La FDA advierte de los graves problemas neurológicos Después epidural Inyecciones de corticosteroides
FDA Warns of Serious Neurologic Problems After Epidural Corticosteroid Injections
ROCKVILLE, Md -- April 23, 2014 -- The US 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 FDA is requiring the addition of a Warning to the drug labels of injectable corticosteroids to describe these risks.
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 the FDA has not approved corticosteroids for such use.
The 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. Serious adverse events included death, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, stroke, seizures, nerve injury, and brain oedema. 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.
Additional Information for Healthcare 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.
* 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:https://www.accessdata.fda.gov/scripts/medwatch/
To raise awareness of the risks of epidural corticosteroid injections in the medical community, the 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 finalised.
As part of the FDA's ongoing effort to investigate this issue, they 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.
Seguimiento a dos años de inyecciones con guía fluoroscópica en cervical peridural en dolor axial o discogénico del cuello
Two-Year Follow-Up Results of Fluoroscopic Cervical Epidural Injections in Chronic Axial or Discogenic neck Pain: A Randomized, Double-Blind, Controlled Trial
Laxmaiah Manchikanti1,Kimberly A. Cash, Vidyasagar Pampati, Yogesh Malla
International Journal of Medical Sciences 2014; 11(4):309-320. doi: 10.7150/ijms.8069
Abstract
Study Design: A randomized, double-blind, active-controlled trial. Objective: To assess the effectiveness of cervical interlaminar epidural injections of local anesthetic with or without steroids for the management of axial or discogenic pain in patients without disc herniation, radiculitis, or facet joint pain. Summary of Background Data: Cervical discogenic pain without disc herniation is a common cause of suffering and disability in the adult population. Once conservative management has failed and facet joint pain has been excluded, cervical epidural injections may be considered as a management tool. Despite a paucity of evidence, cervical epidural injections are one of the most commonly performed nonsurgical interventions in the management of chronic axial or disc-related neck pain. Methods: One hundred and twenty patients without disc herniation or radiculitis and negative for facet joint pain as determined by means of controlled diagnostic medial branch blocks were randomly assigned to one of the 2 treatment groups. Group I patients received cervical interlaminar epidural injections of local anesthetic (lidocaine 0.5%, 5 mL), whereas Group II patients received 0.5% lidocaine, 4 mL, mixed with 1 mL or 6 mg of nonparticulate betamethasone. The primary outcome measure was ≥ 50% improvement in pain and function. Outcome assessments included numeric rating scale (NRS), Neck Disability Index (NDI), opioid intake, employment, and changes in weight. Results: Significant pain relief and functional improvement (≥ 50%) was present at the end of 2 years in 73% of patients receiving local anesthetic only and 70% receiving local anesthetic with steroids. In the successful group of patients, however, defined as consistent relief with 2 initial injections of at least 3 weeks, significant improvement was illustrated in 78% in the local anesthetic group and 75% in the local anesthetic with steroid group at the end of 2 years. The results reported at the one-year follow-up were sustained at the 2-year follow-up. Conclusions: Cervical interlaminar epidural injections with or without steroids may provide significant improvement in pain and functioning in patients with chronic discogenic or axial pain that is function-limiting and not related to facet joint pain.
Keywords: Chronic neck pain, cervical discogenic pain, cervical axial pain, cervical disc herniation, cervical epidural injections, epidural steroids, local anesthetics.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3936024/pdf/ijmsv11p0309.pdf
Manejo de dolor crónico por hernia cervical discal y radiculitis con inyecciones epidurales interlaminares guiadas con fluoroscopía
Management of chronic pain of cervical disc herniation and radiculitis with fluoroscopic cervical interlaminar epidural injections.
Manchikanti L, Cash KA, Pampati V, Wargo BW, Malla Y.
Int J Med Sci. 2012;9(6):424-34. doi: 10.7150/ijms.4444. Epub 2012 Jul 23.
