ADVERSE REACTIONS
In a placebo-controlled study with a treatment duration of two weeks, the adverse events reported for Renagel Capsules (N=24) were similar to those reported for placebo (N=12). In a cross-over study with treatment durations of eight weeks each, the adverse events reported for Renagel Capsules (N=82) were similar to those reported for calcium acetate (N=82) and included headache, infection, pain, hypertension, hypotension, thrombosis, diarrhea, dyspepsia, vomiting, and cough increased. In a parallel design study with treatment duration of 52 weeks, adverse events reported for Renagel Tablets (N=99) were similar to those reported for calcium (calcium acetate and calcium carbonate) (N=101). (Table 3).
Table 3. Treatment-Emergent Adverse Events >/= 10 % from a Parallel Design Trial of Renagel Tablets versus Calcium for 52 Weeks of Treatment
|
Adverse Event
|
Renagel
(N=99) |
Calcium
(N=101) |
Patients
%
|
Patients
%
|
|
Gastrointestinal Disorders
|
|
Vomiting
|
22.2
|
21.8
|
|
Nausea
|
20.2
|
19.8
|
|
Diarrhea
|
19.2
|
22.8
|
|
Dyspepsia
|
16.2
|
6.9
|
|
Constipation
|
8.1
|
11.9
|
|
Infections and Infestations
|
|
Nasopharyngitis
|
14.1
|
7.9
|
|
Bronchitis
|
11.1
|
12.9
|
|
Upper Respiratory Tract Infection
|
5.1
|
10.9
|
|
Musculoskeletal, Connective Tissue and Bone Disorders
|
|
Pain in Limb
|
13.1
|
14.9
|
|
Arthralgia
|
12.1
|
17.8
|
|
Back Pain
|
4.0
|
17.8
|
|
Skin Disorders
|
|
Pruritus
|
13.1
|
9.9
|
|
Respiratory, Thoracic and Mediastinal Disorders
|
|
Dyspnea
|
10.1
|
16.8
|
|
Cough
|
7.1
|
12.9
|
|
Vascular Disorders
|
|
Hypertension
|
10.1
|
5.9
|
|
Nervous System Disorders
|
|
Headache
|
9.1
|
15.8
|
|
General Disorders and Site Administration Disorders
|
|
Mechanical Complication of Implant
|
6.1
|
10.9
|
|
Pyrexia
|
5.1
|
10.9
|
|
In the parallel design study, the major reason for drop out in the Renagel group was gastrointestinal adverse events. In a long-term, open-label extension trial, adverse events possibly related to Renagel Capsules and which were not dose-related, included nausea (7%), constipation (2%), diarrhea (4%), flatulence (4%), and dyspepsia (5%). During post-marketing experience, the following adverse events have been reported in patients receiving Renagel although no direct relationship to Renagel could be established: pruritis, rash, and abdominal pain.
|
