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Old 12-03-2012, 01:55 AM
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fmichael fmichael is offline
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Join Date: Sep 2006
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fmichael fmichael is offline
Senior Member
fmichael's Avatar
 
Join Date: Sep 2006
Location: California
Posts: 1,239
15 yr Member
Default agree re Bacolofen, etc., but what was the FDA doing when it okayed Soma in 2007???

Quote:
Originally Posted by rsdno View Post
First if it was a primary muscle relaxer your heart would relax and you would die . The Docs say the only good one is Baclofen it helps muscle spasms but Soma adds potency and what soma is mixed with does a double head bang I guess other drugs like Morphine or alcohol if you just want to get losaded then Soma ,I take Baclofen and I have 3 Diazepam a day Avinza best Morphine and Diazepam makes me sleeps or maybe buzzed its Valium ,IO know the Baclofen really helps and I read in Lancet and JAMA its only muscle relaxer .(they never had a few soma and opiates from Vicodin to Oxy they potentiate each other but Doctors on Res said please try this instead I was taking 360 Soma and 360 #4 and I was out there ,I like being as close to being me better ,but we are all different , I first had RSD DXed in 1968 but we all hurt the same at this instant the past is gone get out of pain and keep your brain ,being a loadie looks awful to me

Gentle Hug
rsdno
Hey. We're in agreement on Baclofen. Am advised my neurologist that it is by far and away the best (if not really) the only medicine specifically used for CNS induced spasms, as opposed to those cause by strains, sprains and other muscle injuries, such as Flexeril or Soma: see below. So it's a leading med for folks with MS as well. I currently take the maximum suggested oral dose of 50 mg/day. And for people with far more severe hardship - say dystonia - there are implanted Baclofen pumps, although I understand that's a mater not without controversy. And for me - once I stopped practicing law at least - the side-effects are minimal: but when I was still working, it had an unacceptable effect on my memory. (Sort of a joke though, compared to the number CRPS was going to wind up doing on my memory as time went on.)

And completely agree with your advice to others:
keep your brain, being a loadie looks awful to me
There may be more problems, however, in combining Baclofen with Soma (carisoprodol), or even using Soma on a long-term basis, than you've been told by your docs. (Funny how that happens too often in the world of prescription medicine and devices.) This from the FDA mandated Prescribing Information sheet for Soma:
SOMA should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration.
* * *
SOMA has sedative properties (in the low back pain trials, 13% to 17% of patients who received SOMA experienced sedation compared to 6% of patients who received placebo) and may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a motor vehicle or operating machinery. There have been post-marketing reports of motor vehicle accidents associated with the use of SOMA.

Since the sedative effects of SOMA and other CNS depressants (e.g., alcohol, benzodiazepines,opioids, tricyclic antidepressants) may be additive, appropriate caution should be exercised with patients who take more than one of these CNS depressants simultaneously.

In the post-marketing experience with SOMA, cases of dependence, withdrawal, and abuse have been reported with prolonged use. Most cases of dependence, withdrawal, and abuse occurred in patients who have had a history of addiction or who used SOMA in combination with other drugs with abuse potential. However, there have been post-marketing adverse event reports of SOMA-associated abuse when used without other drugs with abuse potential. Withdrawal symptoms have been reported following abrupt cessation after prolonged use. To reduce the chance of SOMA dependence, withdrawal, or abuse, SOMA should be used with caution in addiction-prone patients and in patients taking other CNS depressants including alcohol, and SOMA should not be used more than two to three weeks for the relief of acute musculoskeletal discomfort. [Emphasis added.]
And incredibly, Soma was approved for release in 2007 under (ahem) a prior administration, based on only the following:
The safety and efficacy of SOMA for the relief of acute, idiopathic mechanical low back pain was evaluated in two, 7-day, double blind, randomized, multicenter, placebo controlled, U.S. trials (Studies 1 and 2). Patients had to be 18 to 65 years old and had to have acute back pain (≤ 3 days of duration) to be included in the trials. Patients with chronic back pain; at increased risk for vertebral fracture (e.g., history of osteoporosis); with a history of spinal pathology (e.g., herniated nucleus pulposis, spondylolisthesis or spinal stenosis); with inflammatory back pain, or with evidence of a neurologic deficit were excluded from participation. Concomitant use of analgesics (e.g., acetaminophen, NSAIDs, tramadol, opioid agonists), other muscle relaxants, botulinum toxin, sedatives (e.g., barbiturates, benzodiazepines, promethazine hydrochloride), and anti-epileptic drugs was prohibited.
That's right folks, the trials lasted for all of two weeks and people using any other analgesics were specifically excluded, so of course there could be no pre-release reports of drug interactions. Oh yeah, this too:
Long term studies in animals have not been performed to evaluate the carcinogenic potential of carisoprodol.

SOMA was not formally evaluated for genotoxicity. In published studies, carisoprodol was mutagenic in the in vitro mouse lymphoma cell assay in the absence of metabolizing enzymes, but was not mutagenic in the presence of metabolizing enzymes . . . .

SOMA was not formally evaluated for effects on fertility. Published reproductive studies of carisoprodol in mice found no alteration in fertility although an alteration in reproductive cycles characterized by a greater time spent in estrus was observed at a carisoprodol dose of 1200 mg/kg/day. In a 13-week toxicology study that did not determine fertility, mouse testes weight and sperm motility were reduced at a dose of 1200 mg/kg/day. In both studies, the no effect level was 750 mg/kg/day, corresponding to approximately 2.6 times the human equivalent dosage of 350 mg four times a day, based on a body surface area comparison. The significance of these findings for human fertility is not known.
And with that, I suspect I've said enough about Soma.

But of course medication is not and can't be the complete answer to spasms: if it was I would have to be sitting around wasted on Marinol [a synthetic Delta-9 THC] for much of the time, as I was for years. Instead, a new type of physical therapy, specifically "nerve gliding" exercise entered my life, and that had made all the difference. Please see my post from Thursday, look for a "DPT" in the New To Board - Physical Therapy Question thread.

Forgive me for going on, but you have my full attention. Be well, friend.

Mike
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