New Vaccine for
Cervical Cancer
Proper name:
Quadrivalent
Human
Papillomavirus
(Types 6,
11, 16, 18)
Recombinant
Vaccine
Tradename:
GARDASIL
Manufacturer:
Merck & Co.,
Inc.,
West
Point, PA,
License
#0002
Indication
for Use:
Vaccination
in females 9
to 26 years
of age for
prevention
of the
following
diseases
caused by (HPV)
Types 6, 11,
16, and 18:
1. Cervical
Cancer
2. Genital
Warts
(Condyloma
Acuminata)
and the
following
precancerous
or
dysplastic
lesions:
Cervical
adenocarcinoma
in situ (AIS)
Cervical
intraepithelial
neoplasia (CIN)
grade 2 and
grade 3
Vulvar
intraepithelial
neoplasia (VIN)
grade 2 and
grade 3
Vaginal
intraepithelial
neoplasia (VaIN)
grade 2 and
grade 3
Cervical
intraepithelial
neoplasia (CIN)
grade 1
Approval
date August
6, 2006
Source:
Center For
Biologics
and Research
of the FDA
http://www.fda.gov/cber/products/hpvme
r060806.htm
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New Vaccine for
Cervical
Cancer.....................................1
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New Med for
Parkinson's
Disease....................................1
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Medication
Errors.......................................1
-
Psychological
Effects of
Ecstasy....................................2
-
What Is a
Proteome.................2
-
OB Patient Death
Leads To
Procedure Changes in
WI........2
-
Sudden Children
Deaths with
Dexadrine................................2
-
Carbon Monoxide
Dangers
In
Boating...............................2
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New Med for Parkinson's
Disease |
The Food and Drug Administration
today approved Azilect (rasagiline), a new molecular entity, for the
treatment of Parkinson's disease. The drug is a monoamine oxidase
type--B (MAO-B) inhibitor that blocks the breakdown of dopamine, a
chemical that sends information to the parts of the brain that
control movement and coordination.
"This is a welcome development for
the more than 50,000 Americans who are each year diagnosed with
Parkinson's disease, " said Dr. Steven Galson, Director of the
Center for Drug Evaluation and Research. "Parkinson's is a
relentless disease with limited treatment options, and each new
therapy is an important addition to the physicians' treatment
options."
Parkinson's disease is a chronic, progressive neurodegenerative
condition caused by the destruction of the brain cells that produce
dopamine. As the level of this chemical declines, messages from the
brain telling the body how and when to move are delivered more
slowly, leaving a person incapable of initiating and controlling
movements in a normal way.
Azilect may be associated with
hypertensive crisis if patients also consume tyramine-rich foods,
beverages (such as cheese and red wine) or dietary supplements or
amines contained in many cough/cold medications. Therefore, patients
will need to avoid these sources of tyramine and amines when taking
Azilect. As with most other medications for Parkinson's, Azilect has
the potential to cause involuntary movements (dyskinesias),
hallucinations and lowered blood pressure. These side effects are
described in the product labeling.
During development, melanoma was
diagnosed in a small number of patients treated with Azilect.
Although the FDA has concluded that the available data do not
establish that Azilect is associated with
an increased risk for
melanoma, it appears that compared to the general population,
patients with Parkinson's disease have an increased risk for this
form of skin cancer. In order to address the question of whether or
not Azilect itself increases such risk, the drug's manufacturer will
perform a Phase 4 (postmarket) study. The product labeling will
recommend that patients undergo periodic dermatologic examinations.
Source:USFDA
http://www.fda.gov/bbs/topics/NEWS/
2006/NEW01373.html
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Medication Errors Injure 1.5
Million People and Costs
Billions of Dollars Annually
Medication errors
are among the most common medical errors, harming at least 1.5
million people every year, says a new report from the Institute
of Medicine of the National Academies. The extra medical costs
of treating drug-related injuries occurring in hospitals alone
conservatively amount to $3.5 billion a year, and this estimate
does not take into account lost wages and productivity or
additional health care costs, the report says.
The committee that wrote the report recommended a series of
actions for patients, health care organizations, government
agencies, and pharmaceutical companies. The recommendations
include steps to increase communication and improve interactions
between health care professionals and patients, as well as steps
patients should take to protect themselves. The report also
recommends the creation of new, consumer-friendly information
resources through which patients can obtain objective,
easy-to-understand drug information. In addition, it calls for
all prescriptions to be written electronically by 2010 and
suggests ways to improve the naming, labeling, and packaging of
drugs to reduce confusion and prevent errors.
Co-chair J. Lyle Bootman, dean and
professor, College of Pharmacy, University of Arizona, Tucson,
said, "Our recommendations boil down to ensuring that consumers
are fully informed about how to take medications safely and
achieve the desired results, and that health care providers have
the tools and data necessary to prescribe, dispense, and
administer drugs as safely as possible and to monitor for
problems. The ultimate goal is to achieve the best care and
outcomes for patients each time they take a medication."
Source: EMTALA and Healthlaw Resources
http://www.medlaw.com/healthlaw/Drugs_
Pharmacy/4_1/iom-medication-errors-inj.shtml
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