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Thread: Spine Magazine: Methyl Prednisolone Treatment is a Hoax

  1. #1

    Spine Magazine: Methyl Prednisolone Treatment is a Hoax

    How many times do we see the pharmaceutical companies market something that doesn't work or even harms the patient?

    Well, it's been happening with the supposed only treatment for SCI: It DOESN'T WORK and hurts patients who get it!!

    Spinal Treatment May Not Improve Neurologic RecoveryMethylprednisolone sodium succinate also found to increase pneumonia risk over non-treatment
    Publish date: Sep 17, 2009



    THURSDAY, Sept. 17 (HealthDay News) -- Treatment with high-dose methylprednisolone sodium succinate (MPSS) does not improve neurologic recovery in patients who have suffered acute spinal cord injury and increases the risk of pneumonia as a complication, according to a study in the Sept. 15 issue of Spine.

    Yasuo Ito, M.D., of the Kobe Red Cross Hospital in Japan, and colleagues treated all patients who presented with cervical cord injury during 2003 to 2005 with MPSS, following the protocol of the Second National Acute Spinal Cord Injury Study. During the subsequent period of 2005 to 2007, all patients were not treated with MPSS. Patient improvement in the two groups was evaluated and compared using the American Spinal Injury Association (ASIA) motor score.
    Three months after treatment, the researchers found that the average improvement in ASIA motor score in the MPSS-treated group was 12.4 points compared to 13.8 points in the group not treated with MPSS. Among patients with complete motor loss, the average ASIA motor score improved 9.0 points in the MPSS group and 12.6 points in the non-MPSS group, while among patients with partial motor loss, the average ASIA motor scores improved 14.1 and 15.5 points, respectively. Nineteen patients in the MPSS group contracted pneumonia compared to 11 patients in the non-MPSS group.
    "We found no evidence supporting the opinion that high-dose MPSS administration facilitates neurologic improvement in patients with spinal cord injury. We believe MPSS should be used under limited circumstances because of the high incidence of pulmonary complication," the authors conclude.


  2. #2
    too bad that 20 years later no one's come up with anything to replace it.

  3. #3
    Quote Originally Posted by antiquity View Post
    too bad that 20 years later no one's come up with anything to replace it.
    It really should just be stopped. Patients who didn't get the methyl prednisolone treatment actually do better according to the study.

  4. #4
    Doodles,

    I think that you better read the studies before concluding that methylprednisolone treatment of spinal cord injury is a hoax.

    The study by Ito cannot challenge two multicenter randomized study with a non-randomized single center study. Methylprednisolone is a generic drug. No drug company is currently pushing this drug for spinal cord injury. The data supporting the use of methylprednisolone comes from NIH-funded studies in the 1980's and 1990's. To date, there has not yet been a clinical trial that has provided the kind of evidence that challenges the conclusion from these trials. Let me describe them.

    One multicenter study in the United States from 1985 to 1995 (involving 14 centers) randomized 487 patients from 1985-1989 (NASCIS II) to placebo, naloxone, or a 24-hour course of methylprednisolone. This study [1], the first and only placebo-controlled multicenter study of a treatment for acute spinal cord injury showed that the methylprednisolone significantly improved 6- and 12-month motor and sensory recovery by about 20% compared to placebo, but only in patients that were treated within 8 hours after injury. Naloxone showed a trend of improving patients but it did not reach significance. The study indicated no significant differences of pneumonia or any of 15 different potential complications between placebo and any of the treatments.

    The second study (NASCIS III) randomized 499 patients from 1992-1996 to a 24-hour course of methylprednisolone, a 48-hour course of methylprednisolone, and a 48-hour course of tirilizad mesylate [2]. NASCIS III showed that 6-12 month neurological outcomes of all three treatment groups did not differ when the treatment was started within 3 hours after injury. However, when the treatment was started within 3-8 hours after injury, the 48-hour methylprednisolone treated group had significantly better 6- and 12-month motor and sensory recovery compared to the other two groups. There was, however, a trend towards increased severity of pneumonia (but not the incidence of pneumonia) in patients that received the 48-hour course of methylprednisolone.

