Stelara risk of rare serious skin conditions says Health Canada

[Fred]

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.

Quote:

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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.

Source: NO LINKS ALLOWED

[Quest4Cure]

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.

Quote:

---

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.

Source: NO LINKS ALLOWED

[D Foster]

Does it mean " These skin conditions can occur within a few days of the patient receiving STELARA®.  They can be severe and lead to hospitalization." when first starting using Stelara or every time you inject the Stelara ?

[Fred]

Does it mean " These skin conditions can occur within a few days of the patient receiving STELARA®.  They can be severe and lead to hospitalization." when first starting using Stelara or every time you inject the Stelara ?

I'm not sure what happened to Quests post, but in answer to your question Dave I have found the following updated information which may shed a bit more light on it.

Quote:

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By the time of this review, Health Canada had received 5 reports of skin exfoliation (2 serious and 3 non-serious) and 1 non-serious report of exfoliative dermatitis. None of the reports contained enough information to determine whether or not the drug caused the cutaneous skin reaction.

Very few skin-related side effects have been reported for STELARA and even fewer of these can be categorised as exfoliative dermatitis and erythrodermic psoriasis.

Internationally, 20 cases of exfoliative dermatitis and erythrodermic psoriasis have been reported in association with the use of STELARA. In 12 of the 20 cases, the reaction occurred shortly after the individual started the medication and in 4 of these, the affected patient had a similar reaction when given the medication again. However, it is difficult to determine to what extent STELARA contributed to the exfoliative dermatitis and erythrodermic psoriasis or if the patient’s underlying psoriasis could also have contributed.

Health Canada will continue its ongoing monitoring of adverse reaction information involving STELARA, as it does for all health products on the Canadian market, to identify and assess potential harms.

Source: NO LINKS ALLOWED

[Caroline]

I'm not impressed.
Still it seems that very little times this occurs in many thousands of patients.
I think I would take the risk .

[Fred]

I'm not impressed.
Still it seems that very little times this occurs in many thousands of patients.
I think I would take the risk .

Yep you're probably more likely to get run over by a Camel than die from a treatment for psoriasis.

[Caroline]

I'm not impressed.
Still it seems that very little times this occurs in many thousands of patients.
I think I would take the risk .

Yep you're probably more likely to get run over by a Camel than die from a treatment for psoriasis.

It seems that falling refrigerators are also dangerous, even more dangerous than terrorist attacks.

[D Foster]

I'm not impressed.
Still it seems that very little times this occurs in many thousands of patients.
I think I would take the risk .

Yep you're probably more likely to get run over by a Camel than die from a treatment for psoriasis.

It seems that falling refrigerators are also dangerous, even more dangerous than terrorist attacks.  

Good god I have just been hit by a camel and the fridge it was carrying dropped on my foot.
It looks like it can hit at anytime though it will not worry me.

[Quest4Cure]

I'm not impressed.
Still it seems that very little times this occurs in many thousands of patients.
I think I would take the risk .

Yep you're probably more likely to get run over by a Camel than die from a treatment for psoriasis.

It seems that falling refrigerators are also dangerous, even more dangerous than terrorist attacks.  

Good god I have just been hit by a camel and the fridge it was carrying dropped on my foot.
It looks like it can hit at anytime though it will not worry me.

Hello all,

Of course at the end of the day everything is an informed judgment call when it comes to bio drugs or any other drug. That call only you can make and your doctor. Bio drugs seem to have a fear involved more that most other new drugs, and for good reason. If all else has failed to help then some are informed by their doctors and my doctor always leaves the decision up to me. In the end it's all about the quality of life.
Every drug has side effects some more serious than others even OTC drugs. Yet many of us do take bio meds seriously and some have no other choice. Back in the 80's a bio drug was used to treat my herniated disc. It was enzyme from a papaya plant. It had many risks. Yet it didn't have the risk of surgery causing scar tissue to build up requiring more surgery down the line.
By forgoing unwarranted fear becoming informed as best as possible doesn't always take the fear away. Some bio drugs have helped many, but they are not for everyone. Everyone reacts differently to all meds. Positive and negative results are in the literature from all bio drugs. Very small print and several pages long.
All the clinical trials and statistics are available. If you have any questions ask your doctor he knows your medical history.
The bio drugs help many people, but they are not for everyone. And he who has great fear of taking biologics should not take them....unless the fear is first addressed. There are always two sides of the coin. Ten years ago there was very little on the market for psoriasis or psoriatic arthritis and many other diseases.
I wish my gram and mom had the choices I have today for treatment. Not just for P. or PSA. But heart and diabetes as well as many other diseases where research has given so many a good quality of life. We are living longer today with a better quality of life.

[mataribot]

Any treatment you take for psoriasis you run the risk flaring EP or PP. This is just a non issue it's not even funny.