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.
Ethylene 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 the national regulatory
authority for health products, SAHPRA may recall health products as a crucial
measure to address safety concerns and quality issues in the interest of public
health.
"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 said it was mandated to regulate and apply due
diligence to health products to ensure that products in circulation in South
Africa and those exported from SAHPRA-licensed manufacturers are safe for
public consumption.
It said it applies this due
diligence throughout the product lifecycle, from registration through to
post-market monitoring.
"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.
SAHPRA is tasked with
regulating - monitoring, evaluating, investigating, inspecting and registering
- all health products.
This includes clinical trials,
complementary medicines, medical devices and in-vitro diagnostics (IVDs) and
overseeing radiation control in South Africa.
Source: SAnews.gov.za
(Tshwane)