Abstract
STUDY DESIGN: A randomized, double-blind, active controlled trial. OBJECTIVE: To evaluate the effectiveness of cervical interlaminar epidural injections of local anesthetic with or without steroids in the management of chronic neck pain and upper extremity pain in patients with disc herniation and radiculitis. SUMMARY OF BACKGROUND DATA: Epidural injections in managing chronic neck and upper extremity pain are commonly employed interventions. However, their long-term effectiveness, indications, and medical necessity, of their use and their role in various pathologies responsible for persistent neck and upper extremity pain continue to be debated, even though, neck and upper extremity pain secondary to disc herniation and radiculitis, is described as the common indication. There is also paucity of high quality literature. METHODS: One-hundred twenty patients were randomly assigned to one of 2 groups: Group I patients received cervical interlaminar epidural injections of local anesthetic (lidocaine 0.5%, 5 mL); Group II patients received 0.5% lidocaine, 4 mL, mixed with 1 mL of nonparticulate betamethasone. Primary outcome measure was ≥ 50 improvement in pain and function. Outcome assessments included Numeric Rating Scale (NRS), Oswestry Disability Index (ODI), opioid intake, employment, and changes in weight. RESULTS: Significant pain relief and functional status improvement (≥ 50%) was demonstrated in 72% of patients who received local anesthetic only and 68% who received local anesthetic and steroids. In the successful group of participants, significant improvement was illustrated in 77% in local anesthetic group and 82% in local anesthetic with steroid group. CONCLUSIONS: Cervical interlaminar epidural injections with or without steroids may provide significant improvement in pain and function for patients with cervical disc herniation and radiculitis.
KEYWORDS: Chronic neck pain, cervical disc herniation, cervical epidural injections, epidural steroids, local anesthetics, upper extremity pain
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3410361/pdf/ijmsv09p0424.pdf
Efectividad de inyecciones peridurales cervicales en el manejo del dolor crónico del cuello y extremidades superiores
Effectiveness of cervical epidural injections in the management of chronic neck and upper extremity pain.
Diwan S, Manchikanti L, Benyamin RM, Bryce DA, Geffert S, Hameed H, Sharma ML, Abdi S, Falco FJ.
Pain Physician. 2012 Jul-Aug;15(4):E405-34.
Abstract
BACKGROUND: Chronic persistent neck pain with or without upper extremity pain is common in the general adult population with prevalence of 48% for women and 38% for men, with persistent complaints in 22% of women and 16% of men. Multiple modalities of treatments are exploding in managing chronic neck pain along with increasing prevalence. However, there is a paucity of evidence for all modalities of treatments in managing chronic neck pain. Cervical epidural injections for managing chronic neck pain are one of the commonly performed interventions in the United States. However, the literature supporting cervical epidural steroids in managing chronic pain problems has been scant. STUDY DESIGN: A systematic review of cervical interlaminar epidural injections for cervical disc herniation, cervical axial discogenic pain, cervical central stenosis, and cervical postsurgery syndrome. OBJECTIVE: To evaluate the effect of cervical interlaminar epidural injections in managing various types of chronic neck and upper extremity pain emanating as a result of cervical spine pathology. METHODS: The available literature on cervical interlaminar epidural injections in managing chronic neck and upper extremity pain were reviewed. The quality assessment and clinical relevance criteria utilized were the Cochrane Musculoskeletal Review Group criteria as utilized for interventional techniques for randomized trials and the criteria developed by the Newcastle-Ottawa Scale criteria for observational studies. The level of evidence was classified as good, fair, and limited based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF). Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to December 2011, and manual searches of the bibliographies of known primary and review articles. OUTCOME MEASURES: The primary outcome measure was pain relief (short-term relief = up to 6 months and long-term > 6 months). Secondary outcome measures were improvement in functional status, psychological status, return to work, and reduction in opioid intake. RESULTS: For this systematic review, 34 studies were identified. Of these, 24 studies were excluded and a total of 9 randomized trials, with 2 duplicate studies, met inclusion criteria for methodological quality assessment. For cervical disc herniation, the evidence is good for cervical epidural with local anesthetic and steroids; whereas, it was fair with local anesthetic only. For axial or discogenic pain, the evidence is fair for local anesthetic, with or without steroids. For spinal stenosis, the evidence is fair for local anesthetic, with or without steroids. For postsurgery syndrome, the evidence is fair for local anesthetic, with or without steroids. LIMITATIONS: The limitations of this systematic review continue to be the paucity of literature. CONCLUSION: The evidence is good for radiculitis secondary to disc herniation with local anesthetics and steroids, fair with local anesthetic only; whereas, it is fair for local anesthetics with or without steroids, for axial or discogenic pain, pain of central spinal stenosis, and pain of post surgery syndrome.
http://www.painphysicianjournal.com/2012/august/2012;15;E405-E434.pdf
Atentamente
Anestesiología y Medicina del Dolor
www.anestesia-dolor.org
FDA Warns of Serious Neurologic Problems After Epidural Corticosteroid Injections
ROCKVILLE, Md -- April 23, 2014 -- The US 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 FDA is requiring the addition of a Warning to the drug labels of injectable corticosteroids to describe these risks.
