FDA
10th January 2014

NSAIDs – ISS Insight & Meeting Announcement

During this joint meeting, the committees will discuss data and analyses published in 2006 or later that are relevant to further understanding the relationship between nonsteroidal anti-inflammatory drugs (NSAIDs) and cardiovascular thrombotic risk that is currently described in NSAID class labeling.

NSAIDs – ISS Insight & Meeting Announcement

February 10-11, 2014 8:00 a.m. to 5:00 p.m.: Joint Meeting of the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee Meeting Announcement

Where:

FDA White Oak Campus
Building 31
The Great Room (Rm. 1503)
White Oak Conference Center
10903 New Hampshire Avenue
Silver Spring, Maryland

During this joint meeting, the committees will discuss data and analyses published in 2006 or later that are relevant to further understanding the relationship between nonsteroidal anti-inflammatory drugs (NSAIDs) and cardiovascular thrombotic risk that is currently described in NSAID class labeling.

More than 17,000,000 Americans use nonsteroidal anti-inflammatory drugs (NSAIDs) every day, but is the labeling sufficient?

Every major pharmaceutical manufacturer in the world markets drugs to reduce pain and inflammation. Key products include both prescription (Rx) and over-the-counter (OTC) options, such as Advil/Motrin (ibuprofen), Celebrex (celecoxib), Naprosyn (naproxen), and Voltaren (diclofenac).

A major public health issue that has been elucidated in recent years (after many, many decades of NSAID use) is that NSAIDs are associated with an increased risk of cardiovascular (CV) events, such as heart attack and stroke. Initially, it was thought that the risk was largely related to a specific type of NSAID called COX-2 selective inhibitors (e.g., celecoxib and rofecoxib). In fact, in 2004, Merck withdrew its blockbuster COX-2 pain medication Vioxx due to alleged adverse CV events from exposure to the drug, and subsequently paid almost a billion dollars in a legal settlement. Now the question is whether this risk extends equally to the traditional NSAIDs (e.g., ibuprofen and aspirin), which are widely used in both Rx and OTC settings.

In February 2005, FDA held a joint meeting of its Arthritis Drugs and Drug Safety & Risk Management Advisory Committees to discuss the overall benefit/risk considerations for COX-2 selective NSAIDs. The Committees concluded that each NSAID should be individually evaluated for CV risk, and that each is suspect when used chronically; until proven otherwise, patients and physicians should be warned.  Bextra was subsequently withdrawn from the market in April 2005; Celebrex remained on the market, but with a box warning. FDA requested labeling changes for all NSAIDs highlighting the risk of cardiovascular events with these agents (including OTC NSAIDs).

Importantly, the Committees agreed that the absence of an established increased risk is not the same as no increased risk; evidence sufficiently powered and controlled to rule out an increase in incidence is needed. So what have the data shown since the 2005 meeting – is this indeed an effect shared by all NSAIDs? Rightfully so, another FDA hearing is now scheduled to re-visit these issues. This meeting will provide an opportunity for NSAID manufacturers to discuss differences between their drugs, and potentially, provide some better insight into the benefit-risk profiles of NSAIDs in the interest of public health. For example: What about Rx vs. OTC? What about short term vs. long term use?

Please click HERE for the current roster of the Arthritis Advisory Committee.

Please click HERE for the current roster of the Drug Safety and Risk Management Advisory Committee.

ISS has over a decade of experience helping companies prepare for FDA advisory committee meetings for both new and established products that have come under scrutiny for various post-marketing safety signals. Our expertise is particularly deep in the area of Rx and OTC NSAIDs. Through this blog, we will keep you informed about new FDA actions, including advisory committee hearings, which could affect both Rx and OTC NSAIDs. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

Do you want to find out what happens during this drug’s FDA AdComm meeting? Great news – ISS can help you! Click on the link below in order to receive a summary of this meeting’s outcome!

Drug AdComm Follow-up Request

 

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