FDA pulls Darvon off the market: confirms heart danger

The FDA asked for the discontinuation of the sales of all painkillers containing proxyphene, mostly known under the branded names of Darvon and Darvocet, because of the potential for serious heart problems.

If you are taking any painkiller that contains proxyphene, please contact your doctor to seek their advice.

Please be forewarned that the drug can cause withdrawal symptoms if you suddenly stop taking it. Talk to your doctor about how to taper off of it, and what else you could do to help manage your pain.

Brand names of proxyphene include but not limited to-

Darvon
Darvon-N
PP-Cap

Brand names that have a of combination of products

Balacet (containing Acetaminophen and Propoxyphene)
Darvocet A500 (containing Acetaminophen and Propoxyphene)
Darvocet-N (containing Acetaminophen and Propoxyphene)
Darvon Compound 32 (containing Aspirin, Caffeine, and Propoxyphene)
Darvon Compound-65 (containing Aspirin, Caffeine, and Propoxyphene)
PC-CAP (containing Aspirin, Caffeine, and Propoxyphene)
Propacet (containing Acetaminophen and Propoxyphene)
Propoxyphene Compound 65 (containing Aspirin, Caffeine, and Propoxyphene)
Wygesic (containing Acetaminophen and Propoxyphene)
Darvocet

Fentanyl Recall

Many chronic pain patients take extended-released medications to help regulate their pain. Similar to once a week birth control pills, extended-released pain medications give chronic pain patients a steady stream of medication without letting them worry about when to take their next dose. After all, it is always easier to manage your pain that it is to subdue it.

I have tried many types of extended-released medication, everything from birth control pills to topical lidocaine patches. Unlike short acting (2-4 hours) medications, extended-released meds can be difficult to tell when they are not working correctly. Hence, why I find this recall very important to tell you about.

This week Actavis Inc. announced a voluntary recall to the wholesale and retail levels only of 18 lots of Fentanyl Transdermal System 25 mcg/hour C-II patches manufactured for Actavis by Corium International in the United States. (via) The company said that they were unaware of any patients who had experienced adverse effects from the products. (via)Reports say that the patches are releasing the medication at a faster rate than intended. Patients treated with a patch that releases fentanyl faster than intended could experience symptoms of opioid overdose, including excessive sedation, respiratory depression, and apnea. (via)

Please read the following for more information:
Actavis Press Release: 21/OCT/2010
Med Page Today

Dancing away your pain!

Get your grove on and dance your pain away!

Ever imagined yourself belly dancing your pains away? Shaking your hips, flowing with the rhythm and to the beat of the drums, letting yourself dance the pain away!

Well, a recent research study done at the Federal University of São Paulo proves that by simply keeping active, you can improve your quality of life. They wanted to show that belly dancing could be an effective treatment for pain in fibromyalgia patients.

The entire study consisted of 80 females, ½ of which was a control group, ages 18-65. To qualify, all the participants’ course of treatment should of not changed in three years preceding the study.

All the dance students “ took one-hour belly dance classes twice a week for 16 weeks… Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.” (via)

In order to measure the outcome of the dance program, all the dancers where asked how they felt at three different times during the program. They were questioned before they started, again at 16 weeks, and lastly at 32 weeks. The number of questions the dancers were asked gave the researchers an in depth view on the outcome of the study. Everything was examined in order to have a complete patient profile including; pain levels, physical functionality (aka the 6 minute walk test), and quality of life questionnaires. Some of the quality of life questionnaires included but not limited to the Fibromyalgia Impact Questionnaire, pain, functionality, vitality, mental and emotional states, social aspects, and self-image.

Now, not to bore you with all the facts and figures of all the results, here’s the jest of the study: GET MOVING! No, really folks, seriously the “control group” of dancers slowly progressed on all the quality of life tests. Having said that, an interesting thing happened with the fibromyalgia group of dancers; at the 16-week mark, on most of their testing perimeters, their functionality scales became slightly worse than from were they started. But, not giving up does pay off! By the end of the 32-week course, the functionality scales perimeters went dramatically up for the dancers with fibromyalgia.

What does this all mean? Remember when your Mom would tell you it’s going to get worse before it gets better? That statement is true for when you add an exercise program into your life. Remember to take little steps toward finding a path that is healthy for you. Don’t try to go do an all night dance-a-thon on your first week, but try walking for ten minutes in the morning. Just remember, don’t give up. Keep your body moving. Keep stretching and keep a positive outlook on life.

