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Abstract
Generic medications represent 90% of prescriptions in the US market and provide a tremendous financial benefit for patients. Recently, multiple generic drugs have been recalled due to the presence of carcinogens, predominantly N-nitrosodimethylamine (NDMA), including an extensive recall of extended-release (ER) metformin products in 2020.Primary pharmaceutical quality testing and database analysis.We tested marketed metformin immediate-release (IR) and ER tablets from a wide sample of generic manufacturers for the presence of carcinogenic impurities NDMA and N,N-dimethylformamide (DMF). We examined the association of level of impurity with drug price and the impact of the 2020 FDA recalls on unit price and prescription fill rate.Postrecall NDMA levels were significantly lower in metformin ER samples (standardized mean difference?=?-2.0; P?=?.01); however, we found continued presence of carcinogens above the FDA threshold in 2 of 30 IR samples (6.67%). Overall, the presence of contaminant levels was not significantly associated with price for either IR (NDMA: R2?=?0.142; P?=?.981; DMF: R2?=?0.382; P?= .436) or ER (NDMA: R2?=?0.124; P?=?.142; DMF: R2?=?0.199; P?=?.073) samples. Despite recalls, metformin ER prescription fills increased by 8.9% while unit price decreased by 19.61% (P?
View details for DOI 10.37765/ajmc.2024.89450
View details for PubMedID 38603530