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

Authors

  • Antonis S Manolis Third Department of Cardiology, Athens University School of Medicine, Athens, Greece

Keywords:

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

Abstract

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.

References

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.

Downloads

Published

2019-04-26

Issue

Vol. 14 No. 2 (2019)

Section

Editorial

License

Authors who publish with this journal agree to the following terms:

a. Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.

b. Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.

c. Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).