UPDATE: Two Patients On Sanofi's Multaq Have Liver Failure
Adds FDA statement, detail, background.)
By A H Mooradian
Of DOW JONES NEWSWIRES
PARIS (Dow Jones)--French pharmaceutical giant Sanofi-Aventis SA (SAN.FR) Friday said two patients treated with its Multaq atrial fibrillation drug have suffered liver failure and require transplants, though no causal link has been established between taking the drug and the disease.
Sanofi sent a letter to healthcare providers in the U.S. about the case, company spokesman Jean-Marc Podvin told Dow Jones Newswires Friday. "Patient safety is Sanofi's priority," Podvin said. The company is also "working with European health authorities and in the countries where Multaq is approved and those where it is submitted for review."
In a separate statement on its website Friday, the U.S. Food and Drug Administration said it was "alerting healthcare professionals and patients about cases of rare, but severe liver injury, including two cases of acute liver failure leading to liver transplant in patients treated with the heart medication dronedarone (Multaq)."
The company wouldn't disclose in which country the two cases of liver failure happened. On its Multaq website, Sanofi-Aventis cautions that patients with "severe liver problems" should not take the drug. ..read more
By A H Mooradian
Of DOW JONES NEWSWIRES
PARIS (Dow Jones)--French pharmaceutical giant Sanofi-Aventis SA (SAN.FR) Friday said two patients treated with its Multaq atrial fibrillation drug have suffered liver failure and require transplants, though no causal link has been established between taking the drug and the disease.
Sanofi sent a letter to healthcare providers in the U.S. about the case, company spokesman Jean-Marc Podvin told Dow Jones Newswires Friday. "Patient safety is Sanofi's priority," Podvin said. The company is also "working with European health authorities and in the countries where Multaq is approved and those where it is submitted for review."
In a separate statement on its website Friday, the U.S. Food and Drug Administration said it was "alerting healthcare professionals and patients about cases of rare, but severe liver injury, including two cases of acute liver failure leading to liver transplant in patients treated with the heart medication dronedarone (Multaq)."
The company wouldn't disclose in which country the two cases of liver failure happened. On its Multaq website, Sanofi-Aventis cautions that patients with "severe liver problems" should not take the drug. ..read more
Liver damage reported with heart drug
FDA issues warning about Multaq tablets
FDA issues warning about Multaq tablets
.
Updated: Friday, 14 Jan 2011, 3:52 PM CSTPublished : Friday, 14 Jan 2011, 3:52 PM CST
MATTHEW PERRONE
WASHINGTON (AP) - Federal health officials are warning doctors and patients that a recently-launched heart drug from Sanofi-Aventis SA has been linked to liver damage in a handful of patients.
The Food and Drug Administration said Friday it has received several reports of liver damage with Multaq tablets, including two cases in which patients had to have their livers removed. Both patients were women and roughly 70 years old. They had been taking the drug for 4.5 months and 6 months, respectively...read more
MATTHEW PERRONE
WASHINGTON (AP) - Federal health officials are warning doctors and patients that a recently-launched heart drug from Sanofi-Aventis SA has been linked to liver damage in a handful of patients.
The Food and Drug Administration said Friday it has received several reports of liver damage with Multaq tablets, including two cases in which patients had to have their livers removed. Both patients were women and roughly 70 years old. They had been taking the drug for 4.5 months and 6 months, respectively...read more
Hepatologists test drug on advanced liver cancer patients
2:03 p.m. EST, December 28, 2010
2:03 p.m. EST, December 28, 2010
Hepatologists at the University of Florida have begun a new clinical trial in search of a better way to treat patients who have advanced, inoperable primary liver cancer but have trouble tolerating standard doses of the only drug available to help them.Funded through a $650,000 grant from Bayer HealthCare Pharmaceuticals Inc. and Onyx Pharmaceuticals Inc., the makers and marketers of Sorafenib — the only FDA-approved drug for advanced liver cancer — the six-month, randomized pilot study will evaluate whether patients with a dual diagnosis of cirrhosis and liver cancer are better able to tolerate the drug if given doses that differ from the manufacturer's recommendation...read more..
Can Higher Levels of HLA-G Improve Liver Transplant Outcome?
Ron Shapiro, MD
Authors and Disclosures
Posted: 01/14/2011
Ron Shapiro, MD
Authors and Disclosures
Posted: 01/14/2011
Hi. My name is Ron Shapiro. I am a Transplant Surgeon at the University of Pittsburgh. Today, I want to talk to you about a very interesting study from Stanford[1] that looked at soluble human leukocyte antigen-G (HLA-G) in the retransplant recipient.
We have always known that the liver is a more tolerogenic organ than other solid organs in transplantation, and some of the explanation has been related to speculation that HLA-G is involved. The group from Stanford established that HLA-G levels in tolerant liver transplant recipients were substantially higher than in nontolerant patients or in patients with acute rejection. This would be an important marker and one that we need to explore in other solid-organ recipients, with a view toward seeing if we can promote tolerance in our recipients.
