Your question is a complicated one, and as such, I have broken my
answer down by medical and legal aspects. Please keep in mind that
this answer is for informational purposes only, and not intended to
replace sound medical or legal advice.
Arachnoiditis, as you already know, is a chronic inflammation of the
arachnoid layer of the meninges, the covering of the spinal cord and
brain. The arachnoid layer?s function is to secrete the spinal fluid
(CSF) that circulates through the cerebrospinal column, bathing and
nourishing the brain.
?The initial phase of the inflammatory process involves influx of
white blood cells in response to an insult to the subarachnoid space,
such as blood (trauma, surgery), foreign substance (dye, etc) or
infectious agent (e.g. meningitis). This is initiated via the action
of cytokines, (proteins that act as immune modulators). There is
infiltration by macrophages and mesenchymal cells; the latter
transform into fibroblasts, which make collagen (scar tissue). Usually
the fibrinolytic process, which breaks down excess scar tissue, limits
this, but in arachnoiditis the scar tissue continues to form. ?
You can see an illustration of how arachnoiditis progresses here
According to this MSN site, from 1998-2002, there were 15578 adverse
reactions to Depo Medrol, with arachnoiditis but one of the many types
Causes of Arachnoiditis
From the ASAM (Arachnoiditis Sufferers Action and
Monitoring Society) web site, written by Sarah Andreae-Jones MB BS (Smith) :
·Spinal surgery (especially multiple)
·Myelographic dyes (especially oil-based such as Myodil (Pantopaque))
·Epidural steroid injections (e.g.Depo-Medrol)
·Other intraspinal drugs such as amphotericin B and methotrexate
·Multiple lumbar punctures
·Infection e.g. meningitis
·Chronic disc prolapse
?If the steroid is inadvertently injected into the subarachnoid space
rather than the epidural space serious disability and incapacitation
can result. Although all foreign body substances introduced into the
subarachnoid space are "irritating" others can be highly neurotoxic.
The most significant example of such neurotoxic agents are those
containing ethylene glycols to allow for slow release (i.e.
Depo-Medrol, Depo-Medrone, Aristocort and Methylprednisolone
Suspension. When introduced into the subarachnoid space these
materials can be highly neurotoxic and productive of a potentially
disabling condition referred to as adhesive arachnoiditis. Since none
of these steroids is approved, by their manufacturers, for epidural
injection, and that they are clearly know to be toxic if misinjected,
it is interesting to note that they still appear to be used by the
majority of physicians now performing epidural steroid injections.?
High resolution MRI can accurately diagnose arachnoiditis. You mention
no current MRI is available, but you may be able get a new one ordered
by your physician.
Depo Medrol?s Role / Off Label Uses
Description of ?Intrathecal?
Intrathecal (meaning subarachnoid, into the arachnoid space) drug
delivery places medication directly into the cerebrospinal fluid that
surrounds the spinal cord
?Off-label drug use means prescribing a drug for a condition for which
it has not received FDA approval. The term also refers to drugs
ordered for a different population group, such as children instead of
adults, or at a different dose or duration than was determined by the
FDA to have a favorable risk-benefit ratio.
"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,"
says pharmacist Larry Sasich, of the consumer watchdog group Public
Citizen, in Washington, DC.?
Somerset Medical Center
Since oil-based contrast media was withdrawn from the market, the use
of Depo Medrol has greatly increased, and seems to be the causative
agent of increasing numbers of cases of arachnoiditis. When given
intrathecally, it is being used as an ?off label? treatment. This,
simply put, is utilizing a drug for a purpose other than the original
or recommended use. This is quite often done in the medical practice,
as evidenced by the use of beta-blockers, intended for cardiovascular
purposes, being used for migraines, and oral contraceptives used for
treating axillary cysts.
