Acne drug under scrutiny after suicide claims
However, in Australia, the Therapeutic Goods Administration has said it will await the results of the European review before commencing a review of its own.
“The TGA is aware of the proposed European review of isotretinoin and will evaluate this information to determine whether a review should be undertaken in Australia,” the TGA said in a statement.
According to the regulator's database of adverse events, there have been 14 reports of suicide in the last five years in which the brand Roaccutane (Roche) was listed as a suspected cause.
The product information for isotretinoin, which is available in generic versions, includes a precaution for psychiatric disorders and behaviours, including rare reports of suicidal ideation and behaviours.
This week media reports emerged in the United Kingdom that an expert group at the Medicines and Healthcare Products Regulatory Agency will meet next month and in June to establish the