Patients taking losartan, valsartan or irbesartan that do not comply can exchange their medicines at their pharmacy
A number of medicines for high blood pressure and heart failure contain an impurity. These are medicines containing losartan, valsartan or irbesartan. The manufacturers of these drugs are recalling the batches that do not comply. This is done in consultation with the Healthcare and Youth Inspectorate (IGJ) and the Medicines Evaluation Board (MEB). The majority of the drugs tested do meet the limit and do not need to be recalled. There is no direct risk to patients.
What is going on?
Medicines for high blood pressure and heart failure are also known as sartans. They are only available by prescription. An azide impurity, also called AZBT, has been found in these drugs. This impurity is higher than is allowed for medicines. In recent months, all manufacturers have tested their sartans for AZBT. The parties that are above the limit are now removed from the market as a precaution because they do not meet the quality requirements.
Pharmacists inform patients
The numbers of the medicines containing too much of the impurity are known to the pharmacists. They help patients to exchange their medicines for an equivalent medicine. Patients using sartans from other parties or brands can continue to do so. No AZBT above the permitted limit has been found with these drugs.
All manufacturers of losartan, valsartan and irbesartan are now adapting their production process. They also test the new drugs for the presence of AZBT before they come on the market. Products with too high a content may no longer be placed on the market.
What does this mean for patients?
Patients taking losartan, valsartan or irbesartan that do not comply can exchange their medicines at their pharmacy. This is reimbursed by the health insurer. Pharmacists contact users about this. Users can also check for themselves whether they have a medicine that needs to be exchanged. They can check the number on the medicine package from this list.
Patients who are unsure whether their sartan is on the list are advised to contact their pharmacy. If the drug is on the list, the pharmacy will provide a replacement drug. Patients who are on vacation can exchange their medicines at the pharmacy after their vacation. There is no immediate risk at this point, this recall is primarily a precautionary measure; medicines must be safe and meet the safety requirements that have been set.
Advice
Do you use these medicines and do you have any questions? Please contact your pharmacy or attending physician. It is advised not to stop taking the medication yourself. The benefits of the drugs outweigh the drawbacks of the impurity.
For questions that patients cannot turn to their pharmacy or treating physician, patients can contact the National Health Care Hotline.
What is the risk?
AZBT is created during the production of the active ingredient of the drug concerned. Laboratory tests have shown that this substance may be carcinogenic. Patients who have taken sartans with AZBT above the limit are not at direct risk.
The limit for this impurity is strict. If 100,000 patients use the maximum dose of a drug for their entire life, which contains the maximum permitted amount of the impurity every day, then 1 person of these 100,000 people may develop a form of cancer. The risk resulting from this additional exceeding of the limit in the lots found is very small. But because the impurity is above the limit and drugs should be as safe as possible, the said drugs are being recalled. The professional groups and patient associations involved have been informed about this.
Which medicines are involved?
This concerns a number of batches of medicines containing the active ingredient losartan, valsartan or irbesartan. A number of other parties are being recalled as a precaution. The test data is not yet known. The batch numbers are in this overview.
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