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Fosamax Plus D (Alendronate Sodium / Cholecalciferol) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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.

FOSAMAX

FOSAMAX has been evaluated for safety in approximately 8000 postmenopausal women in clinical studies.

Postmenopausal women

FOSAMAX daily

In two identically designed, three-year, placebo-controlled, double-blind, multicenter studies (United States and Multinational; n=994), discontinuation of therapy due to any clinical adverse experience occurred in 4.1% of 196 patients treated with FOSAMAX 10 mg/day and 6.0% of 397 patients treated with placebo. In the Fracture Intervention Trial (n=6459), discontinuation of therapy due to any clinical adverse experience occurred in 9.1% of 3236 patients treated with FOSAMAX 5 mg/day for 2 years and 10 mg/day for either one or two additional years and 10.1% of 3223 patients treated with placebo. Discontinuations due to upper gastrointestinal adverse experiences were: FOSAMAX, 3.2%; placebo, 2.7%. In these study populations, 49-54% had a history of gastrointestinal disorders at baseline and 54-89% used nonsteroidal anti-inflammatory drugs or aspirin at some time during the studies. Adverse experiences from these studies considered by the investigators as possibly, probably, or definitely drug related in ≥1% of patients treated with either FOSAMAX or placebo are presented in Table 1.

Table 1: Osteoporosis Treatment Studies in Postmenopausal Women: Adverse Experiences Considered Possibly, Probably, or Definitely Drug Related by the Investigators and Reported in ≥1% of Patients
United States/Multinational StudiesFracture Intervention Trial
FOSAMAX 1
%
(n=196)
Placebo
%
(n=397)
FOSAMAX 2
%
(n=3236)
Placebo
%
(n=3223)
Gastrointestinal
    abdominal pain
    nausea
    dyspepsia
    constipation
    diarrhea
    flatulence
    acid regurgitation
    esophageal ulcer
    vomiting
    dysphagia
    abdominal distention
    gastritis

6.6
3.6
3.6
3.1
3.1
2.6
2.0
1.5
1.0
1.0
1.0
0.5

4.8
4.0
3.5
1.8
1.8
0.5
4.3
0.0
1.5
0.0
0.8
1.3

1.5
1.1
1.1
0.0
0.6
0.2
1.1
0.1
0.2
0.1
0.0
0.6

1.5
1.5
1.2
0.2
0.3
0.3
0.9
0.1
0.3
0.1
0.0
0.7
Musculoskeletal
    musculoskeletal (bone,        muscle or joint) pain
    muscle cramp


4.1
0.0


2.5
1.0


0.4
0.2


0.3
0.1
Nervous System/Psychiatric
    headache
    dizziness

2.6
0.0

1.5
1.0

0.2
0.0

0.2
0.1
Special Senses
    taste perversion

0.5

1.0

0.1

0.0

1 10 mg/day for three years
2 5 mg/day for 2 years and 10 mg/day for either 1 or 2 additional years

Rarely, rash and erythema have occurred.

The adverse experience profile was similar for the 401 patients treated with either 5- or 20-mg doses of FOSAMAX in the United States and Multinational studies. The adverse experience profile for the 296 patients who received continued treatment with either 5- or 10-mg doses of FOSAMAX in the two-year extension of these studies (treatment years 4 and 5) was similar to that observed during the three-year placebo-controlled period. During the extension period, of the 151 patients treated with FOSAMAX 10 mg/day, the proportion of patients who discontinued therapy due to any clinical adverse experience was similar to that during the first three years of the study.

FOSAMAX once-weekly

In a one-year, double-blind, multicenter study, the overall safety and tolerability profiles of once weekly FOSAMAX 70 mg and FOSAMAX 10 mg daily were similar. The adverse experiences considered by the investigators as possibly, probably, or definitely drug related in ≥1% of patients in either treatment group are presented in Table 2.

Table 2: Osteoporosis Treatment Studies in Postmenopausal Women: Adverse Experiences Considered Possibly, Probably, or Definitely Drug Related by the Investigators and Reported in ≥1% of Patients
Once Weekly FOSAMAX
70 mg
%
(n=519)
FOSAMAX
10 mg/day
%
(n=370)
Gastrointestinal  
    abdominal pain 
    dyspepsia 
    acid regurgitation
    nausea
    abdominal distention
    constipation
    flatulence
    gastritis
    gastric ulcer

3.7
2.7
1.9
1.9
1.0
0.8
0.4
0.2
0.0

3.0
2.2
2.4
2.4
1.4
1.6
1.6
1.1
1.1
Musculoskeletal
    musculoskeletal (bone, muscle,
        joint) pain
    muscle cramp

2.9

0.2

3.2

1.1

Concomitant use with estrogen or estrogen/progestin products

In two studies (of one and two years’ duration) of postmenopausal osteoporotic women (total: n=853), the safety and tolerability profile of combined treatment with FOSAMAX 10 mg once daily and estrogen ± progestin (n=354) was consistent with those of the individual treatments.

