Carcinogenic Impurities in Generic Sartans: An Issue of Authorities’ Control or a Problem with Generics?

Antonis S Manolis


The recent flood tide of recalls of sartan generics due to carcinogenic impurities has brought to the forefront the issue of the safety and efficacy of generic drugs. Several of these issues are discussed in this editorial. Rhythmos 2019;14(2):23-26.


hypertension; sartans; angiotensin receptor blockers; generics; drug excipients; carcinogens; drug recalls

Full Text:



Charoo NA, Ali AA, Buha SK, Rahman Z. Lesson Learnt from Recall of Valsartan and Other Angiotensin II Receptor Blocker Drugs Containing NDMA and NDEA Impurities. AAPS PharmSciTech 2019;20:166.

Farrukh MJ, Tariq MH, Malik O, Khan TM. Valsartan recall: global regulatory overview and future challenges. Ther Adv Drug Saf 2019;10:2042098618823458.

Leclerc J. Recall of N-Nitrosodimethylamine-Contaminated Pseudogeneric Valsartan: Best Generics Finally No Better Than Others? Can J Cardiol 2018;34:1370.e13.

Heller FR, Dupont AG. Generics: need for clinical concern? Acta Clin Belg 2009;64:415-22.

Chow SC. Bioavailability and Bioequivalence in Drug Development. Wiley Interdiscip Rev Comput Stat 2014;6:304-12.

Gagne JJ, Sarpatwari A, Desai RJ. Role of Authorized Generics in Postapproval Surveillance of Generic Drug Products. Clin Pharmacol Ther 2019;105:313-15.


  • There are currently no refbacks.