Safety concern over skin drug

[Posted: Tue 22/03/2005]

By Deborah Condon

The Irish Medicines Board (IMB) has said it is aware of safety issues relating to a drug currently available in Ireland for the treatment of atopic dermatitis (eczema).

The American Food and Drug Administration (FDA) recently issued a public health advisory to healthcare professionals about two eczema drugs, Elidel and Protopic. While Elidel is not available in Ireland, Protopic is.

The FDA's advisory stated that these drugs should be prescribed only as directed 'and only after other eczema treatments have failed to work because of a potential cancer risk associated with their use'.

The decision to issue the advisory was taken following a review of three different animal studies.

"The data showed that the risk of cancer increased as the amount of the drug given increased The data also included a small number of reports of cancers in children and adults treated with Elidel or Protopic", the FDA said.

Speaking to irishhealth.com, a spokesperson for the IMB said that it 'is aware of the issues relating to Protopic', adding that these are currently being reviewed on an EU basis.

"The IMB is an active participant in the EU review of Protopic and will take whatever regulatory actions are considered appropriate following the outcome of this process", the spokesperson added.


Top of page


Back to News