Men

In two placebo-controlled, double-blind, multicenter studies in men (a two-year study of FOSAMAX 10 mg/day and a one-year study of once weekly FOSAMAX 70 mg) the rates of discontinuation of therapy due to any clinical adverse experience were 2.7% for FOSAMAX 10 mg/day vs. 10.5% for placebo, and 6.4% for once weekly FOSAMAX 70 mg vs. 8.6% for placebo. The adverse experiences considered by the investigators as possibly, probably, or definitely drug related in ≥2% of patients treated with either FOSAMAX or placebo are presented in Table 3.

Table 3: Osteoporosis Studies in Men: Adverse Experiences Considered Possibly, Probably, or Definitely Drug Related by the Investigators and Reported in ≥2% of Patients
Two-year StudyOne-year Study

FOSAMAX
10 mg/day
%
(n=146)

Placebo
%
(n=95)
Once Weekly FOSAMAX 70 mg
%
(n=109)

Placebo
%
(n=58)
Gastrointestinal
    acid regurgitation
    flatulence
    gastroesophageal
          reflux disease
    dyspepsia
    diarrhea
    abdominal pain
    nausea

4.1
4.1
0.7

3.4
1.4
2.1
2.1

3.2
1.1
3.2

0.0
1.1
1.1
0.0

0.0
0.0
2.8

2.8
2.8
0.9
0.0

0.0
0.0
0.0

1.7
0.0
3.4
0.0

Laboratory Test Findings

In double-blind, multicenter, controlled studies, asymptomatic, mild, and transient decreases in serum calcium and phosphate were observed in approximately 18% and 10%, respectively, of patients taking FOSAMAX versus approximately 12% and 3% of those taking placebo. However, the incidences of decreases in serum calcium to <8.0 mg/dL (2.0 mM) and serum phosphate to ≤2.0 mg/dL (0.65 mM) were similar in both treatment groups.

FOSAMAX PLUS D

In a fifteen-week double-blind, multinational study in osteoporotic postmenopausal women (n=682) and men (n=35), the safety profile of FOSAMAX PLUS D (70 mg/2800 IU) was similar to that of FOSAMAX once weekly 70 mg. In the 24-week double-blind extension study in women (n=619) and men (n=33), the safety profile of FOSAMAX PLUS D (70 mg/2800 IU) administered with an additional 2800 IU vitamin D3 was similar to that of FOSAMAX PLUS D (70 mg/2800 IU).

Post-Marketing Experience

The following adverse reactions have been identified during post-approval use of FOSAMAX and FOSAMAX PLUS D. 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.

Body as a Whole: hypersensitivity reactions including urticaria and rarely angioedema. Transient symptoms of myalgia, malaise, asthenia and rarely, fever have been reported with alendronate, typically in association with initiation of treatment. Rarely, symptomatic hypocalcemia has occurred, generally in association with predisposing conditions. Rarely, peripheral edema.

Gastrointestinal: esophagitis, esophageal erosions, esophageal ulcers, rarely esophageal stricture or perforation, and oropharyngeal ulceration. Gastric or duodenal ulcers, some severe and with complications have also been reported [see Dosage and Administration; Warnings and Precautions; Patient Counseling Information].

Localized osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection, often with delayed healing, has been reported rarely [see Warnings and Precautions].

Musculoskeletal: bone, joint, and/or muscle pain, occasionally severe, and rarely incapacitating [see Warnings and Precautions]; joint swelling.

Nervous System: dizziness and vertigo.

Skin: rash (occasionally with photosensitivity), pruritus, alopecia, rarely severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis.

Special Senses: rarely uveitis, scleritis or episcleritis.



