Heparin batches recalled in four European countries
Batches of heparin products have been recalled from sale in four European countries.
The national medicines safety organisations in Germany, Denmark, France
and Italy all asked pharmacists to return some batches of the drug produced
by manufacturer Baxter following fears of contamination. But there are
no plans, for the time being, to follow suit in the UK, the Medicines
and Healthcare products Regulatory Agency confirmed on 31 March 2008.
A spokeswoman said the agency was “intensively” reviewing
yellow card reports for heparin products and was contacting UK manufacturers
for drug samples, which were currently being evaluated in the agency
laboratory. She said: “Further test results are expected later
this week. At present, there is no information to suggest there are increased
numbers of adverse reactions in the UK market as has occurred elsewhere.
“The MHRA will continue to monitor the situation closely and would
implement a recall without delay if the situation changes.”
The recall of heparin by some EU states comes a month after Baxter temporarily
suspended production of the drug at its plant in China. The move followed
an increase in reports of adverse drug reactions — including around
20 possible patient deaths — in cases where high
bolus doses of the drugs were involved (PJ, 23 February 2008, p206).
US medicines regulators have since confirmed that the drug had been contaminated
and traced the source back to China.
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