Consumers and health professionals are advised that, since publishing the below monitoring communication on 18 March 2014, the TGA has received only one further report of this adverse event.
Analysis of the cases reported to the TGA, together with a review of Australian and international data, has found insufficient evidence of a definite link between natalizumab and melanoma. Based on this finding, the TGA is closing this issue in its Early Warning System.
If you are taking natalizumab and notice any new spots on your skin or a change in an existing mole, or if you have questions or concerns about this issue, speak to your health professional. It is important that you do not stop taking your medicine without first consulting your doctor.
Health professionals are advised to consider discussing this issue with patients who are being treated with natalizumab and to continue monitoring them for any new or changed skin lesions and report any cases of melanoma or other malignant conditions to the TGA.
The TGA will continue to monitor this issue and will publish further information if it becomes available.
Monitoring communication
18 March 2014
The TGA is monitoring reports of melanoma in patients being treated with natalizumab and encourages consumers and health professionals to report all such cases.
Natalizumab (marketed as Tysabri in Australia) is used to treat patients with relapsing-remitting multiple sclerosis to delay the progression of physical disability and reduce the frequency of relapse.
Melanoma is potentially life-threatening and Australia has one of the highest incidence rates of this condition in the world.1
Three cases of melanoma in patients being treated with natalizumab have been reported to the TGA.
An ongoing TGA review of this issue has found insufficient evidence to show a definite link between natalizumab and melanoma. However, given the high incidence of melanoma in Australia, this remains an issue of concern for the TGA.
Information for consumers
This monitoring communication highlights a potential safety concern.
If you have been prescribed natalizumab, do not stop taking your medicine.
However, if you notice any new spots on your skin or a change in an existing mole, speak to your health professional.
If you have any questions or concerns about this issue, speak to your health professional.
Information for health professionals
If you have prescribed natalizumab or are managing a patient who is taking this medicine, monitor them for any new or changed skin lesions and ensure patients with any suspicious lesions undergo further investigation.
Please report to the TGA all cases of melanoma in patients being treated with natalizumab. This will assist the TGA in determining if any further action is required.
Reporting problems
Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.
Reference
- Australian Institute of Health and Welfare and Australasian Association of Cancer Registries 2012. Cancer in Australia: an overview 2012. Cancer series no. 74. Cat. no. CAN 70. Canberra: AIHW. Available online [accessed on 4 Mar 2014].