GAITHERSBURG, Md., May 27 — Healthcare workers urged the FDA not to rush into a cumbersome Risk Evaluation and Mitigation Strategy (REMS) aimed at curbing misuse of opioid painkillers.

The FDA’s Center for Drug Evaluation and Research is holding a two-day public hearing here to get input from physicians, patients, pharmacists, hospice workers, addiction groups, and others, to decide what factors it should consider in drafting a REMS.

In February, following years of research and adverse event reports indicating widespread misuse of prescription opioids, the agency announced its intent to require REMS plans for such agents.

The FDA does not believe current strategies to prevent misuse are adequate. They are largely based on label information and a requirement that prescribers of opioids register with the Drug Enforcement Administration (DEA).

The move to issue a REMS represents the FDA’s most significant use yet of authority it was granted under the FDA Amendments Act of 2007.

The FDA had kicked off its opioid REMS drive by sending letters to 16 companies that make 24 extended-release and patch formulations of opioid drugs, informing them that they will have to eventually comply with a REMS.

(See FDA to Step Up Regulation of Extended-Release Opioids)

While the agency is examining what should be contained in a REMS for a range of opioid drugs, Wednesday’s hearing dealt mostly with Purdue Pharma’s extended-release oxycodone (OxyContin).

Ever since the first reports of widespread misuse of oxycodone in 2000, reports of opioid misuse have continued to grow, according to Bob Rappaport, M.D., director of the FDA unit overseeing anesthesia and analgesic drugs.

Data from the National Survey on Drug Use and Health in 2007 suggested that 33 million people over the age of 12 used an opioid for a nonmedical purpose at some point. Most obtained the drug for free from a friend or relative.

At the Wednesday hearing, physicians urged panel members not to impose strict guidelines that would put an undue burden on healthcare workers who already face difficulties in prescribing opioids.

A hospice nurse told the panel that it is already hard to find physicians willing to write opioid prescriptions for terminal patients. Several witnesses agreed that stricter oversight and regulations of opioids could restrict the drug for terminal patients.

But focusing a REMS on extended-release oxycodone could be problematic as well, some witnesses said.

“I feel REMS for sustained-release opioids will have a chilling effect on care of the terminally ill,” said Joel Policzer, M.D., a hematologist and national medical director of VITAS Innovative Hospice Care/Palliative Care Solution in Miami.

A REMS that just targets extended-release oxycodone would lead prescribers and patients to choose a pain-killer with less stringent reporting requirements, perhaps regular-release opioids, and may result in inadequate pain treatment, said Gregory Terman, M.D., Ph.D., of the department of anesthesiology and pain medicine at the University of Washington in Seattle.

For their part, pharmacists opposed creating new regulations. They already must check the DEA’s list to ensure both the patient and the prescriber are registered.

“Community pharmacists should not be put in the position of being pharmacy police,” said Ronna Hauser, Pharm.D., vice president of policy and regulatory affairs with the National Community Pharmacists Association.

While many of the healthcare-worker witnesses appeared to oppose any sort of REMS, some suggestions included:

• Limiting the number of pills dispensed per pharmacy visit (for instance, only dispensing 15 pills at a time in a 60-pill prescription)
• Launching a federally-mandated “take back” or “buy back” program to dispose of unused medication
• Mandating that those seeking DEA licensure be able to demonstrate opioid pharmacology competency
• Creating a national pharmacy clearinghouse to monitor filled opioid prescriptions in real time
• Requiring patients to sign a contract promising their physician they will take their opioid only as prescribed
• Requiring better physician training about pain management.

Several speakers recommended trying out the REMS in a pilot program before widespread implementation.

Day one of the hearing began with emotional and contentious testimony from member of two opposing groups — patients who said oxycodone is the only medication to alleviate their excruciating pain, and relatives of people who overdosed on the oxycodone who said it either needs to be banned or strictly limited to terminal cancer patients.

Pain patients said they are already stigmatized by their use of opioids, and do not need additional law enforcement or FDA-imposed requirements that make it harder to get and fill their prescriptions, they said.

Speakers who warned of the highly addictive quality of opioids urged the panel to place a moratorium on extended-release opioids while allowing their use in cancer patients.

On Thursday, the panel will hear from industry representatives and physicians.

Related Article(s):

• FDA to Step Up Regulation of Extended-Release Opioids

The sciatic nerve is the largest in the body and for most of our lives we are blissfully unaware of it. Only when the pain strikes do we devote our attention to sciatic nerve relief and seek how to banish the discomfort.

Starting at the bottom of the spine, this nerve, as thick as your thumb, splits into two and travels down each leg down to the feet. Due to its size, it doesn’t take much to apply pressure on the nerve and the result can vary from a numbness to excruciating pain. Either is unpleasant.

