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thematrix777 [userpic]

(no subject)

November 10th, 2008 (01:55 pm)

ETHEX Corporation Initiated Nationwide Voluntary Recalls of Specific Lots of Five Generic Products Due to the Potential for Oversized Tablets

Propafenone HCl Tablets - 150 mg, 225 mg, and 300 mg
Isosorbide Mononitrate Extended Release Tablets - 30 mg and 60 mg
Morphine Sulfate Extended Release Tablets - 15 mg
Morphine Sulfate Immediate Release Tablets - 15 mg and 30 mg
Dextroamphetamine Sulfate Tablets - 10 mg

FOR IMMEDIATE RELEASE -- St. Louis, MO- November 7, 2008 - ETHEX Corporation announced today that it has voluntarily recalled to the consumer level specific lots of five generic /non-branded products that it markets. These lots have been recalled as a precaution, due to the possibility that they may contain oversized tablets. Oversized tablets may contain more than the intended levels of the active drug ingredient, which could result in patients receiving as much as about twice the expected dosage of these drugs.

Overdoses of Propafenone HCl, Isosorbide Mononitrate, Morphine sulfate and Dextroamphetamine Sulfate can have serious or life-threatening consequences. In the case of Propafenone HCl, these consequences can include arrhythmias (irregular heartbeat) and low blood pressure. In the case of Isosorbide Mononitrate, these consequences can include fainting and low blood pressure. In the case of Morphine Sulfate, these consequences can include respiratory depression (difficulty or lack of breathing) and low blood pressure. In the case of Dextroamphetamine Sulfate, these consequences can include rapid heart rate and high blood pressure.

The lots involved in the recall were all shipped prior to May 22, 2008 and are as follows:

Propafenone HCl Tablets, 150 mg: Lots: 73761, 78184, 79373, 81240, 81241, 81242, 83470, 84357, 90525, and 90526 with expiration dates ranging from 3/2009 to 3/2011

Propafenone HCl Tablets, 225 mg: Lots: 71720, 74831, 76014-15, 81243-45, 89731, 90527-29, and 90657 with expiration dates ranging from 3/2009 to 2/2011

Propafenone HCl Tablets, 300 mg: Lots: 72834, 76016-18, 81246, 89092, 89732, 90530, 90532, and 91641-42 with expiration dates ranging from 6/2009 to 3/2011

Isosorbide Mononitrate Extended Release Tablets, 30 mg: Lots: 62355, 66423, and 68102 with expiration dates ranging from 11/2008 to 8/2009

Isosorbide Mononitrate Extended Release Tablets, 60 mg: Lots: 63466, 66034, 67351, and 67354 with expiration dates ranging from 12/2008 to 11/2009

Morphine Sulfate Extended Release Tablets, 15 mg: Lots: 81175, 82514-16, 89660, 89664, 89667, 90249-51, and 91687 with expiration dates ranging from 12/2008 to 2/2010

Morphine Sulfate Immediate Release Tablets, 15 mg: Lots: 77852-54, 81746, 82519-20, 84113, and 90276-78 with expiration dates ranging from 9/2009 to 1/2011

Morphine Sulfate Immediate Release Tablets, 30 mg: Lots: 75093, 77855-57, 82297, 82521-22, 87239, 88925, and 90288-98 with expiration dates ranging from 8/2009 to 3/2011

Dextroamphetamine Sulfate Tablets, 10 mg: Lots:73934, 75892, 77945, 81137, 86320 with expiration dates ranging from 6/2009 to 5/2011

The 150 mg Propafenone Hydrochloride Tablets is a white, scored round film coated tablet with "ETH" on one side and "331" with a bisect on the reverse. The 225 mg Propafenone Hydrochloride Tablets is a white, scored round film coated tablet with "ETH" on one side and "332" with a bisect on the reverse. The 300 mg Propafenone Hydrochloride Tablets is a white, scored round film coated tablet with "ETH" on one side and "333" with a bisect on the reverse.