    NASCIS II recommended that the 24-hour course of methylprednisolone be given to both complete and incomplete spinal cord injury as soon as possible after injury and not to be given if it cannot be started within 8 hours. NASCIS III recommended that the 48-hour course of methylprednisolone be given to patients only when the drug can started between 3-8 hours after injury. The drug should not be used when it cannot be started within 8 hours after injury. Both studies were multicenter, double-blind, randomized studies. These are the most rigorous of all clinical trial designs.

    The Ito, et al. study reported in the article and published in Spine [3] is a non-randomized study. From 2003-2005, 38 patients with cervical spinal cord injury were treated with the 24-hour course of methylprednisolone (MP) within 8 hours after injury. From 2005-2007, 41 patients with cervical spinal cord injury were not given methylprednisolone. The first MP treated group showed an improvement of 3-month 9 motor points improvement in complete spinal cord injury, compared to 12.4 motor points in complete spinal cord injury patients not treated with MP. Incomplete patients showed an average 3-month motor improvement of 14.1 points after MP treatment, compared 15.5 points in the non-MP treated group. Apparently, 19 of 38 patients treated with MP developed pneumonia and this was significantly higher than the group that did not receive MP.

    The article covering the Ito study should have stated the following:
    • In medicine, there are different grades of clinical trials. The most rigorous clinical trials are those that are double-blind, randomized, placebo-controlled and multicenter trials. Slightly less rigorous are trials that concurrently compares different therapies. The least rigorous trial are sequential, non-blinded (open-label), and non-randomized studies. NASCIS II was a double-blind, randomized, placebo-controlled study involving 487 patients. NASCIS III was a double-blind, randomized, controlled study involving 499 patients. The Ito study was an open-label, non-randomized study involving 38+41=79 patients.
    • Neither NASCIS II or III found significant treatment induced differences of neurological scores at 3 months after spina cord injury and but both found significant differences at 6 and 12 months after injury. Three months is simply too early after the injury to see a difference in recovery.
    • In the Ito study, 18 of 38 patients treated with MP developed pneumonia. That is nearly half of the patients, a surprisingly high incidence of pneumonia. In NASCIS II and NASCIS III, where 162+332=494 patients received 24-48 hour courses of MP, less than 10% of the MP patients developed pneumonia.

    It is difficult to imagine why anybody would think that a small, single-center, non-randomized, non-concurrent, non-blinded study involving 38 patients treated with MP can negate and overturn the experience of two multicenter, double-blind, randomized studies involving nearly 494 patients treated with MP. Since 1990, when NASCIS II was published, millions of people must have received high-dose methylprednisolone.

    There was no difference in the 3-month neurological scores, which is consistent with the results of NASCIS II and III, which detected differences in neurological recovery only at 6 and 12 months after injury. It is difficult for me to understand why these authors did not do longer followup of their patients. Did they not read the previous studies? This oversight does not give me confidence in the study.

    Regarding the increased incidence of pneumonia in MP treated patients, we have long known that high-dose MP can increase infections. In fact, NASCIS III found that the 48-hour course of MP increased the incidence of severe pneumonia and therefore recommended that longer course of MP be given only to patients who are treated between 3-8 hours after injury. However, even the 48-hour course of MP did not cause pneumonia in half of the patients with cervical spinal cord injury.

    MP is a treatment that is given not only to spinal cord injury but also to many people with multiple sclerosis, transverse myelitis, lupus erythematosus, Guillian-Barre, and SARS. Yes, high-dose methylprednisolone is the standard therapy for Severe Acute Respiratory Syndrome. If MP caused 50% of pneumonia in these patients, we would have known about this risk.

