Health Minister Dr Chitalu Chilufya has told Parliament that ZAMRA recorded 32 suspected adverse drug reaction reports from health facilities across the country since January 2019 which were caused by Gemyntacin.
In a ministerial statement, Dr Chilufya said the drug was manufactured by Chinese and Kenyan companies.
Dr Chilufya said his ministry, through Zambia Medicines Regulatory Authority (ZAMRA), had quarantined all stocks of Gentamycin that were still in medical stores and has further recalled all stocks that were already distributed.
“Mr Speaker, through the highly alert and robust pharmacovigilance system that the government has set up, ZAMRA received 32 suspected adverse drug reaction reports from across the country from January 2019. The Drug reactions were reported from the following facilities; six from Levy Mwanawasa Teaching Hospital, seven from Kabwe Central Hospital, 10 from Choma General Hospital, seven from Livingstone Central Hospital, one from Chipata Central Hopsital, [and] one from Mumbwa District Hospital,” Dr Chilufya said.
He told the House that the named drug was causing headache, dizziness, heart palpitations and vomiting after being administered.
“Mr Speaker, the common reaction that was presented were as follows; headache, dizziness, heart palpitations and vomiting following the administration of the gentamycin Sulphate BP injection….Mr Speaker, these were the symptoms that were reported on the recording forms that all health workers who are trained in pharmacovigilance reported from the different facilities. This medicine, Mr Speaker, was imported into the country for supply to public health facilities from a company based in China known as CSPC and also a company in Kenya. Gentamycin injection from the suspected batches were sampled and underwent some routine analysis in the country and some samples were sent to North-West University in South Africa for quality analysis,” Dr Chilufya said.
And Dr Chilufya said samples of the drug had been sent to the North-West University of South Africa for quality analysis.
“However as a precautionary measure, the Ministry of Health through the Zambia Medicines Regulatory Authority quarantined any stocks of Gentamycin that were still in medical stores and recalled all stocks that were already distributed and some are quarantined within the facilities. This drug has been withdrawn from all public health facilities pending further analysis from North-West University in South Africa. Mr Speaker I want to assure the public that the Government of the Republic of Zambia through the Ministry of Health has strengthened activities at Zambia Medicines Regulatory Authority in order to safeguard the public against consumption of any drugs that may be unsafe,” said Dr Chilufya.