The 30 mg Isosorbide Mononitrate Extended Release Tablet is an oval, reddish-pink, film-coated tablet with a debossed "E" bisecting "30" on one side and bisect on the other side. The 60 mg Isosorbide Mononitrate Extended Release Tablet is an oval, yellow film-coated tablet with a debossed "E" bisect "60" on one side and bisect on the other side.

The 15 mg Morphine Sulfate Extended Release Tablet is a green oval tablet with "15" on one side and an "E" on the reverse. The 15 mg Morphine Sulfate Immediate Release Tablet is a round brown tablet with a "15" on one side and an "ETH" on the reverse. The 30 mg Morphine Sulfate Immediate Release Tablet is a capsule shaped brown tablet with "30" on one side and an "ETHEX" on the reverse.

The 10 mg Dextroamphetamine Sulfate Tablet is a round, flat-face, bevel edge, orange mottled tablet debossed "ETHEX" and "312" on one side and double-scored on the other side.

ETHEX Corporation has initiated recall notifications to wholesalers and retailers who have received any inventory of the recalled product lots with instructions for returning the recalled products. The notification also includes instructions for the retailers/pharmacies to contact consumers who were dispensed these drugs for replacement of the product and/or refund. If the wholesalers and retailers have not already done so, they are urged to contact the number below regarding procedures for returning the recalled products. If consumers have any questions about the recall, they should call the number listed below for customer inquiries, their physician, their pharmacist or other health care provider.

Consumers who experience any adverse reactions to these drugs should contact their physician and/or healthcare provider immediately.

Any customer inquiries related to this action should be addressed to ETHEX Customer Service at 1-800-748-1472, or fax to ETHEX Customer Service at 314-646-3751 or sent via email to: customer-service@ethex.com with representatives available Monday through Friday, 8:00 am to 5:00 pm Central Standard Time (CST).

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

Any adverse reactions experienced with the use of these products, and/or quality problems may also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.


http://ping.fm/FKUbM

thematrix777 [userpic]

(no subject)

September 16th, 2008 (06:06 pm)

Gene therapy for chronic pain gets first test in people


The gene transfer vector (left) is injected into the skin in the area of pain (red line right). From the skin the vector is carried into sensory nerves and releases the inhibitory neurotransmitter locally in the spinal cord (red oval). Image: Univers ...
The gene transfer vector (above) is injected into the skin in the area of pain (red line, right). From the skin, the vector is carried into sensory nerves and releases the inhibitory neurotransmitter locally in the spinal cord (red oval). Image: University of Michigan

This week, University of Michigan scientists will begin a phase 1 clinical trial for the treatment of cancer-related pain, using a novel gene transfer vector injected into the skin to deliver a pain-relieving gene to the nervous system. A gene transfer vector is an agent used to carry genes into cells. In this groundbreaking clinical trial, the investigators will use a vector created from herpes simplex virus (HSV) – the virus that causes cold sores – to deliver the gene for enkephalin, one of the body's own natural pain relievers.
"In pre-clinical studies, we have found that HSV-mediated transfer of enkephalin can reduce chronic pain," says David Fink, M.D., Robert Brear Professor and chair of the department of neurology at the U-M Medical School. Fink developed the vector with collaborators and will direct the study.

"After almost two decades of development and more than eight years of studies in animal models of pain, we have reached the point where we are ready to find out whether this approach will be effective in treating patients," Fink says. The investigators are recruiting 12 patients with intractable pain from cancer to examine whether the vector can be used safely to deliver its cargo to sensory nerves.

The trial represents two firsts, says Fink: It is the first human trial of gene therapy for pain, and the first study to test a nonreplicating HSV-based vector to deliver a therapeutic gene to humans. Fink says the technique may hold promise for treating other types of chronic pain, including pain from nerve damage that occurs in many people with diabetes.

The HSV vector, genetically altered so it cannot reproduce, has a distinct advantage, Fink says: "Because HSV naturally travels to nerve cells from the skin, the HSV-based vector can be injected in the skin to target pain pathways in the nervous system."

Gene therapy for pain

Chronic pain is an important clinical problem that, despite a wide array of therapeutic options, cannot be effectively treated in a substantial number of patients. Fink notes that one key problem in treating pain is that the targets of conventional pain-relieving medications tend to be widely distributed in the nervous system, so that "off target" side effects of the drugs often preclude the use of those drugs at fully effective doses.