    References
    1. Bracken MB, Shepard MJ, Collins WF, Holford TR, Young W, Baskin DS, Eisenberg HM, Flamm E, Leo-Summers L, Maroon J and et al. (1990). A randomized, controlled trial of methylprednisolone or naloxone in the treatment of acute spinal-cord injury. Results of the Second National Acute Spinal Cord Injury Study. N Engl J Med 322: 1405-11. Department of Epidemiology and Public Health, Yale University School of Medicine, New Haven, CT 06510. Studies in animals indicate that methylprednisolone and naloxone are both potentially beneficial in acute spinal-cord injury, but whether any treatment is clinically effective remains uncertain. We evaluated the efficacy and safety of methylprednisolone and naloxone in a multicenter randomized, double-blind, placebo-controlled trial in patients with acute spinal-cord injury, 95 percent of whom were treated within 14 hours of injury. Methylprednisolone was given to 162 patients as a bolus of 30 mg per kilogram of body weight, followed by infusion at 5.4 mg per kilogram per hour for 23 hours. Naloxone was given to 154 patients as a bolus of 5.4 mg per kilogram, followed by infusion at 4.0 mg per kilogram per hour for 23 hours. Placebos were given to 171 patients by bolus and infusion. Motor and sensory functions were assessed by systematic neurological examination on admission and six weeks and six months after injury. After six months the patients who were treated with methylprednisolone within eight hours of their injury had significant improvement as compared with those given placebo in motor function (neurologic change scores of 16.0 and 11.2, respectively; P = 0.03) and sensation to pinprick (change scores of 11.4 and 6.6; P = 0.02) and touch (change scores, 8.9 and 4.3; P = 0.03). Benefit from methylprednisolone was seen in patients whose injuries were initially evaluated as neurologically complete, as well as in those believed to have incomplete lesions. The patients treated with naloxone, or with methylprednisolone more than eight hours after their injury, did not differ in their neurologic outcomes from those given placebo. Mortality and major morbidity were similar in all three groups. We conclude that in patients with acute spinal-cord injury, treatment with methylprednisolone in the dose used in this study improves neurologic recovery when the medication is given in the first eight hours. We also conclude that treatment with naloxone in the dose used in this study does not improve neurologic recovery after acute spinal-cord injury.
    2. Bracken MB, Shepard MJ, Holford TR, Leo-Summers L, Aldrich EF, Fazl M, Fehlings M, Herr DL, Hitchon PW, Marshall LF, Nockels RP, Pascale V, Perot PL, Jr., Piepmeier J, Sonntag VK, Wagner F, Wilberger JE, Winn HR and Young W (1997). Administration of methylprednisolone for 24 or 48 hours or tirilazad mesylate for 48 hours in the treatment of acute spinal cord injury. Results of the Third National Acute Spinal Cord Injury Randomized Controlled Trial. National Acute Spinal Cord Injury Study. Jama 277: 1597-604. OBJECTIVE: To compare the efficacy of methylprednisolone administered for 24 hours with methyprednisolone administered for 48 hours or tirilazad mesylate administered for 48 hours in patients with acute spinal cord injury. DESIGN: Double-blind, randomized clinical trial. SETTING: Sixteen acute spinal cord injury centers in North America. PATIENTS: A total of 499 patients with acute spinal cord injury diagnosed in National Acute Spinal Cord Injury Study (NASCIS) centers within 8 hours of injury. INTERVENTION: All patients received an intravenous bolus of methylprednisolone (30 mg/kg) before randomization. Patients in the 24-hour regimen group (n=166) received a methylprednisolone infusion of 5.4 mg/kg per hour for 24 hours, those in the 48-hour regimen group (n=167) received a methylprednisolone infusion of 5.4 mg/kg