[ad_1]
The South African Health Products Regulatory Agency (Sahpra) has asked the local pharmaceutical company Pharma Dynamics to urgently recall high blood pressure medications containing valsartan, which It distributes on behalf of the Chinese company Zhejiang Huahai Pharmaceuticals.
The development follows the initiatives taken by the European Medicines Agency and the US Food and Drug Administration in July: the two regulatory bodies have launched drug recalls containing generic valsartan manufactured by Zhejiang Huahai Pharmaceuticals. These products may contain N-nitrosodimethylamine (NDMA), a possible carcinogen for humans. Sahpra said the presence of NDMA was unexpected, and perhaps due to changes in the manufacture of valsartan
Sahpra said that drugs containing valsartan were commonly used to treat patients with high blood pressure. They are also used in patients who have had heart failure or a recent heart attack. Valsartan is available alone or in combination with other medications
The recall does not apply to all drugs containing valsartan, but only to those manufactured by Zhejiang Huahai Pharmaceuticals.
Sahpra advised patients taking the medications concerned urgently to consult their pharmacist or doctor and to continue taking their pills until they are replaced.
"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. He urged health professionals to report any adverse reaction associated with drugs containing valsartan to his pharmacovigilance unit at 012-395. -9133 or the National Center for Adverse Drug Reaction Monitoring at 021-4471618, or by using the reporting form available on its website.
Pharma Dyn Amics stated that its affected products were Dynaval Co 80 / 12.5mg, 160 / 12.5mg and 160 / 25mg.
CEO Erik Roos said it was the first product recall to affect the 17-year-old company.
We are actively working with Sahpra to ensure a quick recall of all affected products and we will fully refund all returned Dynaval Co products. "
Roos says neither Dynaval 80mg and 160mg tablets, nor any other Pharma Dynamics products were affected by the recall.
[ad_2]
Source link
