ACANYA SIDE EFFECTS
- Generic Name: clindamycin phosphate 1.2% and benzoyl peroxide 2.5%
- Brand Name: Acanya Gel
- Drug Class: Acne Agents, Topical Combos
SIDE EFFECTS
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reactions observed in the clinical trials of a drug cannot always be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The following selected adverse reactions occurred in less than 0.2% of subjects treated with ACANYA Gel: application site pain (0.1%); application site exfoliation (0.1%); and application site irritation (0.1%).
During clinical trials, subjects were assessed for local cutaneous signs and symptoms of erythema, scaling, itching, burning and stinging. Most local skin reactions increased and peaked around Week 4 and continually decreased over time reaching near baseline levels by Week 12. The percentage of subjects that had symptoms present before treatment, the maximum value recorded during treatment, and the percent with symptoms present at Week 12 are shown in Table 1.
Table 1: Percent of Subjects with Local Skin Reactions. Combined Results from the Two Phase 3 Trials (N = 773)
| Before Treatment (Baseline) | Maximum During Treatment | End of Treatment (Week 12) | |||||||
| Mild | Mod.* | Severe | Mild | Mod.* | Severe | Mild | Mod.* | Severe | |
| Erythema | 22 | 4 | 0 | 25 | 5 | < 1 | 15 | 2 | 0 |
| Scaling | 8 | < 1 | 0 | 18 | 3 | 0 | 8 | 1 | 0 |
| Itching | 10 | 2 | 0 | 15 | 2 | 0 | 6 | < 1 | 0 |
| Burning | 3 | < 1 | 0 | 8 | 2 | 0 | 2 | < 1 | 0 |
| Stinging | 2 | < 1 | 0 | 6 | 1 | 0 | 1 | < 1 | 0 |
| *Mod. = Moderate | |||||||||
Postmarketing Experience
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.
Anaphylaxis, as well as allergic reactions leading to hospitalizations, has been reported in postmarketing use of products containing clindamycin/benzoyl peroxide.
DRUG INTERACTIONS
Erythromycin
ACANYA Gel should not be used in combination with topical or oral erythromycin-containing products due to its clindamycin component. In vitro studies have shown antagonism between erythromycin and clindamycin. The clinical significance of this in vitro antagonism is not known.
Neuromuscular Blocking Agents
Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, ACANYA Gel should be used with caution in patients receiving such agents.