spinal epidurals are not FDA approved (California) (Californ

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spinal epidurals are not FDA approved (California) (Californ

Postby 4anewusers on Sun Jul 23, 2017 9:33 am

https://www.fda.gov/Drugs/DrugSafety/ucm394280.htm

Questions: In California are requests for spinal epidurals to treat back pain including the product being used AND the dose? I am not seeing this in the Maximus determinations I have reviewed.

There is more than one product being used for spinal epidurals and no clear guidelines for amounts being given. Please note a surgeon in So CA was investigated by CA State Medical Board about the high amounts of steroids being used in his WC patients. Are claims adjusters, UR and IMR reviewers requesting this information before approving this procedure? Also, are patients being notified in writing that these products were never FDA approved to be placed in the epidural space of the spine and this is "off label" use, including a list of possible complications including but not limited to- infection, arachnoiditis, nerve damage, paralysis, loss of vision, cauda equine syndrome and stroke?

FDA Safety Announcement

"[04-23-2014] The U.S. Food and Drug Administration (FDA) is warning that injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death. The injections are given to treat neck and back pain, and radiating pain in the arms and legs. We are requiring the addition of a Warning to the drug labels of injectable corticosteroids to describe these risks. Patients should discuss the benefits and risks of epidural corticosteroid injections with their health care professionals, along with the benefits and risks associated with other possible treatments.

Injectable corticosteroids are commonly used to reduce swelling or inflammation. Injecting corticosteroids into the epidural space of the spine has been a widespread practice for many decades; however, the effectiveness and safety of the drugs for this use have not been established, and FDA has not approved corticosteroids for such use. We started investigating this safety issue when we became aware of medical professionals’ concerns about epidural corticosteroid injections and the risk of serious neurologic adverse events.1 This concern prompted us to review cases in the FDA Adverse Event Reporting System (FAERS) database and in the medical literature (see Data Summary).2-16

To raise awareness of the risks of epidural corticosteroid injections in the medical community, FDA’s Safe Use Initiative convened a panel of experts, including pain management experts to help define the techniques for such injections which would reduce preventable harm. The expert panel’s recommendations will be released when they are finalized.

As part of FDA’s ongoing effort to investigate this issue, we plan to convene an Advisory Committee meeting of external experts in late 2014 to discuss the benefits and risks of epidural corticosteroid injections and to determine if further FDA actions are needed.

Injectable corticosteroids include methylprednisolone, hydrocortisone, triamcinolone, betamethasone, and dexamethasone. This safety issue is unrelated to the contamination of compounded corticosteroid injection products reported in 2012.


Facts about corticosteroids
•A class of drugs commonly used to reduce swelling or inflammation
•Injectable corticosteroids include methylprednisolone, hydrocortisone, triamcinolone, betamethasone, and dexamethasone
•Corticosteroids are not approved by FDA for injection into the epidural space of the spine.


Additional Information for Patients
•Rare but serious problems have occurred after injection of corticosteroids into the epidural space of the spine to treat neck and back pain, and radiating pain in the arms and legs.
•These serious problems include loss of vision, stroke, paralysis, and death.
•The effectiveness and safety of injection of corticosteroids into the epidural space of the spine have not been established, and FDA has not approved corticosteroids for this use.
•Discuss the benefits and risks of epidural corticosteroid injections with your health care professional, along with the benefits and risks associated with other possible treatments.
•Seek emergency medical attention immediately if you experience any unusual symptoms after receiving an epidural corticosteroid injection, such as loss of vision or vision changes; tingling in your arms or legs; sudden weakness or numbness of your face, arm, or leg on one or both sides of the body; dizziness; severe headache; or seizures.
•Report any side effects from epidural corticosteroid injections to the FDA MedWatch program, using the information in the "Contact FDA" box at the bottom of this page.


