Dr Burton is an expert in the treatment of complex spinal problems and has become a well-known advocate for arachnoiditis sufferers by promoting public awareness of the condition. His publication of the Burton Report in 2000 has raised awareness world-wide.
Depo victims must endure a lifetime of agony with a disability that affects every aspect day-to-day living. Arachnoiditis patient Zana G. describes her life as "sheer hopeless hell."
The condition, Zana says has "decimated my personal and professional lives, eradicated my hobbies, killed my love life, laid waste to my ability to travel and vacation with family and friends, made me a prisoner to my house, and my bed, driven my friends and family away."
A major complaint heard from many victims is that ESIs are being administered off-label for conditions not approved by the FDA, without the patient's knowledge of their unapproved status.
The dangers associated with this off-label procedure has even prompted Pfizer, the maker of Depo, to post a warning on its web site against epidural use which states in part:
DEPO-MEDROL Sterile Aqueous Suspension is contraindicated for intrathecal administration. This formulation of methylprednisolone acetate has been associated with reports of severe medical events when administered by this route.
The Pfizer site also lists adverse reactions reported with the epidural administration as:
Arachnoiditis Bowel/bladder dysfunction
Meningitis Headache
Paraparesis/paraplegia Seizures
Sensory disturbances
These warnings are nothing new. As far back as 1981, Upjohn, the Depro manufacturer at the time, stated "we would advise against the epidural/extradural routes of administration because of possible adverse reactions".
These warnings are rarely discussed with patients which means they have no opportunity to make an informed decision about whether or not to undergo the procedure after assessing the risk/benefit of the injections.
Advocacy groups say patients should always be advised when a drug is not approved. "Consumers should be told when they are receiving a drug for off-label use and make an informed decision if they want to accept the risk," according to pharmacist Larry Sasich, of the consumer watchdog group Public Citizen.
Dennis says patients will not be given this information unless they specifically ask for it. "Even then," he says, "there is no guarantee that their doctor will even know this latest update."
Therefore, a main goal of EDNC, he says, "is to have the FDA reevaluate the efficacy and safety of this steroid when used "off label" for epidural injections with the hope that they will label the steroid as contraindicated for epidural administration."
The fact is, there is no proof that Depo provides any benefit. According to the Injectable Corticosteroid Suspensions, 28 February 2006, Products""description, by the American Society of Health-System Pharmacists: "Currently, no clinical evidence conclusively shows that epidural corticosteroid injections are either effective or ineffective for relieving low back pain."
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