Valeant Pharmaceuticals International Inc’s experimental drug to treat the skin disorder psoriasis carries a potential risk of suicide.
However, the risk is challenging to assess due to limited data, according to a preliminary review by the US Food and Drug Administration (FDA), recently published.
Reported on www.reuters.com, in clinical trials of the drug, brodalumab, there were six suicides across all programs: four in psoriasis studies, one in a rheumatoid arthritis study and one in a psoriatic arthritis study.
‘We have uncertainty about whether the signal for completed suicide is a risk related to brodalumab treatment,’ FDA reviewers said.
‘From the available data, we cannot conclude whether or not suicide is a drug-related risk.’
If approved, brodalumab has the potential to be used in a large number of patients in the United States and likely prescribed by a doctor that may not be familiar with screening for and diagnosing suicidal thinking and behaviour, the reviewers said.
‘There are several risk management options that could provide some assurance that doctors and patients understand the safe use conditions of taking the drug.
‘However, no risk management strategy will completely eliminate the risk,’ they said.
Read the full story about the experimental drug.
