Pharma Dynamics to recall drug amid review

The South African Health Products Regulatory Agency (SAHPRA) has asked local generic drug manufacturer Pharma Dynamics to urgently recall high blood pressure medicines containing valsartan supplied by Chinese firm Zhejiang Huahai Pharmaceuticals, citing possible cancer risks.

Pharma Dynamics distributes the products in SA.

The affected products are only supplied to the private sector and currently reach about 12,460 patients a month.

SAHPRA has joined medicine regulators in Europe and the US in conducting a safety review of medicines containing Zhejiang Huahai’s valsartan, which it said may have been contaminated with N-nitrosodimethylamine (NDMA), which is a possible human carcinogen.

The European Medicines Agency announced an EU-wide recall of medicines containing Zhejiang Huahai’s valsartan on July 5, and last week the US Food and Drug Administration asked three firms — Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries — to recall their valsartan products.

SAHPRA said the presence of NDMA was unexpected, and possibly due to changes in the manufacture of valsartan.

The recall does not apply to all medicines containing valsartan, but only to those with active ingredients made by Zhejiang Huahai.

SAHPRA advised patients who were taking the affected medicines to consult their pharmacist or doctor, and continue taking their pills until they had a replacement.

In a statement, SAHPRA said it would “continue to investigate and assess whether the impurity may pose any risk to patients, and collect more data on the safety of valsartan-containing medicines as it becomes available. Any new information or recommendations will be communicated to the public.”

SAHPRA acting CEO Portia Nkambule said Adcock Ingram had also registered medicines containing Zhejiang Huahai’s valsartan, but they had not yet been launched in SA.

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

This was the first product recall to affect the 17-year-old company, said Pharma Dynamics CEO Erik Roos.

“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.