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 the FDA has not approved corticosteroids for such use.
The 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. Serious adverse events included death, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, stroke, seizures, nerve injury, and brain oedema. 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.
Additional Information for Healthcare 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.
* 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:https://www.accessdata.fda.gov/scripts/medwatch/
To raise awareness of the risks of epidural corticosteroid injections in the medical community, the 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 finalised.
As part of the FDA's ongoing effort to investigate this issue, they 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.
Seguimiento a dos años de inyecciones con guía fluoroscópica en cervical peridural en dolor axial o discogénico del cuello
Two-Year Follow-Up Results of Fluoroscopic Cervical Epidural Injections in Chronic Axial or Discogenic neck Pain: A Randomized, Double-Blind, Controlled Trial
Laxmaiah Manchikanti1,Kimberly A. Cash, Vidyasagar Pampati, Yogesh Malla
International Journal of Medical Sciences 2014; 11(4):309-320. doi: 10.7150/ijms.8069
Abstract
Study Design: A randomized, double-blind, active-controlled trial. Objective: To assess the effectiveness of cervical interlaminar epidural injections of local anesthetic with or without steroids for the management of axial or discogenic pain in patients without disc herniation, radiculitis, or facet joint pain. Summary of Background Data: Cervical discogenic pain without disc herniation is a common cause of suffering and disability in the adult population. Once conservative management has failed and facet joint pain has been excluded, cervical epidural injections may be considered as a management tool. Despite a paucity of evidence, cervical epidural injections are one of the most commonly performed nonsurgical interventions in the management of chronic axial or disc-related neck pain. Methods: One hundred and twenty patients without disc herniation or radiculitis and negative for facet joint pain as determined by means of controlled diagnostic medial branch blocks were randomly assigned to one of the 2 treatment groups. Group I patients received cervical interlaminar epidural injections of local anesthetic (lidocaine 0.5%, 5 mL), whereas Group II patients received 0.5% lidocaine, 4 mL, mixed with 1 mL or 6 mg of nonparticulate betamethasone. The primary outcome measure was ≥ 50% improvement in pain and function. Outcome assessments included numeric rating scale (NRS), Neck Disability Index (NDI), opioid intake, employment, and changes in weight. Results: Significant pain relief and functional improvement (≥ 50%) was present at the end of 2 years in 73% of patients receiving local anesthetic only and 70% receiving local anesthetic with steroids. In the successful group of patients, however, defined as consistent relief with 2 initial injections of at least 3 weeks, significant improvement was illustrated in 78% in the local anesthetic group and 75% in the local anesthetic with steroid group at the end of 2 years. The results reported at the one-year follow-up were sustained at the 2-year follow-up. Conclusions: Cervical interlaminar epidural injections with or without steroids may provide significant improvement in pain and functioning in patients with chronic discogenic or axial pain that is function-limiting and not related to facet joint pain.
Keywords: Chronic neck pain, cervical discogenic pain, cervical axial pain, cervical disc herniation, cervical epidural injections, epidural steroids, local anesthetics.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3936024/pdf/ijmsv11p0309.pdf
Manejo de dolor crónico por hernia cervical discal y radiculitis con inyecciones epidurales interlaminares guiadas con fluoroscopía
Management of chronic pain of cervical disc herniation and radiculitis with fluoroscopic cervical interlaminar epidural injections.
Manchikanti L, Cash KA, Pampati V, Wargo BW, Malla Y.
Int J Med Sci. 2012;9(6):424-34. doi: 10.7150/ijms.4444. Epub 2012 Jul 23.
