An important medicine used for treating hypertension, Aldactone, has been withdrawn from the market. The withdrawal comes after a company statement from Avas Pharmaceuticals S.r.l., raising concerns about the drug. Giovanni D’Agata, President of Rights Desk, was the one who initially sounded the alarm.
The Milanese pharmaceutical company requested the immediate suspension of the distribution and administration of Aldactone following an update in the Official Journal regarding the drug’s dossier for high blood pressure treatment. Specifically, six product lots of Aldactone 16cps 25 mg capsule rigide (AIC 019822028) have been removed from the market.
The affected lots are as follows: 0R2L9 expiring 09/30/2025 and new expiry 09/30/2023; 0R2LA expiring 09/30/2025 and new expiry 09/30/2023; 0R2LC expiring 09/30/2025 and new expiry 09/30/2023; 0R2LE expiring 09/30/2025 and new expiry 09/30/2023; 0R2LJ expiring 09/30/2025 and new expiry 09/30/2023; 0R2LK expiring 09/30/2025 and new expiry 09/30/2023.
Aldactone is a medication commonly used to counteract excess fluids in the body and prevent edema. It contains spironolattone, a diuretic drug that helps the body produce a greater quantity of urine. Diuretic drugs aim to alleviate discomfort caused by an excessive concentration of fluids.
Patients suffering from primary and secondary hyperaldosteronism, a condition characterized by increased aldosterone hormone production, low potassium levels in the blood, and high blood pressure, are advised to pay attention to the withdrawal of Aldactone. Additionally, individuals with essential arterial hypertension, which refers to high blood pressure of unknown cause, are also included in the recommendations if other treatments have not been adequate or sufficient.
As a result of Avas Pharmaceuticals S.r.l.’s statement, all patients regularly taking Aldactone are urged to contact their family doctor. They should seek explanations and ensure they can safely continue with their usual therapy.