FDA: Voluntary Withdrawal Due to Risk of Heart Attack, Stroke, Chest Pain
By Todd Zwillich WebMD Medical News
Reviewed by Louise Chang, MD
March 30, 2007 -- A popular drug for irritable bowel syndrome and constipation was pulled from the U.S. market Friday amid new evidence that it raises the risk of heart attacks and strokes.
Novartis, the manufacturer of Zelnorm, confirmed that Food and Drug Administration officials asked for the drug’s withdrawal.
Agency officials said they based their decision on a Swiss government analysis of 29 Zelnorm studies that showed a higher chance of cardiovascular events, such as heart attack, stroke, or severe heart-related chest pain in patients treated with Zelnorm compared with those given a placebo.
The analysis turned up 13 cases of heart attack, stroke, or angina (chest pain related to heart disease) in about 11,600 patients who took the drug. One of the 13 died, the agency said. This was compared with just one nonfatal event in more than 7,000 patients who took the placebo.
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Monday, April 02, 2007
You Win A Few, You Lose A Few
Posted by Don Burke March 26, 2007 4:23PM
Just a few hours after Guillermo Mota arrived in camp this afternoon, the Mets revealed what had been surmised all weekend. Duaner Sanchez will be lost for at least the first four months of the season after suffering a hairline fracture of a bone in the front of his right shoulder.
According to general manager Omar Minaya, Sanchez will undergo surgery at a still to be determined date. It will be six to eight weeks before the reliever, who has been sidelined since season-ending shoulder surgery on Aug. 1, can begin his latest rehab program. And it will be another six to eight weeks after that before he'll be ready to pitch in a game.
Check the calendar. That means Sanchez won't be back until at least August, meaning he will likely have missed more than a year since the July 30th traffic accident in Miami that caused the initial damage to his shoulder.
Sanchez said he felt discomfort in his shoulder last Thursday during his first session off a mound since the accident. He lasted just 11 pitches before stopping with what he described as a tingling sensation that radiated from his right shoulder down to his finger tips. At the time, X-rays revealed nothing and doctors who examined Sanchez here said the sensation was caused by scar tissues and adhesions tearing away.
As Maxwell Smart used to say, "Missed it by that much.''
Source
Just a few hours after Guillermo Mota arrived in camp this afternoon, the Mets revealed what had been surmised all weekend. Duaner Sanchez will be lost for at least the first four months of the season after suffering a hairline fracture of a bone in the front of his right shoulder.
According to general manager Omar Minaya, Sanchez will undergo surgery at a still to be determined date. It will be six to eight weeks before the reliever, who has been sidelined since season-ending shoulder surgery on Aug. 1, can begin his latest rehab program. And it will be another six to eight weeks after that before he'll be ready to pitch in a game.
Check the calendar. That means Sanchez won't be back until at least August, meaning he will likely have missed more than a year since the July 30th traffic accident in Miami that caused the initial damage to his shoulder.
Sanchez said he felt discomfort in his shoulder last Thursday during his first session off a mound since the accident. He lasted just 11 pitches before stopping with what he described as a tingling sensation that radiated from his right shoulder down to his finger tips. At the time, X-rays revealed nothing and doctors who examined Sanchez here said the sensation was caused by scar tissues and adhesions tearing away.
As Maxwell Smart used to say, "Missed it by that much.''
Source
FDA Accepts Synthemed's Pre-Market Approval (PMA) Application for REPEL-CV(R)
ISELIN, N.J., March 28 /PRNewswire-FirstCall/
-- SyntheMed, Inc. (OTC: SYMD) (BULLETIN BOARD: SYMD) , a biomaterials company engaged in the development and commercialization of anti-adhesion and drug delivery products, today announced that the US Food and Drug Administration (FDA) has accepted for review the Company's Pre-market Approval (PMA) application for REPEL-CV(R) Adhesion Barrier. REPEL-CV is a bioresorbable film designed to be placed over the surface of the heart at the conclusion of an open heart surgical procedure to reduce the formation of post-operative adhesions (scar tissue).
"Adhesions pose serious health risks to patients who have cardiac reoperations as well as result in higher costs for the hospitals where these procedures are performed," stated Robert P. Hickey, President and Chief Executive Officer, SyntheMed, Inc. "Our clinical trial results have demonstrated that REPEL-CV has the potential to reduce OR time, patient exposure to anesthesia and other complications associated with cardiac adhesions. The FDA acceptance of our PMA filing marks another important step toward our goal of making REPEL-CV available to patients in the US who may require secondary open heart surgery."
