Xopenex HFA (Levalbuterol Tartrate) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

Adverse event information concerning XOPENEX HFA (levalbuterol tartrate) Inhalation Aerosol in adults and adolescents is derived from two 8-week, multicenter, randomized, double-blind, active- and placebo-controlled trials in 748 adult and adolescent patients with asthma that compared XOPENEX HFA Inhalation Aerosol, a marketed albuterol HFA inhaler, and an HFA-134a placebo inhaler. Table 2 lists the incidence of all adverse events (whether considered by the investigator to be related or unrelated to drug) from these trials that occurred at a rate of 2% or greater in the group treated with XOPENEX HFA Inhalation Aerosol and more frequently than in the HFA-134a placebo inhaler group.

Table 2: Adverse Event Incidence (% of Patients) in Two 8-Week Clinical Trials in Adults and Adolescents ≥ 12 Years of Age*

Body System    Preferred Term	XOPENEX HFA Inhalation Aerosol 90 mcg (n=403)	Racemic Albuterol HFA 180 mcg (n=179)	Placebo (n=166)
* This table includes all adverse events (whether considered by the investigator to be related or unrelated to drug) from these trials that occurred at a rate of 2% or greater in the group treated with XOPENEX HFA Inhalation Aerosol and more frequently than in the HFA-134a placebo inhaler group.
Body as a Whole
Pain	4.0	3.4	3.6
Central Nervous System
Dizziness	2.7	0.6	1.8
Respiratory System
Asthma	9.4	7.3	6.0
Pharyngitis	7.9	2.2	2.4
Rhinitis	7.4	2.2	3.0

Adverse events reported by less than 2% and at least 2 or more of the adolescent and adult patients receiving XOPENEX HFA Inhalation Aerosol and by a greater proportion than receiving HFA-134a placebo inhaler include cyst, flu syndrome, viral infection, constipation, gastroenteritis, myalgia, hypertension, epistaxis, lung disorder, acne, herpes simplex, conjunctivitis, ear pain, dysmenorrhea, hematuria, and vaginal moniliasis. There were no significant laboratory abnormalities observed in these studies.

Adverse event information concerning XOPENEX HFA Inhalation Aerosol in children is derived from a 4-week, randomized, double-blind trial of XOPENEX HFA Inhalation Aerosol, a marketed albuterol HFA inhaler, and an HFA-134a placebo inhaler in 150 children aged 4 to 11 years with asthma. Table 3 lists the adverse events reported for XOPENEX HFA Inhalation Aerosol in children at a rate of 2% or greater and more frequently than for placebo.

Table 3: Adverse Event Incidence (% of Patients) in a 4-Week Trial in Children Aged 4-11 Years*

Body System    Preferred Term	XOPENEX HFA Inhalation Aerosol 90 mcg (n=76)	Racemic Albuterol HFA 180 mcg (n=39)	Placebo (n=35)
* This table includes all adverse events (whether considered by the investigator to be related or unrelated to drug) from the trial that occurred at a rate of 2% or greater in the group treated with XOPENEX HFA Inhalation Aerosol and more frequently than in the HFA-134a placebo inhaler group.
Body as a Whole
Accidental injury	9.2	10.3	5.7
Digestive System
Vomiting	10.5	7.7	5.7
Respiratory System
Bronchitis	2.6	0	0
Pharyngitis	6.6	12.8	5.7

The incidence of systemic beta-adrenergic adverse effects (e.g., tremor, nervousness) was low and comparable across all treatment groups, including placebo.

Postmarketing

In addition to the adverse events reported in clinical trials, the following adverse events have been observed in postapproval use of levalbuterol inhalation solution. These events have been chosen for inclusion due to their seriousness, their frequency of reporting, or their likely beta-mediated mechanism: angioedema, anaphylaxis, arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles), asthma, chest pain, cough increased, dyspnea, nausea, nervousness, rash, tachycardia, tremor, urticaria. Because these events have been reported spontaneously from a population of unknown size, estimates of frequency cannot be made.

In addition, XOPENEX HFA Inhalation Aerosol, like other sympathomimetic agents, can cause adverse reactions such as hypertension, angina, vertigo, central nervous system stimulation, sleeplessness, headache, and drying or irritation of the oropharynx.

REPORTS OF SUSPECTED XOPENEX HFA SIDE EFFECTS / ADVERSE REACTIONS

Possible Xopenex HFA side effects / adverse reactions in 47 year old female

Reported by a consumer/non-health professional from United States on 2011-10-18

Patient: 47 year old female weighing 81.2 kg (178.6 pounds)

Reactions: Malaise, Food Allergy

Suspect drug(s):
Symbicort

Spiriva

Pulmicort

Albuterol

Singulair

Xopenex HFA
    Indication: Asthma

Other drugs received by patient: Ambien CR; Doxycycline; Triamterene and Hydrochlorothiazide; Amlodipine; Hydroxyzine; Anti Fungal

Possible Xopenex HFA side effects / adverse reactions in 65 year old female

Reported by a consumer/non-health professional from United States on 2011-10-21

Patient: 65 year old female

Reactions: HIP Arthroplasty, Rotator Cuff Repair, Hyponatraemia, Knee Arthroplasty, Metabolic Disorder, Blood Glucose Increased, Hypokalaemia

Adverse event resulted in: hospitalization

Suspect drug(s):
Xopenex HFA
    Dosage: ;prn;inhalation
    Indication: Chronic Obstructive Pulmonary Disease

Xopenex HFA
    Dosage: ;prn;inhalation
    Indication: Asthma

Xopenex HFA
    Dosage: ;prn;inhalation
    Indication: Bronchitis

Possible Xopenex HFA side effects / adverse reactions in 23 year old female

Reported by a consumer/non-health professional from United States on 2011-10-24

Patient: 23 year old female weighing 45.4 kg (99.8 pounds)

Reactions: Hypersensitivity, Rash

Adverse event resulted in: life threatening event

Suspect drug(s):
Xopenex HFA