In my never ending search for more information, I found this great website/ blog on dancing for pain relief! Check it out here-> http://dancingwithpain.com
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For more information on the clinical trial please see-> Effectiveness of Dance on Patients With Fibromyalgia

All backed up; opioid induced constipation

274783-main_FullConstipation is often a side effect of opioid use. It seems like you can never win. You take one medication to get rid of your pain, and then another one to get rid off all the side effects. It is estimated that out of all the patients who taken opiates for chronic pain, 40-90% will develop constipation. ( Via) There are many medications that your doctor can prescribe to you. Just like all medication regimens, finding the perfect cocktail is always a challenge.
Of course, when it comes to your bowel, this challenge is not always a fun one.

Besides what your doctor tells you, there are many things you can do to help yourself.
Diet and overall lifestyle changes will have a big impact on your GI system.
Try to make sure you:

• Increase the amount of fluid you drink per day.

• Eat more fiber. If this is difficult try adding a fiber wafer to your morning meal. Remember fiber doesn’t always mean oatmeal and whole grains. Fresh vegetables and fruits are wonderful sources of fiber, especially pears, apples, bananas, raspberries, and oranges!

• Get moving! Increase your exercise and daily activity.

• Allow time for privacy on the toilet. Also, stock you bathroom with good things to read. After all, if you are going to be in there awhile, might as well read a trashy novel or two!

If your stomach hurts from being bloated, try taking a hot bath, or using a hot water bottle. I move the hot water bottle from my stomach to my lower back from time to time.

Another trick to get things moving is to gently massage your stomach in small circles in a clockwise rotation. Start below your ribcage and work your way around. You will not need to use much pressure. This massage helps to get your intestines moving. It feels best for me after I take a hot bath when my body is a little more relaxed.

Herbs:
Just like western medications, there are many herbs that can help or hurt your medical situation. And should be taken only under the advisement of a medical professional. Some western medications can be affected by relatively what seem to be harmless eastern herbal remedies.

New advances in medicine are happening daily! There are now medications made specifically for people affected with opioid induced constipation (OIC). If you have been taking opioids for a while because of your chronic pain, one of these two medications just might help.

Methylnaltrexone (available as Relistor(R)) helps restore bowel function in patients.” It is delivered via subcutaneous injection and specifically targets opioid-induced constipation. When given alongside opioid therapy, it is designed to displace the opioid from binding to peripheral receptors in the gut, decreasing the opioid’s constipating effects and inducing laxation. Methylnaltrexone blocks peripheral opioid receptors in the gut and unlike other opioid antagonists has restricted ability to cross the blood-brain barrier. As a result, it antagonizes only the peripherally located opioid receptors in the GI tract, so it’s action reverses opioid-induced constipation without precipitating withdrawal symptoms or affecting or reversing the central analgesic effects of opioids .” (Via)

Another medication, brand name Targinact, combines the extended released opioid Oxycodone with extended release Naloxone to help the GI tract. This combination is a wonder duo! Naloxone is most commonly used to counter the effects of opioid overdose. Naloxone is an opioid receptor competitive antagonist. (Not to be confused with Naltrexone, which is an opioid receptor antagonist with qualitatively different effects, used for dependence treatment. Low-dose Naltrexone is in pain study trails at Stanford right now. Read my posting about the study.) By being an opioid receptor competitive antagonist, “Naloxone provides an inability for the opioid receptor to have an effect on the gut, counteracting opioid-induced constipation – without impacting on the centrally acting analgesic efficacy of oxycodone.” (Via) It binds to the receptor so that it does not bind to your gut.
Science just keeps improving!
opioid4

A major drug deal was signed this week between AstraZeneca and Nektar Therapeutics for the continued development of NKTR-118 and NKTR-119 programs. Both of these studies are something to watch out for in the near future. NKTR-118 is drug still in its testing phrase “that combines Nektar’s advanced small-molecule polymer conjugate technology platform with naloxol, a derivative of the opioid-antagonist drug naloxone.” (Via) NKTR-119 combines the drug from NKTR-118 and determines what opioid combination will work best with it to help eliminate constipation associated with opioid usage.

AstraZeneca and Nektar are both major players in the pharmaceutical market. It will be exciting to see what this new partnership will bring to the table!