You asked ?what did the drug manufacture do to prove it was safe to
the FDA and then promote its use near the spine.?. Actually, the use
of Depo Medrol was not approved or proven safe to use in the
sub-arachnoid(intrathecal) space. This is what is called an ?Off Label
Use? . Drug companies must submit all research results to the FDA for
approval, before allowing the public to use a new medication. At this
time, the use for which the drug was specified and researched is the
use that is approved. "We would not approve for an extremely narrow
use, if we thought the drug was going to be used more broadly after
marketing," says Laurie Burke, a pharmacist with the FDA. "If we know
it is going to be used widely, we will ask for more data." What
happens sometimes is, after a time, a new drug may be studied by
another group, who finds a use other than the originally specified and
FDA approved. When this study gets published in a medical or
scientific journal, it becomes almost ?Approved by proxy?, without
resubmitting the research on the new use to the FDA for final
approval. Once the drug is commonly accepted for an off label use, it
is almost impossible to stuff the ?Off Label Genie? back in the
Indeed, this Pain Physician article, 2002, actually gives somewhat of
a protocol for administering methylprednisolone epidurally, warning
of administering it intrathecally. On page 4, ?Nelson spearheaded a
crusade against intraspinal therapy using steroids and argued that
methylprednisolone acetate was neurotoxic. The controversy prompted a
review of the literature concerning epidural steroids. These reviews
found that epidural steroids had been used extensively throughout the
world, with the majority of published medical opinions supporting
their use. However, although two of the reviewers recognized that
intrathecal injections of steroids could result in nerve damage, but
both reviewers referred to the available literature
attesting to the chemical safety of corticosteroid preparations used
in the epidural space. Subsequently, Bogduk et al in a 1994 review
concluded that there was no evidence of any deleterious effect of
steroid preparations provided they were injected accurately into the
epidural space, but also that none of the commercially available
formulations of steroids was free of at least some potential risk of
deleterious effects if it was to be injected deliberately or
inadvertently into the intrathecal space. This report, however,
cautioned that the use of any steroid preparation intended for
epidural injection should be accompanied by the utmost precautions to
ensure accurate epidural injection and to preclude intrathecal
From the law firm of Cunningham, Bounds, Yance, Crowder, and Brown,
L.L.C , an article ?OFF LABEL USE: Are drug companies liable for
injuries in light of Proctor v. The UpJohn Company?? by Michael A.
Worel and William C. Louv, PhD.
?Many doctors do not like to have the government dictate the practice
of medicine and, indeed, their practices are not governed/restricted
by official package inserts. Doctors argue that they want and need the
newest and best science they can get to benefit their patients. They
see the package insert as only one piece of guidance. Package inserts
have also been criticized to be arcane, difficult to read, and not up
For the pharmaceutical industry, regulation of off label use has been
problematic, particularly as the FDA has been slow to review and
approve revisions on labels in the face of new and compelling
evidence. Also, evidence that is of substantial importance to medical
practice may not represent information adequate to compel development
of new labeling or primary studies for new indications. In the area of
HIV, for example, the science has led the labels by several years.
Major breakthroughs are known through the published literature, but
pharmaceutical companies have been prohibited from distributing such
information to HIV practitioners, irrespective of the importance to
their practices in this rapidly evolving field. Also, to wait for
approval before disseminating information on a new breakthrough
substantially affects the company's bottom line in such a highly
More on Off Label Use:
The rationale for using Depo medrol for back pain and inflammation is
that the main ingredient, methlyprednisone, is an anti-inflammatory
medication. However, Depo Medrol is not just a steroid -- it contains
preservatives such as polyethylene glycol, also used as car
anti-freeze, and alchohols. It is widely known that these
preservatives are toxic when introduced into the sub-arachnoid space.
In rat studies, nerves exposed to either methlyprednisone or
ethylene glycol and alcohol showed demyelination (an eroding of the
outer coating of the nerves) and scarring. Even the injection of
distilled water into nerve roots can cause lesions.
