SA recalls BP drug due to potentially carcinogenic impurities

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The SA Health Products Regulatory Authority has recalled the commonly used blood pressure drug valsartan, following the discovery of carcinogenic-linked impurities found in ingredients sourced from a Chinese manufacturer.

Health-e News reports that concerns were sparked around the world after the US Food and Drug Administration and the European Medicines Agency recently released public statements and recalled valsartan-containing medicines linked to the Chinese manufacturer Zhejiang Huahai Pharmaceuticals.

An impurity called N-nitrosodimethylamine (NDMA), which is classified as a probable human carcinogen, was found in the recalled products which contained ingredients sourced from the Chinese company.

The report says it has confirmed with the South African Health Products Regulatory Authority (Sahpra) that South Africans are indeed affected as two local pharmaceutical companies had received their active ingredients from the affected site in China. According to Sahpra’s acting CEO Portia Nkambule, Adcock Ingram’s registered medicines containing the impurity are not yet available on the market and the drugs are currently under quarantine.

But, she said: “Pharma Dynamics has medicines containing valsartan on the market and an urgent recall letter has been issued to healthcare professionals (on 20 July 20) in order for stock to be removed from circulation.”

Valsartan-containing medicines are used to treat people with high blood pressure to lower the risk of having a heart attack or stroke. “They are also used in patients who have had heart failure or those who have suffered a recent heart attack,” said Nkambule. “Patients on the affected medicines are advised to contact their healthcare professional who will need to switch them to an unaffected valsartan-containing product or an alternative agent.”

She said that “these patients would need to be monitored to ensure that they respond similarly to the new product”.

The report says the evidence available on NDMA’s carcinogenic potential comes from studies done on animals which show the growth of tumours after exposure to the impurity. According to Professor Andy Gray from the University of KwaZulu-Natal’s pharmacology department, the impurity may have been present in the medicines since 2012 and “tracking the effects of such an impurity over such a long period will be exceptionally difficult, as will teasing out its impact from other potential causes of cancer”.


While other manufacturers in South Africa using valsartan have reported that they did not source their ingredients from the affected site in China, Sahpra said that it is in the process of “performing an urgent pharmaco-vigilance inspection of all manufacturers of all valsartan-containing medicines”.

Sahpra urged healthcare professionals to report any adverse reactions associated with valsartan-containing medicines to its pharma-covigilance unit at 012-395-9133 or to the National Adverse Drug Event Monitoring Centre at 021-4471618, or by using the reporting form available on its website, reports Business Day.

Pharma Dynamics said its affected products were Dynaval Co 80/12.5mg, 160/12.5mg and 160/25mg.

CEO Erik Roos said this was the first product recall to affect the 17-year-old company. “We have been actively working with Sahpra to ensure a swift recall of all affected products and we will issue a full refund for all returned Dynaval Co products,” he said.

Health-e News report
Business Day report

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