Forteo (Teriparatide) - Side Effects and Adverse Reactions

ADVERSE EVENTS

The safety of teriparatide has been evaluated in 24 clinical trials that enrolled over 2800 women and men. Four long–term Phase 3 clinical trials included 1 large placebo–controlled, double–blind, multinational trial with 1637 postmenopausal women; 1 placebo–controlled, double–blind, multinational trial with 437 men; and 2 active–controlled trials including 393 postmenopausal women. Teriparatide doses ranged from 5 to 100 mcg/day in short–term trials and 20 to 40 mcg/day in the other trials. A total of 1943 of the patients studied received teriparatide, including 815 patients at 20 mcg/day and 1107 patients at 40 mcg/day. In the clinical trials, a total of 1432 patients were treated with teriparatide for 3 months to 2 years, of whom 1137 were treated for greater than 1 year (500 at 20 mcg/day and 637 at 40 mcg/day). The maximum duration of treatment was 2 years. Adverse events associated with FORTEO usually were mild and generally did not require discontinuation of therapy.

In the two Phase 3 placebo–controlled clinical trials in men and postmenopausal women, early discontinuation due to adverse events occurred in 5.6% of patients assigned to placebo and 7.1% of patients assigned to FORTEO. Reported adverse events that appeared to be increased by FORTEO treatment were dizziness and leg cramps.

Table 5 lists adverse events that occurred in the two Phase 3 placebo–controlled clinical trials in men and postmenopausal women at a frequency ≥2.0% in the FORTEO groups and in more FORTEO–treated patients than in placebo–treated patients, without attribution of causality.

Table 5. Percentage of Patients with Adverse Events Reported by at Least 2% of FORTEO-Treated Patients and in More FORTEO-Treated Patients than Placebo-Treated Patients from the Two Principal Osteoporosis Trials in Women and Men Adverse Events are Shown Without Attribution of Causality

	FORTEO N=691	Placebo N=691
Event Classification	(%)	(%)
Body as a Whole
Pain	21.3	20.5
Headache	7.5	7.4
Asthenia	8.7	6.8
Neck pain	3.0	2.7
Cardiovascular
Hypertension	7.1	6.8
Angina pectoris	2.5	1.6
Syncope	2.6	1.4
Digestive System
Nausea	8.5	6.7
Constipation	5.4	4.5
Diarrhea	5.1	4.6
Dyspepsia	5.2	4.1
Vomiting	3.0	2.3
Gastrointestinal disorder	2.3	2.0
Tooth disorder	2.0	1.3
Musculoskeletal
Arthralgia	10.1	8.4
Leg cramps	2.6	1.3
Nervous System
Dizziness	8.0	5.4
Depression	4.1	2.7
Insomnia	4.3	3.6
Vertigo	3.8	2.7
Respiratory System
Rhinitis	9.6	8.8
Cough increased	6.4	5.5
Pharyngitis	5.5	4.8
Dyspnea	3.6	2.6
Pneumonia	3.9	3.3
Skin and Appendages
Rash	4.9	4.5
Sweating	2.2	1.7

Serum calcium — FORTEO transiently increases serum calcium, with the maximal effect observed at approximately 4 to 6 hours post–dose. Serum calcium measured at least 16 hours post–dose was not different from pretreatment levels. In clinical trials, the frequency of at least 1 episode of transient hypercalcemia in the 4 to 6 hours after FORTEO administration was increased from 1.5% of women and none of the men treated with placebo to 11.1% of women and 6.0% of men treated with FORTEO. The number of patients treated with FORTEO whose transient hypercalcemia was verified on consecutive measurements was 3.0% of women and 1.3% of men.

Immunogenicity — In a large clinical trial, antibodies that cross–reacted with teriparatide were detected in 2.8% of women receiving FORTEO. Generally, antibodies were first detected following 12 months of treatment and diminished after withdrawal of therapy. There was no evidence of hypersensitivity reactions, allergic reactions, effects on serum calcium, or effects on BMD response.

Postmarketing Reports

Since market introduction, adverse events reported have included:

• Possible allergic events soon after injection: acute dyspnea, oro/facial edema, generalized urticaria, chest pain (less than 1 in 1000 patients treated).

• Hypercalcemia greater than 2.76 mmol/L (11 mg/dL) (less than 1 in 100 patients treated); hypercalcemia greater than 3.25 mmol/L (13 mg/dL) (less than 1 in 1000 patients treated).

• Injection site and injection technique events including pain, swelling, erythema, localized bruising, pruritus and minor bleeding at the injection site (less than 1 in 30 patients treated). These usually have been mild and transient.

• Muscle spasms, such as of the leg or back, are reported commonly (between 1 and 10 patients per 100 patients treated), sometimes shortly after the first dose. Serious back spasms have been reported very rarely (less than 1 in 10,000 patients treated).

REPORTS OF SUSPECTED FORTEO SIDE EFFECTS / ADVERSE REACTIONS

Possible Forteo side effects / adverse reactions in 73 year old female

Reported by a consumer/non-health professional from Germany on 2011-10-03

Patient: 73 year old female

Reactions: Dyspnoea, Listless, Nausea, Bone Pain, Arrhythmia, Myalgia, Sleep Disorder, Arthralgia, Heart Rate Increased, Dizziness, Depression, Asthenia, Heart Rate Abnormal, Muscle Spasms

Suspect drug(s):
Forteo

Other drugs received by patient: Vitamin D; Diclofenac Sodium; Calcium Carbonate

Possible Forteo side effects / adverse reactions in 73 year old female

Reported by a consumer/non-health professional from Germany on 2011-10-03

Patient: 73 year old female

Reactions: Femoral Neck Fracture, Fall

Adverse event resulted in: hospitalization

Suspect drug(s):
Forteo
    Dosage: unk, qd
    Start date: 2011-06-01
    End date: 2011-08-01

Forteo
    Dosage: unk, qd
    Indication: Osteoporosis
    Start date: 2010-06-21
    End date: 2011-04-01

Other drugs received by patient: Magnesium; Iron; Calcium +vit D

Possible Forteo side effects / adverse reactions in 79 year old female

Reported by a consumer/non-health professional from Japan on 2011-10-03

Patient: 79 year old female

Reactions: Nasopharyngitis, Lung Disorder

Suspect drug(s):
Forteo