Avoid contaminated Clexane for pregnant women, says MHRA
Background
At the end of April 2008, the MHRA issued a warning that certain
batches of Clexane syringes contained low
levels of the contaminant OSCS (PJ, 3
May 2008, p529).
The MHRA recommended that, since the risk associated with the contamination
was minimal, the affected batches should continue to be supplied
to avoid a shortage of low molecular weight heparins.
The MHRA subsequently
advised against
the use of parallel-imported packs of Clexane because
some batches supplied to overseas markets were contaminated with
higher levels of OSCS (PJ, 17 May 2008, p588). |
Batches of Clexane (enoxaparin sodium; Sanofi-Aventis) contaminated with small amounts of over-sulphated chondroitin sulphate (OSCS) should not be used for pregnant women, the Medicines and Healthcare products Regulatory Agency advised last week.
The MHRA says that, although there is no evidence of any specific risks
to women who are pregnant, or to the developing fetus, use of affected
Clexane should be avoided on a purely precautionary basis.
Sanofi-Aventis has announced that uncontaminated 40mg syringes are now
available — the strength most commonly prescribed for use during
pregnancy.
Clexane 40mg syringes with the batch numbers 04329, 04351,
04352 and 14326 are free of the contaminant.
The company is asking pharmacists
to check that Clexane dispensed to pregnant patients is not contaminated.
Pharmacists unable to obtain stock from these batches from their usual
supplier are advised to contact Sanofi-Aventis (tel 0800 854430), which
will arrange a direct delivery for individual patient use.
EMEA review The European Medicines
Agency (EMEA), as part of its review of the risks associated with
OSCS contamination of heparin products, has looked at what long-term
approaches could be adopted to minimise the possibility of future
contamination.
The EMEA’s Committee for Medicinal Products for Human Use (CHMP) has recommended
that European Pharmacopoeia monographs for heparins be updated to include tests
for detecting OSCS.
The EMEA also stated last week: “The CHMP was of the opinion that it is
necessary to operate in a co-ordinated way within the EU to address all issues
relating to the contamination. This includes any investigation into the origin
of the contamination and any inspection of factories where heparins are made.”
The CHMP believes that an international dialogue should be started with China
to strengthen supervision of manufacture.
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