Additional Information for Health Care Professionals
•Rare but serious neurologic adverse events have been reported with epidural corticosteroid injections, including spinal cord infarction, paraplegia, quadriplegia, cortical blindness, stroke, and death.
•These serious neurologic events have been reported with and without the use of fluoroscopy.
•The effectiveness and safety of epidural administration of corticosteroids have not been established, and FDA has not approved corticosteroids for this use.
•Discuss with patients the benefits and risks of epidural corticosteroid injections and other possible treatments.
•Counsel patients to seek emergency medical attention immediately if they experience symptoms after receiving an epidural corticosteroid injection, such as loss of vision or vision changes; tingling in their arms or legs; sudden weakness or numbness in their face, arm, or leg on one or both sides of the body; dizziness; severe headache; or seizures.
•Report adverse effects following epidural corticosteroid injections to the FDA MedWatch program, using the information in the "Contact FDA" box at the bottom of this page.


Data Summary

FDA reviewed a sampling of cases from the FDA Adverse Event Reporting System (FAERS) database, as well as cases in the medical literature of serious neurologic adverse events associated with epidural corticosteroid injections.2-16 Serious adverse events included death, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, stroke, seizures, nerve injury, and brain edema. Many cases were temporally associated with the corticosteroid injections, with adverse events occurring within minutes to 48 hours after the corticosteroid injections. In some cases, diagnoses of neurologic adverse events were confirmed through magnetic resonance imaging or computed tomography scan. Many patients did not recover from these reported adverse events."

http://www.doctoroz.com/article/depth-i ... ons?page=1


The above is an investigation on spinal epidurals. I wish some savvy investigative reporters would investigate spinal epidurals in the CA WC system.
Patient Advocate for medical device safety and ethics. •Modern medicine offers important benefits, yet it also has the capacity to cause harm;•Those harms arise from three central failings: the overuse, underuse, and misuse of medical services.
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Re: spinal epidurals are not FDA approved (California) (Californ

Postby LawAdvocate on Mon Jul 24, 2017 11:11 am

1. Who cares? The FDA does not approve a lot of things and their track record is dismal. The FDA is so far behind real world medicine they are a joke. They haven't approved medical marijuana either but it works for a number of conditions in certain forms and doses. I can name at least a dozen more medications that should be approved without thinking that countries that offer real medicine are already using with no issues.

2. There are adverse effects to every medical procedure and medication. The human body is a large chemistry experiment and what works for some does not work for others. What effects some, does not effect others. The adverse effects were RARE - do you know the medical definition of that word? It means it occurs in less than 2% of the ESIs reported in the US.

3. This is old news - so did the 2014 advisory committee meet? What happened? I know, but do you?

4. Stop spreading fear, know your physician and that FYI - more people have been helped than harmed, myself included.

5. You are obviously not a female, because we get epidurals for child birth - the risk factors you listed are mostly related to the epidural process, not the medication injected.

Spreading non-information helps no one, they tell you this when you have an epidural and you make your call than. Why should we investigate the CA system - Applicants at that point have attorney's for the most part and have chosen questionable doctors - so when you let your attorney select a physician rather than researching and selecting a physician, you don't get what you medically need, you get medical care to which you are legally entitled.

Having sat through two insane physician lectures this weekend as part of my continuing education credits, let me tell you - they kept saying - when the physician says x and y, please listen. We don't get to listen because you all choose physicians most claims professionals wouldn't even consider taking their dog to.
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Re: spinal epidurals are not FDA approved (California) (Californ

Postby steve appell on Tue Jul 25, 2017 3:24 pm

""I wish some savvy investigative reporters would investigate spinal epidurals in the CA WC system."

Please tell me why you want this IV and EXACTLY what is the problem?
DO you want injections disallowed in their entirety?
Do you want certain combinations of injected drugs disallowed?
Do you want specific procedures disallowed?
Please be more specific!
Steve

appellandassociates.com
6311 Van Nuys Bl #480
Van Nuys, Ca 91401
wcexaminer@aol.com


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Re: spinal epidurals are not FDA approved (California) (Californ

Postby 4anewusers on Wed Jul 26, 2017 7:23 am

I care. You must be unaware of what a certain spine surgeon in southern CA was doing to his work comp patients with using extremely high amounts of these steroids in an unsafe manor and is under investigation from CA State Medical Board for this, and other practices. He is not the only doctor doing this. He also liked to prescribe compound creams and liked using hardware made in Temecula. He is not the only one, and since there are no standards or limits physicians can place whatever products they want and any amount into patients spine. This is dangerous, and the CA State Medical Board caught one infamous doctor after auditing his records for something unrelated.

