Lots of generic drugs based on valsartan, used in arterial hypertension, are being recalled in Europe. They could contain traces of a harmful substance, potentially carcinogenic in chronic use. However, you should not interrupt your treatment, but return to see your doctor.
The National Medicines Safety Agency (ANSM) alerted Friday on the recall of certain batches of generic drugs based on valsartan (or valsartan / hydrochlorothiazide), widely used in the treatment of arterial hypertension. The incriminated batches will no longer be delivered to pharmacies and are placed in quarantine throughout Europe, due to the possible presence of impurities.
The defect was reported to European health agencies by one of the producers of valsartan, the Chinese generic Zhejiang Huahai Pharmaceuticals, after failing health checks. Due to a change in the manufacturing process, some lots may contain traces of N-nitrosodimethylamine (NDMA), a potentially carcinogenic substance on prolonged exposure. What justify a recall of boxes, as a precaution.
Do not interrupt your treatment
“There is no acute risk for the patient”, reassures the ANSM, which advises to continue his treatment. “” It is crucial not to stop your treatment “, adds Professor Jean-Jacques Mourad (AP-HP), specialist in hypertension, reached by phone. “Stopping can lead to significant complications, such as flare-ups of heart failure or elevated blood pressure, including an increased risk of stroke.”
The list of incriminated lots is available on the ANSM website. The other valsartan-based specialties, as well as the other drugs of the same therapeutic class (sartans) are not affected by the problem. In all cases, it is recommended to continue treatment and wait for the next dispensation at the pharmacy. It is of course possible to inquire with your pharmacist or doctor.
Ongoing investigation
NDMA is a volatile compound, classified as probably carcinogenic to humans by WHO. It is found in small amounts in the environment – water, air, food products. In the current state of knowledge, low-dose consumption is not likely to induce a health risk. An investigation is underway at European level in order to better assess the impact of the presence of NDMA in the antihypertensive drugs concerned.
Valsartan is used to stabilize blood pressure to prevent the onset or recurrence of stroke or myocardial infarction. It has been available in generics since 2012. The nine suppliers affected by the recall in France subcontracted, in part or completely, the production of the molecule to Zhejiang Huahai Pharmaceuticals. This is a common model for generics, usually made in China or India to reduce production costs.
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