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The National Department of Health (NDoH) and the South African Health Products Regulatory Authority (SAHPRA) are currently reviewing all drugs containing an ingredient related to a Chinese manufacturer
. The European Medicines Agency recently recalled a drug containing valsartan, linked to Chinese manufacturer Zhejiang Huahai Pharmaceuticals – and the South African authorities followed suit.
Rapid Recall of All the Products Affected
Contains N-nitrosodimethylamine (NDMA), classified as a carcinogen. Carcinogens are substances that can cause cancer when exposed to living tissue
. Many pharmaceutical companies use valsartan as an active ingredient to control blood pressure and prevent heart failure, but in South Africa, only Pharma Dynamics is affected. works with SAHPRA to recall their variants, Dynaval Co.
In a statement, Erik Roos, CEO of Pharma Dynamics, said that they were working actively with SAHPRA to ensure a quick recall of all relevant products and that 39, they will issue a "Pharma Dynamics is the leading provider of cardiovascular drugs in South Africa, both in terms of value and volume, and we remain committed to providing the highest quality of care to patients." History of providing quality drugs without a single class one product recall, "said Roos.
Adcock Ingram also has a drug containing the ingredient ent valsartan, but it is not not currently available on the market.
There are still no indications as to whether any other drugs should be recalled.
All drugs containing valsartan do not occur are not recalled
In a statement, the health department says that the active ingredient is sourced from Zheijiang Huahai Pharmaceuticals, and it is believed that the presence of NDMA is due to a change in the way that the 39, ingredient has been manufactured.
Authorities add that reminder letters have already been distributed to health professionals, but they add all drugs containing valsartan are recalled.
recalled in 20 countries
Authorities add that patients who are currently taking the drug may be receiving another medicine containing valsartan or treatment alternative after consulting your doctor or pharmacist.
They add that patients who are in a clinical trial with valsartan shou I will talk to the doctor who treated them at the trial. In the meantime, the SAHPRA will continue to study and evaluate whether the impurity may pose a risk to patients and gather more data on the safety of drugs containing valsartan as soon as they are safe. they will be available.
Ring the alarm on the impurity in the drug after performing multiple tests. The drug containing valsartan, originally from Zhejiang Huahai Pharmaceuticals, has since been recalled in more than 20 countries.
South African health professionals are asked to report any adverse events, particularly to the SAHPRA Pharmacovigilance Unit. 395 9133 or the National Center for Adverse Drug Reaction at (021) 447 1618.
Otherwise, health professionals can complete the Adverse Drug Reaction Reporting Form and send it by email to [email protected].
Image credit: iStock
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