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Boniva (Ibandronate Sodium) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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Clinical Trials Experience

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

Treatment and Prevention of Postmenopausal Osteoporosis

Daily Dosing

The safety of BONIVA 2.5 mg once daily in the treatment and prevention of postmenopausal osteoporosis was assessed in 3577 patients aged 41 – 82 years. The duration of the trials was 2 to 3 years, with 1134 patients exposed to placebo and 1140 exposed to BONIVA 2.5 mg. Patients with pre-existing gastrointestinal disease and concomitant use of non-steroidal anti-inflammatory drugs, proton pump inhibitors and H2 antagonists were included in these clinical trials. All patients received 500 mg calcium plus 400 IU vitamin D supplementation daily.

The incidence of all-cause mortality was 1% in the placebo group and 1.2% in the BONIVA 2.5 mg daily group. The incidence of serious adverse events was 20% in the placebo group and 23% in the BONIVA 2.5 mg daily group. The percentage of patients who withdrew from treatment due to adverse events was approximately 17% in both the BONIVA 2.5 mg daily group and the placebo group. Table 1 lists adverse events from the treatment and prevention studies reported in ≥2% of patients and more frequently in patients treated daily with BONIVA than patients treated with placebo.

Table 1 Adverse Events Occurring at a Frequency ≥2% and More Frequently in Patients Treated with BONIVA than in Patients Treated with Placebo Daily in the Osteoporosis Treatment and Prevention Studies
Body System Placebo
%
(n=1134)
BONIVA 2.5 mg
%
(n=1140)
Body as a Whole

Back Pain 12.2 13.5
Pain in Extremity 6.4 7.8
Infection 3.4 4.3
Asthenia 2.3 3.5
Allergic Reaction 1.9 2.5
Digestive System

Dyspepsia 9.8 11.9
Diarrhea 5.0 6.8
Tooth Disorder 2.3 3.5
Vomiting 2.1 2.7
Gastritis 1.9 2.2
Metabolic and Nutritional Disorders

Hypercholesterolemia 4.2 4.8
Musculoskeletal System

Myalgia 5.1 5.7
Joint Disorder 3.3 3.6
Arthritis 2.7 3.2
Nervous System

Headache 5.8 6.5
Dizziness 2.6 3.7
Vertigo 2.5 3.0
Nerve Root Lesion 1.9 2.2
Respiratory System

Upper Respiratory Infection 33.2 33.7
Bronchitis 6.8 10.0
Pneumonia 4.3 5.9
Pharyngitis 1.5 2.5
Urogenital System

Urinary Tract Infection 4.2 5.5

Gastrointestinal Adverse Events

The incidence of adverse events in the placebo and BONIVA 2.5 mg daily groups were: dyspepsia (10% vs. 12%), diarrhea (5% vs. 7%), and abdominal pain (5% vs. 6%).

Musculoskeletal Adverse Events

The incidence of adverse events in the placebo and BONIVA 2.5 mg daily groups were: back pain (12% vs. 14%), arthralgia (14% vs. 14%) and myalgia (5% vs. 6%).

Ocular Adverse Events

Reports in the medical literature indicate that bisphosphonates may be associated with ocular inflammation such as iritis and scleritis. In some cases, these events did not resolve until the bisphosphonate was discontinued. There were no reports of ocular inflammation in studies with BONIVA 2.5 mg daily.

Monthly Dosing

The safety of BONIVA 150 mg once monthly in the treatment of postmenopausal osteoporosis was assessed in a two year trial which enrolled 1583 patients aged 54 – 81 years, with 395 patients exposed to BONIVA 2.5 mg daily and 396 exposed to BONIVA 150 mg monthly. Patients with active or significant pre-existing gastrointestinal disease were excluded from this trial. Patients with dyspepsia or concomitant use of non-steroidal anti-inflammatory drugs, proton pump inhibitors and H2 antagonists were included in this study. All patients received 500 mg calcium plus 400 IU vitamin D supplementation daily.

After one year, the incidence of all-cause mortality was 0.3% in both the BONIVA 2.5 mg daily group and the BONIVA 150 mg monthly group. The incidence of serious adverse events was 5% in the BONIVA 2.5 mg daily group and 7% in the BONIVA 150 mg monthly group. The percentage of patients who withdrew from treatment due to adverse events was 9% in the BONIVA 2.5 mg daily group and 8% in the BONIVA 150 mg monthly group. Table 2 lists the adverse events reported in ≥2% of patients.

