per day
    Administration route: Oral
    Indication: Multiple Allergies
    Start date: 2011-04-01

Unspecified Treatment
    Indication: Dyspnoea
    End date: 2011-04-25



Possible Brovana side effects / adverse reactions in 76 year old female

Reported by a physician from United States on 2012-01-09

Patient: 76 year old female

Reactions: Malaise, Hypersensitivity, Dyspnoea, Polyp, Joint Swelling, Oedema Peripheral, Anaemia, Rectal Haemorrhage, Asthenia

Adverse event resulted in: hospitalization

Suspect drug(s):
Brovana

Other drugs received by patient: Spironolactone; Metoprolol Succinate; Tracleer; Furosemide



Possible Brovana side effects / adverse reactions in 69 year old female

Reported by a consumer/non-health professional from United States on 2012-02-15

Patient: 69 year old female

Reactions: Pneumonia, Laboratory Test Abnormal, Blood Creatine Phosphokinase Decreased, Fungal Infection, Muscle Spasms

Adverse event resulted in: hospitalization

Suspect drug(s):
Brovana

Other drugs received by patient: Celebrex; Baclofen; Ropinirole; Prednisone TAB; Orphenadrine Citrate



See index of all Brovana side effect reports >>

Drug label data at the top of this Page last updated: 2014-06-30

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