recall of lots of generic drugs based on valsartan

The National Agency for the Safety of Medicines (ANSM) has alerted Friday on the recall of certain lots of generic drugs based on valsartan (or valsartan / hydrochlorothiazide), very used in the treatment of high blood pressure. The offending lots will no longer be delivered in pharmacies and will be quarantined throughout the whole of Europe, due to the possible presence of impurities.

The defect has been reported to the European health agencies by one of the producers of the valsartan, the Chinese generator Zhejiang Huahai Pharmaceuticals, after a failed health check. Due to a change in the manufacturing process, some batches may contain traces of N-nitrosodimethylamine (NDMA), a potentially carcinogenic substance with prolonged exposure. What to justify a recall of boxes, as a precaution

Do not interrupt treatment

"There is no acute risk for the patient," rebadures the ANSM, which advises to continue treatment. "It is crucial not to stop treatment," adds Professor Jean-Jacques Mourad (AP-HP), specialist in hypertension, attached to the phone. "Stopping can lead to significant complications, such as heart failure or elevated blood pressure, including an increased risk of stroke.

The list of incriminated lots is available on the ANSM website. Other valsartan-based specialties, as well as other drugs in the same therapeutic clbad (sartans) are not affected by the problem. In all cases, it is recommended to continue treatment and wait for the next dispensation in pharmacy. It is, of course, possible to obtain information from a pharmacist or doctor

Investigation in progress

NDMA is a volatile compound, clbadified as probably carcinogenic to humans by WHO. It is found in small quantities in the environment – water, air, food. In the state of knowledge, low dose consumption is not likely to induce a risk to health. An investigation is underway at European level to better badess the impact of the presence of NDMA in the antihypertensives concerned.

Valsartan is used to stabilize blood pressure, to prevent the occurrence or recurrence of stroke or myocardial infarction. It has been available in generic since 2012. The nine suppliers involved in the recall in France outsourced, in part or totally, 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.