Often the sciatic nerve is pinched by one of the disks of the spine. The jelly like center can squeeze out a little and then presses on the nerve. Often this type of pain can go right down one leg towards the foot.

When the pain strikes, the first thing to do is to try and rest as much as possible for at least 48 hours. Try to get as comfortable as you can in bed and use extra pillows to support you where it hurts. Ice packs and a hot water bottle can be alternated to see which gives the best sciatic nerve relief.

Only after the pain starts to subside can you start to think of any methods of prevention to reduce the chances of it coming back again. Remember that exercise and stretching, although useful, should only be started gently at first or they can make the situation worse.

Correct posture also can reduce the possibility of the pain coming back again but it is difficult for people to change habits of a lifetime.

There is a time in just about everybody’s life that they will have some kind of low back ache pain. For some fortunate people, the condition will last for only a day or two, but in others it will linger on longer and may even remain for the rest of their lives. Preventive matters need to be taken to control this debilitating condition. By understanding the reasons of that cause it, you can prevent any future bouts of the condition.

Many low back ache pain problems are caused due to poor posture. Posture related problems have increased for many because we are hunched over a computer all day. While you are at your desk, be sure that you sit up straight and take occasional breaks to walk around, this increases circulation.

Improper lifting practices are another reason why so many people are sufferers of debilitating backaches. If you have to lift a heavy object, keep your knees bent and let your legs do most of the lifting. By using your legs to lift, it prevents all of the weight from straining your back. This reduces the amount of stress on your back and can save you a lifetime of discomfort and pain.

Backs need to be exercised and stretched. When your back is not active for long periods of time, it tends to get weak. This inactivity can cause painful conditions when you indulge in activities that require the use of your back. Make sure to do some simple back exercises and stretch your back whenever possible.

But there is good news. Many back problems can be stopped before they begin to be a problem.

So, how do you cure your back problems? What if you that you could cure your low back ache pain permanently. Would that be important to you? Certainly it would; you’re in pain, you’re not stupid! By following a simple program of exercises, you can get rid of your low back ache pain forever!

Herniated disc back pain is a dreaded occurrence for many dorsopathy sufferers. The actual words “herniated disc” are enough to cause anxiety and worry over possible agony, surgery and disability. In reality, the spinal disc is a much maligned structure, rarely responsible for the plethora of painful conditions typically blamed on it. This is due to the extremely common nature of disc bulges and ruptures, as well as the universality of disc degeneration.

Herniated discs can occur anywhere in the spine, but are usually found at either end. The cervical spine, also known as the neck, is an area which must bend and flex constantly, as well as hold up the significant weight of the head. The discs in the neck wear out fast from all this movement and degenerative disc disease is often diagnosed in one or more vertebral levels by the age of 30 and sometimes much younger. The lumbar spine, also known as the lower back, is the most common location for degenerative disc disease to occur and these age and activity related changes are usually in effect by the age of 20, especially at L4/L5 and L5/S1. Herniated discs are also common in both of these spinal regions and can occur from injury, normal degeneration or idiopathic reasons.

Herniated discs are thought to create pain in several possible ways. The most common is called foraminal stenosis, also known as a pinched nerve. This condition exists when a bulging or ruptured disc puts pressure on one of the spinal nerve roots which exit the spinal column at every vertebral level. While this situation can occur, it is very rare, since the disc would have to completely close off the neuroforaminal opening under extreme pressure in order to compress the nerve sufficiently. Furthermore, even when this rare event does happen, continued compression of the nerve root will result in absolute lack of sensation. This is objective numbness, not the subjective numbness often experienced by many patients. Additionally, there will be no pain or tingling, although real muscular weakness in the area served by the pinched nerve is likely.

The next possible source of herniated disc back pain is due to spinal stenosis. This is diagnosed when the disc applies pressure to the actual spinal cord, narrowing the spinal canal through which the cord passes. Many cases of spinal stenosis are completely asymptomatic, while occasionally, this condition can be a real problem. The most symptomatic instances of spinal stenosis exist when bone spurs (osteophytes) are the source of the narrowed canal and most disc bulges simply do not create any noticeable effect on the cord.

The third way that herniated disc back pain may be explained is from chemical radiculitis. This is when the proteins from the interior of the disc bleed out of the damaged disc structure and irritate surrounding nerve tissue. This is a controversial diagnosis and is not openly accepted in many medical sectors. It seems that if this condition does indeed exist, it only affects some people with particularly sensitive nerve tissue, since many people suffer severe ruptures and experience no pain at all.

