Heart and high blood pressure remind: what you need to know

The South African Health Products Regulatory Authority (SAHPRA), in collaboration with other regulatory agencies, reviews recently recalled drugs internationally, but they say that you should NOT stop taking them without replacement drugs. Drugs containing valsartan (produced by Zhejiang Huahai Pharmaceuticals in China) are recalled by Pharma Dynamics in collaboration with SAHPRA.

Reminder letters have already been distributed to health care professionals for the following drugs containing valsartan that are affected and therefore urgently recalled in South Africa:

• Dynaval Co 80 / 12.5 mg (compressed); Registration number: 44 / 7.1.3 / 0018
• Dynaval Co 160 / 12.5 mg (tablet); registration number: 44 / 7.1.3 / 0019
• Dynaval Co 160/25 mg (tablet); Registry Number: 44 / 7.1.3 / 0020

The recent international recall of drugs containing the active substance valsartan, provided by Zhejiang Huahai Pharmaceuticals in China, triggered the review of these drugs locally in response the potential risk of cancer. In a statement Tuesday evening, the South African Health Products Regulatory Authority (SAHPRA) – formerly the Drug Control Board – said the review had been launched because of the detection of an impurity , N-nitrosodimethylamine in valsartan. active substance that the company provides to manufacturers producing some of the drugs containing valsartan in South Africa.

NDMA is classified as a probable carcinogen for human (carcinogen: any substance exposed to living tissue that can cause cancer) based on laboratory test results.

The presence of NDMA is unexpected and would be related to changes in the way that valsartan was Portia Nkambule, Acting CEO: SAHPRA, said that drugs containing valsartan are commonly used to treat patients with severe pain. high blood pressure to reduce complications such as heart attacks and strokes

"They are also used in patients who have had heart failure or a recent heart attack.Valsartan is available alone or in combination with 39, other drugs, "she said

but she said that all drugs containing valsartan are not affected and recalled.

Here's what you need to know and do the medications concerned: [19659003] Consult your doctor or pharmacist urgently and continue taking the medicine until you have a replacement medicine. The conditions under which drug treatment, namely heart failure and high blood pressure, are serious, and patients could be injured if you abruptly stop taking it without replacement medication. You may receive a different medicine than valsartan (or an alternative treatment) when you consult your doctor or pharmacist.

Your blood pressure needs to be closely monitored during the change process.

If you have questions about your treatment and the medications that are affected, talk to your pharmacist who can tell you if your medicine is being recalled.

If you are in a clinical trial with valsartan and you have questions, talk to the doctor who treated you during the trial.

"SAHPRA will continue to investigate and evaluate whether the impurity may pose a risk to patients, and collect more data on the safety of drugs containing valsartan as soon as it becomes available. She stated that health professionals in South Africa are urged to report any adverse reactions, particularly those associated with drugs containing valsartan, to the SAHPRA (012) pharmacovigilance unit.) 395 9133 or at the National Center for Adverse Drug Reaction at (021) 4471618.