Refunds pledge as BP drug recalled

A Cape Town-based pharmaceutical company has promised to refund all patients who return blood pressure and heart disease medication containing an ingredient that carries the risk of causing cancer.

Last week it was revealed that medicines containing the active pharmaceutical ingredient, valsartan, had been recalled by the South African Health Products Regulatory Authority (SAHPRA).

The recall came weeks after the drug was removed from shelves in Europe and the US because the Chinese manufactured active ingredient was contaminated.

A locally affected product is the Dynaval Co 80/12.5mg, 160/12.5mg and 160/25mg, which is supplied by Pharma Dynamics.

Pharma Dynamics issued a statement with the CEO, Erik Roos, saying the company had been working closely with SAHPRA to ensure a swift recall of all affected products in SA.

“The health and safety of patients is of paramount concern to us. Regular quality checks are done at site level and when the impurity was detected earlier this month, international health authorities were immediately notified and recall protocols were followed.

“Pharma Dynamics is South Africa’s leading provider of cardiovascular medication both in terms of value and volume and we remain committed to providing the highest quality of care to patients,” said Roos.

The company has advised patients to consult with a healthcare professional before discontinuing the use of the medication.

“Pharma Dynamics will also refund all returned Dynaval Co products and patients can return products to the pharmacy where it was originally dispensed,” the statement said.

Valsartan is made in China and a chemical used in rocket fuel, called N-Nitrosodimethylamine, had allegedly contaminated the drug's production at Zhejiang Huahai, a Chinese supplier which ships the medicine worldwide.

N-Nitrosodimethylamine is thought to be carcinogenic, meaning it could cause cancer in humans, so production of the pills has stopped.

Roos emphasised that neither Dynaval 80mg and 160mg tablets, nor any other Pharma Dynamics products have been affected.

The recall came weeks after the drug was removed from shelves in Europe and US