Deaths Reported After Doctors Ignored Kenalog Warning & FDA Failed To Adequately Warn

Seven months ago Bristol-Myers Squibb issued a public safety alert and changed the label of the Kenalog injection to indicate that use of it in epidurals had been linked with “serious medical events, including death” and that use of it as an epidural injection was “not recommended.”

But according to reports Doctors are still injecting the steroid in a way the company warns they shouldn’t, following reports that patients have died or become paralyzed after receiving steroidal shots.

The company will not go so far as to say Kenalog was responsible for those deaths or injuries and the Food and Drug Administration failed to issue its own alert, as it usually does, when Bristol-Myers Squibb changed the labels on Kenalog.

Used for neck and back pain, Kenalog and the Pfizer Inc. (PFE) drug Depo-Medrol are the most frequently administered steroids in epidural injections. Over eight million such shots were given in the U.S. in 2010.

Bloomberg reports that experts believe this warning from the drug company has largely gone ignored or unnoticed.

Physicians are either ignoring the Bristol-Myers warning or aren’t aware of it, according to doctors who use Kenalog or who work with others who do. “It is still being given in abundance,” said Christopher Gharibo, head of pain medicine in the anesthesiology department at NYU-Hospital for Joint Diseases in New York.

Neither Bristol-Myers nor the U.S. Food and Drug Administration publicized the label revision, even though the FDA is reviewing the safety of epidural steroid shots. While not required to alert doctors or patients, the FDA has broadcast changes to other drugs’ prescribing information. In June, around the time the Kenalog label was rewritten, it issued a press release about a muscle injury risks warning that Merck & Co. applied to its Zocor cholesterol pill.

The FDA defended its actions on Kenalog to Bloomberg, saying that a press release on the potential dangers of the injection was emailed to about 200,000 who receive regular updates from the agency. Whether there are actual prescribing physicians receiving those updates is unknown and based on the increased use of Kenalog, especially use that seems to ignore warning about its specific use in epidural injections.

Use of Kenalog is on the rise and as many as 8 million injections of the steroid were administered in 2010, presumably many of them as epidural treatments.

Bloomberg presumes use of Kenalog as an epidural steroid injection continues to rise because it is covered by most major insurers, so doctors who use it are guaranteed to be reimbursed for its use.

Kenalog has been implicated in at least 88 adverse reaction reports of serious injuries after its use as an epidural injection to the back or neck. At least 13 deaths have been reported among people who received any epidural steroid injection to the back or neck since 2008 when that injection, and some of those include the use of Kenalog.

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8 Responses to Deaths Reported After Doctors Ignored Kenalog Warning & FDA Failed To Adequately Warn

  1. anonymous October 16, 2012 at 6:20 pm #

    “Bloomberg presumes use of Kenalog as an epidural steroid injection continues to rise because it is covered by most major insurers, so doctors who use it are guaranteed to be reimbursed for its use.”

    Again, Why are we allowing insurance companies to determine what is & isn’t done?

    There are other treatments that are being used for a variety of conditions these corticosteroid injections are used for, yet the FDA & insurance companies won’t allow them/or pay for them.

    I have to wonder how many more will become paralyzed, have any one of the many complications corticosteroids create (even non-epidural injections & even corticosteroid inhalers have their risks), yet then too, they can be used with some success, off-label as they have been used for many, many years, despite the side-effects & other problems

    Corticosteroids are a double-edge sword. They can help one problem, yet create many others not discussed here. These drugs clearly should be a last resort, which many times that is already the case.

    Until & unless the FDA allows other methods to be used & research to continue, do the doctors using these really have much choice?

    We clearly need more research in pain & autoimmune medicine, as it is one of the top complaints. Doctors prescribing other approved drugs that are known to treat pain, and their patients, have to jump through a lot of drugs that have just as many, if not more side-effects, with little to no proof that most of these are effective. Very effective some anti-inflammatories can destroy the kidneys if used improperly, those with asthma can have rebound attacks on corticosteroid inhalers, immature infants can grow up to have severe hormonal imbalances, yet saves an infant at a young age.

    Any corticosteroid use can imbalance other hormones, which will also often require treatment, can disable people and even though these side-effects have supposedly, “no known antidote”, a tea from the Ephedra plant that was outlawed, in large part because it was at first altered,”standardized” (another form of creating a drug from the plant in a lab), then chemically synthesized & ultimately outlawed altogether, even though the plant itself, when used properly, was a great treatment with no side-effects.

    Autoimmune & metabolic problems are just the tip of the iceberg of problems that drugs such as Kenalog can create or exacerbate.

    We need research to find alternatives for corticosteroids that don’t have these problems. One shouldn’t have to go bankrupt, have their neighbors get together to make treks to other countries & so on to go out of the country to be treated.

    Hopefully, whoever becomes our next president will work with our researchers, doctors & patients to use & find alternatives. They also need to make natural ephedra legal, yet restrict sales to adults that can be responsible with it.& other natural medicines.

    It seems insurance companies are simply trying to get out of treating the many things corticosteroids are used for, while supplying no alternatives for those suffering, or that might otherwise die.

    If drugs were ALL sold OTC, healthcare would cost less & the FDA could work on proper labeling of food & drugs, forcing individuals to either seek out proper medical care for advise if they aren’t comfortable with, or unable to discern, or administer, what they need.