per hour for 48 hours, and those in the tirilazad group (n=166) received a 2.5 mg/kg bolus infusion of tirilazad mesylate every 6 hours for 48 hours. MAIN OUTCOME MEASURES: Motor function change between initial presentation and at 6 weeks and 6 months after injury, and change in Functional Independence Measure (FIM) assessed at 6 weeks and 6 months. RESULTS: Compared with patients treated with methylprednisolone for 24 hours, those treated with methylprednisolone for 48 hours showed improved motor recovery at 6 weeks (P=.09) and 6 months (P=.07) after injury. The effect of the 48-hour methylprednisolone regimen was significant at 6 weeks (P=.04) and 6 months (P=.01) among patients whose therapy was initiated 3 to 8 hours after injury. Patients who received the 48-hour regimen and who started treatment at 3 to 8 hours were more likely to improve 1 full neurologic grade (P=.03) at 6 months, to show more improvement in 6-month FIM (P=.08), and to have more severe sepsis and severe pneumonia than patients in the 24-hour methylprednisolone group and the tirilazad group, but other complications and mortality (P=.97) were similar. Patients treated with tirilazad for 48 hours showed motor recovery rates equivalent to patients who received methylprednisolone for 24 hours. CONCLUSIONS: Patients with acute spinal cord injury who receive methylprednisolone within 3 hours of injury should be maintained on the treatment regimen for 24 hours. When methylprednisolone is initiated 3 to 8 hours after injury, patients should be maintained on steroid therapy for 48 hours.
    3. Ito Y, Sugimoto Y, Tomioka M, Kai N and Tanaka M (2009). Does high dose methylprednisolone sodium succinate really improve neurological status in patient with acute cervical cord injury?: a prospective study about neurological recovery and early complications. Spine (Phila Pa 1976) 34: 2121-4. Department of Orthopaedic Surgery, Kobe Red Cross Hospital, Kobe, Japan. y-ito@kobe.jrc.or.jp. STUDY DESIGN: Consecutive cohort study. OBJECTIVE: To reconsider effects of the Second National Acute Spinal Cord Injury Study. SUMMARY OF BACKGROUND DATA: High dose methylprednisolone sodium succinate (MPSS) for the patients with acute spinal cord injury has been considered standard treatment in the several countries. However, many authors have criticized the effect of MPSS because of lack of evidence about neurologic improvement and the high incidence of complications. METHODS: During 2-year, all patients with cervical cord injury were treated with MPSS within 8 hours of their injuries based on the Second National Acute Spinal Cord Injury Study protocol (MPSS group). During the next 2-year, all patients were treated without MPSS (non-MPSS group). There were 38 patients in the MPSS group and 41 in the non-MPSS. Early spinal decompression and stabilization was performed as soon after injury in both the groups. RESULTS: According to The American Spinal Injury Association (ASIA) motor score, there was an average improvement by 3 months postinjury of 12.4 points in the MPSS group and 13.8 points in the non-MPSS group. In patients with complete motor loss, average ASIA motor score improved 9.0 points in the MPSS group and 12.6 points in the non-MPSS group. For patients with incomplete motor loss, average ASIA motor score improvement was 14.1 and 15.5 points in the MPSS and non-MPSS groups, respectively.In the MPSS group, 19 patients developed pneumonia, 13 developed urinary tract infections, and 5 developed wound infections. Incidence of pneumonia was significantly increased with the use of MPSS medication. CONCLUSION: We found no evidence supporting the opinion that high-dose MPSS administration facilitates neurologic improvement in patients with spinal cord injury. We believe MPSS should be used under limited circumstances because of the high incidence of pulmonary complication.




