Dr. Hooman Noorchashm of the American Patient Defense Union (APDU) recently sent a strong letter to Mr. Doug Lankler, the Executive Vice President and General Counsel for Pfizer Global in NYC. This APDU warning stemmed from their serious concerns about increased reports of devastating neurological harm caused by the widespread, off-label epidural injection of Pfizer’s Depo-Medrol without patients’ specific consent to its use. Here I read Dr. Noorchashm’s letter where he not only requests that Pfizer’s risk-managers move swiftly to issue a warning to all practitioner guilds setting the standards of care for spinal pain management, he strongly encourages Pfizer to try once again to place an absolute contraindication for the off-label neuroaxial administration for their steroid suspension Depo-Medrol in the United States.
It should be noted that back in 2013 Pfizer Inc. sent an amended label request to global Health Authorities with changes to the Warnings & Contraindication Sections for their steroid Depo-Medrol, including a new specific Contraindication for epidural administration. Many nations have complied without protest. Among them are New Zealand, Australia, Canada, France, Italy, Switzerland, Russia with 12 more pending. Unfortunately the United States is not among them.
Even though Pfizer submitted their label change request to all the Health Authorities around the world, only the USA’s FDA holds the CORE Data-Sheet. Therefore Pfizer’s request to initiate these important safety changes to Depo-Medrol’s Core DataSheet in 2013 met strong opposition by member societies in the powerful and lucrative ESI INDU$TRY. Thus it was deliberately played down and not taken very seriously by Pfizer and the FDA despite a 15 to 7 vote to “Contraindicate ESI’s” by their own independent Safe-Use Initiative and AADPAC Advisory Panels. The “Epidural Contraindication” decision was therefore rejected by the FDA in 2014 without explanation.
I can honestly say that the patient community I represent owes Dr. Noorchashm a debt of gratitude for his tireless efforts against the increased use of Pfizer’s Depo-Medrol for epidural administration despite its poor safety and efficacy records.
The slaughter will sadly continue until Pfizer demands the FDA to add an “ESI Contraindication” to the CORE Data-Sheet in the USA.
Link to Pfizer’s Tracking Changes: https://jmp.sh/ooWuGCw Link to Pfizer’s Completed DataSheet: https://jmp.sh/uxCiBGK
PLEASE FILE A MED-WATCH VOLUNTARY ADVERSE EVENT REPORT WITH THE FDA if you believe that you or a loved one may have been harmed by an ESI… Please file a FDA MedWatch Report. Use Form 3500B Link: https://www.accessdata.fda.gov/script…
Thank you for watching!
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. You can contact Dennis Capolongo directly by email: TheEDNC@verizon.net