Supposedly, in 1981, the makers of Depo Medrol advised against
intrathecal administration because of possible adverse reactions. For
unknown reasons, this information was removed from the data sheet in
1997. It may have been thought safe, if administered exactly into the
epidural space, and the site, whose link is below this paragraph
states "the epidural space is not wholly separate from the subdural
and/ or subarachnoid space" and that the spaces are "not only
contiguous, but continuous". He concluded that epidural delivery of
drugs may not guarantee that the substance will remain isolated in the
epidural space alone and cites a 2.5% risk of inadvertent drug
injection directly into the subarachnoid space.? And ?Yuen et al
(1995*13) state that neurological. complications " may be more severe
in the presence of spinal stenosis". Rocco et al (1997*14) in a study
of pressure gradients in the epidural space, concluded that as
resistance to inflow of fluid was significantly higher in the diseased
epidural space, "spread of anesthetics might be difficult to predict"
?Other authors suggest that arachnoiditis reactions can occur simply
from the vasoconstrictive component of an anesthetic, while others
have noted that even minor contaminants or preservative agents can be
responsible for this condition. It needs to be stressed that any drug
preparation injected into the spinal column, may contain preservatives
such as benzyl alcohol, polyethylene glycol, and chlorobutanol (a
derivative of chloroform). All of these substances carry a risk of
Dr. J. Antonio Aldrete says, on this page that is promoting his book
"Arachnoiditis: The Silent Epidemic"
??the concentration of the preservatives contained in the various
preparations of steroids as the culprits, and emphasizes the
indications for corticosteroids in the inflammatory and the
Depo Medrol Label 2/26/03
Photo of Depo Medrol label 3/15/04
?The drug most commonly reported to be at the root of these cases is
Depo Medrol. The company, which produces it, marks all their package
inserts, "Not for Intrathecal use", that is not for the spinal cord,
but it is exactly where the doctors are using it. Though the drug is
not licensed for such uses in the first place and, despite the warning
on the package insert, they inject thousands of litres into human
spinal columns daily. They rationalise this use, and, what is worse,
they are allowed to operate in this ad hoc way by government health
departments around the world, simply because there was a body of
thought that Depo Medrol is efficacious for lower back pain.?
Posted on a Medhelp Neurology and Neurosurgery Forum:
?Reports of severe complications from epidural steroid nerve block
injections of depo-medrol:
ESI's using Depo-Medrol are harming people! Epidural steroid nerve
block injections are widely used to treat back pain. It is "not
recommended" by the drug maker because of the "severe medical events"
that have been reported to them and the FDA! There are new studies
that link severe chronic pain syndromes with complications of this non
FDA approved procedure. (Arachnoiditis, Epidural Fibrosis, Severe
Sensory Nerve Disruption, etc.) By using the Freedom of Information
Act, we have discovered that there have been well over 15,000 adverse
event reports and 356 deaths attributed to Depo-Medrol between 1998
and 2002. (A very high number despite that fact that only 1.5% of all
adverse events get reported to the FDA!) (A 1999 Harvard Study)
Pfizer Inc. recently purchased Pharmacia/Upjohn, the manufacturer of
the most commonly used injectable steroid, Depo-Medrol! They have
recently issued a new WARNING on the use of this non-FDA approved drug
for spinal surgery as well as for epidural administration. They say
that Depo-Medrol is "NO LONGER RECOMMENDED" for epidural
administration in a newly published Pfizer document titled:
"DEPO-MEDROL - REFORMULATION-EPIDURAL USE" The warning covers BOTH
formulations they make!
(Another misconception is that there is a preservative-free
formulation of the drug, which supposedly is safer in the opinion of
the doctors who use it! These doctors are not only wrong about this,
it's incompetence if they believe this is so!
Both formulations, the single dose and the multi-dose formulation,
have preservatives added, MGPC and Benzyl Alcohol respectively... both
are neurotoxic and potentially damaging to neuro-tissue. Besides, both
formulations contain huge amounts of Polyethylene Glycol, a chemical
cousin of automobile antifreeze and a major ingredient in DOT-3 Brake
Fluid! If this isn't bad enough, they then mix Depo-Medrol with other
chemicals, such as anesthetics, like Marcaine, and ionic dyes, such as
Isovue, again AGAINST THE RECOMMENDATION OF PFIZER! PFIZER CLAIMS THAT
THIS PRACTICE CAN INCREASE THE "TOXIC RISKS BECAUSE OF CHEMICAL
INCOMPATIBILITIES", THEREFORE THEY HAVE WARNED DOCTORS NOT TO DO IT!
Any doctor that may be reading this should call Pfizer immediately and
ask for a written copy of their newly posted Warning.
All patients should be advised that they will not be told this
information unless they specifically ask their doctors for it. Even
then, there is no guarantee that their doctor will even know this
Try this Google search: "Depo-Medrol Harm"
Dennis J. Capolongo / EDNC
Center for Pharmaceutical Safety
The preservatives, polyethelene glycol, benzyl alcohol, and MGPC, in
Depo Medrol may be to blame, more so than the steroid itself.
