Exubera Side Effects

Please note - some side effects for Exubera may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Exubera - for the Consumer

Exubera Powder

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Exubera Powder:

Cough; dry mouth; increased sputum production; runny or stuffy nose; sore throat.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; wheezing; muscle pain); changes in vision; chest pain or discomfort; chills; confusion; dizziness; drowsiness; fainting; fast or irregular heartbeat; headache; loss of consciousness; mood changes; seizures; shortness of breath; slurred speech; swelling; tremor; trouble breathing; trouble concentrating; unusual hunger; unusual sweating; weakness.

Exubera Side Effects - for the Professional

Exubera

The safety of Exubera alone, or in combination with subcutaneous insulin or oral agents, has been evaluated in approximately 2500 adult patients with type 1 or type 2 diabetes who were exposed to Exubera. Approximately 2000 patients were exposed to Exubera for greater than 6 months and more than 800 patients were exposed for more than 2 years.

Non-Respiratory Adverse Events

Non-respiratory adverse events reported in ≥1% of 1977 Exubera-treated patients in controlled Phase 2/3 clinical studies, regardless of causality, include (but are not limited to) the following:

Metabolic and Nutritional: hypoglycemia
Body as a whole: chest pain
Digestive: dry mouth
Special senses: otitis media (type 1 pediatric diabetics)

The rates and incidence of hypoglycemia were comparable between Exubera and subcutaneous regular human insulin in patients with type 1 and type 2 diabetes. In type 2 patients who were not adequately controlled with single oral agent therapy, the addition of Exubera was associated with a higher rate of hypoglycemia than was the addition of a second oral agent.

A range of different chest symptoms were reported as adverse reactions and were grouped under the non-specific term chest pain. These events occurred in 4.7% of Exubera-treated patients and 3.2% of patients in comparator groups. The majority (>90%) of these events were reported as mild or moderate. Two patients in the Exubera and one in the comparator group discontinued treatment due to chest pain. The incidence of all-causality adverse events related to coronary artery disease, such as angina pectoris or myocardial infarction was comparable in the Exubera (0.7% angina pectoris; 0.7% myocardial infarction) and comparator (1.3% angina pectoris; 0.7% myocardial infarction) treatment groups.

Dry mouth was reported in 2.4% of Exubera-treated patients and 0.8% of patients in comparator groups. Nearly all (>98%) of dry mouth reported was mild or moderate. No patients discontinued treatment due to dry mouth.

Pediatric type 1 diabetics in Exubera groups experienced adverse events related to the ear more frequently than did pediatric type 1 diabetics in treatment groups receiving only subcutaneous insulin. These events included otitis media (Exubera 6.5%; SC 3.4%), ear pain (Exubera 3.9%; SC 1.4%), and ear disorder (Exubera 1.3%; SC 0%).

Respiratory Adverse Events

Table 6 shows the incidence of respiratory adverse events for each treatment group that were reported in ≥1% of any treatment group in controlled Phase 2 and 3 clinical studies, regardless of causality.

In 3 clinical studies, patients who completed a cough questionnaire reported that the cough tended to occur within seconds to minutes after Exubera inhalation, was predominantly mild in severity and was rarely productive in nature. The incidence of this cough decreased with continued Exubera use. In controlled clinical studies, 1.2% of patients discontinued Exubera treatment due to cough.

Nearly all (>97%) of dyspnea was reported as mild or moderate. A small number of Exubera-treated patients (0.4%) discontinued treatment due to dyspnea compared to 0.1% of comparator-treated patients.

The majority of these events were reported as mild or moderate. A small number of Exubera-treated patients discontinued treatment due to pharyngitis (0.2%) and sputum increased (0.1%); no patients discontinued treatment due to epistaxis.

The effect of Exubera on the respiratory system has been evaluated in over 3800 patients in controlled phase 2 and 3 clinical studies (in which 1977 patients were treated with Exubera). In randomized, open-label clinical trials up to two years duration, patients treated with Exubera demonstrated a greater decline in pulmonary function, specifically the forced expiratory volume in one second (FEV1) and the carbon monoxide diffusing capacity (DLCO), than comparator treated patients. The mean treatment group differences in FEV1 and DLCO, were noted within the first several weeks of treatment with Exubera, and did not progress over the two year treatment period. In one completed controlled clinical trial in patients with type 2 diabetes following two years of treatment with Exubera, patients showed resolution of the treatment group difference in FEV1 six weeks after discontinuation of therapy. Resolution of the effect of Exubera on pulmonary function in patients with type 1 diabetes has not been studied after long-term treatment.

Figures 3 through 6 display the mean FEV1 and DLCO change from baseline versus time from two ongoing randomized, open-label, two year studies in 580 patients with type 1 and 620 patients with type 2 diabetes.

Figure 3: Change from Baseline FEV1 (L) in Patients with Type 1 Diabetes (Mean +/-Standard Deviation)

Figure 4: Change from Baseline FEV1 (L) in Patients with Type 2 Diabetes (Mean +/- Standard Deviation)

Following 2 years of Exubera treatment in patients with type 1 and type 2 diabetes, the difference between treatment groups for the mean change from baseline FEV1 was approximately 40 mL, favoring the comparator.

Figure 5: Change from Baseline DLco (mL/min/mmHg) in Patients with Type 1 Diabetes (Mean +/- Standard Deviation)

Figure 6: Change from Baseline DLco (mL/min/mmHg) in Patients with Type 2 Diabetes (Mean +/- Standard Deviation)

Following 2 years of Exubera treatment, the difference between treatment groups for the mean change from baseline DLCO was approximately 0.5mL/min/mmHg (type 1 diabetes), favoring the comparator, and approximately 0.1mL/min/mmHg (type 2 diabetes), favoring Exubera.

During the two-year clinical trials, individual patients experienced notable declines in pulmonary function in both treatment groups. A decline from baseline FEV1 of ≥ 20% at last observation occurred in 1.5% of Exubera-treated and 1.3% of comparator-treated patients. A decline from baseline DLCO of ≥ 20% at last observation occurred in 5.1% of Exubera-treated and 3.6% of comparator treated patients.

Side Effects by Body System

Respiratory

Respiratory side effects have included respiratory tract infection, increased cough, pharyngitis, rhinitis, sinusitis, dyspnea, increased sputum, bronchitis, epistaxis, laryngitis, pneumonia, and voice alteration. In clinical trials up to two years duration, patients treated with insulin inhalation demonstrated a greater decline in pulmonary function, specifically the forced expiratory volume in one second (FEV1) and the carbon monoxide diffusing capacity (DLCO), than comparator-treated patients. The mean treatment group difference in pulmonary function favoring the comparator group, was noted within the first several weeks of treatment with insulin inhalation, and did not change over the two-year treatment period.

Metabolic

Metabolic side effects have included hypoglycemia.

Gastrointestinal

Gastrointestinal side effects have included dry mouth.

General

General side effects have included chest pain.

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