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Manufacturers of Some Diabetes Drugs
to Strengthen Warning on Heart Failure Risk
Companies Will Include Boxed Warning on Drug Label
|
The U.S. Food and Drug Administration today announced manufacturers of certain
drugs approved to treat Type 2 diabetes have agreed to add a stronger warning
on the risk of heart failure, a condition that occurs when the heart does not
adequately pump blood. The information will be included in the form of a "boxed" warning-FDA's
strongest form of a warning. The upgraded warning emphasizes that the drugs
may cause or worsen heart failure in certain patients.
After a review of postmarketing adverse event reports, FDA determined that
an updated label with a boxed warning on the risks of heart failure was needed
for the entire thiazolidinedione class of antidiabetic drugs. This class
includes Avandia (rosiglitazone), Actos (pioglitazone) Avandaryl (rosiglitazone
and glimepiride), Avandamet (rosiglitazone and metformin), and Duetact (pioglitazone
and glimepride). These drugs are used in conjunction with diet and exercise,
to improve blood sugar control in adults with type 2 (non-insulin-dependent)
diabetes. FDA had asked the drug's manufacturers, GlaxoSmithKline and
Takeda, to address these concerns.
"Under FDA's postmarketing surveillance program, we carefully
monitor new safety information for marketed drugs and take appropriate action
when necessary to inform patients and health care providers of new information," said
Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation
and Research. "This new boxed warning addresses FDA's concerns
that despite the warnings and information already listed in the drug labels,
these drugs are still being prescribed to patients without careful monitoring
for signs of heart failure."
Read more..... |
Breast Cancer Vaccine Looks Safe, Study Shows |
| A vaccine designed to treat breast cancer appeared to be safe in
women with advanced disease and showed signs of actually slowing down
tumors, U.S. researchers reported on Friday. Dendreon
Corporation, maker of the Provenge prostate cancer vaccine, calls the
new vaccine Neuvenge. It targets a type of breast cancer called
her2/neu-positive breast cancer, which affects between 20 percent and
30 percent of breast cancer patients. Like Provenge, Neuvenge is made using immune cells from the cancer patient, so it is a tailor-made vaccine.
Dr. John Park of the University of California, San Francisco and
colleagues tested it in 18 women with advanced her2/neu-positive breast
cancer, whose cancer had spread despite treatment. Writing in the
Journal of Clinical Oncology, the researchers said the vaccine did not
cause any serious side effects and appeared to help at least one
patient.
|
| Penn Researchers Find Diabetes Drug
Kills Some Cancer Cells |
Researchers at the University of Pennsylvania School of Medicine have found that a commonly prescribed diabetis drug kills tumor cells that lack a key regulatory gene called p53. Results from current studies in mice may result in new therapies for a subset of human cancers that tend to be aggressive and resistant to existing treatments. Additionally, the findings open up a new avenue for targeting cancers whose hallmark is the absence of this regulatory gene.
The Penn team reported their findings last month in Cancer Research.
"This is the first time you can show that tumor growth is impaired by a diabetes drug," says senior author Craig B. Thompson, MD, Director of the Abramson Cancer Center and Chairman and Professor of Cancer Biology and Medicine. "It is specific for tumors that lack p53, which is the most common mutation in human cancer."
More than half of all human cancers have lost the p53 gene. Yet even in an era of molecularly targeted therapies scientists have had trouble figuring out how to compensate for the absence of a gene. Unlike a genetic mutation that changes the function or activity of a gene, which can be inhibited by a well-tailored drug, loss of a gene leaves nothing for the drug to target.
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"Wake-Up Pill" Under Study to Treat Patients with Bipolar Disorder |
|
A preliminary study of 85 patients with bipolar disorder shows that
a drug used to treat patients with sleep disorders might also control
the depressive symptoms associated with bipolar disorder. At least 44
percent of the participants in the study reported improved symptoms, a
noteworthy improvement for a disorder in which new treatments are
needed, according to the study's author, Mark Frye, M.D., director of
the Mayo Clinic Mood Disorders Clinic and Research Program.
The study appears in the August issue of the American Journal of Psychiatry.
"There are very few treatments for the depressive phase of bipolar
disorder and as a result there is an urgent need to evaluate potential
new therapeutics," says Dr. Frye. "Mood stabilizers in general are
better at treating mania than depression, but the depressive phase of
the illness is far more common. We really need continued research in
this area."
