MHRA advises on erythropoietins
New prescribing advice for recombinant human erythropoietins is highlighted in the December 2007 issue of the Medicines and Healthcare products Regulatory Agency’s Drug
Safety Update.
Recombinant human erythropoietins (epoetins) are indicated for the treatment
of anaemia in patients with chronic renal disease and for treating patients
with non-myeloid cancer who develop anaemia after chemotherapy.
The new advice warns that overcorrection of haemoglobin concentration
in patients with chronic renal disease may increase the risk of death
and serious cardiovascular events and, in patients with cancer, may increase
the risk of thrombosis.
“Recombinant human erythropoietins should not be given to patients
with cancer who do not fulfil the criteria in the authorised cancer indications,” it
says.
The update also highlights measures to minimise the risk of overdose
with dosulepin and to discourage its use for new patients. It explains
that, since last month, pack sizes have been limited and child resistant
blister packs introduced.
Two safety issues relating to the use of medicines during pregnancy are
also included. Angiotensin-converting enzyme inhibitors and angiotensin
II receptor antagonists should not be used during any stage of pregnancy.
Their use by women who are planning pregnancy should be avoided unless
absolutely necessary, it says.
In addition,
updated safety information has been issued for mycophenolate mofetil
(Cellcept) relating to congenital malformations after use during
pregnancy.
Finally, the update warns about the risks of myocardial ischaemia with
short-acting beta agonists. It says that patients with a history of,
or risk factors for, heart disease should not be given beta agonists
for management of premature labour.
In addition, these patients should
be alert to symptoms of worsening heart disease if taking beta agonists
for respiratory disease. |
The
Pharmaceutical Journal
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