?This product contains benzyl alcohol which is potentially toxic when
administered locally to neural tissue?
?Since the withdrawal of oil-based myelography Depo-Medrol and
Depo-Medrone have become the principal cause of clinically significant
adhesive arachnoiditis in the Western world.Depo-Medrol (and other
similar suspensions) are being administered epidurally as routine
off-label and ill-advised, treatments for back pain. The rationale
given for the use of these suspensions is that their main ingredient,
methylprednisolone, is an anti-inflammatory agent. Although basically
true in concept suspensions of synthetic glucocorticoids are effective
anti-inflammatory agents but they also contain preservatives such as
polyethylene glycol, known better as a anti-freeze in car cooling
systems. Other preservatives include alcohol. Both ethylene glycol and
alcohol are well-recognized toxic agents if introduced into the
sub-arachnoid space. Wood (1980 *1) studied the effects of injections
of methylprednisolone acetate into rat sciatic nerves. Nerves treated
with either the steroid or its vehicle showed damage, including
collagen (scar) formation and demyelination.
The manufacturers Depo-Medrol (Upjohn Pharmaceutical Co., Kalamazoo,
Michigan, U.S.A.) stated in 1981 that "we would advise against the
epidural/ extradural routes of administration because of possible
adverse reactions". However, this specific recommendation was
withdrawn from the data sheet in 1997.?
The fact that the doctor did not place a drain during your surgery may
or may not have any bearing on this case, as the causative agents are
probably the Depo Medrol and/or the preservatives. A subarachnoid
bleed *can* cause a local arachnoiditis, but it is unlikely that if
pooled blood collected outside the subarachnoid space that it would
cause a problem. Perhaps the surgeon felt there was no need for a
?Keep in mind that PP&U does not differentiate between the severe
medical events caused by Depo-Medrol when injected intrathecally
(inside your spinal cord) or epidurally (around your spinal cord).
(Please refer to your PDR or to the drug's Package Insert shown
above.) The dangerous risks to your spine and overall health remain
the same because Depo-Medrol contains high formulations of neurotoxins
such as Benzyl Alcohol, known as "the preservative" in multidose
vials, Myristyl Gamma Picolinium Chloride (MGPC), the other
unmentioned preservative used in single dose vials, and high
concentrations of the suspension agent Polyethylene Glycol, known best
to auto-mechanics as DOT3 Brake Fluid!?
Depo Medrol Facts
Depo-Medrol is a white aqueous sterile suspension containing
Methylprednisolone acetate USP 40mg/ml in a 1ml vial.
?These compounds inhibit inflammatory response whether the inciting
agent is mechanical, chemical or immunological.
Joints not suitable for injection are those that are anatomically
inaccessible such as the spinal joints and those like the sacroiliac
joints that are devoid of synovial space. Treatment failures are most
frequently the result of failure to enter the joint space. Little or
no benefit follows injection into surrounding tissue. If failures
occur when injections into the synovial spaces are certain, as
determined by aspiration of fluid, repeated injections are usually
futile. Local therapy does not alter the underlying disease process
and, whenever possible, comprehensive therapy including physiotherapy
and orthopaedic correction should be employed.
? For synovial, soft tissue or intralesional injection. It is
available in three strengths:
20 mg/mL; 40 mg/mL; 80 mg/mL.
Each mL of these preparations contains:
Methylprednisolone acetate......................... 20 mg 40 mg 80 mg
Polyethylene glycol 3350............................29.5 mg 29.1 mg 28.2 mg
Polysorbate 80 .....................................1.97 mg 1.94 mg 1.88 mg
Monobasic sodium phosphate .........................6.9 mg 6.8 mg 6.59 mg
Dibasic sodium phosphate USP........................1.44 mg 1.42 mg 1.37 mg
Benzyl alcohol....................9.3 mg 9.16 mg 8.88 mg added as a preservative
Sodium Chloride was added to adjust tonicity.
When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid.
The pH of the finished product remains within the USP specified range;
ie, 3.5 to 7.0.?
Contraindications of Depo Medrol:
Systemic fungal infections.
