Angiotensin receptor antagonist use decreased after recalls for potentially carcinogenic impurities
Click Here to Manage Email Alerts
The use of angiotensin II receptor antagonists, particularly generic valsartan, losartan and irbesartan, decreased since being recalled for potentially carcinogenic impurities, according to a research letter published in JAMA.
The FDA has reported recalls of 57 losartan, 139 valsartan and 16 irbesartan national drug codes since Aug. 8, which were associated with impurities including N-nitrosodimethylamine (NDMA), N-nitroso-N-diethylamine (NDEA) and N-nitroso-N-methyl-4-aminobutyric acid (NMBA), according to the research letter.
“Our study provides a comprehensive look at how use patterns changed in the wake of recalls in a nationally representative U.S. database,” Rishi J. Desai, MS, PhD, assistant professor of medicine in the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital, told Healio. “This is important information to understand the scope of the issue by documenting what proportion of overall angiotensin II receptor antagonist use prior to recalls was for products/national drug codes facing recalls and to identify if recalls resulted in meaningful reduction in use of angiotensin II receptor antagonists as class because this would be indicative of treatment disruptions.”
Researchers analyzed 9 million generic angiotensin II receptor antagonist prescriptions filled by 1.7 million patients between January 2018 and March 2019.
Several calculations and estimations were made including angiotensin II receptor antagonist utilization, use of recalled products and utilization of angiotensin II receptor antagonist as a class in proportion to the use of all antihypertensive medications. Generic angiotensin II receptor antagonist prescriptions that were assessed were valsartan, losartan, irbesartan, eprosartan, candesartan, olmesartan and telmisartan.
The use of generic valsartan as a proportion to overall angiotensin II receptor antagonists decreased from June 2018 to March 2019 (21% to 10%). Generic losartan use increased from June to October 2018 (67% to 73%), then decreased in March 2019 to 71% after losartan recalls. Increases were also seen in the use of generic olmesartan (6% to 8%) and irbesartan (4% to 6%) between June 2018 and March 2019.
The use of angiotensin II receptor antagonists as a class slightly increased from 15.4% of total antihypertensive medication prescriptions in January 2018 to 16.9% in March 2019.
A higher proportion of national drug codes were affected by valsartan recalls (33.9%) compared with irbesartan (11.6%) and losartan (11.7%). Generic losartan, valsartan and irbesartan national drug codes affected by the recalls in June 2018 accounted for 37% of overall use of generic angiotensin II receptor antagonists, which then decreased to 21% in March 2019.
“It is important to ensure treatment continuation with the best alternative option for patients on treatment with products facing recalls to avoid risks posed by disruptions in management of their chronic conditions including hypertension and heart failure,” Desai said in an interview. “As for the potential cancer risk, the FDA has maintained that any such risk is likely to be very small and it would be helpful to communicate this with patients to alleviate any concerns they may have.” – by Darlene Dobkowski
For more information:
Rishi J. Desai, MS, PhD , can be reached at Brigham and Women’s Hospital, Harvard Medical School, 1620 Tremont St., Suite 3030-R, Boston, MA 02120; email: rdesai@bwh.harvard.edu.
Disclosures: Desai reports he serves as a principal investigator on research grants from Bayer, Novartis and Vertex. Please see the study for all other authors’ relevant financial disclosures.
Read more about
Click Here to Manage Email Alerts