Table 2 Adverse Events with an Incidence of at Least 2% in Patients Treated with BONIVA 2.5 mg Daily or 150 mg Once-Monthly for Treatment of Postmenopausal Osteoporosis
Body System/Adverse Event BONIVA
2.5 mg Daily
%
(n=395)
BONIVA
150 mg Monthly
%
(n=396)
Vascular Disorders

Hypertension 7.3 6.3
Gastrointestinal Disorders

Dyspepsia 7.1 5.6
Nausea 4.8 5.1
Diarrhea 4.1 5.1
Constipation 2.5 4.0
Abdominal Pain * 5.3 7.8
Musculoskeletal and Connective Tissue Disorders

Arthralgia 3.5 5.6
Back Pain 4.3 4.5
Pain in Extremity 1.3 4.0
Localized Osteoarthritis 1.3 3.0
Myalgia 0.8 2.0
Muscle Cramp 2.0 1.8
Infections and Infestations

Influenza 3.8 4.0
Nasopharyngitis 4.3 3.5
Bronchitis 3.5 2.5
Urinary Tract Infection 1.8 2.3
Upper Respiratory Tract Infection 2.0 2.0
Nervous System Disorders

Headache 4.1 3.3
Dizziness 1.0 2.3
General Disorders and Administration Site Conditions

Influenza-like Illness † 0.8 3.3
Skin and Subcutaneous Tissue Disorders

Rash ‡ 1.3 2.3
Psychiatric Disorders

Insomnia 0.8 2.0
* Combination of abdominal pain and abdominal pain upper † Combination of influenza-like illness and acute phase reaction ‡ Combination of rash pruritic, rash macular, rash papular, rash generalized, rash erythematous, dermatitis, dermatitis allergic, dermatitis medicamentosa, erythema and exanthem


Gastrointestinal Adverse Events

The incidence of adverse events in the BONIVA 2.5 mg daily and BONIVA 150 mg monthly groups were: dyspepsia (7% vs. 6%), diarrhea (4% vs. 5%), and abdominal pain (5% vs. 8%).

Musculoskeletal Adverse Events

The incidence of adverse events in the BONIVA 2.5 mg daily and BONIVA 150 mg monthly groups were: back pain (4% vs. 5%), arthralgia (4% vs. 6%) and myalgia (1% vs. 2%).

Acute Phase Reactions

Symptoms consistent with acute phase reactions have been reported with bisphosphonate use. Over the two years of the study, the overall incidence of acute phase reaction symptoms was 3% in the BONIVA 2.5 mg daily group and 9% in the BONIVA 150 mg monthly group. These incidence rates are based on the reporting of any of 33 acute-phase reaction like symptoms within 3 days of the monthly dosing and lasting 7 days or less. Influenza like illness was reported in no patients in the BONIVA 2.5 mg daily group and 2% in the BONIVA 150 mg monthly group.

Ocular Adverse Events

Two patients who received BONIVA 150 mg once-monthly experienced ocular inflammation, one was a case of uveitis and the other scleritis.

One hundred sixty (160) postmenopausal women without osteoporosis participated in a 1-year, double-blind, placebo-controlled study of BONIVA 150 mg once-monthly for prevention of bone loss. Seventy-seven subjects received BONIVA and 83 subjects received placebo. The overall pattern of adverse events was similar to that previously observed.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of BONIVA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hypersensitivity

Allergic reactions including anaphylaxis, angioedema, bronchospasm and rash have been reported (see CONTRAINDICATIONS [4] ).

Hypocalcemia

Hypocalcemia has been reported in patients treated with BONIVA (see WARNINGS AND PRECAUTIONS [5.2]).

Musculoskeletal Pain

Bone, joint, or muscle pain (musculoskeletal pain), described as severe or incapacitating, has been reported (see WARNINGS AND PRECAUTIONS [5.3] ).

Jaw Osteonecrosis

Osteonecrosis of the jaw has been reported in patients treated with BONIVA (see WARNINGS AND PRECAUTIONS [5.4] ).



REPORTS OF SUSPECTED BONIVA SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Boniva side effects / adverse reactions in 62 year old female

Reported by a physician from United States on 2011-10-04

Patient: 62 year old female weighing 82.0 kg (180.4 pounds)

Reactions: Vitamin D Deficiency, Femur Fracture, Osteoporosis, Cyst, Fall, Arthropathy, Uterine Leiomyoma, Blood Cholesterol Increased, Exostosis, Pain in Extremity, Bursitis, Breast Calcifications, Joint Injury, Osteoarthritis, Diverticulum, Ventricular Tachycardia, Presyncope, Hypothyroidism, Tooth Disorder, Arthritis, Hypertension

Adverse event resulted in: hospitalization

Suspect drug(s):
Fosamax Plus D
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2007-10-01
    End date: 2008-01-01