This study was completed in 2005 when Dr. Frye was with the University of California, Los Angeles (UCLA). Read more..... |
|
Drug Protects Brain Cells in Huntington's Disease Model, Researchers Find |
A drug used in some countries to treat the symptoms of Huntington's disease prevents death of brain cells in mice genetically engineered to mimic the hereditary condition, UT Southwestern Medical Center researchers have found.
The research sheds light on the biochemical mechanisms involved in the disease and suggests new avenues of study for preventing brain-cell death in at-risk people before symptoms appear.
"The drug can actually prevent brain cells from dying," said Dr. Ilya Bezprozvanny, associate professor of physiology at UT Southwestern. "It's much more important than people thought."
The study, of which Dr. Bezprozvanny is senior author, appears in the July 25 issue of The Journal of Neuroscience.
The drug, called tetrabenazine (TBZ), is commercially distributed as Xenazine or Nitoman and blocks the action of dopamine, a compound that some nerve cells use to signal others. TBZis approved for use in several countries, but not the U.S., to treat uncontrollable muscle movements in Huntington's and other neurological conditions.
|
Vaccine Breakthrough in War Against Anthrax
|
An exotic anthrax vaccine administered in just a couple of doses
through the nose could provide better protection than the standard
vaccine, which involves six injections over 18 months followed by
annual boosters. The breakthrough is part of an emerging trend in
vaccinations away from injections towards nasal doses.
Researchers at the University of Michigan in Ann Arbor, US, used an antigen derived from Bacillus anthracis, the bacterium that causes anthrax. The antigen doesn't cause sickness itself, but provokes a protective immune response.
Instead
of injecting the antigen, the researchers mixed it with a soybean oil
emulsion that had been formulated into droplets only 400 nanometres in
diameter. The nanoemulsion carries the droplets into the nasal
passages, where they are detected by the immune system.
"This
is similar to formulations designed to penetrate the skin that were
developed by the cosmetics industry. It penetrates through the pores of
the mucosa," says James R. Baker Jr, an immunologist on the team that
carried out the work. When the antigen is applied to the nose without
the emulsion it causes little or no immune response, he says. Read more.....
|
FDA Approves Updated Warfarin (Coumadin) Prescribing Information |
The U.S. Food and Drug Administration announced today the approval of updated
labeling for the widely used blood-thinning drug, Coumadin, to explain that
people's genetic makeup may influence how they respond to the drug.
Manufacturers of warfarin, the generic version of Coumadin, are to add similar
information to their products' labeling, FDA said.
The labeling change highlights the opportunity for healthcare providers to
use genetic tests to improve their initial estimate of what is a reasonable
warfarin dose for individual patients. Testing may help optimize the use of
warfarin and lower the risk of bleeding complications from the drug.
These labeling updates are based on an analysis of recent studies that found
people respond to the drug differently based, in part, on whether they have
variations of certain genes.
FDA estimates that 2 million persons start taking warfarin in the United States
every year to prevent blood clots, heart attacks and stroke. Warfarin is a
difficult drug to use because the optimal dose varies and depends on many risk
factors including a patient's diet, age, and the use of other medications. Read more..... |
Believe it or not
|
Biker fails to notice missing legA Japanese biker failed to notice his leg had been severed below the knee when he hit a safety barrier, and rode on for more than a mile, leaving a friend to pick up the missing limb.
The 54-year-old office worker was out on his motorcycle with a group of friends in the city of Hamamatsu, west of Tokyo, on Monday, when he was unable to negotiate a curve in the road and bumped into the central barrier, the Mainichi Shimbun said.
He felt excruciating pain, but did not notice that his right leg was missing until he stopped at the next junction, the paper quoted local police as saying.
The man and his leg were taken to a hospital, but the limb had been crushed in the collision, the paper said. |
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News From MedWatch |
| Keep up-to-date on all of the recent
MedWatch reports that gives you timely safety information on the drugs and other
medical products regulated by the U.S. Food and Drug Administration by CLICKING HERE
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Recently Approved Drugs/Indications |
| Keep up-to-date on all of the recently approved drugs and/or approved new indications on already FDA approved drugs by CLICKING HERE
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FDA Recalls and Safety Alerts in the Past 60 Days: |
| To see a list of all FDA Recalls and product safety alerts for the last 60 days CLICK HERE
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Drug Shortages: |
| As many of you are aware, many drugs in the US are either unavailable or in short supply. To view a list of these drugs CLICK HERE
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