Known hypersensitivity to components
In order to minimise the incidence of dermal and subdermal atrophy,
care must be exercised not to exceed recommended doses in injections.
Multiple small injections into the area of the lesion should be made
whenever possible. The technique of intra-synovial and intramuscular
injection should include precautions against injection or leakage into
Injection into the deltoid muscle should be avoided because of a high
incidence of subcutaneous atrophy.
Depo-Medrol should not be administered by any route other than those
listed under INDICATIONS. It is critical that, during administration
of Depo-Medrol, appropriate technique be used and care taken to assure
proper placement of drug.
Administration by other than indicated routes has been associated with
reports of serious medical events including: arachnoiditis,
meningitis, paraparesis/paraplegia, sensory disturbances,
bowel/bladder dysfunction, seizures, visual impairment including
blindness, ocular and periocular inflammation, and residue or slough
at injection site.
Corticosteroids should not be injected into unstable joints
New Zealand Medicines and Medical Devices Safety Authority
?DEPO-MEDROL Sterile Aqueous Suspension is contraindicated for
intrathecal administration. Reports of severe medical events have been
associated with this route of administration. DEPO-MEDROL is
contraindicated for use in premature infants because the formulation
contains benzyl alcohol. Benzyl alcohol has been reported to be
associated with a fatal "gasping syndrome" in premature infants.
DEPO-MEDROL is also contraindicated in systemic fungal infections and
patients with known hypersensitivity to the product and its
This undated document from Pfizer clearly states that Depo Medrol is
not indicated for intrathecal use. (Middle of Page 2)
?Furthermore, epidural anaesthesia may cause subarachnoid cysts or
cavities, which are also recognised complications of arachnoiditis.
Torres et al suggested that "meningeal inflammation may have left
scars which later induced ischemia and subsequent cavitation."
Alternatively, CSF flow may have been impeded, thus dilating the
central canal and causing compressive ischaemia, thence myelomalacia
and cavitation. They discussed seven patients with spinal
arachnoiditis secondary to epidural anaesthesia, all of whom had
subarachnoid cysts and five had cord cavitation.?
?It is important to put the above information into context, but
unfortunately, there is insufficient data to allow this, as the true
incidence of arachnoiditis remains unknown.(adverse drug reactions are
What is probable is that those who have pre-existing spinal problems
(whether recognised or not) are likely to have a higher risk of
adverse events following epidural or spinal anaesthesia. In the
meantime, until further research is carried out, it would seem
advisable to counsel caution with these procedures in patients who
have back problems .
Arachnoiditis is a recognised complication of epidural anaesthesia and
this should be mentioned as a risk (albeit probably rare) in obtaining
informed consent to this invasive procedure.?
Depo Medrol Litigation
?Part of the reason that more people are not suing
for their injuries is that Arachnoiditis does not
manifest itself for a number of years...by then the
Statute of Limitations have run out. By then they
also have had so many tests and injections for pain,
it is hard to pin down? This was written by one Arachnoiditis forum member
This is the lawsuit report of a 38 year old woman with arachnoiditis.
?Tirante, now 51, charged that Dr. Syed Hussain negligently injected
Depo-Medrol into her spine while performing a spinal tap to treat her
lower back pain in 1986 at Newcomb Medical Center?
Mayer, Brown & Platt are defense lawyers for the litigation against
Upjohn . ?Off-Label Use Post-Verdict Proceedings and Appeal- We
represented Upjohn in the post-verdict proceedings and appeal of a
$127 million jury verdict including punitive damages based upon the
off-label use of Depo-Medrol?
Depo Medrol is covered in this book ?Why Lawsuits are Good for
America? by Carl T. Bogus.
Also by Carl. T. Bogus, ?The Contract and the Consumer?, published by
the American Prospect, Online Edition, March 1995. This suit involved
Depo Medrol?s off-label use in the eye.
?This was a gross distortion. A jury had rendered a verdict of $127
million against Upjohn, but not because it deemed that to be
"reasonable compensation" for the plaintiff's loss. More than $124
million of the award was punitive damages, to punish Upjohn for
promoting its drug, Depo- Medrol, for use in a manner that was not
approved by the Food and Drug Administration and without warning
physicians about the risks. Indeed, Upjohn had so effectively marketed
its drug for this unapproved purpose (injecting it near the eye) that
ophthalmologists were using it this way one million times per year. As
is common with jury verdicts involving large settlements, the courts
reduced the award. The plaintiff's final recovery, including both
compensatory and punitive damages, was about $6 million.?
