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Kenya recalls children’s cough syrup over suspected toxicity

Kenya’s drug regulator is recalling a batch of Johnson & Johnson children’s cough syrup, a day after Nigeria recalled the same batch of medication under the Benylin Paediatric brand.

In a statement released on Thursday, the  Pharmacy and Poisons Board (PPB) said that it had launched investigations and recommended that sales of certain batches of the product be stopped and returned to suppliers.

According to PPB, Benylin pediatric 100mls cough syrup Batch No 329304, “was found to cause acute oral toxicity in laboratory animals,” it said.

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It added that human consumption of Diethylene glycol results in toxic effects, including abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death.

“We have commenced investigations into the supply of the drug and that a sampling of the drug’s batches had been initiated and implementation of regulatory actions will be based on the laboratory findings,” read part of a statement by the Pharmacy and Poisons Board.

The board directed all pharmaceutical outlets to immediately stop the distribution, sale, and issuing of the product and advised members of the public to return the product to the nearest healthcare facility.

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“The public or patients who experience adverse reactions or events following the use of this product in children are advised to direct such patients to immediate medical attention from a qualified healthcare professional,” the board added.

At the same time, it assured the public that it had established mechanisms to ensure that medicines supplied to the Kenyan market met the required quality, safety and efficacy standards.

“We encourage the public to be vigilant at all times and report any suspected poor-quality medicines or adverse drug reactions to the nearest healthcare facility and the Pharmacy and Poisons Board,” it said.

The batch being recalled was made by J&J in South Africa in May 2021 with an expiration date of April 2024, PPB said.