Recall Of Blood Pressure Meds Over Ingredient Botch

Leslie Hanson
July 8, 2018

The Health Products Regulatory Authority (HPRA) has stated it is undertaking a precautionary recall of a number of specific medicines* containing the active ingredient valsartan that are used to treat blood pressure and heart conditions.

The Medicines and Healthcare products Regulatory Agency (MHRA) has urged pharmacies in the United Kingdom to recall all batches of valsartan medicines as a precaution amid fears that an impurity compromised the manufacturing process at a facility in China.

"We will communicate the outcome of our investigations and ensure that any other affected products are recalled".

There are alternative valsartan-containing medicines and other treatments available to patients. The EMA and national agencies were working with Zhejiang Huahai Pharmaceuticals on measures to reduce or remove altogether the impurity in future batches of valsartan produced at at company's facility, the Bulgarian medicines agency said.

However, it is important for people using the medicines "not to interrupt" their treatment, and the ministry recommended patients consult their doctor or pharmacist with any questions. The review was triggered after the company detected an impurity, N-nitrosodimethylamine (NDMA), a substance classified as "probable cancerogen".

"The European Medicines Agency and other EU regulators are working together to investigate the extent of the issue and any possible impact for patients". The medication is also used by patients who have had heart disease or a recent heart attack. The health risk of abruptly discontinuing this medicine is higher than any potential risk presented by the impurity.

The HPRA will provide further updates on this matter as more information becomes available.

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