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Spironolactone 25 mg. Spironolactone, sold under the brand name Aldactone among others, is a diuretic medication primarily used to treat fluid build-up due to heart failure, liver scarring, or kidney disease. [4]
FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
The trial was stopped early because the beneficial effect of spironolactone on all-cause death exceeded the prespecified discontinuation requirements. Spironolactone reduced the risk of death by 30% compared to placebo. Additionally, there was a 35% reduction in the risk of hospitalization for worsening heart failure in the spironolactone group.
The producer must either fix the default or take the drug off the market. [7] Drugs and medical devices are typically recalled if the product is defective, contaminated, contains a foreign object, fails to meet specifications, mislabeled, or misbranded. [8] Misbranding was the most common reason for pharmaceutical recalls in 2015, accounting ...
The company can be reached at 888-770-7119 from 8:30 a.m. to 6 p.m. Eastern Time Monday through Friday or online at this online recall page. Imaged of recalled oven gloves. / Credit: QVC Inc.
Spironolactone has been identified as an inhibitor of NRG1‐ERBB4 signaling. [142] Spironolactone has been found to act as a potent inhibitor of the pannexin 1 channel, and this action appears to be involved in its antihypertensive effects independently of MR antagonism. [143] Spironolactone has been found to block hERG channels. [144]
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About one-third of the participants were taking a cholesterol-lowering medication during the study, but no one started or stopped their medication during the follow-up. During six years of yearly ...