Celgene's Revlimid linked to 14 cases of serious skin reactions, says FDA report
A US Food and Drug Administration postmarket safety review of Celgene's Revlimid (lenalidomide) identified 14 cases of serious skin reactions, including reports of Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme, associated with its use.
The immunomodulatory agent has anti-angiogenic and antineoplastic properties. Used to treat multiple myeloma, the drug was approved in the USA two years ago in combination with dexamethasone for the treatment of patients who had received at least one prior therapy (Marketletter July 10, 2006).
Revlimid was first approved by the FDA for transfusion-dependent anemia caused by myelodysplastic syndromes (Marketletter January 9, 2006).
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