Until then, make sure you eat right, drink plenty of water, and consult your doctor if you have any questions about what you can do for your GI system.

For further reading check out:

What’s the Best Source of Fiber: The Diet Channel

Scientific America

Medscape

University of Maryland Medical Center

Cooley Team

Also take the time and read this great blog about how you can take care of your intestines on Lumigrate.

Stanford Tests T3 for the Treatment of Fibromyalgia

nav_imageStanford Systems Neuroscience and Pain Lab does it again. Dr. Ian Carroll, MD, MS, and Dr. Jarred Younger, PhD are currently enrolling patients now in a new clinical trial to help fibromyalgia patients. Dr. Younger also worked on Stanford’s research of low dose Naltrexone for the treatment of fibromyalgia.

Stanford says on their site:(via)
“We are investigating whether the thyroid hormone T3 is one such treatment that may alleviate the symptoms of Fibromyalgia. There is significant overlap between the symptoms ofhypothyroidism (low thyroid hormone production), depression, chronic fatigue, and Fibromyalgia. Patients with low thyroid hormone production who have been treated with T3 for depression have had some improvement in symptoms.

This is the first study to examine whether T3 may help with the symptoms of Fibromyalgia. Studies such as this are a necessary step to having an investigational drug become a mainstream treatment. Your participation is a vital part of the search for an effective Fibromyalgia treatment.”

To understand how your thyroid works, here’s a great site:www.endocrineweb.com/thyfunction.html

I also found out about Dr. John C. Lowe. Here is a great interview with him about the subject on about.com.

To see any other clinical trials going on, looking at the clinical trials.gov page is always a good place stop.
Look here to see what they have to say about the study.

Click here to see Stanford enrollment form -> http://snapl.stanford.edu/t3/

Also, check out Lumigrate’s educational video: Hypothyroidism: Misunderstood, Misdiagnosed, Missed! by Dr. Scott Rollins lum-hypothyroid_0

Men and fibro

I love my father for more reasons than I can count. He is by far the greatest man I have ever known. My father has stood by me through all of my endeavors. During all the ups and downs with fibro, my Dad is there to hold my hand, wipe my tears, and make me laugh. But, I do wonder how my health condition effects him?

mhnThe Men’s Health Network is conducting a survey to gauge just that. They have teamed together with the American Pain Foundation and National Fibromyalgia Association to conduct this survey nationwide. Fibromyalgia is typically labeled a “women’s” disease. However, it does not discriminate, and men are affected by it too. Only about 10-20% of all fibro patients are male. Men are raised to be strong and not show pain. Overall, males tend to be less vocal about their health condition. The associations conducting this survey believe the numbers of recorded male patients affected with fibro is not accurate.

If you want to learn more about the survey, please click on the following link:
www.menshealthnetwork.org/fmsurvey.php.

News articles about this:
Medical News Service (posted 8/19)

PR News Wire (posted 8/18)

Pain Week 2009

LasVegasOn September 9th -12th, 2009, Las Vegas is being taken over by people who bet on something other than just a game of cards or a roll of the dice; this group makes intelligent bets on the understanding of pain as a public health issue. During this upcoming week in September, groups of health care professionals gather to discuss and learn how they can understand, treat, and improve the lives of those of us who live in pain at the PAIN Week ‘09, “the national conference on pain for frontline practitioners.”

This conference, believe it or not, is the ONLY national forum that is around to handle all the educational needs of the professional health care community. Everyone from physicians, pharmacists, to psychologists, and nurses are in attendance to discuss the complexities surrounding a pain patient’s life.

I’m sure with everything in news today, they will have tons to talk about at the conference! From issues about health care reform to the FDA black box labeling of Acetaminophen (Tylenol), political issues will be bouncing off the walls. The soaring costs of prescription pain medications limits people from getting their pain fully treated, especially in this economy. Hey, just by the simple fact that over the past decade alone, outpatient spending on prescription painkillers more than tripled, rising from $13.2B in 2006 from $4.2 B in 1996, (via) makes me want to stash all my pain killers for a rainy day pain attack. Add that to the economy collapsing, and the FDA coming down harsher on painkillers, the pain management doctors and patients certainly have their work cut out for them with medications alone.

