http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3642757/
Multiple type of spinal injections, whether epidural/translaminar or transforaminal, facet injections, are offered to patients with/without surgical spinal lesions by pain management specialists (radiologists, physiatrists, and anesthesiologists). Although not approved by the Food and Drug Administration (FDA), injections are being performed with an increased frequency (160%), are typically short-acting and ineffective over the longer-term, while exposing patients to major risks/complications…
Results: Multiple recent reports cite contaminated epidural steroid injections resulting in meningitis, stroke, paralysis, and death. The Center for Disease Control (CDC) specifically identified 25 deaths (many due to Aspergillosis), 337 patients sickened, and 14,000 exposed to contaminated steroids. Nevertheless, many other patients develop other complications that go unreported/underreported: Other life-threatening infections, spinal fluid leaks (0.4-6%), positional headaches (28%), adhesive arachnoiditis (6-16%), hydrocephalus, air embolism, urinary retention, allergic reactions, intravascular injections (7.9-11.6%), stroke, blindness, neurological deficits/paralysis, hematomas, seizures, and death.
Conclusions: Although the benefits for epidural steroid injections may include transient pain relief for those with/without surgical disease, the multitude of risks attributed to these injections outweighs the benefits.
http://abcnews.go.com/Health/epidural-steroid-injection-risk-incurable-arachnoiditis/story?id=17552260
Helen Bertelli, a mother of two young girls from Raleigh, N.C., has been crippled with weird symptoms — electric shocks, muscle cramps and the sensation that water is running down her legs — all since she received an epidural steroid injection for back pain in 2011.
Three months after a medical “fellow” administered the shot at a pain clinic, she had trouble urinating, then both her feet went numb.
“I had this feeling I was connected to the end of a guitar string and someone was plucking it,” said Bertelli, 36, and a former runner and hiker. “My legs just exploded like there were fireworks in them. My muscles twitched like they were boiling.”
For months doctors told her the knife-like pains were in her head, but six months later, Bertelli was diagnosed with arachnoiditis, an incurable condition that can be associated with epidural steroid injections…
http://nationalpainreport.com/fda-warns-about-epidurals-8823722.html
“I am relieved and hopeful that things are on the right track, but there is still much more that needs to be done to stop these ineffective, harmful pain treatments from maiming and crippling people and ruining their lives,” said Dawn Gonzalez, whose spine was permanently damaged by an epidural during child birth. She now suffers from arachnoiditis and is an advocate for Arachnoiditis Society for Awareness and Prevention (ASAP).
“They need to do something to warn specifically about arachnoiditis, and do something to help those of us that have already been damaged by these procedures. They will find that these instances are not in fact rare like they say, but are in epidemic proportions relative to the number of these injections that have been given over the last 10 or so years.” …
http://www.burtonreport.com/infspine/epiduralsteroidshistory.htm
How then historically, given this checkered background, did epidural steroid injections (ESI) become such a widespread non-specific treatment for low back pain? There can be no question but that this “shotgun” therapy is commonly used in the United States, as well as other countries. It’s popularity seems to relate, to a large degree, to be a “knee-jerk” means of providing short-term back pain relief. The only rationale for ESI use is the generalized anti-inflammatory action of steroids and also the observation that many patients with back pain can recover spontaneously if their initial pain is moderated. Statistics demonstrate however that the same result can be achieved with most forms of other non-invasive therapies…
In a 1999 review of 13 studies published on the use of epidural steroids 8 of the reports showed no measurable benefits (Rozenberg S et al: Efficacy of epidural steroids in low back pain and sciatica, Rev. Rhum. Engl. Ed., 66:79-85, 1999 (Feb)). In a review editorial published in the British Medical Journal the authors pointed out that randomized controlled studies and the systematic reviews of randomized trials have not shown convincing evidence that ES injections provide predictable relief for sciatica and/or back pain (Samanta A, SamanthaJ: Is epidural injection of steroids effective for low back pain? BMJ, 328:1509-10, 2004)…
http://www.health.harvard.edu/blog/new-recommendations-aim-to-improve-safety-of-pain-relieving-spinal-steroid-injections-201505077991
Following the recommendations is entirely voluntary, and there are no studies to prove they actually prevent injuries…
https://en.wikipedia.org/wiki/New_England_Compounding_Center_meningitis_outbreak
Doses from these three lots had been distributed to 75 medical facilities in 23 states, and doses had been administered to about 14,000 patients after May 21 and before September 24, 2012. Patients began reporting symptoms in late August, but, because of the unusual nature of the infection, clinicians did not begin to realize the cases had a common cause until late September. Infections other than meningitis were also associated with this outbreak, which spanned 19 states. As of March 10, 2013, 48 people had died and 720 were being treated for persistent fungal infections…
http://www.pharmacist.com/track-and-trace-law-2015-deadlines-new-requirements
January 1 and July 1 are key deadlines in 2015 for new requirements for pharmacists under the Drug Supply Chain Security Act—the track-and-trace part of the compounding and track-and-trace legislation known as the Drug Quality and Security Act and signed into law in 2013…
By January 1, 2015, dispensers (primarily pharmacies) must establish systems for verification and handling of suspect or illegitimate product, according to the FDA website. The agency published a related draft guidance in June 2014…
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