This is an Australian legal document, July 2002. Because of copyright
issues, I can only provide a snippet here:
?The author is a resident of Western Australia. While attending the
public hospital Sir Charles Gairdner Hospital in Perth and two other
hospitals between 1977 and 1989, the author was given 24 Intrathecal
spine injections of the drug Depo-Medrol manufactured by the Pharmacia
& Upjohn Company, allegedly without his consent. The doctors informed
the author that the injections were harmless.
2.2 In 1977 the Health Department of Australia advised the Pharmacia &
Upjohn Company that their product was unsuitable for Intrathecal use,
and suggested that they introduce a warning on the product
instructions. This, however, was not done. Then in 1982, the Pharmacia
& Upjohn Company applied to the Australian Drug Evaluation Committee
to have the drug passed for use in epidural spinal injections. The
Committee rejected the application in 1983. However, the Commonwealth
Government Health Insurance Commission continued to pay for these
injections. In 1992, the Federal Labour Government Health Minister,
Brian Howe, disclosed in Parliament that Depo-Medrol had never been
passed or evaluated by the Australian Drug Evaluation Committee, and
that the drug was of experimental use. According to the author,
Depo-Medrol injected Intrathecally is a known cause of Arachnoiditis,
a disease that inflames the arachnoid lining (one of the three
coverings that envelops the brain and the spinal cord).?
I have e-mailed Mr. Tony O?Reilly, a lawyer in Australia/New Zealand,
who specializes in litigation and Depo Medrol. ?Tony is currently
leading a team of lawyers for The Upjohn Company in the Depo-Medrol
litigation, one of the largest product liability cases currently
before Australian courts.?
Depo Medrol causes loss of an eye:
Other legal resources:
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An e-mail, received by an arachnoiditis forum member named Alva, from
the FDA. You may be interested in filing an FDA Adverse Reaction
Pfizer/Pharmacia & Upjohn (PP&U)
When the complainant requested that he and PP&U go further by placing
the company's other published Warning against mixing or diluting the
drug with other chemicals, such as anesthetics or ionic dyes directly
onto the glass vial itself, (PP&U claims chemical incompatibility but
we feel it's more about the accumulative neurotoxicity), his response
was that the vial label wasn't large enough, therefore "there is no
space left for any additional text." This is outrageous!
Arachnoiditis Foundation, Inc.
P.O. Box 4627, Seaside, FL 32459-4627
Arachnoiditis, Fact or Fallacy?
Personal Story: A grandmother in New Zealand
This MSN group has quite a few links to Depo Medrol problems
Illustration of a needle entering the subarachnoid (intrathecal) space
Intrathecal infusion device
COFWA (Circle of Friends with Arachnoiditis) has several video clips
about arachnoiditis, and will soon have a full length video available.
Arachnoiditis Support Forum
Contact arachnoiditis sufferers world wide:
Depo Medrol Forums
Sign up for an arachnoiditis newsletter on this site:
You may be interested in seeing the illustrations here, referring to
Well, oldobsolete (and I doubt if you are!), I believe I have
addressed all your concerns by providing you with links to information
that will be useful to both you and any attorney you may hire.
I could find no evidence of any ?window of opportunity? for stopping
the arachnoiditis once the nerve damage had been done. It certainly
appears that you have sufficient evidence to discuss this with a good
medical malpractice attorney, particularly with a pre-surgical MRI
showing no arachnoiditis AND a post surgical MRI showing evidence of
arachnoiditis now. As evidenced by the MSN Groups sites, there is a
grass roots effort to help Depo Medrol-induced arachnoiditis
sufferers, and I hope you gain some insight from the information
contained in my answer.
If any part of my answer is unclear, or if I have duplicated
information you already head, please utilize the Answer Clarification
button, before rating. This will allow me to assist you further, if
depo medrol contraindications
Intrathecal depo medrol
Subarachnoid space depo medrol
Depo medrol protocol
Depo medrol indications