I do not want these injections stopped as they can be beneficial to patients. I have also had some epidurals to treat back pain. After helping patients who have been harmed I would never have an epidural again.

I would like some clear guidelines of the products being used for this procedure and the amounts being used. I would also like patients to be clearly notified of the possible complications and that this procedure is not FDA approved. How is this a bad thing? Don't you want to keep patients as safe as possible and limit secondary complications that may cause further disability and expense to the carrier?
Last edited by 4anewusers on Wed Jul 26, 2017 7:35 am, edited 1 time in total.
Patient Advocate for medical device safety and ethics. •Modern medicine offers important benefits, yet it also has the capacity to cause harm;•Those harms arise from three central failings: the overuse, underuse, and misuse of medical services.
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Re: spinal epidurals are not FDA approved (California) (Californ

Postby LawAdvocate on Wed Jul 26, 2017 7:35 am

There are already existing guidelines as to what is to be done and dosages.

There are always rogue doctors, welcome to reality. Nothing he did except the hardware made in Temecula was illegal. That is what medical malpractice insurance is for, rogue doctors.

The FDA does not have the power to approve or disapprove a procedure, they are called the Food and Drug Administration for a reason. You are clearly totally uniformed as to the scope of the FDA's jurisdiction. They can only approve medications and not even dosages or regulate off-label use. I don't want the FDA any where near my medical care due to their dismal track record.

People are clearly notified of the adverse effects at the time of the decision to use an ESI, at the actual ESI appointment , etc. This is standard medical procedure. I have had 6 in my life, I have also been present with friends for many more. No surgery center or hospital is going to risk their liability insurance for the failure to advise a patient of the adverse effects of every procedure and the anesthesia being used.

So you still have not figured out what happen to the Advisory Committee in 2014? it was a non-issue given the RARE risks of less than 1.9% of the epidurals given in the US. Non-issue, Chicken Little - the sky is not falling. That is my pet peeve taking non-information and spreading fear and disinformation. That is all you have done here. I can't decide if you are willfully ignorant and can't research on your own or if you are just that obtuse.

This is not a bad thing or a good thing, everything you are asking for is already in place.
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Re: spinal epidurals are not FDA approved (California) (Californ

Postby 4anewusers on Wed Jul 26, 2017 7:40 am

I am not requesting the incompetent FDA to do anything. I do not care what the FDA conclusion was as they are incompetent and cater to industry. I am kindly asking the insurance carriers to step it up and request the amount and product being used before approval. This is not currently happening. How can you state the dosage and amounts are being submitted on RFA's or even to MAXIMUS? I pulled dozens of MAXIMUS approvals for epidurals and not one mentioned the product used or amount. I have reviewed patients records and do not see the amount or product when requesting an epidural. Maybe the insurance carrier you work for is demanding it. Here are links to MAXIMUS approvals for epidurals. Where is the product being used or amount in these approvals?
http://www.dir.ca.gov/serp.html?q=epidu ... F-8&nojs=1


While you may have been notified of the possible risks many patients are not given informed consent.

It is estimated that 1% of adverse events are reported to the FDA. Also, the FDA does not post publically all of the maude reports.

A group of Rouge physicians can cost insurance carriers millions, and can cause great harm and destruction to patients.
Last edited by 4anewusers on Thu Jul 27, 2017 1:46 pm, edited 1 time in total.
Patient Advocate for medical device safety and ethics. •Modern medicine offers important benefits, yet it also has the capacity to cause harm;•Those harms arise from three central failings: the overuse, underuse, and misuse of medical services.
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Re: spinal epidurals are not FDA approved (California) (Californ

Postby LawAdvocate on Wed Jul 26, 2017 11:09 am

I am kindly asking the insurance carriers to step it up and request the amount and product being used before approval. This is not currently happening.


it is happening. So another false premise. Recall we are not obliged to give a UR response to a physician who is not in the MPN if we have one, a physician who has not established their standing in the case by providing proof of referral to the pain management specialist from the validly elected PTP per LC 4603.2(b)(1), and we do not owe a UR response on any disputed body part or when the claim is disputed entirely. All of the physicians named in the Pacific Hospital lawsuit were not generally found on MPNs, so there would have been no response.