    Quote Originally Posted by Doodles View Post
    How many times do we see the pharmaceutical companies market something that doesn't work or even harms the patient?

    Well, it's been happening with the supposed only treatment for SCI: It DOESN'T WORK and hurts patients who get it!!

    Spinal Treatment May Not Improve Neurologic RecoveryMethylprednisolone sodium succinate also found to increase pneumonia risk over non-treatment
    Publish date: Sep 17, 2009



    THURSDAY, Sept. 17 (HealthDay News) -- Treatment with high-dose methylprednisolone sodium succinate (MPSS) does not improve neurologic recovery in patients who have suffered acute spinal cord injury and increases the risk of pneumonia as a complication, according to a study in the Sept. 15 issue of Spine.

    Yasuo Ito, M.D., of the Kobe Red Cross Hospital in Japan, and colleagues treated all patients who presented with cervical cord injury during 2003 to 2005 with MPSS, following the protocol of the Second National Acute Spinal Cord Injury Study. During the subsequent period of 2005 to 2007, all patients were not treated with MPSS. Patient improvement in the two groups was evaluated and compared using the American Spinal Injury Association (ASIA) motor score.
    Three months after treatment, the researchers found that the average improvement in ASIA motor score in the MPSS-treated group was 12.4 points compared to 13.8 points in the group not treated with MPSS. Among patients with complete motor loss, the average ASIA motor score improved 9.0 points in the MPSS group and 12.6 points in the non-MPSS group, while among patients with partial motor loss, the average ASIA motor scores improved 14.1 and 15.5 points, respectively. Nineteen patients in the MPSS group contracted pneumonia compared to 11 patients in the non-MPSS group.
    "We found no evidence supporting the opinion that high-dose MPSS administration facilitates neurologic improvement in patients with spinal cord injury. We believe MPSS should be used under limited circumstances because of the high incidence of pulmonary complication," the authors conclude.

    Last edited by Wise Young; 09-19-2009 at 02:53 PM.

  5. #5
    Quote Originally Posted by Wise Young View Post
    One multicenter study in the United States from 1985 to 1995 (involving 14 centers) randomized 487 patients from 1985-1989 (NASCIS II) to placebo, naloxone, or a 24-hour course of methylprednisolone. This study [1], the first and only placebo-controlled multicenter study of a treatment for acute spinal cord injury showed that the methylprednisolone significantly improved 6- and 12-month motor and sensory recovery by about 20% compared to placebo, but only in patients that were treated within 8 hours after injury. Naloxone showed a trend of improving patients but it did not reach significance. The study indicated no significant differences of pneumonia or any of 15 different potential complications between placebo and any of the treatments.

    The second study (NASCIS III) randomized 499 patients from 1992-1996 to a 24-hour course of methylprednisolone, a 48-hour course of methylprednisolone, and a 48-hour course of tirilizad mesylate [2]. NASCIS III showed that 6-12 month neurological outcomes of all three treatment groups did not differ when the treatment was started within 3 hours after injury. However, when the treatment was started within 3-8 hours after injury, the 48-hour methylprednisolone treated group had significantly better 6- and 12-month motor and sensory recovery compared to the other two groups. There was, however, a trend towards increased severity of pneumonia (but not the incidence of pneumonia) in patients that received the 48-hour course of methylprednisolone.

    NASCIS II recommended that the 24-hour course of methylprednisolone be given to both complete and incomplete spinal cord injury as soon as possible after injury and not to be given if it cannot be started within 8 hours. NASCIS III recommended that the 48-hour course of methylprednisolone be given to patients only when the drug can started between 3-8 hours after injury. The drug should not be used when it cannot be started within 8 hours after injury. Both studies were multicenter, double-blind, randomized studies. These are the most rigorous of all clinical trial designs.

    It is difficult to imagine why anybody would think that a small, single-center, non-randomized, non-concurrent, non-blinded study involving 38 patients treated with MP can negate and overturn the experience of two multicenter, double-blind, randomized studies involving nearly 494 patients treated with MP. Since 1990, when NASCIS II was published, millions of people must have received high-dose methylprednisolone.

    There was no difference in the 3-month neurological scores, which is consistent with the results of NASCIS II and III, which detected differences in neurological recovery only at 6 and 12 months after injury. It is difficult for me to understand why these authors did not do longer followup of their patients. Did they not read the previous studies? This oversight does not give me confidence in the study.

    Dr. Young, it is quite understandable that you would defend the large trials that promoted the use of methyl prednisolone, since you were one of the lead investigators on those two large trials.

    However, large is not always better. Early improvement is a good indicator of later improvement. and the two large NASCI trials have come under scrutiny and question several times in the past 20 years, almost all disputing the reported findings. Finally we have another trial, which is sinificant in that it corroborates the fact that the NASCI findings were flawed. Let's move on, and stop using the methyl prednisolone in the US as they decided in Canada several years ago.

    As the saying goes: If you beat statistics enough (ie large trials), they can confess to just about anything.

  6. #6
    Senior Member wheelchairTITAN's Avatar
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    Quote Originally Posted by Doodles View Post
    How many times do we see the pharmaceutical companies market something that doesn't work or even harms the patient?