"This provides the rationale for using gene transfer to treat pain," Fink says. "We use the vector to deliver and express a chemical that breaks down very quickly in the body. The targeted delivery allows us to selectively interrupt the transmission of pain-related signals and thus reduce the perception of pain."

Enkephalin is one member of the family of opioid peptides that are naturally produced in the body. Opioid peptides exert their pain-relieving effects by acting at the same receptor through which morphine and related opiate drugs achieve their pain-relieving effects. In this trial the enkephalin peptide, produced as a result of the gene transfer, will be released selectively in the spinal cord at a site involved in transmitting pain from the affected body part to the brain.

"We hope that this selective targeting will result in pain-relieving effects that cannot be achieved by systemic administration of opiate drugs, " Fink says. "This trial is the first step in bringing the therapy into clinical use. A treatment is at least several years off."

Preclinical studies led to human trial

The phase I clinical trial represents the culmination of studies performed by investigators working in the U-M laboratory co-directed by Fink and his wife, Marina Mata, M.D., also a professor of neurology at U-M, along with colleagues at the University of Pittsburgh led by Joseph Glorioso, Ph.D. In published studies, the researchers have demonstrated that HSV-mediated gene transfer is effective in rats with pain resulting from inflammation, nerve damage or spinal cord injury, and in mice with pain caused by cancer.

The extensive preclinical data in animal models were reviewed by the Recombinant DNA Advisory Committee at the National Institutes of Health. The Food and Drug Administration approved an investigational new drug application for the therapy in February.

thematrix777 [userpic]

Chronically Ill Enthusiastically Anticipate Virtual Internet Conference Sept 8-12

September 5th, 2008 (08:53 am)

SEPT 2008—SAN DIEGO – SBWIRE– Traveling expenses, hard beds, peers wearing too much perfume, long treks to conference rooms, and exhausting days make up the typical conference–all which make it nearly impossible for the chronically ill to attend events where they can find encouragement and education. National Invisible Chronic Illness Awareness Week’s “virtual” conference online is more than just practical. It’s necessary.

 

Having a virtual conference available to listen to is like a miracle to me!  I no longer have to miss opportunities due to financial difficulties or inability to travel.  I can’t wait!” says Kimberly Strange of Indiana who lives with neuropathic pain in legs following her back surgery.

 

National Invisible Chronic Illness Awareness Week, September 8-14, 2008 is featuring twenty live seminars, with some of the top chronic illness advocates online today at www.invisibleillness.com. Jenni Prokopy of chronicababe.com; Laurie Edwards of achronicdose.com; Rosalind Joffe of keepworkinggirlfriend.com; Christine Miserandino of butyoudontlooksick.com all come together to provide a wide variety of seminars. Seminars will be conducted via Blog Talk Radio, and the week is sponsored by Rest Ministries, the largest Christian organization that serves the chronically ill.

 

“This is a unique and exciting way for those of us who cannot travel to conferences of any kind, to ‘attend’ and become encouraged,” says Lynn Severance from Washington. “It will help dispel the isolation that exists as so many of us watch the “rest of the world’ have the opportunity to go and learn and fellowship with friends in a conference setting.”

 

Lisa Copen, 39, founder of Rest Ministries and initiator behind National Invisible Chronic Illness Awareness Week says, “Regardless of one’s spiritual beliefs there is an underlying need to be understood, to feel like those you love have some idea about what you are going through; how it can be difficult to look fine while you are feeling so poorly. We hope we can provide a place where people find others who understand, and gain new insight, as well as increase awareness publicly.”

 

One of the ways to meet the needs of the chronically ill is to provide the type of forum where they can learn, connect with others and interact with professionals. For the chronically ill, who typically have difficulty sleeping, extreme fatigue, trouble walking and sitting, and even chemical sensitivities, a virtual conference, where people can stay comfortable, attend free and avoid traveling is the perfect fit.