REPORTS OF SUSPECTED FOSAMAX PLUS D SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Fosamax Plus D side effects / adverse reactions in 77 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-03

Patient: 77 year old female weighing 90.0 kg (198.0 pounds)

Reactions: Vitamin D Deficiency, Asthma, Paronychia, Pruritus, Polyp Colorectal, Sciatica, Osteomyelitis, Gingival Abscess, Tricuspid Valve Incompetence, Erythema, Lumbar Spinal Stenosis, Chondropathy, Back Pain, Intervertebral Disc Protrusion, Pain in Extremity, Ear Disorder, Laceration, Lumbar Vertebral Fracture, Chondromalacia, Restless Legs Syndrome, Adverse Drug Reaction, Fall, Foot Fracture, Urinary Tract Disorder, Rotator Cuff Syndrome, Intervertebral Disc Degeneration, Bone Disorder, Exostosis, Scoliosis, Tooth Fracture, Cataract, Spondylolisthesis, Dental Caries, Drug Hypersensitivity, Rash, Facet Joint Syndrome, Radius Fracture, Osteoarthritis, Osteonecrosis of JAW, Radiculitis, Sinus Disorder, Bronchitis, Loose Tooth, Tooth Disorder, Oral Torus

Adverse event resulted in: hospitalization

Suspect drug(s):
Fosamax Plus D
    Administration route: Oral
    Indication: Osteopenia
    Start date: 2007-01-01
    End date: 2009-01-01

Fosamax
    Administration route: Oral
    Indication: Osteopenia
    Start date: 2003-01-01
    End date: 2005-01-01



Possible Fosamax Plus D side effects / adverse reactions in 59 year old female

Reported by a physician from United States on 2011-10-03

Patient: 59 year old female weighing 73.0 kg (160.6 pounds)

Reactions: Foot Deformity, Contusion, Femur Fracture, Sciatica, Fall, Myalgia, Foot Fracture, Intervertebral Disc Degeneration, LOW Turnover Osteopathy, Intervertebral Disc Protrusion, Rheumatoid Factor Positive, Urinary Tract Infection, Musculoskeletal Pain, Anaemia, Urethral Caruncle, Hyperlipidaemia, Osteoarthritis, Atrophic Vulvovaginitis, Essential Hypertension, LOW Density Lipoprotein Increased

Adverse event resulted in: hospitalization

Suspect drug(s):
Fosamax Plus D
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2002-01-01
    End date: 2002-01-01

Fosamax Plus D
    Administration route: Oral
    Indication: Osteopenia
    Start date: 2002-01-01
    End date: 2002-01-01

Fosamax
    Administration route: Oral
    Start date: 2006-09-01
    End date: 2008-10-01

Fosamax
    Administration route: Oral
    Start date: 2006-09-01
    End date: 2008-10-01

Fosamax Plus D
    Administration route: Oral
    Start date: 2006-08-01

Fosamax Plus D
    Administration route: Oral
    Start date: 2006-08-01

Fosamax
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2001-01-01
    End date: 2006-08-01

Fosamax
    Administration route: Oral
    Indication: Osteopenia
    Start date: 2001-01-01
    End date: 2006-08-01

Other drugs received by patient: Alendronate Sodium; Centrum; Alendronate Sodium



Possible Fosamax Plus D side effects / adverse reactions in 56 year old female

Reported by a physician from United States on 2011-10-03

Patient: 56 year old female weighing 75.0 kg (165.0 pounds)

Reactions: Thrombosis, Femur Fracture, Upper Limb Fracture, Arthropathy, Peroneal Nerve Palsy, Joint Effusion, Back Pain, Claustrophobia, Bursitis, Breast Calcifications, Pancreatitis Viral, Gastroenteritis Viral, Nerve Injury, Bunion, Joint Contracture, Hepatitis, Fracture Nonunion, Fall, Limb Crushing Injury, Foot Fracture, Intervertebral Disc Degeneration, Blood Cholesterol Increased, Exostosis, Pelvic Fracture, Gouty Arthritis, Vomiting, Nausea, Musculoskeletal Pain, Haemorrhoids, Drug Hypersensitivity, Muscular Weakness, Joint Dislocation, Appendix Disorder, Osteoarthritis, Skin Papilloma, Impaired Healing, Arthralgia, Gait Disturbance, Tooth Disorder

Adverse event resulted in: hospitalization, disablity

Suspect drug(s):
Fosamax Plus D
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2006-09-01
    End date: 2008-03-01

Fosamax
    Dosage: 1 x week
    Administration route: Oral
    Indication: Osteoporosis Prophylaxis
    Start date: 1998-01-01
    End date: 2006-09-01

Fosamax
    Dosage: 1 x week
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 1998-01-01
    End date: 2006-09-01

Fosamax
    Administration route: Oral
    Start date: 2008-02-07

Fosamax
    Administration route: Oral
    Start date: 2008-02-07

Other drugs received by patient: Primidone; Boniva; Calcium (Unspecified) and Vitamin D (Unspecified); Crestor; Vitamin D (Unspecified)



See index of all Fosamax Plus D side effect reports >>

Drug label data at the top of this Page last updated: 2008-04-08

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