    Well, it's been happening with the supposed only treatment for SCI: It DOESN'T WORK and hurts patients who get it!!
    DOODLES ... What basis do you have for taking this position? Is it based on this one article?

    What scientific position is your concluson based on?

    What do you, DOODLES, have in this negative position that you espouse?

    Do you have any conflicts of interest ... you are willing to attack others so sharing your own would be important.

    Do you have a law suit outstanding partially or wholly on this issue?

    Intelligent people would like to hear more of your wisdom on this topic. Thanks!
    William

    William

    ... rolling since 1989
    ...

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  7. #7

    Consortium for Spinal Cord Medicine

    Quote Originally Posted by wheelchairTITAN View Post
    DOODLES ... What basis do you have for taking this position? Is it based on this one article?

    What scientific position is your concluson based on?

    What do you, DOODLES, have in this negative position that you espouse?

    Do you have any conflicts of interest ... you are willing to attack others so sharing your own would be important.

    Do you have a law suit outstanding partially or wholly on this issue?

    Intelligent people would like to hear more of your wisdom on this topic. Thanks!
    William
    Hello William,

    Your own country has rejected using Methyl prednisolone based on a large body of scientific data. They initially used it too, just as in the US, but they are sufficiently convinced it doesn't work and they have discontinued its use.

    Even in the US:

    Early Acute Management in
    Adults with Spinal Cord Injury:
    A Clinical Practice Guideline
    for Health-Care Providers
    Consortium for Spinal Cord Medicine

    Pharmacologic Neuroprotection in
    Patients with Spinal Cord Injury
    22. No clinical evidence exists to definitively recommend
    the use of any neuroprotective pharmacologic agent,
    including steroids, in the treatment of acute spinal
    cord injury in order to improve functional recovery.
    23. If it has been started, stop administration of methylprednisolone
    as soon as possible in neurologically
    normal patients and in those whose prior neurologic
    symptoms have resolved to reduce deleterious side
    effects.
    http://www.norcalmobility.com/pdf/early%20acute%20management%20of%20sci.pdf

  8. #8
    Senior Member wheelchairTITAN's Avatar
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    Quote Originally Posted by Doodles View Post
    Let's move on, and stop using the in the US as they decided in Canada several years ago.
    This medication and the use of it is NOT banned Canada.

    Please check the ACTUAL HealthyOntario web site for the tryue published information. This information provided below was shown as published (September 18, 2009 at 11:47 AM EDT). http://www.healthyontario.com/DrugDe...oz%20Canada%29

    I have no idea where you get the notion or information that Canada has stopped using methylprednisolone. It would be nice if you widened your reading sources.

    Here is information from the Government of Ontario on methylprednisolone ...

    I have given you information from the HealthyOntario site on "methylprednisolone" below ... reading will enlighten and set you free!

    Any emphasis in bold is directly from the HealthyOntario web site ( no mark ups from me). Enjoy!http://www.healthyontario.com/DrugDe...oz%20Canada%29

    Methylprednisolone sodium succinate (by Sandoz Canada) Brand Names: Methylprednisolone sodium succinate (by Sandoz Canada)

    Common Name: methylprednisolone

    What is this drug used for?

    Methylprednisolone belongs to a group of medications called corticosteroids. Corticosteroids are hormones that are produced naturally in our body, and necessary for many important bodily functions. Methylprednisolone is a synthetic (manmade) corticosteroid medication that has been developed to imitate the actions of naturally occurring corticosteroid hormones in the body. A particularly important action of methlyprednisolone is to relieve inflammation that causes symptoms such as swelling, itching, and redness.
    Symptoms of inflammation are often seen with allergic reactions such as severe allergic skin reactions, reactions to insect bites, and anaphylaxis (a severe, life-threatening allergic reaction). Other conditions and symptoms associated with inflammation can also be treated with corticosteroids. These include painful swollen joints caused by arthritis, and relief of asthma symptoms caused by inflamed breathing passages. Methylprednisolone may also be used to treat people who are not able to produce enough of their own corticosteroid naturally (e.g., Addison's disease). Additional conditions that may be treated with methylprednisolone include severe skin conditions (e.g., psoriasis), certain eye conditions, ulcerative colitis, certain blood disorders, leukemia, lupus, and multiple sclerosis.
    Your doctor may have suggested this medication for conditions other than the ones listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
    Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
    Is there any reason not to take this drug?