Abstract
STUDY DESIGN: A randomized, double-blind, active controlled trial. OBJECTIVE: To evaluate the effectiveness of cervical interlaminar epidural injections of local anesthetic with or without steroids in the management of chronic neck pain and upper extremity pain in patients with disc herniation and radiculitis. SUMMARY OF BACKGROUND DATA: Epidural injections in managing chronic neck and upper extremity pain are commonly employed interventions. However, their long-term effectiveness, indications, and medical necessity, of their use and their role in various pathologies responsible for persistent neck and upper extremity pain continue to be debated, even though, neck and upper extremity pain secondary to disc herniation and radiculitis, is described as the common indication. There is also paucity of high quality literature. METHODS: One-hundred twenty patients were randomly assigned to one of 2 groups: Group I patients received cervical interlaminar epidural injections of local anesthetic (lidocaine 0.5%, 5 mL); Group II patients received 0.5% lidocaine, 4 mL, mixed with 1 mL of nonparticulate betamethasone. Primary outcome measure was ≥ 50 improvement in pain and function. Outcome assessments included Numeric Rating Scale (NRS), Oswestry Disability Index (ODI), opioid intake, employment, and changes in weight. RESULTS: Significant pain relief and functional status improvement (≥ 50%) was demonstrated in 72% of patients who received local anesthetic only and 68% who received local anesthetic and steroids. In the successful group of participants, significant improvement was illustrated in 77% in local anesthetic group and 82% in local anesthetic with steroid group. CONCLUSIONS: Cervical interlaminar epidural injections with or without steroids may provide significant improvement in pain and function for patients with cervical disc herniation and radiculitis.
KEYWORDS: Chronic neck pain, cervical disc herniation, cervical epidural injections, epidural steroids, local anesthetics, upper extremity pain
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3410361/pdf/ijmsv09p0424.pdf
Efectividad de inyecciones peridurales cervicales en el manejo del dolor crónico del cuello y extremidades superiores
Effectiveness of cervical epidural injections in the management of chronic neck and upper extremity pain.
Diwan S, Manchikanti L, Benyamin RM, Bryce DA, Geffert S, Hameed H, Sharma ML, Abdi S, Falco FJ.
Pain Physician. 2012 Jul-Aug;15(4):E405-34.
Abstract
BACKGROUND: Chronic persistent neck pain with or without upper extremity pain is common in the general adult population with prevalence of 48% for women and 38% for men, with persistent complaints in 22% of women and 16% of men. Multiple modalities of treatments are exploding in managing chronic neck pain along with increasing prevalence. However, there is a paucity of evidence for all modalities of treatments in managing chronic neck pain. Cervical epidural injections for managing chronic neck pain are one of the commonly performed interventions in the United States. However, the literature supporting cervical epidural steroids in managing chronic pain problems has been scant. STUDY DESIGN: A systematic review of cervical interlaminar epidural injections for cervical disc herniation, cervical axial discogenic pain, cervical central stenosis, and cervical postsurgery syndrome. OBJECTIVE: To evaluate the effect of cervical interlaminar epidural injections in managing various types of chronic neck and upper extremity pain emanating as a result of cervical spine pathology. METHODS: The available literature on cervical interlaminar epidural injections in managing chronic neck and upper extremity pain were reviewed. The quality assessment and clinical relevance criteria utilized were the Cochrane Musculoskeletal Review Group criteria as utilized for interventional techniques for randomized trials and the criteria developed by the Newcastle-Ottawa Scale criteria for observational studies. The level of evidence was classified as good, fair, and limited based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF). Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to December 2011, and manual searches of the bibliographies of known primary and review articles. OUTCOME MEASURES: The primary outcome measure was pain relief (short-term relief = up to 6 months and long-term > 6 months). Secondary outcome measures were improvement in functional status, psychological status, return to work, and reduction in opioid intake. RESULTS: For this systematic review, 34 studies were identified. Of these, 24 studies were excluded and a total of 9 randomized trials, with 2 duplicate studies, met inclusion criteria for methodological quality assessment. For cervical disc herniation, the evidence is good for cervical epidural with local anesthetic and steroids; whereas, it was fair with local anesthetic only. For axial or discogenic pain, the evidence is fair for local anesthetic, with or without steroids. For spinal stenosis, the evidence is fair for local anesthetic, with or without steroids. For postsurgery syndrome, the evidence is fair for local anesthetic, with or without steroids. LIMITATIONS: The limitations of this systematic review continue to be the paucity of literature. CONCLUSION: The evidence is good for radiculitis secondary to disc herniation with local anesthetics and steroids, fair with local anesthetic only; whereas, it is fair for local anesthetics with or without steroids, for axial or discogenic pain, pain of central spinal stenosis, and pain of post surgery syndrome.
http://www.painphysicianjournal.com/2012/august/2012;15;E405-E434.pdf
Atentamente
Anestesiología y Medicina del Dolor
www.anestesia-dolor.org
