Cardiovascular medication, Valsartan, recalled in SA
The molecule was recalled across several international markets including the USA and Europe as many originator and generic suppliers source valsartan from the same manufacturer.
The presence of the impurity, N-nitrosodimethylamine (NDMA), could be linked to changes in the way the active substance was manufactured, but a thorough investigation is currently underway to determine the exact cause. The NDMA is classified as a probable human carcinogen (carcinogen is any substance that when exposed to living tissue may cause the production of causing cancer) based on the results from laboratory tests, Sahpra said.
It stated that it will 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. At this stage no definitive information has been received to indicate an immediate threat to patients as investigations are still underway. The authority is advising patients to consult with their doctor or pharmacist and to continue taking the medicine until they have a replacement medicine.
The molecule, which has been on the SA market for 21 years, is used globally to treat cardiovascular disease.
Products affected
A locally affected product is Dynaval Co 80/12.5 mg, 160/12.5 mg and 160/25 mg, which is supplied by Pharma Dynamics. CEO, Erik Roos, says the company has been working closely with Sahpra to ensure a swift recall of all affected products in South Africa.
“The health and safety of patients is of paramount concern to us. Regular quality checks are done at site level and once the impurity was detected earlier this month, international health authorities were immediately notified and recall protocols were followed.
Neither Dynaval 80 mg and 160 mg tablets, nor any other Pharma Dynamics products have been affected.
Roos adds that SAHPRA has classified the recall as a class II type B recall, which requires affected pharmaceutical companies to only notify healthcare practitioners, pharmacists and other authorised prescribers and dispensers of the recall as it doesn’t pose a serious threat to life.
Patients are advised to consult with a healthcare professional before discontinuing the use of valsartan.
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