Thank you... Watch Video
We have always known that the liver is a more tolerogenic organ than other solid organs in transplantation, and some of the explanation has been related to speculation that HLA-G is involved. The group from Stanford established that HLA-G levels in tolerant liver transplant recipients were substantially higher than in nontolerant patients or in patients with acute rejection. This would be an important marker and one that we need to explore in other solid-organ recipients, with a view toward seeing if we can promote tolerance in our recipients.
Thank you... Watch Video
Britain Boosts Funds for Hepatitis C-Infected Patients
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From U.S. Centers for Disease Control and Prevention
January 14, 2011
On Monday, Britain's government announced it will provide more support for patients infected with hepatitis C virus through state health services in the 1970s and 1980s. Approximately £100 million to £130 million (US $159 million to $203 million) in additional support will be provided over the next five years for patients with serious liver disease linked to HCV infection through blood products or transfusions during the period. The infections occurred before heat-treatment of blood began in 1985. A test for HCV was introduced in 1991....continue reading
January 14, 2011
On Monday, Britain's government announced it will provide more support for patients infected with hepatitis C virus through state health services in the 1970s and 1980s. Approximately £100 million to £130 million (US $159 million to $203 million) in additional support will be provided over the next five years for patients with serious liver disease linked to HCV infection through blood products or transfusions during the period. The infections occurred before heat-treatment of blood began in 1985. A test for HCV was introduced in 1991....continue reading
Tongue piercings worse with metal
Stainless steel and titanium studs more prone to accumulate bacteria
By Nathan Seppa
By Nathan Seppa
Meanwhile, piercing the tongue places a person at risk of mouth infections that can spread to other parts of the body, earlier work has shown. For example, oral piercings have been linked in rare cases to hepatitis C, toxic shock syndrome, brain abscesses and a heart infection called endocarditis. The researchers note that several of the bacteria found in abundance on metal studs also show up in systemic infections.
From HIV and Hepatitis
HCV
HCV Protease Inhibitor Boceprevir Accepted for Priority Review in U.S. and Europe
Company Collaboration to Test BMS-790052 + PSI-7977 Combo for Hepatitis C
Peregrine Starts Phase 2 Trial of Monoclonal Antibody Hepatitis C Treatment
HCV Protease Inhibitor Boceprevir Accepted for Priority Review in U.S. and Europe
Company Collaboration to Test BMS-790052 + PSI-7977 Combo for Hepatitis C
Peregrine Starts Phase 2 Trial of Monoclonal Antibody Hepatitis C Treatment
HIV
U.S. Antiretroviral Therapy Guidelines Updated, but No Major Changes
Small Difference in Physical Function between Older HIV Positive and Negative People
UCSF Launches HIV and Aging Initiative in San Francisco
RNA Interference Combination Strategy Shows Promise in Laboratory Study
U.S. Antiretroviral Therapy Guidelines Updated, but No Major Changes
Small Difference in Physical Function between Older HIV Positive and Negative People
UCSF Launches HIV and Aging Initiative in San Francisco
RNA Interference Combination Strategy Shows Promise in Laboratory Study
Stem Cells
UCSC research could aid in bone marrow transplants
By TOVIN LAPAN - Santa Cruz Sentinel
SANTA CRUZ - Researchers at UC Santa Cruz studying a specific type of stem cells have made a discovery that could help improve the process for performing bone marrow transplants, used to treat lymphoma and leukemia among other illnesses...read more...
By TOVIN LAPAN - Santa Cruz Sentinel
SANTA CRUZ - Researchers at UC Santa Cruz studying a specific type of stem cells have made a discovery that could help improve the process for performing bone marrow transplants, used to treat lymphoma and leukemia among other illnesses...read more...
Other News
Kala azar casts shadow over Nepal’s poor
By Dr Cesar Chelala/New York
Nepal presents a sad paradox. Endowed with exquisite beauty, it is at the same time home to a series of infectious diseases that take a heavy toll on its population. Perhaps the less known among them, and the most neglected, is kala azar. The name literally means “black sickness” because of the darkened skin of some patients...read more
Pertussis Outbreaks Costly for Local Health Depts
2 hours ago A pertussis outbreak saps resources -- both time and money -- from local health departments, an analysis of a 26-person, school-based outbreak in Omaha, Neb., showed...read more
2 hours ago A pertussis outbreak saps resources -- both time and money -- from local health departments, an analysis of a 26-person, school-based outbreak in Omaha, Neb., showed...read more
Chew Bars Recalled Due to High Lead Levels
Concerns about lead levels have prompted the recall of all Toxic Waste brand Nuclear Sludge Chew Bars.
A test conducted by the California Department of Health found that a lot of the bars contained elevated levels of lead (0.24 parts per million), which could threaten the health of infants, small children and pregnant women. The U.S. limit is 0.1 ppm.
