Safety vs price in the generic drug market: metformin.
Am J Manag Care
; 30(4): 161-168, 2024 04.
Article
in En
| MEDLINE
| ID: mdl-38603530
ABSTRACT
OBJECTIVES:
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. STUDYDESIGN:
Primary pharmaceutical quality testing and database analysis.METHODS:
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.RESULTS:
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 < .05).CONCLUSIONS:
Recalls of metformin ER medications were effective in lowering NDMA levels below the FDA threshold; however, some samples of generic metformin still contained carcinogens even after FDA-announced recalls. The absence of any correlation with price indicates that potentially safer products are available on the market for the same price as poorer-quality products.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Metformin
Limits:
Humans
Language:
En
Journal:
Am J Manag Care
Journal subject:
SERVICOS DE SAUDE
Year:
2024
Document type:
Article
Country of publication: