The National Medicines Regulatory Authority of Senegal, L’Agence sénégalaise de Règlementation pharmaceutique (L’ARP), has announced a temporary interruption in the supply of Pfizer’s Aldactazine (spironolactone/altizide) 25/15 mg and Aldactone (spironolactone), 50 mg and 75 mg tablets.
Reason for unavailability
L’ARP confirmed receiving communication from Pfizer indicating a delay in the production of these diuretic tablets. This delay has been attributed to the unavailability of the excipient polymethacrylate de potassium, a crucial component in the formulation and manufacture of the two products.
Use of the products
An aldosterone antagonist and potassium-sparing diuretic, Aldactone is used as an add-on therapy for managing hypertension, heart failure, and edema in patients with liver cirrhosis, congestive heart failure, or kidney disease.
Aldactazine on the other hand combines the aldosterone antagonistic effects of spironolactone with the thiazide diuretic effects of altizide to manage hypertension and edema caused by various disease states.
Crucial dates
According to the notice published by L’ARP:
Aldactazine 25 mg/15 mg: Supply interruption is estimated to commence on 1st June 2024, with normal supply expected to resume on 16th September 2024, resulting in a three and a half month out-of-stock period.
Aldactone 50 mg and 75 mg tablets: The supply interruption for the 50 mg tablets is expected to start on 8th July 2024, and for the 75 mg tablets on 7th October 2024. The resumption of supply for these products is estimated to be at the end of the year, with no exact date specified.
Effects and Recommendations by the Authority
This supply chain disturbance is expected to inconvenience patients on long-term therapy with these medicines. Consequently, the authority has advised users of the branded Pfizer products to switch to generic options, specifically those supplied by Arrow Pharmaceuticals.
The agency has committed to informing all stakeholders when the supplies resume.
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