Besides political barriers, the educational forum’s aim is to determine effective treatment protocols among current and emerging therapies. Pain is just one of those things, like a hair cut, that is different for everyone; what might work great for one person, is horrible for another. I simply loathe the fact that when someone finds out that I have chronic pain, and then proceed to give me an hour lecture on how to “heal thyself”. Most of us who live with a chronic ailment, know what works for us and what does not. The learning comes into play when new therapies are developed. Hence, the reason behind PAIN Week, for health professionals, the ones treating those living in pain, to understand, discuss, and evaluate new ways to care for us.

For more information, please see PAIN Week’s site

Coming soon to a pharmacy near you: generic pain meds!

In the world of pain management, we have to take the good with the bad. And sometimes with all the treatments we have to make ourselves feel better, the bad part of pain medications out way the good. Their level of toxic-feeling side effects, then the medications we take to lessen those side effects, and of course the price of these medications all add up to their negative points. One insurance company will pay for a medication, where another won’t. When they don’t cover it, you cry at the price. But, it’s always an issue to cry then when you write the check for the pain medication, or cry later when you are rolling on the floor dying in pain at home. With all the endless variables of what is going to work for your condition, you might just as well play the lotto- you might have better luck.

There is hope because this strange field of pain medications and their side effects is going to change sooner than we think. The pain management world is big money business. Which, for us means that they will keep trying new medications and therapies for us. Years ago, Endo labs made a break through with their Lidoderm patch, thus changing the way pain relief was given to a patient. The topical patch gave relief over the course of a day with little to no side effects. Now, Endo is facing the big challenge of the Lidoderm patch coming in generic form. Great for us, less money! Bad for Endo.

The research field will keep advancing in the field of pain management. Business analysis say that this trend will keep growing for the next 3-5 years! We will see an increase in generic pain medications. Even though many of the branded medications have been the fore-runners in the treatments, its time they stepped aside. New treatments will be pushing their way into the market, and making their mark to help many patients find relief. Many of these will not cost as much as their older competitors, which is a great advantage in this recession.

According to one report (via), many of the new drugs hitting the market are reducing their R and D They are building off of brands they already have in production, either by line extensions or expanded formulations. They have learned what they need to know by the medications they have on the market and are just expanding on them. This will help build companies into being more specialized in the pain management arena, and make use of their products with expired patents.

Hopefully, with many more players in the pain management research field, we will have medications that cost us less, with better results and with less side effects! After all life is short, and I want to live every moment to the fullest!
Read more of this post

Study of Naltrexone effects continues

Researchers at Standford are now into their next stage of clinical trials of looking at low doses of Naltrexone for use with fibromyalgia patients. The first study which was implemented early in 2007 showed hope that Naltrexone might work for fibro patients with little side effects. Typically, Naltrexone is used in 50 mg dose to help treat alcohol and opiate addiction. They tested the drug for fibro in a very low dose, around to 4.5 mg. Instead of blocking the bodies pain receptors, the dosage of the medication “modulated activity of glial cells to act as a neuroprotectant and suppressant of proinflammatory cytokines”. (medpagetoday) The study was lead by Jarred Younger, PhD and Sean Mackey, MD, PhD. Here’s a great chart showing their results:
ldn
“Overall, self-reported, daily fibromyalgia symptoms (scale 0 – 100, with 100 being most severe symptoms). Time periods are: baseline, placebo, LDN, and washout. The data are separated into drug responders (solid line, 6 people) and drug nonresponders (broken line, 4 people). Drug responders are individuals who had at least a 30% greater reduction of symptoms during LDN versus placebo.” -stanford.edu

Hopefully by the end of this year we will know if the dug will help those of us with fibromyalgia.

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Link to Stanford post

RLS: Gene mutation found

images-3Fibromyalgia patients commonly also suffer from RLS (Restless Leg Syndrome). This past week in Wheeling, W.VA scientist discovered the first ever gene mutation to be associated with RLS. Researches say that it is a functional gene mutation, found on the MEIS1 gene, which plays a vital role in development.
Another break-though is that the MEIS1 gene mutation, even though it is very rare, was found in family members who all had RLS.
For a while now, scientists have touched on the notion that fibromyalgia could have genetic links. The syndrome is commonly seen passed down on the maternal side of the family.
RLS researchers also found a mutation in gene BTBD9. These mutations combined with MEIS1 mutations showed up together on RLS patients more than the general public. But, this genetic combo mutation is thought to be non-functional.

For more info, please visit medpagetoday

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