    Methylprednisolone should not be used by anyone who:

    • is allergic to methylprednisolone or to any of the ingredients of the medication
    • has acute psychoses
    • has chicken pox
    • has herpes simplex keratitis
    • has Cushing's syndrome
    • has peptic ulcer
    • has systemic (in the blood) fungal infections
    • has tuberculosis
    • has vaccinia (reaction to smallpox vaccine)
    • has very high creatinine levels in the blood

    What about possible side effects?
    Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

    • The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
      Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
    • changes in the skin pigmentation at the place of injection
    • dizziness or lightheadedness
    • facial redness
    • flushing
    • increased appetite
    • increased sweating
    • indigestion
    • nervousness or restlessness
    • redness, swelling, or pain at the place of injection

    Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

    Check with your doctor as soon as possible if any of the following side effects occur:

    • blurred or reduced vision
    • confusion
    • excitement
    • frequent urination
    • hallucinations
    • increased thirst
    • mental depression
    • mood swings
    • restlessness
    • shortness of breath
    • skin rash

    The following side effects may occur if the medication is taken over long periods of time. Contact your doctor if any of these occur:

    • acne
    • bloody or black, tarry stools
    • continuing abdominal or stomach pain
    • eye pain or cataracts (clouding of the lens) or other vision problems
    • fever
    • headache
    • irregular heartbeat
    • menstrual problems
    • "moon face" (filling or rounding out of face)
    • muscle cramps or pain
    • muscle weakness
    • nausea
    • seizures
    • sensitivity of the eyes to light


    • sores in the mouth
    • swelling of the feet or lower legs
    • symptoms of a yeast infection (e.g., thick, white vaginal discharge, itching or burning during urination)
    • tearing of the eyes
    • thin, shiny skin
    • trouble sleeping
    • unusual bruising
    • unusual increase in hair growth
    • unusual tiredness or weakness
    • vomiting
    • weight gain that occurs quickly
    • wounds that will not heal

    Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

    What if I am taking other drugs?

    There may be an interaction between methylprednisolone and any of the following:

    • antidiabetic medications (e.g., insulin, metformin)
    • antihypertensive medications (e.g., metoprolol)
    • antipsychotics (e.g., haloperidol)
    • ASA (acetylsalicylic acid)
    • atracurium
    • cyclosporine and other immunosuppressants
    • digoxin
    • diltiazem
    • erythromycin
    • fluoroquinolones (e.g., moxifloxacin, ciprofloxacin, levofloxacin)
    • furosemide


    • insulin
    • itraconazole
    • ketoconazole
    • neostigmine, pyridostigmine
    • oral antidiabetic drugs (e.g., metformin)
    • pancuronium
    • phenobarbital
    • phenytoin
    • quetiapine
    • rifampin
    • salbutamol
    • vaccines (e.g., vaccines for measles, mumps, rubella)
    • warfarin

    If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

    • stop taking one of the medications,
    • change one of the medications to another,
    • change how you are taking one or both of the medications, or
    • leave everything as is.

    An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
    Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