The last possible explanation for disc related back pain is the unusual diagnosis of discogenic pain. In this condition, the damaged disc is said to be the actual source of discomfort, which makes little sense, since intervertebral discs do not have nerves or even a dedicated blood supply. Instead, they are nourished through the cartilaginous end plates which attach the discs to the surrounding upper and lower vertebral bones. Some doctors believe it is the tiny nerves in these endplates which are painful, but that seems highly unlikely, since most patients report pain which is far too great and widespread to be sourced from such tiny and anatomically limited neurological tissues.

In the end, most patients do not enjoy relief from a wide range of conservative treatments or even surgeries directed at herniated discs and degenerative disc disease. This has nothing at all to do with the talent of the doctor or the method of treatment. Instead, therapy fails since the diagnosis is completely wrong. Statistics show that herniated discs are often completely asymptomatic and even those which do cause trouble usually resolve with or without treatment in 6 to 8 weeks. Disc conditions are almost never the real reason for chronic back pain. Once you understand this simple fact, it is easy to see why the condition has such a treatment-resistant reputation… It is not that the damage to the spine is so great; it is instead that the pain is being blamed on a complete innocent and coincidental spinal scapegoat.

A Trapped nerve is a very painful condition that often starts in the back that is caused when the nerves become compressed due to pressure from the surrounding muscles and tendons. The situation can become worse if not treated in a timely fashion. If the pain in the back lasts for more than a few days it is best to do something more than get rest. Not all back pains can be attributed to trapped nerves.

It can happen when you lift a heavy load or when you turn abruptly in one direction or the other. The nerves in the spinal column are responsible for carrying signals from the brain to the different parts of the body and back. The nerves are very delicate and thin as they can carry signals very fast. If there is undue pressure on these nerves for a relatively longer period of time then it could lead to a trapped nerve. The condition has other names as well such as pinched nerves and sciatica.

Apart from the pain, you may also experience symptoms such as stiffness in the neck, arms and legs. You may feel numbness in the fingers and the toes. It is like someone is poking you with pins and needles. The pain intensifies due to several factors like the disc in the back is protruding placing a lot of pressure on the nerve roots. There can also be inflammation of the nerve roots or tightness in the muscles that may be putting more pressure on the nerves. The nerve roots become trapped resulting in increase pain.

There are some therapies that are often used for trapped nerves and these include massage, medications for temporarily relieving the pain, exercised for the back such as stretching and preventive exercises such as yoga. All these therapies bring comfort to the back and the pain gets subdued. With any pain the aim of a specialist is to diagnose the problem and find out what is the exact cause of the pain. Not all back pain could be due to trapped nerves. In case the muscles are putting pressure on the nerves, then those muscles are identified and then gentle stretching exercises are suggested. Hence we see how important it is to find the cause so that the right kind of treatment can be administered soon.

Treatments like a good massage are often recommended as it relaxes the pressure from the nerves. Medications can only work to give temporary relief. The pain may return later.

There are some great resources for finding solutions to a trapped nerve, just don’t wait until the pain gets too bad.

Sciatica is a kind of symptom that irritates the root of the nerve, causing numbness or pain at your lower back. It is normally caused by the compression of lumbar nerves or sacral nerves or by compression of the sciatica nerve itself. Nerve roots can be compressed due to different reasons and conditions and eventually cause sciatica. Treatment for sciatica usually differs from patient to patient.

If you feel lower back pain when you’re squatting, walking on toes, rotating the spine, bending forward and backward, sitting, lying on back, and raising one leg at a time, these are the signs of sciatica symptoms. Therapy and treatment should be taken as soon as possible before it deteriorates.

Normally, therapy for sciatica is done by reducing the pressure and compression of the lower back. Other therapies such as taking anti-inflammatory medications, physical massage therapy, non-surgical spinal decompression and stretching exercises for muscle rebalancing are also found effective in sciatica treatment.

However, though effective, these Sciatica medications and treatments do not cure Sciatica entirely. They are just effective to remove the pain caused by Sciatica.

The new medical breakthrough for back and sciatica treatment- Muscle Balance Therapy (MBT) is a new revolutionary treatment for sciatica or long term back pain patients. Muscle Balance Therapy addresses the root cause of your condition while at the same time brings relief to your symptoms through simple effective exercises.

In a nutshell, Muscle Balance Therapy program will identify the main cause of your sciatica, suggest the MBT muscle exercises for your symptom and bring your pain and body back to a more neutral state.Once your muscles are more balanced and you’re feeling better, you will be able to return to your workplace or to your favorite activity with the confidence and security that you need to live a full and productive life.

When it comes to getting fast back pain relief there really are just three simple steps to follow.

