|
The European Medicines Evaluation Agency (EMEA) has urged doctors
to exercise caution when prescribing Wyeth's treatment for rheumatoid
arthritis Enbrel (etanercept) following 10 reports of serious blood
reactions, five of them fatal.
While this may not seem like a large number, only about 5,500 people
are currently taking the drug in the entire European Union (EU).
In a public statement, the EMEA said: "In
the majority of these cases, there was a close temporal relationship
between the start of treatment with etanercept and the occurrence
of haematological disorders (range 2 weeks to 5 months).
Since the clinical experience with etanercept is still limited as
this product has only recently been marketed, onset after this period
cannot be ruled out."
Enbrel is a recombinant tumor necrosis factor (TNF) receptor that
has been prescribed to an estimated 80,000
patients worldwide.
It was launched in the United States in November 1998 and in the
EU in February 2000.
The EMEA pointed out that although the adverse blood reactions
were rare, caution should be exercised in patients with a previous
history of blood disorders being treated with Enbrel.
Additionally, all patients should be informed that if they develop
signs and symptoms suggestive of blood disorders or infections whilst
on Enbrel they should seek immediate medical advice, where they
should be evaluated urgently and immediately, including getting
a full blood count.
The drug's label was also changed in the United States last month
in response to the reported adverse reactions.
The New England Journal
of Medicine October 12, 2000; Volume 343.
| 