Safety and Tolerability Compared to Placebo
The safety of CAMBIA was evaluated in 2 phase III, placebo-controlled trials with 1018 migraineurs.1
Treatment-related adverse events with incidence >1% and greater than placebo in the 2 phase III clinical studies combined.1
|Event||CAMBIA (n=634)||Placebo (n=646)|
- No patients withdrew due to a serious reaction1
- The most common adverse events resulting in discontinuation of patients following CAMBIA dosing in controlled clinical trials were urticaria (0.2%) and flushing (0.2%)1
- The majority of adverse events were mild to moderate and transient2,3
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS (CONTINUED)
Anemia has occurred in NSAID-treated patients. This may be due to occult or gross blood loss, fluid retention, or an incompletely described effect upon erythropoiesis. If a patient treated with CAMBIA has any signs or symptoms of anemia, monitor hemoglobin or hematocrit.
NSAIDs, including CAMBIA, may increase the risk of bleeding events. Concomitant use of warfarin and other anticoagulants, antiplatelet agents (e.g., aspirin), and serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs) may increase this risk. Monitor these patients and any patient who may be adversely affected by alterations in platelet function for signs of bleeding.
1. CAMBIA [package insert]. Newark, CA: Depomed, Inc; 2016. 2. Diener HC, Montagna P, Gács G, et al. Efficacy and tolerability of diclofenac potassium sachets in migraine: a randomized, double-blind, cross-over study in comparison with diclofenac potassium tablets and placebo. Cephalalgia. 2006;26(5):537-547. 3. Lipton RB, Grosberg B, Singer RP, et al. Efficacy and tolerability of a new powdered formulation of diclofenac potassium for oral solution for the acute treatment of migraine: results from the International Migraine Pain Assessment Clinical Trial (IMPACT). Cephalalgia. 2010;30(11):1336-1345.