Yes, I realize that you may have been suffering from chronic pack pain of some type for years, and reading that you can relieve it with 3 steps seems unrealistic. But I’ve been through the same thing and know how tough it is, so I can certainly relate to how you are feeling right now.

1. Discover Your Muscle Imbalances

The last thing you want to do is begin any sort of treatment without knowing if your spine and pelvis are not aligned properly. If you don’t know this, then your back pain will just get worse from any treatment attempts.

A professional back therapist can assist you in determining the underlying cause of your pain. Generally it would be one of four main dysfunctions causing the problem.

If you’ve had pain for years then you may have been told why its happening and you are ready for treatment.

If your doctor has been unable to find a cause (as can often happen with nothing obvious showing up) then you can carefully proceed to natural relief methods.

My mother in fact also suffered from severe chronic pain from age 35 to 55. She spent hundreds of dollars on specialists, tests and treatments only to continually be told that there was nothing wrong with her bone structure or muscular system.

At that stage she proceeded to undertake some natural treatments and back pain and saw almost immediate improvement.

I have pointed out here the importance of finding out where your muscle imbalances lie and if there are any skeletal reasons for your back pain.

In the second part of this article series I will reveal the two final steps to follow in order to get fast back pain relief.

Knowing how to fix lower back pain can give you a whole new lease on life. Pain the lower back area can be crippling and if you are a person who suffers from this condition constantly then I’m sure you are desperate for answers - I know, because I’ve been there myself.

Causes of Back Pain

One of the most common causes of discomfort in the lower back area is lordosis which is an excessive inward curve in the back. It can be caused by a number of things including:

• Excess sitting down
• Pregnancy
• Spinal problems

The pain occurs because your ab muscles are stretch and as such they are weakened. They are meant to contribute to stabilizing your torso along with the lower back but because the abs are weak, your back is doing all the work and this means pain occurs.

Some of the do it yourself ways for how to fix lower back pain include:

Sitting Less
Get up and walk around every 20 minutes and avoid sitting for long periods.

Stretches
Put your arms above your head, bend forward to a 90 degree angle to the group and hold it for 10 seconds. Do this regularly and you’ll strengthen your torso and stretch your back.

Of course, your back pain may not be caused by lordosis or you simply may not respond positively to these home exercises. But they are certainly worth a try, and there are plenty of other things you can then attempt to do - it is simply a matter of finding something that works for you.

Ouch. This is not the first time you feel intense pressure at your lower back. But this time, it is worse because you need both hands to press onto the table to get yourself stand up without feeling nagging ache at your hip and tailbone area .

The pain and compression is gradually increasing isn’t it? Well it is time to give your lower back a good treatment now.

The good thing to tell you is, you can always get rid of your pain with simple massage at home. Rub a hot towel gently on the point where you feel pain or uncomfortable. Treat it 1-2 times 20-30 minutes a day and you shall feel a lot better the next day.

The bad thing is, these treatments CANNOT cure your back. They can merely bring you short term relief- where you might feel good for the entire afternoon but suddenly being haunted by the pain for the rest of your day.

Most of these back treatment fail because they begin at the end– that is, they only focus on the pain, which is just a symptom, they are not solving the bigger problem– Your injury.

A word of caution: If you feel even slight back pain, either at the position of your upper or lower back,? you should start taking it very seriously– your body is telling you that something is not working correctly.?

Failing to address this situation without giving immediate proper treatment to your lower back now will likely result in a higher level of pain and having to work much harder and longer to get yourself back to a pain free state.

One of the most effective way to treat your lower back is doing the RIGHT exercise therapy.

If you have sciatica or someone that you know and love suffers from it, Sciatic Pain is more than just a medical term. It is a painful reality that you would almost give anything to be rid of. Treatment for Sciatic pain can range from totally useless to quite effective and can run from moderately priced to too costly to be a real option for most people. We are going to help cover many of them right here.

The simplest treatment for this affliction is something that people can manage themselves. It is getting plenty of rest. Relaxation gives the nerve and the inflammation to it a chance to return to a more normal and less painful state.

If you visit your doctor there are a variety of things that he or she may prescribe to aid in the treatment of your sciatic condition. This would probably be a muscle relaxant and/or analgesics. It may also be as involved as an injection on anesthetic around the area of the spinal cord. Of course there is always the surgical option.

However, for some people, drugs and surgery are not even to be considered. These are far from natural treatments, and both drugs and surgery present some serious side-effects to consider. There are natural alternative therapies that address treatment for sciatic pain.? I am referring to things such as chiropractic, exercise, massage, yoga, heat and cold, etc. The advantage drugs have is their immediate effect in stopping pain. Natural remedies generally take a bit longer and also require more commitment and perseverance.