A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Welchol Side Effects, and Drug Interactions - Colesevelam
Welchol Side Effects, and Drug Interactions - Colesevelam
SIDE EFFECTS
WelChol™ treatment-emergent adverse events that occurred in greater than 2%
of patients in an integrated safety analysis are presented in Table 4.
Table 4: Frequent (>2%) Treatment-Emergent Adverse
Events
By Treatment Category
BODY SYSTEM/
ADVERSE EVENT |
PLACEBO
(N=258)
% |
WELCHOL™ ONLY
(N=807)
% |
|
Body as a Whole
|
|
Infection
|
13 |
10 |
|
Headache
|
8 |
6 |
|
Pain
|
7 |
5 |
|
Back Pain
|
6 |
3 |
|
Abdominal Pain
|
5 |
5 |
|
Flu Syndrome
|
3 |
3 |
|
Accidental Injury
|
3 |
4 |
|
Asthenia
|
2 |
4 |
|
Digestive System
|
|
Flatulence
|
14 |
12 |
|
Constipation
|
7 |
11 |
|
Diarrhea
|
7 |
5 |
|
Nausea
|
4 |
4 |
|
Dyspepsia
|
3 |
8 |
|
Respiratory System
|
|
Sinusitis
|
4 |
2 |
|
Rhinitis
|
3 |
3 |
|
Cough Increased
|
2 |
2 |
|
Pharyngitis
|
2 |
3 |
|
Musculoskeletal System
|
|
Myalgia
|
0 |
2 |
DRUG INTERACTIONS
WelChol™ has been studied in several human drug interaction studies in which
it was administered with a meal and the test drug. WelChol™ was found to have
no significant effect on the bioavailability of digoxin, lovastatin, metoprolol,
quinidine, valproic acid, and warfarin. WelChol™ decreased the Cmax and AUC
of sustained-release verapamil (Calan SR®) by approximately 31% and 11%, respectively.
Since there is a high degree of variability in the bioavailability of verapamil,
the clinical significance of this finding is unclear. In clinical studies, coadministration
of WelChol™ with atorvastatin, lovastatin, or simvastatin did not interfere
with the lipid-lowering activity of the HMG-CoA reductase inhibitor. Other drugs
have not been studied. When administering other drugs for which alterations
in blood levels could have a clinically significant effect on safety or efficacy,
physicians should consider monitoring drug levels or effects.
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