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.