    HMOs & HMO-style healthcare has killed & disabled far more people than many things, like “managing” (aka restricting treatment from a qualified medical doctor.) There is no reason a person & their doctor(s) should have non-medical personnel, or medical personnel that have not seen a patient, deciding what is “appropriate” or “inappropriate”/ paid for or not paid for, for any “treatment” or prevention for any person.

    Patients & the general public need to be made aware of what is in a medication, remedy, and especially food & weather it is grown organically or not. teachers in schools & parents need to be educated as well, yet ultimately it is the adult patient & parents that with a medical professional to discuss the risks & benefits of any treatment, prevention, etc. & need to do so knowledgeably, based on what is in a drug or food, as well as the history & other people’s experiences.

    “Intellectual Property” should not include drugs that are now “patented”. Sometimes people will fair far better knowing which “inactive ingredients” & their effects are in medications as well. Initially there will likely be a lot of “Fear Response”, yet once people become familiar with these things, including the package inserts & statistics (that should be taught to all by the high school level, along with a good chemistry class or two so they understand labeling & what it means.

    Everyone should also be able to consult with a doctor that has extensive training in those areas, thus Medical Schools.

  2. Deb November 27, 2012 at 9:47 pm #

    This reports states since 2008. It should include since 2000. My husband had very serious burst fractures in vertebrae in 2003. Sent all kinds of info to 3 different lawyers, and all said Kenalog was not responsible. No one knew, or were willing to take a case like this back then.

  3. Mo mccann March 2, 2013 at 10:11 am #

    There is a huge and i believe deliberate blind spot being encouraged re doctors refusing to acknowledge the hundreds, maybe thousands of cases of severe, life changing side effects caused by kenalog and other drugs of the same or simiar chemical composition but with different brand names.

    My once happy. Talented and very active son is nw a shell of a human being. 15 months ago, on nov 3rd 2011, he was given kenalog epidurally fr herniated disc pain. Within 48 hours life as he knew it was over. The side effects were severe and dramatic, his job, fiance, love of life and music were finished. He is now actually physiologically INCAPABLE OF FEELING THE EMOTION OF HAPPINESS. For those of you who do not understand, the hormones in our cerebral matter are released regularly and are actually what is responsible for our “feeling” anything…….my sons have been destroyed/disrupted by kenalog, or more specifically BENZYL ALCOHOL, which s the substance used in kenalog to preserve it……benzyl alcohol is also the stuff they use to dissolve hard to remove oil based paints and laquers. Imagine swamping your brain stem in THAT…yes, thats what they did.

    Doctors? Theres not a single one, it seems, with the moral decency to stand up and say what everybody in these forums KNOWS…..kenalog has destroyed lives, it CONTINUES to destroy lives. Our quality of life as a family is over. He is completely financially dependant on me, his 58 year old mother, he hates being like this. We have talked about not going on, quite calmly, since specialists told us six months ago that the damage is irreversible. I caanot begin to list all the side effects he now lives with on a daily basis, they are too many and i am so bloody tired. I struggle to keep working as we do not want to apply for benefits, but i do not know how we are going to keep going because my own health is not good .
    For the love of God, will somebody somewhere have the guts to properly break this story and stand up to bristol myers pharmaceuticals?

  4. Tammy July 9, 2013 at 5:15 pm #

    I was given 40mg 2ml of kenalog on 3/5/13 for a rash then on 4/25/13 80mg of depro-medrol 1.5ml kenalog which has effected my vision severe headaches and pressure in head! I have been diagnosed with atypical central serious choroilopathy with choradial neovasuclazation caused from kenalog. They say on a scale of 1 to 10, 10 being severe I’m a 9! I am loosing my central vision going from retna specialist to md specialist with no answers on how to stop or reverse damage from this drug! This needs to be off market today FDA should be warning patients of adverse side effects such as GOING BLIND!!! Okay so they say I won’t be in the dark totally just my central vision and it will be illegal for me to drive, I want my life back, I am a healthy 45 year old female who takes zero medications! Just say NO to Cortisone shots!!!
    Please pray for my vision to be restored and headaches to stop, I am praying daily. Thank you

    • Lifechanged August 23, 2013 at 5:28 pm #

      24 injections of kenalog in 10 months. I almost died. Only 1 doctor out of 12, in Spokane, confirms every debilitating side effect, is a result of this overdose. Doctors cover this up because they make money off of us, by poisoning us with this drug. I can barely walk without pain and severe muscle stiffness everywhere I was injected. Injected a year ago. Has completely ruined my quality of life. Doctors are lying to patients. They know these are dangerous, but the make money from it. Beware! It’s dangerous!

      • Sadaka Associates August 26, 2013 at 8:40 am #

        We are so sorry to hear about this! We certainly understand the intense reactions people can have following vaccination. Have you been able to seek treatment?

  5. Louise August 23, 2013 at 9:47 am #

    I am a 39 year old, I have had back spasms since my injury in december 2012, I was given 4 injections of kenalog, It has deteriorated my muscle in my thoracic area, and my spine is shifting because of the lack of muscle from this POISON. Please do not let any physician inject kenalog into your body ANYWHERE. There are thousands of people out there who have had this happen to them. If anyone knows of a way to help us victims please do. This is a very serious damaging drug. has severe side effects, and no way of restoring the damage that this drug (POISON) causes. I do pray for those of you and myself who have been affected by this.

    • Sadaka Associates August 26, 2013 at 8:44 am #

      Hi Louise,
      We are sorry to hear about the reaction to the Kenalog injections. Have you been able to seek treatment for your pain?
      Please, don’t hesitate to reach out to us!

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