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-- SyntheMed, Inc. (OTC: SYMD) (BULLETIN BOARD: SYMD) , a biomaterials company engaged in the development and commercialization of anti-adhesion and drug delivery products, today announced that the US Food and Drug Administration (FDA) has accepted for review the Company's Pre-market Approval (PMA) application for REPEL-CV(R) Adhesion Barrier. REPEL-CV is a bioresorbable film designed to be placed over the surface of the heart at the conclusion of an open heart surgical procedure to reduce the formation of post-operative adhesions (scar tissue).
"Adhesions pose serious health risks to patients who have cardiac reoperations as well as result in higher costs for the hospitals where these procedures are performed," stated Robert P. Hickey, President and Chief Executive Officer, SyntheMed, Inc. "Our clinical trial results have demonstrated that REPEL-CV has the potential to reduce OR time, patient exposure to anesthesia and other complications associated with cardiac adhesions. The FDA acceptance of our PMA filing marks another important step toward our goal of making REPEL-CV available to patients in the US who may require secondary open heart surgery."
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Friday, March 23, 2007
Adhesions Medical Headlines ARDvark Blog
First Oral Once-Daily Mesalamine For Ulcerative Colitis: LIALDA Available Now
Massachusetts Health Insurance Connector Board Votes To Require Prescription Drug Coverage As Part Of Draft Minimum Coverage Requirements
IOF World Congress On Osteoporosis To Be Held For First Time In Asia
Potential Non-Surgical Repair Technology To Replace Spinal Fusion As The Standard Surgical Treatment For Chronic Lower Back Pain
Report Details Options For Covering Uninsured Through Tax Credits, Medicaid; Primers Outline Medicare, Medicaid Basic Information
Epigenetic Studies Will Provide A Better Understanding Of Disease
Lawmakers Call On HHS To Garnish Portion Of Medicare Payments For Health Care Providers Who Owe Back Taxes
Researchers Examine Protein Vital To Reproduction, Regulation May Increase Chances Of Pregnancy
IPP-SHR - Parking Costs Disadvantaging Hospital PATIENTS
Diamics Receives FDA Clearance For Revolutionary New Cervical Sample Collection System
Obesity Drives US Surgical Procedure Volumes Higher
Colon Cancer Survival Linked To Number Of Lymph Nodes Examined
Massachusetts Health Insurance Connector Board Votes To Require Prescription Drug Coverage As Part Of Draft Minimum Coverage Requirements
IOF World Congress On Osteoporosis To Be Held For First Time In Asia
Potential Non-Surgical Repair Technology To Replace Spinal Fusion As The Standard Surgical Treatment For Chronic Lower Back Pain
Report Details Options For Covering Uninsured Through Tax Credits, Medicaid; Primers Outline Medicare, Medicaid Basic Information
Epigenetic Studies Will Provide A Better Understanding Of Disease
Lawmakers Call On HHS To Garnish Portion Of Medicare Payments For Health Care Providers Who Owe Back Taxes
Researchers Examine Protein Vital To Reproduction, Regulation May Increase Chances Of Pregnancy
IPP-SHR - Parking Costs Disadvantaging Hospital PATIENTS
Diamics Receives FDA Clearance For Revolutionary New Cervical Sample Collection System
Obesity Drives US Surgical Procedure Volumes Higher
Colon Cancer Survival Linked To Number Of Lymph Nodes Examined
Met reliever Sanchez in, then out
PORT ST. LUCIE, Fla. -- Duaner Sanchez had gone through all of the warm-up steps, throwing on flat ground, long-tossing and then throwing from behind the mound. But when he climbed onto the mound Thursday for the first time this spring, it took just four minutes and 11 pitches for it all to go wrong.
Sanchez hurled the pitch, then bent over, hands on knees, as pitching coach Rick Peterson and assistant trainer Mike Herbst rushed to his side. Feeling a pop in his surgically repaired right shoulder, Sanchez was sent to the clubhouse to be examined by a doctor.
While the Mets and Sanchez downplayed the damage, the sight of Sanchez hunched over in pain threw one more question mark into the status of the Mets' bullpen.
He did not undergo any X-rays or MRI exams Thursday, being examined by one of the team doctors, Dr. Dan Tomlinson. The initial assessment was that it was scar tissue and adhesions from the surgery -- which included adding a piece of his hamstring over the shoulder -- tearing. But general manager Omar Minaya said that while that appears to be the problem, if it does not respond well in the coming days that the team will then send him for an MRI.
"I just felt a tingle all the way down to my hand," Sanchez said. "Nothing major. It's not a ligament, not a tendon, nothing like that.
"I set myself back [Thursday] because I don't want to risk everything that I've been doing for another two weeks. I set myself back and [will] relax and see what happens [today]."
