"Limited clinical data are available on the epidural route of administration," the group explains, "and use of the product for this indication is not included in the labeling."
"In addition," Pharmacists warns, "some preparations contain benzyl alcohol, a preservative that is not suitable for epidural injection," citing Glucocorticoids In: Drug Facts and Comparisons. St. Louis, MO: Facts and Comparisons; 2000:320-332.
By using the Freedom of Information Act, Dennis discovered that over 350 deaths and over 15,570 severe neurological events were reported to the FDA between 1998 and 2002 on person who received Depo.
In addition, EDNC conducted a survey and found hundreds of patients who complained of serious side effects following the off-label administration of steroid compounds where doctors refused to notify the FDA or the manufacturer through the MedWatch reporting system.
According to a Harvard study, less than 2% of adverse events are reported to the FDA. which means there must be hundreds of thousands of unsuspecting victim that have been injured by the improper use of Depo.
Dr Burton claims there is remarkable amount of ignorance in the medical field regarding ESIs. "Many physicians performing epidural steroid injections on a regular basis," he says, "do not even understand the relationship of this procedure to the possibility of creating adhesive arachnoiditis months later."
This ignorance is inexcusable because studies on the administration of ESIs have been discussed in medical journals for years. In 1999, neuroradiologists from the Center for Diagnostic Imaging in Minneapolis, surveyed 5,334 procedures performed and identified adhesive arachnoiditis as a "well described" potential complication.
The authors of the study stated: "The blind interlaminar technique introduces the potential for erroneous needle placement and subsequent injection of substances into undesired locations, such as the subarachnoid space".
The authors noted that blind needle injection, even by "skilled and experienced procedurists" has been found to be inaccurate in 25-30% of cases, in an article published in the April 1999 issue of the American Journal of Neuroradiol, 20:697-705.
Dr Burton says anestesiologists are the worst offenders when it comes to improper ESIs and statistics verify that claim. The American Association of Anesthesiologists Closed Claims Project / Journal Anesthesiology 2004; 100:98-105, listed ESI complications as accounting for 40% of all AAA malpractice closed-claims between 1970 & 1999.
A section of the Burton reports explains why the majority of lawsuits involve anesthesiologists. Because pain management is big business, anesthesiologists want to be involved in direct patient care, but training in spine care or pain management is typically not a part of their training.
Because reimbursement for administering ESIs is relatively high, Dr Burton says pain management centers have become "procedure mills."
But anesthesiologists are not familiar with adhesive arachnoiditis and the potential for toxicity of steroid suspensions upon entry of the subarachnoid space and mistakenly believe the "blind" needle approach to the space is accurate because they are not trained in the use of x-ray monitoring equipment and so they tend not to use it.
Lastly, an anesthesiologist rarely sees a patient after the procedure to provide them with direct information regarding a patient's progress.
When it comes to ESIs, Dr Burton says many medical professionals seem to be afflicted with the "New Guinea Syndrome," which is identified by the following comparison:
"As remarkable as it seems there are actually primitive tribes in existence today who have not yet connected the act of sexual intercourse with the birth of a child nine months later."
"In addition," Pharmacists warns, "some preparations contain benzyl alcohol, a preservative that is not suitable for epidural injection," citing Glucocorticoids In: Drug Facts and Comparisons. St. Louis, MO: Facts and Comparisons; 2000:320-332.
By using the Freedom of Information Act, Dennis discovered that over 350 deaths and over 15,570 severe neurological events were reported to the FDA between 1998 and 2002 on person who received Depo.
In addition, EDNC conducted a survey and found hundreds of patients who complained of serious side effects following the off-label administration of steroid compounds where doctors refused to notify the FDA or the manufacturer through the MedWatch reporting system.
Dr Burton claims there is remarkable amount of ignorance in the medical field regarding ESIs. "Many physicians performing epidural steroid injections on a regular basis," he says, "do not even understand the relationship of this procedure to the possibility of creating adhesive arachnoiditis months later."
This ignorance is inexcusable because studies on the administration of ESIs have been discussed in medical journals for years. In 1999, neuroradiologists from the Center for Diagnostic Imaging in Minneapolis, surveyed 5,334 procedures performed and identified adhesive arachnoiditis as a "well described" potential complication.
The authors of the study stated: "The blind interlaminar technique introduces the potential for erroneous needle placement and subsequent injection of substances into undesired locations, such as the subarachnoid space".
The authors noted that blind needle injection, even by "skilled and experienced procedurists" has been found to be inaccurate in 25-30% of cases, in an article published in the April 1999 issue of the American Journal of Neuroradiol, 20:697-705.
Dr Burton says anestesiologists are the worst offenders when it comes to improper ESIs and statistics verify that claim. The American Association of Anesthesiologists Closed Claims Project / Journal Anesthesiology 2004; 100:98-105, listed ESI complications as accounting for 40% of all AAA malpractice closed-claims between 1970 & 1999.
A section of the Burton reports explains why the majority of lawsuits involve anesthesiologists. Because pain management is big business, anesthesiologists want to be involved in direct patient care, but training in spine care or pain management is typically not a part of their training.
Because reimbursement for administering ESIs is relatively high, Dr Burton says pain management centers have become "procedure mills."
But anesthesiologists are not familiar with adhesive arachnoiditis and the potential for toxicity of steroid suspensions upon entry of the subarachnoid space and mistakenly believe the "blind" needle approach to the space is accurate because they are not trained in the use of x-ray monitoring equipment and so they tend not to use it.
Lastly, an anesthesiologist rarely sees a patient after the procedure to provide them with direct information regarding a patient's progress.
When it comes to ESIs, Dr Burton says many medical professionals seem to be afflicted with the "New Guinea Syndrome," which is identified by the following comparison:
"As remarkable as it seems there are actually primitive tribes in existence today who have not yet connected the act of sexual intercourse with the birth of a child nine months later."
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