The Therapeutic Goods Administration originally rejected the application to register rasagiline in Australia because of an apparent increase in the risk of melanoma. However it is uncertain that the drug was responsible.
I wish to point out that it is thought that melanoma and Parkinson’s disease share common genetic components.1 Furthermore there is evidence of an association between Parkinson’s disease per se and melanoma.2 Proof of the association led the Food and Drug Administration to instigate a labelling change applicable to all dopaminergic drugs in 2007. It has also been acknowledged by the TGA and the following statement is included in the Australian product information for rasagiline:
During the clinical development program, the occurrence of cases of melanoma prompted the consideration of a possible association with rasagiline. The data collected suggests that Parkinson’s disease, and not any medicinal products in particular, is associated with a higher risk of skin cancer (not exclusively melanoma). Any suspicious skin lesion should be evaluated by a specialist.
In view of the evidence, Lundbeck recommends that all patients with Parkinson’s disease undergo regular skin checks, including those taking rasagiline.
Deborah Pelser Director Scientific Affairs Lundbeck Australia
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