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A first wave of recalls was held in early July. In total, the combination of the two boosters affects three-quarters of these drugs used in heart failure, high blood pressure and after a recent cardiac infarction.
Withdrawal of valsartan medications is taking on a new dimension. After a first wave in early July, the agency of the drug (ANSM) proceeds, Thursday, November 29, additional reminders, because of the presence of a second substance clbadified as probably carcinogenic. This precautionary measure will lead to stockouts, warns the ANSM on its website. Indeed, the combination of the two recalls affects three-quarters of these drugs.
The valsartan is a antihypertensive which blocks the action of angiotensin II. This substance, naturally present in the body, causes a contraction of the arteries which increases the arterial pressure and tires the heart. Medications based on valsartan are therefore often prescribed in case of heart failure, high blood pressure or after a recent infarction.
The first international recall had already been motivated by the presence of an impurity, N-nitrosodimethylamine (NDMA), a substance clbadified as probably carcinogenic in humans. China's Zhejiang Huahai Pharmaceuticals was initially questioned. Two other Chinese laboratories were then pinned. All these companies manufacture the active ingredient on behalf of laboratories that then produce the drug.
The second reminder was decided because of "the possible presence of another impurity, NDEA (N-nitrosodiethylamine)", according to the ANSM. Of a nature close to the first, this impurity is, like her, "clbadified as probably carcinogenic to humans by the World Health Organization", specifies the ANSM. She "has been highlighted as a result of numerous investigations undertaken since July at the European level concerning valsartan ".
In France, between 1.2 and 1.5 million patients are treated with this type of medication. "If you are currently being treated with valsartan, you should consult your doctor who will decide what to do for a change of treatment", recommends the ANSM.
The drug agency also warns: "Pending this consultation, you should under no circumstances interrupt your treatment with valsartan." In addition, ANSM set up a toll-free number in July to answer questions from patients and their families: 0800 97 14 03.
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