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Adverse Reactions in Clinical Trials
Because clinical trials are conducted under widely varying conditions, adverse reaction rate observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In the pivotal clinical trials, adverse reactions were primarily mild to moderate in intensity, occurring in 66% and 30% of patients, respectively. The majority of these events were limited to the skin and 64% had an onset of a skin related adverse reaction early in treatment (by week 8). The most frequent adverse reactions in patients treated with Solagé were erythema (49% of patients), burning, stinging, or tingling (26%), desquamation (14%), pruritus (12%), and skin irritation (5%). Some patients experienced temporary hypopigmentation of treated lesions (5%) or of the skin surrounding treated lesions (7%). Ninety-four of 106 patients (89%) had resolution of hypopigmentation upon discontinuation of treatment to the lesion, and/or re-instruction on proper application to the lesion only. Another 8% (9/106) of patients with hypopigmentation events had resolution within 120 days after the end of treatment. Three of the 106 patients (2.8%) had persistence of hypopigmentation beyond 120 days. Approximately 6% of patients discontinued study participation with Solagé due to adverse reactions. These discontinuations were due primarily to skin redness (erythema) or related cutaneous adverse reactions. Rare cases of depigmentation at sites distant from the application have been reported in Post Marketing Surveillance.
|Adverse Events Occurring in > 1% of the Population – All Studies|
|Body System||Solagé (mequinol 2% tretinoin 0.01%)||Tretinoin, 0.01%||Mequinol, 2%,||Vehicle|
|Skin and Appendages||N||%||N||%||N||%||N||%|
|Rash Vesicular Bullae||18||1.2||8||1.7||0||0.0||0||0.0|
|*In study RD.06.SRE.18091 irritant dermatitis included signs & symptoms of scaling, dryness, stinging/burning, and erythema.|
The following adverse reactions have been reported during post-approval use of Solagé: skin discoloration, erythema, skin exfoliation, skin irritation, and skin burning sensation. 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.
Read the Solage (mequinol and tretinoin) Side Effects Center for a complete guide to possible side effects
Concomitant topical products with a strong skin drying effect, products with high concentrations of alcohol, astringents, spices or lime, medicated soaps or shampoos, permanent wave solutions, electrolysis, hair depilatories or waxes, or other preparations that might dry or irritate the skin should be used with caution in patients being treated with Solagé because they may increase irritation when used with Solagé.
Solagé should not be administered if the patient is also taking drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of augmented phototoxicity.
Read the Solage Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 1/19/2010
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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