EPIDURAL STEROID INJECTIONS ARE NOT FDA APPROVED...PERIOD! [ Please remember to vote THUMBS-UP and Subscribe. This promotes the video to a wider audience, thank you! ] This video, produced by the EDNC in March 2012, illustrates the global controversy surrounding Depo-Medrol (Methylprednisolone Acetate) when used off-label. It raises a fundamental question... if Depo-Medrol was indeed as safe and efficacious for epidural administration as pain doctors claim, why hasn't Pharmacia/Pfizer simply applied for approval from the FDA unless they fear it would be denied, thus destroying the off-license Bi$$ion Dollar Market for the drug and to those who financially benefit from using it?
Despite numerous Med-Watch reports to the FDA of severe medical events, and a well documented poor efficacy record, Depo-Medrol sadly remains the industry standard of care for spinal related pain. How a drug that is neither FDA approved nor recommended by its manufacturer for epidural administration can continue to be used off label by pain specialists, injecting it into unsuspecting patients who have not been informed of the true risks, defies all logic and flies in the face of their Hippocratic Oath.
It's time for the FDA to reopen this controversy and explain why Depo-Medrol is only contraindicated for intrathecal injection and not epidural injection despite the fact that they both carry the same dangerous risks listed in the drug's package insert. Let's finally end the pain and damage it has caused and contraindicate Depo-Medrol for both routes of administration.
The EDNC is a patient advocacy collaborative comprised mostly of business professionals who were seriously harmed by the off-label epidural administration of Pfizer's Depo-Medrol and other similar steroid suspensions. Through a worldwide media network, the EDNC has been very successful in exposing the serious adverse risks by Epidural Steroid Injection (ESI) and the reluctance on behalf of the Pain Management Industry (PMI) to report such injuries to the FDA. Working with other patient advocates, physicians, government officials, media reporters and medical representatives, we intend to keep the pressure on the FDA until their misdirected policies for this off-licensed procedure are reversed. By alerting the public to the dark-side of the PMI, we strive to expose the myths surrounding the safety and efficacy of ESI therapies.
Depo-Medrol and Depo-Medrone are identical steroids (Methylprednisolone Acetate) with different marketed names. The latter was marketed primarily overseas in Europe, etc.
PLEASE FILE A MED-WATCH VOLUNTARY ADVERSE EVENT REPORT WITH THE FDA if you believe you may have been harmed by an ESI... You can either call the FDA at 1-800-332-1088 or download form 3500B and mail it back to them.. Link: https://www.fda.gov/safety/medwatch/howtoreport/downloadforms/default.htm
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM349464.pdf or file online at: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=consumer.reporting1
Dennis James Capolongo
Director / EDNC
FDA Issues a MedWatch Drug Safety Alert on Epidural Steroid Injections (4/23/14) requiring strong label changes: FDA Link: http://www.fda.gov/Drugs/DrugSafety/ucm394280.htm Video Link: http://youtu.be/DKboChc6yt8?list=UUOUBtQNU8UOxwfGGgTimFDA
Further Reading & Video Links:
Dr. Oz Show: http://www.youtube.com/watch?v=QCbzXqrG0ic
Part-1 of FDA/AADPAC Presentation: http://youtu.be/_3RA-BcFV44
Slow Powerpoint Presentation to the FDA/CDER: http://youtu.be/T42JJgy9plg
World In Action: http://www.youtube.com/watch?v=A8V05mMWl9Y from England - sorry for the poor quality.
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