The recall covers all flavors of 0.7-ounce (20-gram) Nuclear Sludge Chew Bars, which were made in Pakistan and sold in the United States by Indianapolis-based Candy Dynamics.
For more information, contact the company at 317-228-5012 Monday through Friday, 9 a.m. to 5 p.m. EST.
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Aretha Franklin Says She Doesn't Have Pancreatic Cancer
Aretha Franklin says there is no truth to reports she has pancreatic cancer.
The 68-year-old Queen of Soul admits she had a recent health scare but wouldn't provide any details. She suffered pain so bad it brought her to her knees. She decided to cancel any further concerts while she sought answers from doctors.
"I went through a number of procedures before I knew what was wrong," she told ACCESS Hollywood.
Franklin said she doesn't know how the pancreatic cancer story starting making the rounds.
"I was sitting there reading the newspaper and it was saying someone in my family said that," she told ACCESS Hollywood. "No one in my family ever said that to anybody."
-----
House to Vote Next Week on Repeal of Health Care Law
House Republicans intend to hold a vote next week to repeal the health care law. The vote was scheduled to take place this week but there was a weeklong pause in legislative business to honor the Arizona shooting victims.
Republicans contend that the health care law is too expensive. But Democrats point to an analysis by the non-partisan Congressional Budget Office, which estimated that repealing the law will add $230 billion to the federal deficit over the next decade, CNN reported.
It's likely that the tone of the debate will closely watched in the wake of the Arizona shooting spree in which Rep. Gabrielle Giffords, D-Arizona, was wounded and six people were killed.
Even if the House votes to repeal the health care law, there's little chance it will survive the Senate or a promised veto by President Barack Obama, CNN reported.
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End Free Medicare Home Visits: Panel
A significant new out-of-pocket charge for home health visits could be imposed on Medicare recipients if lawmakers heed a recommendation released Thursday by the Medicare Payment Advisory Commission.
Currently, there is no charge for home health visits from nurses and other health providers. The advisory panel said a copayment is needed to discourage overuse and possible fraud of the $20 billion-per-year program, the Associated Press reported.
The congressionally-appointed commission voted 13-1 to recommend that Congress implements the new charge. Two members abstained and one was absent.
While the panel did not specify an amount, its staff has suggested that Medicare recipients be charged $150 for a series of related home visits, the AP reported.
-----
From Health Day.....read more...
Concerns about lead levels have prompted the recall of all Toxic Waste brand Nuclear Sludge Chew Bars.
A test conducted by the California Department of Health found that a lot of the bars contained elevated levels of lead (0.24 parts per million), which could threaten the health of infants, small children and pregnant women. The U.S. limit is 0.1 ppm.
The recall covers all flavors of 0.7-ounce (20-gram) Nuclear Sludge Chew Bars, which were made in Pakistan and sold in the United States by Indianapolis-based Candy Dynamics.
For more information, contact the company at 317-228-5012 Monday through Friday, 9 a.m. to 5 p.m. EST.
-----
Aretha Franklin Says She Doesn't Have Pancreatic Cancer
Aretha Franklin says there is no truth to reports she has pancreatic cancer.
The 68-year-old Queen of Soul admits she had a recent health scare but wouldn't provide any details. She suffered pain so bad it brought her to her knees. She decided to cancel any further concerts while she sought answers from doctors.
"I went through a number of procedures before I knew what was wrong," she told ACCESS Hollywood.
Franklin said she doesn't know how the pancreatic cancer story starting making the rounds.
"I was sitting there reading the newspaper and it was saying someone in my family said that," she told ACCESS Hollywood. "No one in my family ever said that to anybody."
-----
House to Vote Next Week on Repeal of Health Care Law
House Republicans intend to hold a vote next week to repeal the health care law. The vote was scheduled to take place this week but there was a weeklong pause in legislative business to honor the Arizona shooting victims.
Republicans contend that the health care law is too expensive. But Democrats point to an analysis by the non-partisan Congressional Budget Office, which estimated that repealing the law will add $230 billion to the federal deficit over the next decade, CNN reported.
It's likely that the tone of the debate will closely watched in the wake of the Arizona shooting spree in which Rep. Gabrielle Giffords, D-Arizona, was wounded and six people were killed.
Even if the House votes to repeal the health care law, there's little chance it will survive the Senate or a promised veto by President Barack Obama, CNN reported.
-----
End Free Medicare Home Visits: Panel
A significant new out-of-pocket charge for home health visits could be imposed on Medicare recipients if lawmakers heed a recommendation released Thursday by the Medicare Payment Advisory Commission.
Currently, there is no charge for home health visits from nurses and other health providers. The advisory panel said a copayment is needed to discourage overuse and possible fraud of the $20 billion-per-year program, the Associated Press reported.
The congressionally-appointed commission voted 13-1 to recommend that Congress implements the new charge. Two members abstained and one was absent.
While the panel did not specify an amount, its staff has suggested that Medicare recipients be charged $150 for a series of related home visits, the AP reported.
-----
From Health Day.....read more...
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