Search Results for 'REMS'

[gregoryglass]

Product: ACE Inhibitors and ARBs
Company: Various
Petition Filer: Dr. Anil Mandel
Petition Number(s): 2006P-0351 (renumbered 2006P-0008)
Date of Petition: September 6, 2006
Responding Petitions: Univeristy of Florida, American Board of Internists

Issue and Implication: Whether ACE (angiotensin converting enzyme) Inhibitors and ARBs (angiotensin receptor blockers) should have increased warning labels, restricted use or product withdrawal due to adverse events.

Action Requested by Petitioner: The Petitioner is requesting the FDA to restrict the use of these products or remove them from the market particularly in patients with diabetes.

Summary of Petition(s): Dr. Mandal states that his organization performed a study examining the incidence of acute renal failure in patients taking these products. He concludes that there is an increase in these events, including death, and the use of these products should be restricted. There were several follow up responses to this peitions from the University of Florida (February 23, 2007) and two from the American Board of Internists (June 5 and November 2, 2007). These have not been published by FDA, and we do not intend to retrieve copies. If interested for these responses, let us know, and we will have these pulled.

FDA Action: On August 4, 2010, FDA denied this petition. On April 18, 2011, it also issued a second letter denying Petitioner's “Appeal.”

Citizen Petition
FDA Action
FDA Letter

Product: ACE Inhibitors and ARBs
Company: Various
Petition Filer: Public Citizen
Petition Number(s): 2012P-1053
Date of Petition: October 11, 2012
Responding Petitions:

Issue and Implication: Whether the labels on the ACE Inhibitors, Angiotensin Receptor Blockers, and aliskiren are sufficient to enable safe and effective use.

Action Requested by Petitioner: The Petititioner would like FDA to add boxed warning labels to all of these products in these drug classes that use of these products in combination with each other increase the risk of renal failure, symptomatic hypotension, and hyperkalemia with no additional benefit when compared to monotherapy. It also request a de facto REMS strategy (Dear Doctor letters, eg) along with a directed request towards Atacand®(candesartan) that its label remove an indication regarding the benefit of use with an ACE Inhibitor.

Summary of Petition(s): As with most of its similar petitions, Petitioner chews through several studies that were conducted on these products and their effects on hypertension. Through its own statistical data analysis, Petitioner argues that the benefits of using these products in combination with each other are marginal when compared to monotherapy. As such, it argues that the adverse events associated with combination therapy (renal failure, eg) are not worth the additional risk of using them in combination.

FDA Action: On April 14, 2015, FDA denied this petition.

Citizen Petition
FDA Action

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