    Other information:
    Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

    Diabetes: Methylprednisolone may cause a loss of control of diabetes by increasing blood glucose (sugar); therefore, people with diabetes should closely monitor their blood glucose while taking this medication.
    Glaucoma: Methylprednisolone may cause the pressure within the eye to increase; therefore, people with glaucoma should be monitored by their doctor while taking this medication.
    Heart disease: Methylprednisolone may cause an elevation of blood pressure, salt and water retention, and increased excretion of potassium. People with heart disease should be monitored by their doctor while taking this medication.
    Infections: Corticosteroids can reduce your body's resistance to infections and make them more difficult to treat. Contact your doctor if you notice any signs of infection such as sore throat, fever, sneezing, or coughing.
    Liver or kidney disease: People with liver disease or kidney disease may not clear methylprednisolone from their bodies at the usual rate and so should be monitored by their doctor while taking methylprednisolone.
    Myasthenia gravis: Myasthenia gravis is a condition that causes specific muscle weakness. Methylprednisolone can cause muscle wasting; therefore, people with this condition should be monitored by their doctor while using this medication.
    Ocular herpes simplex: People who have the herpes simplex virus affecting their eye should be monitored by their doctor while taking methylprednisolone, as the medication may cause a hole in the cornea.
    Osteoporosis (bone disease): Methylprednisolone may worsen osteoporosis because it causes the body to lose more calcium. People who have, or are at risk of getting osteoporosis should be monitored by their doctor while on methylprednisolone.
    Skin test injection: Corticosteroids may cause false results in skin tests (e.g., tuberculosis test). They may also reactivate latent tuberculosis.
    Stomach ulcer: People with stomach ulcers should be monitored by their doctor while taking methylprednisolone, as it may worsen the condition.
    Stress: A dosage adjustment of methylprednisolone may be required for anyone subjected to unusual stress.
    Underactive thyroid (hypothyroidism): People with hypothyroidism should be monitored by their doctor while taking methylprednisolone, as the body may not clear the medication at the usual rate, and its effect may be increased.
    Vaccines: People receiving immunosuppressive doses of corticosteriods should not receive live or live-attenuated (modified) vaccines, as there is a risk of infection and poor immune response to the vaccine.
    Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
    Breast-feeding: Methylprednisolone passes into breast milk. Because of the potential risk to the infant, breast-feeding is not recommended while taking this medication.
    Children: Using methylprednisolone for a long period of time may cause growth suppression (i.e., less increase in height or weight than usual). Children who need long-term treatment should be carefully monitored for growth.

    Special Instructions:
    The recommended dose of methylprednisolone varies widely depending on the condition being treated, response to the medication, the form of the medication being used, the age and size of the person using the medication, and individual circumstances. Injectable medications are given either into a muscle, into a joint, or into a vein by a qualified health professional.

    The dose of the tablet form may range from 4 mg to 48 mg of methylprednisolone daily, or even much higher depending on the specific condition being treated. Taking this medication with food will help to prevent stomach upset.

    Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

    It is important to use this medication exactly as prescribed by your doctor. If you miss a dose of the medication and are taking the medication once a day, but don't remember until the next day, skip the missed dose and go back to your regular dosing schedule. If you are taking the medication more than once daily, skip the missed dose and go back to your regular schedule. Do not take a double dose to make up for a missed one.
    Store this medication at room temperature, protect it from freezing, and keep it out of the reach of children.

    Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
    http://www.healthyontario.com/DrugDe...oz%20Canada%29

    William

    ... rolling since 1989
    ...

    BE NICE!It's free

    P.S. ~ I have "handicapabilities"

    TWITTER: @MacBerry

  9. #9
    Senior Member wheelchairTITAN's Avatar
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    Quote Originally Posted by Doodles View Post
    Hello William,

    Your own country has rejected using Methyl prednisolone based on a large body of scientific data. They initially used it too, just as in the US, but they are sufficiently convinced it doesn't work and they have discontinued its use.

    Even in the US:
    Originally Posted by wheelchairTITAN
    DOODLES ... What basis do you have for taking this position? Is it based on this one article?

    What scientific position is your concluson based on?

    What do you, DOODLES, have in this negative position that you espouse?

    Do you have any conflicts of interest ... you are willing to attack others so sharing your own would be important.

    Do you have a law suit outstanding partially or wholly on this issue?

    Intelligent people would like to hear more of your wisdom on this topic. Thanks!
    William[/QUOTE]

    Answer the questions I posed to you? SEE ABOVE!

    William

    ... rolling since 1989
    ...

    BE NICE!It's free

    P.S. ~ I have "handicapabilities"

    TWITTER: @MacBerry

  10. #10

    In Canada Methyl Prednisolone is NOT used for SCI

    William,

    Thank you for proving my point. In Canada methylpredisolone is NOT used for SCI.

    Please reread you own piece.

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