FDA Approves New Psoriasis Drug With a Very Serious Side Effect
By Julie Ricevuto |
Psoriasis can be a painful and unsightly skin condition, but there’s some news on the horizon for those who suffer from it. The FDA just approved Siliq, a new drug to treat those super thick, red, flakey patches of skin that accompany psoriasis, and the drug’s level of efficacy turns out to be pretty extraordinary.
Unfortunately, there’s a catch: Research has turned up some seriously scary side effects to using Siliq and it’s vital to know them before trying the treatment yourself. “Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with Siliq during clinical trials,” states the press release.
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Understandably, this is a major red flag for the brand, even though Valeant, the distributor of Siliq, didn’t find a “causal relationship” between the medication and the suicide ideation that revealed itself in the trials. Nonetheless, it's fair to say these findings could hinder doctors from prescribing Siliq to patients.
“Siliq would not be the first drug I would run to for the treatment of psoriasis,” explains New York dermatologist, David J. Goldberg, MD. “From a dermatologist's perspective, there are many other effective topical creams, the excimer laser and other biologics available.”
On the other hand, while New York dermatologist Gary Goldenberg, MD, agrees that this drug must be used with extreme caution, he wouldn’t necessarily rule it out. “I would use this medication in patients with moderate to severe psoriasis who failed other options and I’d be careful in patients with a prior or current history of depression of suicidal behavior,” he says.
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Dr. Goldberg points out that it’s important to note that this isn’t the first dermatology drug to have suicidal ideation as an association. Accutane, the drug used to treat severe acne, has also been linked to increased rates of suicide.
Luckily, in an effort to ensure the safety of patients opting for Siliq, the FDA has necessitated that patients must sign a Patient-Prescriber Agreement Form and be made aware of the need to seek medical attention at the first signs of suicidal thoughts before use. Also, the labeling for Siliq is mandated to include a Boxed Warning that requires physicians to inform their patients that there were subjects in the trial that committed suicide.
The takeaway? Siliq certainly shouldn’t be ruled out as a treatment option for patients who have tried other alternatives that ended with poor results, however, it’s important to proceed with caution and discuss thoroughly with your doctor. We’ve reached out to the FDA, but they’ve declined to comment.
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