Boniva
    Indication: Prophylaxis
    Start date: 2008-01-01
    End date: 2008-09-01

Fosamax
    Administration route: Oral
    Start date: 1997-01-01

Fosamax Plus D
    Administration route: Oral
    Indication: Osteopenia
    Start date: 2007-10-01
    End date: 2008-01-01

Fosamax
    Administration route: Oral
    Start date: 1997-01-01

Fosamax
    Administration route: Oral
    Indication: Osteopenia
    Start date: 1997-01-01
    End date: 2007-10-01

Fosamax
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 1997-01-01
    End date: 2007-10-01

Other drugs received by patient: Calcium (Unspecified) and Vitamin D (Unspecified); Chondroitin; OS-CAL; Ambien; Vitamins (Unspecified); Voltaren; Lovenox; Colace; Iron (Unspecified); Dimethyl Sulfone; Glucosamine; Chondroitin Sulfate Sodium and Glucosamine Sulfate; Cranberry; Aspirin; Centrum; Ubidecarenone



Possible Boniva side effects / adverse reactions in 62 year old female

Reported by a physician from United States on 2011-10-04

Patient: 62 year old female weighing 63.0 kg (138.6 pounds)

Reactions: Femur Fracture, Tinnitus, Fall, External Ear Disorder, Hot Flush, Chest Pain, Blood Cholesterol Increased, Oedema, Depression, LOW Turnover Osteopathy, Cellulitis, Nausea, DRY Skin, Scotoma, Stress, Gastric Disorder, Osteoarthritis, Anxiety, Tonsillar Disorder, Diarrhoea, Insomnia, Stress Fracture, Arthritis, Tooth Disorder, Eustachian Tube Disorder, Inflammatory Bowel Disease

Adverse event resulted in: hospitalization, disablity

Suspect drug(s):
Fosamax
    Administration route: Oral
    Indication: Osteopenia
    Start date: 2003-01-01
    End date: 2009-02-01

Fosamax Plus D
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2006-01-24

Fosamax Plus D
    Administration route: Oral
    Indication: Osteopenia
    Start date: 2006-01-24

Alendronate Sodium
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2009-05-08
    End date: 2010-02-01

Boniva
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2010-02-01
    End date: 2010-12-01

Alendronate Sodium
    Administration route: Oral
    Indication: Osteopenia
    Start date: 2009-05-08
    End date: 2010-02-01

Fosamax
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2003-01-01
    End date: 2009-02-01

Boniva
    Administration route: Oral
    Indication: Osteopenia
    Start date: 2010-02-01
    End date: 2010-12-01

Other drugs received by patient: Hormones (Unspecified)



Possible Boniva side effects / adverse reactions in 64 year old female

Reported by a physician from United States on 2011-10-04

Patient: 64 year old female weighing 55.0 kg (121.0 pounds)

Reactions: Polymyalgia Rheumatica, Vitamin D Deficiency, Abdominal Pain, Gingivitis, Femur Fracture, Breast Cyst, Upper Respiratory Tract Infection, Dyspepsia, Irritable Bowel Syndrome, Bone Density Decreased, Tendonitis, Anaemia Postoperative, Gingival Bleeding, Haematuria, Ovarian Cyst, Osteomalacia, Urine Calcium Increased, Intermittent Claudication, Gastrointestinal Disorder, Stress Fracture, Vision Blurred, Essential Hypertension, Adverse Drug Reaction, Pelvic Pain, Fall, Hypokalaemia, Myalgia, Foot Fracture, Adnexa Uteri Cyst, Bone Loss, Neuropathy Peripheral, Perineurial Cyst, Calcium Deficiency, Tooth Fracture, Nausea, Dental Caries, Hyponatraemia, Cystitis, Anxiety, Osteoarthritis, Hyperlipidaemia, Impaired Healing, Diarrhoea, Arthralgia

Adverse event resulted in: hospitalization

Suspect drug(s):
Fosamax
    Administration route: Oral
    Start date: 1999-07-01

Fosamax
    Administration route: Oral
    Start date: 1999-07-01

Fosamax
    Administration route: Oral
    Indication: Senile Osteoporosis
    Start date: 2001-01-14
    End date: 2006-07-02

Boniva
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2006-09-01
    End date: 2008-08-30

Fosamax
    Administration route: Oral
    Indication: Osteopenia
    Start date: 2001-01-14
    End date: 2006-07-02

Other drugs received by patient: Calcium (Unspecified); Cholecalciferol; Vitamin E; Estradiol; Sodium (Unspecified)



See index of all Boniva side effect reports >>

Drug label data at the top of this Page last updated: 2010-12-02

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