"Health Canada is updating the product monograph - or label - for
the AstraZeneca and COVISHIELD COVID-19/ vaccines to add capillary
leak syndrome as a potential side effect, with a warning for
patients with a history of capillary leak syndrome to not get the
AstraZeneca or COVISHIELD COVID-19 vaccine", it said in a statement.
Capillary leak syndrome (CLS) is a very rare, serious condition that
causes fluid leakage from small blood vessels (capillaries),
resulting in limb swelling, low blood pressure, thickening of the
blood and low levels of an important blood protein.
Health Canada and the Public Health Agency of Canada have been
monitoring this condition since it was raised as a potential safety
concern by the European Medicines Agency in April, the statement
added.
Until June 11, one case of capillary leak syndrome following
vaccination with AstraZeneca's vaccine has been reported in Canada,
Health Canada said.
[to top of second column] |
Earlier this month, the
European Medicines Agency's safety committee
said that capillary leak syndrome must be added
as a new side effect to labeling on
AstraZeneca's vaccine, known as Vaxzevria.
Britain's regulator, the MHRA, has previously
said it was considering precautionary advice for
people with a history of CLS but does not see a
causal link with the vaccine.
(Reporting by Kanishka Singh in Bengaluru;
Editing by Raju Gopalakrishnan)
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