 

Four seminars per day, Monday through Friday, September 8-12, are available at www.invisibleillness.com and all will be recorded and archived. Hundreds of people are also blogging for awareness about invisible illness issues on September 8, 2008.

 
This means so much to everyone who is disabled. Please join in and support the effort by passing the word around on your blogs, websites or wherever public place you can to make it a huge success!

thematrix777 [userpic]

Pregabalin Safely Treats Fibromyalgia Pain for Up to 1 Year: Presented at WCP

August 31st, 2008 (07:06 pm)

By Sara Freeman

GLASGOW, United Kingdom -- August 25, 2008 -- Pregabalin safely and effectively treats the chronic, widespread pain associated with fibromyalgia for up to 1 year, according to data from an open-label, extension study.

The study findings, which were presented here on August 20 at the 12th World Congress on Pain (WCP), add to the growing body of evidence showing that pregabalin is an effective option for treating fibromyalgia- related pain.

Pregabalin has been approved for use in the United States as a treatment for fibromyalgia pain since June 2007.

Teresa Leon, Pfizer Global Pharmaceuticals, New York, New York, and associates conducted the latest trial to look at the effects of 12 months of continued treatment with pregabalin following a 13-week treatment trial.

For the open-label extension trial, a total of 429 patients were treated with a pregabalin starting dose of 300 mg daily. Of these patients, 117 were treated with placebo and the remainder had been given doses of pregabalin of 300 to 600 mg/day in the previous trial.

During the 12-month, open-label study, patients were seen once monthly for the first 3 months and every 3 months thereafter. At each visit patients were asked to provide details of any pain they were experiencing using the Present Pain Intensity (PPI) Index and Pain Visual Analog Scale (VAS) of the Short-Form McGill Pain Questionnaire. The PPI Index measured pain on a 6-point scale (0 = no pain, 6 = the worst pain) while the VAS rate pain on a 100-mm scale (0 = no pain, 100 = the worst pain).

Following treatment with pregabalin for a median of 357 days (range 1-402 days), noticeable improvements in pain scores were seen, including a mean decrease of 0.9 points in the PPI Index, with a 21-point reduction in the VAS score from baseline to 12 months of treatment.

"Withdrawal rates owing to adverse effects were relatively low," the researchers said. Permanent discontinuation of pregabalin occurred in 12.4% of patients. Serious adverse events related to pregabalin use were reported by 6.8% of patients, most commonly dizziness, abdominal pain, and somnolence.

Weight gain and peripheral oedema occurred in more patients than previously seen in short-term trials with the drug, although central nervous system effects were less of a problem, "as would be expected with prior pregabalin exposure," Dr. Leon and associates said.

They concluded that not only does the drug remain effective for up to 1 year in patients with chronic pain due to fibromyalgia, but also "the adverse event profile emerging from this study is consistent with previously reported safety and tolerability of pregabalin."


Funding for this study was provided by Pfizer Inc.


[Presentation title: Safety and Tolerability of Pregabalin Treatment in a Long-Term Study in Patients With Fibromyalgia. Abstract PW016]

**Note from thematrix777: Although the study was for Fibromyalgia, because it works on pain, other types of chronic pain
conditions are being looked at.

thematrix777 [userpic]

A Doctor's Way to Get Involved! Anyone Can Join the Cause!

August 13th, 2008 (08:05 am)
sick

current mood: sick

I have known for a long time many people, in all walks of life, have joined in our fight to find a cure for RSD. I thought today I would present just one of those stories. Reflex Sympathetic Dystrophy (RSD) has been around since the Civil War yet there is no cure and no effective treatment to relieve the pain. It is sometimes referred to as CRPS (Complex Regional Pain Syndrome) and most of the time the terms are used inter-changeably although there are small differences.

People in all countries, in any vocation, can be a force when joined with others in getting the word out how much we need help!  

Help with research...Help with a cure.....Help with insurance, workers' comp issues... There are so many things "normal" people do not even have to think about every hour of every day like we with RSD do. Because of the RSD many of us get side problems like neuropathy, osteoarthritis, back issues and the list goes on. It is a progressive, spreading disease. It does not stay in one place; it spreads like wildfire which is one reason why we use fire as our symbol along with the burning type of pain we feel.




