Blood pressure medicine recalled due to cancer risk - but regulator took three weeks to act
A drug to treat high blood pressure for almost 12‚500 South Africans is being recalled after the active ingredient was shown to be contaminated by a potentially cancer-causing chemical.
The recall‚ however‚ comes almost three weeks after the drug was removed from shelves in Europe‚ the UK and the USA because the Chinese manufactured active ingredient was contaminated. The regulator‚ South African Health Products Authority (SAHPRA)‚ did not answer this publication's queries about why it took so long to recall it here.
The drugs being removed from pharmacy shelves are Dynaval Co 80/12‚5mg‚ Dynaval Co 160/12‚5mg and Dynaval Co 160/25mg. They are manufactured by Cape Town-based Pharma Dynamics.
Dynaval is used to treat high blood pressure and heart failure‚ or is given to patients who have had recent heart attacks.
But SAHPRA has warned patients that it is far more dangerous to stop taking blood pressure medicine and risk having a stroke than it is to keep taking it until they have purchased a replacement drug.
It stated: "The conditions the medication treats‚ such as heart failure and high blood pressure‚ are serious‚ and patients could be harmed if you suddenly stop taking it without a replacement medicine."
The active ingredient in Dynaval is called Valsartan and is imported from Chinese factories. Tests show the Valsartan is contaminated with a chemical called N-nitrosodimethylamine (NDMA)‚ which is used to make lubricants and rocket fuel and can be a created as by product of the manufacture of rubber tyres or fish-processing.
It is believed a change in manufacturing process led to the chemical being found in the Valsartan.
It is likely the cancer-causing effects would require prolonged exposure of months or years‚ hence people should not abruptly stop taking treatment warned Pharma Dynamics spokeswoman Nicole Jennings.
Pharma Dynamics was given the go-ahead for the recall on July 20‚ but the recall was only announced by the national health department on Tuesday.
Asked why Pharma Dynamics had not told consumers about the recall more than two weeks ago when it became aware of the problem‚ Jennings said it was not allowed to do so and had to wait for regulator go ahead before announcing or initiating a recall.
This is the first recall in 17 years of the local generic drug company's history.
CEO Erik Roos said: “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. The organisation has a proud 17-year history of providing quality medicines without a single class one product recall.” Roos stressed that neither Dynaval 80mg and 160mg tablets‚ nor any other Pharma Dynamics products‚ had been affected by this recall.
Patients are advised to consult with a healthcare professional before discontinuing the use of Valsartan‚ he urged.
A full recall will be offered to patients when they return their current medicine to a pharmacy‚ the company said.