Nobody blindly authorizes an ESI. Seriously? We follow the MTUS protocols which are nationally recognized and in other situations where MTUS does not apply, we then move on to other nationally recognized protocols.

While you may have been notified of the possible risks many patients are not given informed consent.


Then those people have a lawsuit against both the physician and the facility where the ESI was performed if they were not fully advised of the adverse effects. I doubt it. Since you usually need to sign and I have attended these procedures, I have heard the advisements of adverse effects and seen them as written. People usually don't pay attention, just like in witness situations - case in point, a friend was complaining about a headache afterwards - I told her it was to be expected - no, no they didn't tell her that - sure they did I heard it and showed her on the form she signed.

Fraud is not covered by medical malpractice insurance. Implanting non FDA approved hardware is fraud. Review the cases and you will see they are not claiming medial malpractice, at least the law firms who have a clue.


LOL, no but using equipment not approved for human implantation sure as hell is. I have seen the lawsuits directly, have a friend involved in one. So what are you talking about? Again, uninformed, anecdotal opinion. If your work comp attorney caught wind that an Applicant received implantation of one of these devices and failed to advise his/her client to consult a medical malpractice attorney, that is what legal malpractice insurance covers. I have seen letters to a number of Applicant's to consult a med mal attorney due to the practices and procedures of Pacific Hospital for using devices not approved for human implantation. Fraud is litigated in the civil and criminal arenas, with restitution owed to the harmed parties.

There are no groups of rogue physicians costing the smart carriers millions - and the carriers who they are costing millions - that sounds like their problem for being incompetent.
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Re: spinal epidurals are not FDA approved (California) (Californ

Postby 4anewusers on Wed Jul 26, 2017 12:27 pm

Who approved the spinal epidurals that were in the CA State Medical Board complaint against the surgeon mentioned above that stated he was using unsafe amounts in his epidurals? You may not be privy to the issues out there regarding spinal epidurals, but hopefully someone will do more to protect patients from preventable harm. I do not understand the hostility as it would only be beneficial for the insurance industry to prevent some of this. If your carrier demands information relative to the product and amounts used in patients then they are doing a great job. I know this is not the case for the patients I have come across, unfortunately. I posted this information to help patients, period.

Doctors typically require patients to sign a consent form detailing the risks of any given treatment or procedure. But signing a form alone does not necessarily prove that the patient gave informed consent. The doctor must actually discuss the procedure and risks with the patient. And the patient must understand, to the extent possible, the risks he or she faces.
Last edited by 4anewusers on Thu Jul 27, 2017 1:46 pm, edited 1 time in total.
Patient Advocate for medical device safety and ethics. •Modern medicine offers important benefits, yet it also has the capacity to cause harm;•Those harms arise from three central failings: the overuse, underuse, and misuse of medical services.
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Re: spinal epidurals are not FDA approved (California) (Californ

Postby LawAdvocate on Wed Jul 26, 2017 12:39 pm

LOL.. I said MOST NOT ALL

I said the reparations come from the civil and criminal convictions - my friend was already paid for the restitution from that.

You are clueless as to law and now willfully ignorant.
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Re: spinal epidurals are not FDA approved (California) (Californ

Postby 4anewusers on Wed Jul 26, 2017 1:18 pm

I believe you are writing from a perspective of one work comp carrier and it sounds like they are doing the right thing. I am writing from a perspective of being in contact with patients who have been harmed by epidurals. Not all carriers are doing the right thing and why I am writing about this topic.

Name-calling often occurs when someone has an emotional argument to make with little or no supporting logical argument.
Last edited by 4anewusers on Thu Jul 27, 2017 1:47 pm, edited 1 time in total.
Patient Advocate for medical device safety and ethics. •Modern medicine offers important benefits, yet it also has the capacity to cause harm;•Those harms arise from three central failings: the overuse, underuse, and misuse of medical services.
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