From the timestranscript.com Tuesday, Auguest 5, 2008

NORTH SYDNEY, N.S. - Dr. David L. Shulman, a chronic pain specialist at Toronto's Rothbart Pain Clinic, has taken time from his medical practice to cycle 3,650 km (2,268 miles) this summer to raise awareness of Complex Regional Pain Syndrome.

Last year, Shulman cycled from British Columbia to Marathon, Ont. He left Marathon on July 19, heading for St. John's, NL, to complete the last leg of his cross-Canada trek and is expected to be in St. John's on Aug. 8.

He has designated PARC (Promoting Awareness of RSD and CRPS in Canada) and the McGill Centre for Research on Pain as benefactors of his Ride to Conquer CRPS.

Shulman, who treats a number of people with CRPS in his practice, hopes this ride will raise awareness of a disease he describes as "a bit of a mystery" and funds into research for better treatment options.

CRPS is an organic disease caused by nerve damage in the small C fibres of the body.

PARC is a registered charity which advocates for people with CRPS.

According to Shulman, CPRS usually results from trauma, but not always. "It is a severely disabling condition marked by a sharp, burning pain that surpasses almost any other chronic pain condition of its intensity."

thematrix777 [userpic]

Writer's Block: Being Another Creature

July 25th, 2008 (04:32 pm)
amused

current mood: amused

If you could be any creature, any mobile life form at all, which would it be and why?
I would be an Octopus  the use of both my hands due to RSD (Reflex Sympathetic Dystrophy). When you lose something you realize how much you depend on them.

So, I would like a BUNCH of hands.........lol

thematrix777 [userpic]

Medicare Patient Act Approved !

July 10th, 2008 (01:33 pm)
happy

current mood: happy

Great news! On Wednesday, July 9, the U.S. Senate passed H.R. 6331, the
“Medicare Improvements for Patients and Providers Act of 2008,”
by a veto-proof majority of 69-30.
 
Eighteen Republican senators joined Senate Democrats to make this a truly bipartisan process. See how your senators voted here, and send an e-mail to say thank you for voting on behalf of patients and the doctors who care for them.
 
Thank you so much for your tireless efforts. This was a monumental grassroots effort that really turned the tide, and we proved that together we are stronger!
 
The bill must now be signed into law by President George W. Bush, who has signaled on more than one occasion that he intends to veto it. However, given the fact that the payment cuts have already occurred and that the bill passed both chambers of Congress with the two-thirds majority needed to override a veto, there is some reason to question the next steps by the White House.

 Of course, we will keep you apprised as we learn more.
 
Again, many thanks for your help in this effort!
 
© AMA, Patient's Action Network | All Rights Reserved

To my readers:
So, it looks like the good guys won! Us.....As long as it doesn't get vetoed, our congress finally did a good thing for everyone on medicare. Most of us with RSD and other crippling diseases are on it because of being disabled. It matters a great deal to us because of the big medical costs we have to pay even with medicare or other insurance. The medicines we take are often several hundred dollars a month and considered experimental.

I am very pleased to be able to bring you this good news for a change!

thematrix777 [userpic]

Another RSD Suicide: This Must STOP !

July 9th, 2008 (06:43 pm)
sad

current mood: sad

This is a tribute to a man named Scott Terrill. You have never have heard his name. He is not rich, famous or even terribly good looking. This is a man caught in the ravages of depression caused by Reflex Sympathetic Dystrophy (RSD). This is not the first or the last suicide attributed to RSD. In fact, it is a fairly common cause of death for RSD sufferers. Why?

There are a number of reasons. The disease is not curable; it only gets worse with time. The financial hardships can be devastating and the many, many physical problems  can seriously damage one's self-esteem. I have personally lost any use of my right hand and arm and I have limited use of my left. I need constant care which my husband provides. However, it is embarrassing to have him cut my food up like a baby, help me with personal grooming and some days I am unable to walk he has to carry me to doctors appointments.

