Patients who are taking medicines containing the active substance valsartan have been advised to consult their doctors or pharmacist as the medicine has been recalled.
The South African Health Products Regulatory Authority (SAHPRA), in collaboration with other regulatory agencies are reviewing medicines containing the active substance valsartan, supplied by Zhejiang Huahai Pharmaceuticals, located in Linhai, China.
“This review was triggered because of the detection of an impurity, N-nitrosodimethylamine (NDMA) in the valsartan active substance which the company supplies to manufacturers producing some of the valsartan-containing medicines in South Africa,” South African Health Products Regulatory Authority (SAHPRA) said in a statement.
SAHPRA said not all valsartan-containing medicines are affected and being recalled.
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.
The presence of NDMA is unexpected and is thought to be related to changes in the way valsartan was manufactured.
SAHPRA said the conditions the medication treat such as heart failure and high blood pressure are serious, and patients could be harmed if they suddenly stop taking it without a replacement medicine.
“You may be given a different valsartan medicine (or an alternative treatment) when you consult your doctor or pharmacist. Your blood pressure should be monitored closely during the process of switching.
“If you have any questions about your treatment and which medicines are affected, speak to your pharmacist who can tell you if your medicine is being recalled,” SAHPRA said.
SAHPRA said people who are in a clinical trial with valsartan and have any questions, should speak to the doctor treating them in the trial.
SAHPRA 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.
Any new information or recommendations will be communicated to the public.
“While the review is underway, medicines containing valsartan produced by Zhejiang Huahai Pharmaceuticals are being recalled by Pharma Dynamics in collaboration with SAHPRA. Recall letters have already been circulated to healthcare professionals,” SAHPRA said.
The department said Valsartan containing medicines are commonly used to treat patients with high blood pressure in order to reduce complications such as heart attack and stroke.
They are also used in patients who have had heart failure or a recent heart attack. Valsartan is available on its own or in combination with other medicines.
“Valsartan containing medicines are commonly used to treat patients with high blood pressure in order to reduce complications such as heart attack and stroke. They are also used in patients who have had heart failure or a recent heart attack. Valsartan is available on its own or in combination with other medicines,” SAHPRA said.
The following valsartan-containing medicines are affected and therefore urgently recalled:
- Dynaval Co 80/12,5 mg, tablet, 44/7.1.3/0018
- Dynaval Co 160/12,5 mg, tablet, 44/7.1.3/0019
- Dynaval Co 160/25 mg, tablet, 44/7.1.3/0020
–SAnews.gov.za
