Stelara risk of rare serious skin conditions says Health Canada

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Bad news for Stelara as Health Canada issue Important Safety Information on their website. Though rare, Health Canada say serious skin conditions (exfoliative dermatitis and erythrodermic psoriasis) have been reported in patients treated with Stelara.

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Dear Healthcare Professional:

Subject: Risk of exfoliative dermatitis and erythrodermic psoriasis with STELARA® (ustekinumab)

Janssen Inc., in consultation with Health Canada, would like to inform you of important new safety information regarding the risk of exfoliative dermatitis and erythrodermic psoriasis associated with the use of STELARA®.

STELARA® is approved for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in adult patients.

Cases of exfoliative dermatitis and erythrodermic psoriasis have been reported rarely in psoriasis patients receiving STELARA®. These skin conditions can occur within a few days of the patient receiving STELARA®.  They can be severe and lead to hospitalization.
   
The Product Monograph for STELARA® will be updated to include the adverse events of exfoliative dermatitis and erythrodermic psoriasis.  Please refer to the STELARA® Product Monograph for full prescribing information.
   
The symptoms of exfoliative dermatitis may be indistinguishable from erythrodermic psoriasis.  Advise your patients to watch for and report these symptoms.  In case of occurrence of these symptoms, appropriate therapy should be initiated. Treatment with STELARA® should be discontinued if a drug reaction is suspected.

There have been rare (≥1/10,000 to<1/1,000) reports of exfoliative dermatitis and erythrodermic psoriasis in psoriasis patients receiving ustekinumab.  Patients with plaque psoriasis may develop erythrodermic psoriasis, with symptoms that may be clinically indistinguishable from exfoliative dermatitis, as part of the natural course of their disease.

Physicians should be alert for symptoms of exfoliative dermatitis.  These can appear as redness and shedding of the skin over almost the entire area of the body, which may be itchy and/ or painful.

A copy of this letter and the Canadian Product Monograph can be accessed at the Health Canada Web site and on the Janssen Inc. Web site.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of serious exfoliative dermatitis or erythrodermic psoriasis or other serious or unexpected adverse reactions in patients receiving STELARA® should be reported to Janssen Inc. or Health Canada.

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