The South African Health Products Regulatory Authority (SAHPRA) says it has found no traces of diethylene glycol in the Benylin paediatric cough syrup.
This comes after SAHPRA recalled two batches of the cough syrup, in April, after the Nigerian National Agency for Food and Drug
Administration and Control (NAFDAC) raised concerns about the medicine
containing high levels of diethylene glycol.
COURTESY: BenylinEthylene glycol is toxic to humans when consumed and can
prove fatal. The effects include abdominal pain, vomiting, diarrhoea, inability
to pass urine, headache, altered mental state, and acute kidney injury that may
lead to death.
“The recall was implemented as a precaution to protect
lives, while SAHPRA investigated the reported high levels of diethylene
glycol,” the local drug watchdog explained.
“As part of the investigation of the reported high levels
of diethylene glycol, SAHPRA tested samples of the two affected batches of
Benylin paediatric syrup through an independent laboratory and a method
developed by the World Health Organisation for testing products for the
presence of diethylene glycol. The tests did not find traces of diethylene
glycol in the recalled batches.
“This indicates that units of batches 329303 and 329304,
that were stored at the required temperature, would not contain unacceptable
levels of diethylene glycol,” the statement read.
The watchdog also indicated that there was no record of any
adverse drug reactions relating to diethylene glycol for the two recalled
batches in South Africa or anywhere else where they were exported in Africa.
“SAHPRA will continue to closely monitor medical products
that have the potential of containing unacceptable levels of diethylene glycol.
And we will continue to address safety concerns or quality issues so that the
health of the public is protected,” said SAHPRA CEO, Dr Boitumelo
Semete-Makokotlela.
Done by: Mitchum George
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