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The safety of Panretin® (alitretinoin) gel has been assessed in clinical studies of 385 patients with AIDS-related KS. Adverse events associated with the use of Panretin® (alitretinoin) gel in patients with AIDS-related KS occurred almost exclusively at the site of application. The dermal toxicity begins as erythema; with continued application of Panretin® (alitretinoin) gel, erythema may increase and edema may develop. Dermal toxicity may become treatment-limiting, with intense erythema, edema, and vesiculation. Usually, however, adverse events are mild to moderate in severity; they led to withdrawal from the study in only 7% of the patients. Severe local (application site) skin adverse events occurred in about 10% of patients in the U.S. study (versus 0% in the vehicle control). Table 2 lists the adverse events that occurred at the application site with an incidence of at least 5% during the double-blind phase in the Panretin® (alitretinoin) gel-treated group and in the vehicle control group in either of the two controlled studies. Adverse events were reported at other sites but generally were similar in the two groups.

TABLE 2: Adverse Events with an Incidence of at Least 5% at the Application Site in Either Controlled Study in Patients Receiving Panretin® (alitretinoin) Gel or Vehicle Control

Adverse Event Term Study 1 Study 2
Panretin® (alitretinoin) Gel
N=134 Pts
.%
Vehicle Gel
N=134 Pts.
%
Panretin® (alitretinoin) Gel
N=36 Pts.
%
Vehicle Gel
N=46 Pts.
%
Rash1 77 11 25 4
Pain2 34 7 0 4
Pruritus3 11 4 8 4
Exfoliative dermatitis4 9 2 3 0
Skin disorder5 8 1 0 0
Paresthesia6 3 0 22 7
Edema7 8 3 3 0
Includes Investigator terms:
1Erythema, scaling, irritation, redness, rash, dermatitis
2Burning, pain
3Itching, pruritis
4Flaking, peeling, desquamation, exfoliation
5Excoriation, cracking, scab, crusting, drainage, eschar, fissure or oozing
6Stinging, tingling
7Edema, swelling, inflammation