"Basically what we heard is possibly some scar tissue," Minaya said. "We're going to rest him for the day and go from there. The doctors are not alarmed by it, but we'll see how he is [this] morning. They said it's part of the rehab process. Right now, it seems to be a scar tissue. We'll see where it is [today]."
After a sensational first half of the season last year, Sanchez has endured one troublesome episode after another. A cab he was riding in on July 31 was involved in a crash, separating his shoulder and costing him the rest of the season. While rehabbing, he was thrown out of camp for two days until enduring a tearful meeting with manager Willie Randolph and Minaya for his tardiness and his lack of conditioning, coming to camp overweight.
He had worked his way back to this point, the day that he would finally get on the mound. This trouble, he admitted, frightened him.
"It did," he said. "Anything can scare you if you're not expecting it. I've never been hurt in my life so I'm not expecting anything. When it happens, it scares you a little bit. [But you] step back and don't want to do anything major to it."
"Hopefully, it's some adhesions popping loose," said Randolph, who was on the way to Orlando and did not witness the bullpen session. "We'll see what happens [today]. I'm not concerned if that's what you're going to ask me. We'll just see how he feels.
"It could be something as simple as post-op stuff. Every once in awhile when you're trying to stretch out you might get some of that pulling in there, so hopefully that's all it is. I wasn't counting on him. It's not like it's a setback as far as the season. I didn't think he was going to be ready anyway."
For now, the Mets have Billy Wagner at the back end of the bullpen -- although he endured a four-hit, five-run inning in the Mets' 7-1 loss to the Braves on Thursday -- and then questions. Without Sanchez at the start of the year or Guillermo Mota, who is suspended for the first 50 games of the season for violating the league's drug policy, they are relying on Aaron Heilman (who has had bouts of elbow tendinitis this spring after undergoing off-season surgery) and Scott Schoeneweis as set-up men.
Source
Sanchez hurled the pitch, then bent over, hands on knees, as pitching coach Rick Peterson and assistant trainer Mike Herbst rushed to his side. Feeling a pop in his surgically repaired right shoulder, Sanchez was sent to the clubhouse to be examined by a doctor.
While the Mets and Sanchez downplayed the damage, the sight of Sanchez hunched over in pain threw one more question mark into the status of the Mets' bullpen.
He did not undergo any X-rays or MRI exams Thursday, being examined by one of the team doctors, Dr. Dan Tomlinson. The initial assessment was that it was scar tissue and adhesions from the surgery -- which included adding a piece of his hamstring over the shoulder -- tearing. But general manager Omar Minaya said that while that appears to be the problem, if it does not respond well in the coming days that the team will then send him for an MRI.
"I just felt a tingle all the way down to my hand," Sanchez said. "Nothing major. It's not a ligament, not a tendon, nothing like that.
"I set myself back [Thursday] because I don't want to risk everything that I've been doing for another two weeks. I set myself back and [will] relax and see what happens [today]."
"Basically what we heard is possibly some scar tissue," Minaya said. "We're going to rest him for the day and go from there. The doctors are not alarmed by it, but we'll see how he is [this] morning. They said it's part of the rehab process. Right now, it seems to be a scar tissue. We'll see where it is [today]."
After a sensational first half of the season last year, Sanchez has endured one troublesome episode after another. A cab he was riding in on July 31 was involved in a crash, separating his shoulder and costing him the rest of the season. While rehabbing, he was thrown out of camp for two days until enduring a tearful meeting with manager Willie Randolph and Minaya for his tardiness and his lack of conditioning, coming to camp overweight.
He had worked his way back to this point, the day that he would finally get on the mound. This trouble, he admitted, frightened him.
"It did," he said. "Anything can scare you if you're not expecting it. I've never been hurt in my life so I'm not expecting anything. When it happens, it scares you a little bit. [But you] step back and don't want to do anything major to it."
"Hopefully, it's some adhesions popping loose," said Randolph, who was on the way to Orlando and did not witness the bullpen session. "We'll see what happens [today]. I'm not concerned if that's what you're going to ask me. We'll just see how he feels.
"It could be something as simple as post-op stuff. Every once in awhile when you're trying to stretch out you might get some of that pulling in there, so hopefully that's all it is. I wasn't counting on him. It's not like it's a setback as far as the season. I didn't think he was going to be ready anyway."
For now, the Mets have Billy Wagner at the back end of the bullpen -- although he endured a four-hit, five-run inning in the Mets' 7-1 loss to the Braves on Thursday -- and then questions. Without Sanchez at the start of the year or Guillermo Mota, who is suspended for the first 50 games of the season for violating the league's drug policy, they are relying on Aaron Heilman (who has had bouts of elbow tendinitis this spring after undergoing off-season surgery) and Scott Schoeneweis as set-up men.
