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

ADVERSE REACTIONS

Experience in Adult Patients with COPD

Of the 1,456 COPD patients in the two 12-week, placebo-controlled trials, 288 were treated with BROVANA (arformoterol tartrate) 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. The numbers and percent of patients who reported adverse events were comparable in the 15 mcg twice daily and placebo groups.

The following table shows adverse events where the frequency was greater than or equal to 2% in the BROVANA 15 mcg twice daily group and where the rates of adverse events in the BROVANA 15 mcg twice daily group exceeded placebo. 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 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 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.

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

Other adverse reactions which may occur with selective beta₂-adrenoceptor agonists such as BROVANA include: angina, hypertension or hypotension, tachycardia, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, muscle cramps, nausea, dizziness, fatigue, malaise, hypokalemia, hyperglycemia, metabolic acidosis and insomnia.

Drug Abuse and Dependence

There were no reported cases of abuse or evidence of drug dependence with the use of BROVANA in the clinical trials.

REPORTS OF SUSPECTED BROVANA SIDE EFFECTS / ADVERSE REACTIONS

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