Those of us with Reflex Sympathetic Dystrophy  try to help each other with large support networks. But it takes more than just us. It will take everyone who knows someone; either a family member or friend to care enough to notice the signs.

The pain is constant; the medicines we take make us feel weird; but without them we could not function at all. With all this in mind please read Scott's story.  It needs to be heard and re-told so no one will forget the tragedy that's called R S D.

****************************************************************************************


Georgetown man who appeared on "Supernanny" dies


By Jillian Ogawa
jogawa@herald-leader.com


GEORGETOWN — A Georgetown man struggled for years, battling a painful spine injury and fighting to obtain Social Security benefits. He even reached out to a television reality show, hoping to be a better dad to his two sons.


Friday night, his struggle ended in a Georgetown cemetery. Scott Terrill died of a self-inflicted gunshot wound to the chest after a 90-minute standoff with police.


Terrill carried ”a lot of emotional baggage from the past,“ said Dwayne Russell, pastor of Safe Harbor Baptist Fellowship in Georgetown, who will officiate at his funeral.


Despite those trials, Terrill was a dedicated father, Russell said. His appearance on a Supernanny episode that first aired in January showed his ”desire to be a better dad.“


Terrill, 37, suffered from reflex sympathetic dystrophy since an accident about five years ago, said his mother, Margaret Ng.


The disorder causes sufferers to feel continuous, intense pain out of proportion to the severity of the injury, which gets worse rather than better over time. There is no cure.


Terrill had tried getting a job to work from home, but he could only sit up only a certain amount of hours of the day, Ng said.


”It might not have looked like it on the TV, but he could not get up for more than a couple hours a day because of the RSD,“ she said.


The Supernanny episode featuring Terrill first aired on Jan. 23. Terrill said he had struggled to set boundaries for his sons, Lane and Tate, who were 11 and 5 at the time, because of his own harsh childhood.


In an attempt to avoid repeating the past, Terrill went to the other extreme, where he could not set discipline in his home.


Terrill later became the mascot for the show's ”Foxy Dad of the Year“ competition.


Ng said Terrill went camping with his sons and was also involved with his eldest son's soccer and his children's schooling.


”He was a loving father with a big heart,“ Ng said.


On Friday, Terrill called Georgetown police about 6:50 p.m., Capt. Scott Starns said Monday. He told police he was thinking of killing himself and had a gun.


Terrill asked to speak to Police Chief Greg Reeves, and told him he was at his father's grave at the Georgetown Cemetery.


Officers went to the cemetery, blocking off the scene and evacuating some of the houses nearby.


As he talked to officers, Terrill had a .38-caliber handgun pressed to his chest the whole time, Starns said.


”About an hour and a half into this whole scenario, they thought progress was being made, and he just abruptly squeezed the trigger,“ Starns said.


Scott County Coroner John Goble pronounced Terrill dead at Georgetown Community Hospital about 9 p.m.


Terrill grew up in Georgetown and attended Lexington Catholic High School, where he played basketball. He obtained his GED and went to one year of college at Morehead State University, Ng said.


In 2002 he ran in the Republican primary for a state House seat against Charlie Hoffman, but lost.


At Safe Harbor Baptist Fellowship, Russell said he had not seen or spoken to Terrill in six or seven months. But he said Terrill, a likeable guy who had been active in the church, had remained in contact with other church members.


Terrill's death has greatly affected his congregation, Russell said. Many watched Terrill grow up, and church members have helped take care of his children.


”People who are struggling with those emotional struggles, they need to get connected with other people,“ he said. ”Not one of us as human beings could handle the stresses and struggles of life by ourselves.“
__________________
Kathy WP

thematrix777 [userpic]

All My Favorites

July 5th, 2008 (12:24 pm)

All My Faves | Why Search? (http://ping.fm/bSFP5)

thematrix777 [userpic]

Happy 4th of July Posting on mashables.com

July 3rd, 2008 (04:30 pm)

I just wanted to send out a Happy 4th for everyone ! I hope everyone has a low, low pain day and the holiday can be spent with loving family.

Remember: Don't overdue..Ask for help if you need it.

thematrix777
Fighting the Flame of RSD!

From: http://mashables.com/