(Reuters) – Health Canada said late on Tuesday it has recommended that people with a history of capillary leak syndrome not be inoculated with drugmaker AstraZeneca’s COVID-19 vaccine.

“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.

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.

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