Bayer Recalls Liquid Leukine Cancer Drug
An increase in reports of fainting and other side effects has prompted Bayer AG to withdraw the liquid formulation of its Leukine (generic name: sargramostim) cancer drug from the U.S. market, Bloomberg news reported.
The German drug maker, which made the decision after consultation with the U.S. Food and Drug Administration, is reformulating the drug so it does not include a substance called edentate disodium.
Leukine is designed to boost immune function and fight infection in leukemia patients who have had chemotherapy, and to prolong the lives of patients who have failed bone marrow grafts, Bloomberg reported.
U.S. healthcare professionals should immediately stop using liquid Leukine and return unused vials to the manufacturer, the FDA said.
-----
Arguing With Spouse May Be Healthy: Study
Arguing with your spouse could benefit your health, suggests a U.S. study, which found that the death rate among couples who suppressed anger was twice as high as couples where at least one partner expressed anger.
The 17-year University of Michigan study recorded at least one death in 50 percent of the 26 couples who suppressed their anger, compared to 26 percent of the 166 couples that included at least one person who was willing to express displeasure, Agence France-Presse reported.
At the end of the study, conducted from 1971 to 1988, the likelihood that both partners in a couple were dead was nearly five times higher among anger-suppressing couples.
The findings appear in the January issue of the Journal of Family Communication.
Previous research has shown that suppressing anger increases the risk of stress-related illness such as high blood pressure and heart disease, AFP reported.
-----
Battat Magnabild Construction Sets Recalled
| About 125,000 Battat Magnabild magnetic construction sets are being recalled because small magnets inside the building pieces can fall out and pose a threat to young children. The magnets can be aspirated (accidentally sucked into the lungs). In addition, if a child swallows more than one magnet, the magnets can attract each other and cause intestinal perforations or blockages, which could be fatal, the U.S. Consumer Product Safety Commission said. There have been 16 reports of magnets falling out of building pieces, but no injuries have been reported. |  |
The recall covers the 293-piece (item number BB1502H) and the 180-piece (item number BB1431H) Magnabild Magnetic Building System sets. They were sold in the United States at various retailers and online from 2005 through 2007 for between $30 and $40.
Consumers should immediately take these products away from children and contact Battat Inc., of Plattsburgh, N.Y. for a pre-paid mailer to return the toy and receive a free replacement product, the CPSC said.
For more information, contact Battat at 800-247-6144.
-----
Drug Trials Must Assess Suicide Risk: FDA
The U.S. Food and Drug Administration now requires drug makers to examine whether patients become suicidal during studies of new drugs -- a recent policy change that hasn't been announced publicly, The New York Times reported.
In recent months, the FDA has sent letters to drug makers telling them to include a comprehensive suicide assessment in their clinical trials. The new rule was introduced after a number of cases in which drugs were found to increase the risk of suicidal behavior.
The policy change was not announced publicly because the FDA's oversight of experimental drugs is done privately, the Times reported.
The drug agency has ignored the psychiatric issue for decades and this move is long overdue, according to some FDA critics.
"The list of drugs that causes psychiatric problems is a very long one," Dr. Sidney M. Wolfe, director of Public Citizen's Health Research Group, told the Times.
There's increasing evidence that changes in body chemistry can affect behavior. Previously, it was believed that drugs that didn't reach the brain had little impact on mental health.
Psychiatric problems can be caused by medications used to treat acne, hypertension, pain, heartburn, high cholesterol, bacterial infections, insomnia, and swelling. In many cases, these psychiatric effects were discovered after the drugs were approved and used by millions of patients, the Times reported.
-----
10 Most Expensive Conditions Cost $500 Billion in 2005
The 10 most expensive medical conditions in the United States cost about $500 billion to treat in 2005, says the latest News and Numbers summary from the federal Agency for Healthcare Research and Quality.
Those costs include money paid for visits to doctors' offices, clinics and emergency departments, hospital stays, home health care and prescription medicines.
The estimated 2005 spending for the 10 conditions was:
- Heart conditions -- $76 billion,
- Trauma disorders -- $72 billion,
- Cancer -- $70 billion,
- Mental disorders, including depression -- $56 billion,
- Asthma and chronic obstructive pulmonary disease -- $54 billion,
- High blood pressure -- $42 billion,
- Type 2 diabetes -- $34 billion,
- Osteoarthritis and other joint diseases -- $34 billion,
- Back problems -- $32 billion,
- Normal childbirth -- $32 billion.
The data for this summary were taken from the Medical Expenditure Panel Survey, which looks at health services used by Americans, including frequency, cost and payment methods.
-----
FDA Should Warn About Botulinum Toxin Injections: Public Citizen
The U.S. Food and Drug Administration should immediately order stricter label warnings and directly alert patients and doctors about the potential dangers associated with the use of botulinum toxin (Botox and Myobloc), says a Public Citizen petition filed Thursday with the FDA.
Public Citizen analyzed FDA data and found that drug makers have reported 180 U.S. cases, including 16 deaths, of people who suffered serious adverse reactions after receiving botulinum toxin injections, which are given to block nerve impulses in certain muscles to make them relax.
In these cases, toxin spread from the injection site to other parts of the body, causing paralysis of respiratory muscles and difficulty swallowing (dysphagia). The latter problem can lead to food or liquids entering the respiratory tract and lungs, causing aspiration pneumonia.
Public Citizen said the FDA should follow the lead of European drug regulators, who have issued warnings about the dangers of using botulinum toxin.
"Nobody should be dying from injected botulinum toxin. Educating physicians and patients about what adverse symptoms to look for and when to seek immediate medical attention will save lives," Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said in a prepared statement.
No comments:
Post a Comment