Prednisone drug label action - Reply by March 31st -- Steroid Warning Network

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Date Posted: 15:13:53 03/16/09 Mon
Author: Elise
Subject: Prednisone drug label action - Reply by March 31st

Hi everyone,
If you have steroid induced Osteonecrosis (ON)(aka Avascular Necrosis)AVN, please take a moment (sorry, I know it's long) to read this and act if you agree with what I have written and feel compelled to do so. Please be aware that the suspense date is March 31st. If more voices joined mine, then maybe someone at the FDA will take notice.

I've submitted written comments concerning this particular docket agenda of conveying risk to the public via registered mail and recently spoke to an FDA official about this extremely important issue. I'm providing a link so that you too may submit written comments about your concern that the risk of ON is not disclosed to the public. Once you�ve opened the link, please click on the bubble next to the �add comments� line which will bring up a form to submit an electronic submission and also submit attachments if you so desire for this particular docket meeting.
<a rel=nofollow target=_blank href="http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=09000064807d1f6f">http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=09000064807d1f6f</a>

The agenda for this meeting in a nutshell is assessing how to convey risk to the public. Here is a link that defines the use of CMI's (Consumer Medication Information), Medications Guides, and Patient package inserts, and the agenda for this docket.

In speaking with the point of contact, Ms. Lee Zwanzinger, she assures me that this docket is open for electronic submissions before March 31st.
<a rel=nofollow target=_blank href="http://edocket.access.gpo.gov/2008/E8-28887.htm">http://edocket.access.gpo.gov/2008/E8-28887.htm</a>

I've taken the time to prepare what I believe to be a detailed, worthwhile submission which you can copy and paste to the electronic submission form if time is short for you, or provide your own personal thoughts and views. Thank you for taking the time to act on this very important issue. Our actions may influence future labels for consumers.
Regards,
Elise

********

My particular issue is the lack of transparency and disclosure of a particular risk that has affected me personally and thousands of other patients across this nation.

The CMI for Prednisone doesn't disclose the risk of Osteonecrosis and because of the serious adverse drug experience and life altering effects that all ON patents experience, I believe that it should not only be disclosed, but that it warrants more than "useful" patient information as contained in the CMI and deserves its own Medication Guide or perhaps a black box warning.

As it stands now, the Patient Package Insert for Prednisone is layered with a "professional" page which includes the chemistry of the drug, indications, dosage and if you'll notice under side effects (pg 3), under musculoskeletal, it lists avascular necrosis of the femoral and humeral heads. Now click on the "Consumer" tab and this risk is not disclosed to the consuming public. It lists "bone pain (fracture), (and), "Caution is advised when using this drug in the elderly because they may be more sensitive to its side effects, especially osteoporosis." The professionals know about this risk, but clearly, as detailed in countless stories from patients who knew nothing about this risk, this information is not being disclosed so that patients can make informed decisions about their healthcare.
<a rel=nofollow target=_blank href="http://www.rxlist.com/deltasone-drug.htm">http://www.rxlist.com/deltasone-drug.htm</a>

Yet, upon being handed the diagnosis of Osteonecrosis, thousands of patients each year are blindsided, and many feel deceived by the professionals that they trust to provide the care that they believe will "First, do no harm."

From a report by Michael Aiello, MD "Avascular Necrosis. Femoral Head," it states that "The steroid exposure threshold is approximately 2000 mg of prednisone administered continuously (...)The risk of AVN is greater risk in patients treated for a short duration (6 wk) with high doses (> 20 mg).

This risk does not cease when the therapy is stopped. He highlights the insidious nature of this disease: "AVN may occur up to 3 years following cessation of therapy" so it's imperative that patients be warned of this risk.

He goes on to state: "Because measures to preserve the joint are associated with better prognoses when the diagnosis of AVN is made early in the course of the disease and because the results of joint replacement therapy are poorer in younger age groups than in older patients, it is critical to diagnose AVN as early as possible to prevent or delay progression of the disease."
<a rel=nofollow target=_blank href="http://emedicine.medscape.com/article/386808-overview">http://emedicine.medscape.com/article/386808-overview</a>

At issue then, is how a patient can be diagnosed early for a better prognosis if they don't even know they are at risk for the disease in the first place.

I urge you to please consider this request for a stronger warning on the Prednisone drug label to the consumer in order to convey the risk of the severe adverse reaction of Osteonecrosis (aka Avascular Necrosis) in the form of a Medication Guide or Black Box Warning.

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Replies:

Re: Prednisone drug label action - Reply by March 31st -- No name, 13:58:49 05/03/09 Sun