Pimecrolimus (Elidel) Adverse Reactions
- infection
- lymphadenopathy
- rhinitis
- secondary malignancy
- skin irritation
- superinfection
- urticaria
Pimecrolimus (Elidel) Adverse Reactions
Localized symptoms (8 - 26%), such as feeling of warmth and/or burning and skin irritation, may result from the application of pimecrolimus cream, especially during the first few days of use. These symptoms improve as the atopic dermatitis resolves. Most application site reactions begin within 1 - 5 days of treatment, are mild to moderate in intensity, and last no more than 5 days.
An increased incidence of impetigo, skin infection, superinfection (infected atopic dermatitis), rhinitis and urticaria were found in patients that had used pimecrolimus cream and topical corticosteroids sequentially compared to those using pimecrolimus cream alone. Cases of skin papilloma infection or warts (1%) were observed in younger patients age 2 - 12 years using pimecrolimus cream. In cases where there is a worsening of skin papillomas or they do not respond to conventional therapy, discontinuation of pimecrolimus cream should be considered until there is complete resolution of the warts. During treatment with pimecrolimus cream an increased incidence of varicella zoster virus infection (chickenpox or shingles), herpes simplex infection, or eczema herpeticum has been noted.
During clinical trials, lymphadenopathy was reported during topical pimecrolimus treatment. These cases of lymphadenopathy were usually related to infections and resolved upon appropriate antibiotic therapy. A secondary malignancy, especially lymphomas and skin cancers, may develop in patients receiving pimecrolimus. As of December 2004, the FDA has received 10 post-marketing reports of cancer-related adverse events (6 cutaneous tumors, 1 lymph node/cutaneous tumor related event, and 3 unreported locations) associated with topical pimecrolimus use; 3 cases occurred in patients less than 6 years of age, and 6 cases occurred in adults. Two of the 10 cases were associated with lymphadenopathy. Four cases described lymphomas; 5 cases described a variety of tumors, including basal cell carcinoma and squamous cell carcinoma; and 1 case described granulomatous lymphadenitis. The median time until diagnosis after initiation of treatment with Elidel® was 90 days (range, 7 - 300 days). Due to the post-marketing nature of the reports, a causal relationship between cancer development and topical pimecrolimus has not been established; the role of topical pimecrolimus in the development of lymphomas and skin cancers is uncertain. For example, of the 10 cases, 1 was associated with the presence of nodules prior to the diagnosis of basal cell carcinoma and another with a pre-existing condition associated with an increased risk for malignant transformation. Furthermore, the extent of systemic absorption and subsequent immunosuppression, if any, in each case is unknown.
[ Last revised: 3/7/2005 6:13:00 PM ]
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