Source
Wednesday, March 21, 2007
Adhesions Headlines ARDvark Blog
Drug-Resistant Bacteria Defeatede By Trojan Horse Strategy
Kaiser Daily Health Policy Report Features Medical Malpractice News From Three States
Studies Examine Ovarian Cancer, Uterine Fibroids, Cardiovascular Disease
In New Study, Duloxetine Reduced Non-specific Pain And Emotional Symptoms Associated With Depression
Neuropathic Pain: Symptoms, Models, And Mechanisms
Companies' Health Care Costs Increased By About Twice Inflation Rate In 2006, Study Finds
Postnatal Health And Sexual Problems Persist At 12 Months, But Races Experience Different Levels
Ultrasound Could Help Couples Undergoing IVF
USA Today Examines Working Families Without Health Insurance
Belly Fat May Drive Inflammatory Processes Associated With Disease
Where Should I Have My Outpatient Surgery? Risk Factors Should Be Carefully Considered Before Undergoing Outpatient Surgery
Do Anti-Inflammatories Play A Role In Bleeding During Endoscopy?
Are Journal Rankings Distorting Science?
For Best Survival Benefits In Colorectal Cancer Patients, Follow-Up Endoscopic Surveillance Essential
Potential New Painkiller Drug Developed By Scientists At Leicester And In Italy
Kaiser Daily Health Policy Report Features Medical Malpractice News From Three States
Studies Examine Ovarian Cancer, Uterine Fibroids, Cardiovascular Disease
In New Study, Duloxetine Reduced Non-specific Pain And Emotional Symptoms Associated With Depression
Neuropathic Pain: Symptoms, Models, And Mechanisms
Companies' Health Care Costs Increased By About Twice Inflation Rate In 2006, Study Finds
Postnatal Health And Sexual Problems Persist At 12 Months, But Races Experience Different Levels
Ultrasound Could Help Couples Undergoing IVF
USA Today Examines Working Families Without Health Insurance
Belly Fat May Drive Inflammatory Processes Associated With Disease
Where Should I Have My Outpatient Surgery? Risk Factors Should Be Carefully Considered Before Undergoing Outpatient Surgery
Do Anti-Inflammatories Play A Role In Bleeding During Endoscopy?
Are Journal Rankings Distorting Science?
For Best Survival Benefits In Colorectal Cancer Patients, Follow-Up Endoscopic Surveillance Essential
Potential New Painkiller Drug Developed By Scientists At Leicester And In Italy
Passing gas - Even closer to spring ~ Blog excerpt
Blog excerpt
http://manixter.livejournal.com/1496.html
..........But on friday, I was up until quarter to 6. Just enough time to get a nap in before checking in with the incomming call person and driving home. Nothing specific-- a few general surgery cases with a slow surgeon topped off with a three-peat bowel obstruction. Which is to say, a patient who was on surgery #3 for obstructed bowel-- which means-- adhesions.Then, on sunday, I had the privilage of doing a small bowel transplant on a patient with even more adhesions than I had ever thought possible. For most patients, no matter how specific you get, there are usually 10 other patients that match the description. This is depressing, but it avoids violating HIPPA too too much. Small bowels are rare enough (unfortunately not rare enough for me), that I will try to be as general as possible. Suffice to say, the trifecta of a patient with other medical issues, a family situation that is... less than stable, and the standard bad-things that happen to small bowel transplants means I will see this patient again and again, eventually for her retransplant/ enterectomy. So I am NOT thrilled that I was up all night doing this surgery. Not to mention it wasn't as smooth as pediatric bowel transplants in a patient of that age typically are.
http://manixter.livejournal.com/1496.html
..........But on friday, I was up until quarter to 6. Just enough time to get a nap in before checking in with the incomming call person and driving home. Nothing specific-- a few general surgery cases with a slow surgeon topped off with a three-peat bowel obstruction. Which is to say, a patient who was on surgery #3 for obstructed bowel-- which means-- adhesions.Then, on sunday, I had the privilage of doing a small bowel transplant on a patient with even more adhesions than I had ever thought possible. For most patients, no matter how specific you get, there are usually 10 other patients that match the description. This is depressing, but it avoids violating HIPPA too too much. Small bowels are rare enough (unfortunately not rare enough for me), that I will try to be as general as possible. Suffice to say, the trifecta of a patient with other medical issues, a family situation that is... less than stable, and the standard bad-things that happen to small bowel transplants means I will see this patient again and again, eventually for her retransplant/ enterectomy. So I am NOT thrilled that I was up all night doing this surgery. Not to mention it wasn't as smooth as pediatric bowel transplants in a patient of that age typically are.
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