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Part I of II
EPVC Newsletter
September 2013
Volume 4, Issue 9
Egyptian
Pharmaceutical
Withdrawal & Recall of Syrups Containing Pizotifen
Vigilance Center
following:
(EPVC)

Pizotifen is used in all reference countries to treat migraine headaches in the
form of tablets

Restrict the use of Pizotifen for the treatment of migraine headaches, as the clinical trials submitted by the company
were not sufficient evidence on the safety and effectiveness of the substance
when used to stimulate appetite.
Pharmacovigilance
Department
Inside this issue:
Withdrawal & Recall of
Syrups
Containing
Pizotifen
1
Case of Rash & Convulsion In a child
received
Cortiplex®
B6 Pediatric amp by
intravenous (IV) injection in Alexandria
1,2
FDA approves new
drug to treat HIV
infection
2
On 14/02/2013 the Technical Committee
(TC) at Central Administration of Pharmaceutical Affairs (CAPA) has decided to cancel the marketing authorization and recall of
all the pharmaceutical products that contain
(Pizotifen) in the form of Syrup, this decision followed the Egyptian Pharmacovigilance center (EPVC) recommendations as
Pizotifen is a serotonin antagonist acting
mainly at the 5-HT2A and 5HT2C receptors; it also has some activity as an antihistamine as well as some anticholinergic activity
Case of Rash & Convulsion In a child received
Cortiplex® B6 Pediatric amp by intravenous (IV) injection
in Alexandria
The Egyptian Pharmacovigilance regional
center in Alexandria received a yellow card
concerning a 9 months, 8 kg child who received Cortiplex® B6 Pediatric amp by (IV)
route for Emesis and developed " Rash &
Convulsion". The symptoms appeared after
receiving the dose by incorrect route ,and
disappeared within 15 minutes of discontinuation.
Incorrect administration was due to misconception of route of administration with Cortigen® (which is given both IM & IV).
According to Professional information of
Cortiplex® B6 Pediatric amp (global Napi)
Indications:
 Exogenous & endogenous toxicosis
 Acute infectious diseases such diphtheria,
scarlet fever, typhoid fever, etc….
 Seasonal gastroenteritis with vomiting
such as summer diarrhea of children.
 Acetoanaemic, habitual or other origin of
vomiting.
 Dehydration, infantile dystrophy & marasmus.
 Prolonged convalescence.
Page 2
Part I EPVC
Volume 4, Issue 9
Dosage & administration:
One or two ampoules to be administered daily by intramuscular injection or as
directed by the physician.
References:
Cortiplex B6 Paediatric, Professional Information,Glopal Napi (Click here).
FDA approves new drug to treat HIV infection
The U.S. Food and Drug Administration today approved Tivicay
(dolutegravir), a new drug to treat
for Drug Evaluation and Research.
“The approval of new drugs like Tivicay that add to the existing options
HIV-1 infection.
remains a priority for the FDA”.
Tivicay is an integrase strand transfer inhibitor that interferes with one
of the enzymes necessary for HIV to
multiply. It is a pill taken daily in
combination with other antiretrovi-
About 50,000 Americans become
infected with HIV each year and
about 15,500 died from the disease in
2010, according to the Centers for
ral drug.
Tivicay is approved for use in a
broad population of HIV-infected
patients. It can be used to treat HIVinfected adults who have never taken HIV therapy (treatment-naïve)
and HIV-infected adults who have
previously taken HIV therapy
(treatment-experienced), including
those who have been treated with
other integrase strand transfer inhibitors. Tivicay is also approved for
children ages 12 years and older
weighing at least 40 kilograms (kg)
who are treatment-naïve or treatment-experienced but have not previously taken other integrase strand
transfer inhibitors.
Disease Control and Prevention.
Tivicay’s safety and efficacy in adults
was evaluated in 2,539 participants
enrolled in four clinical trials. Depending on the trial, participants were
randomly assigned to receive Tivicay
or Isentress (raltegravir), each in combination with other antiretroviral
drugs, or Atripla, a fixed-dose combination of efavirenz, emtricitabine and
tenofovir. Results showed Tivicaycontaining regimens were effective in
reducing viral loads.
A fifth trial established the pharmacokinetics, safety and activity of Tivicay
as part of treatment regimens for HIVinfected children ages 12 years and
older weighing at least 40 kg who
have not previously taken integrase
“HIV-infected individuals require
strand transfer inhibitors.
treatment regimens personalized to
fit their condition and their needs,”
said Edward Cox, M.D., M.P.H.,
director of the Office of Antimicrobial Products in the FDA’s Center
Common side effects observed during
clinical studies include difficulty sleeping (insomnia) and headache. Serious
side effects include hypersensitivity
reactions and abnormal liver function in participants co-infected with
hepatitis B and/or C. The Tivicay
label gives advice on how to monitor patients for the serious side effects.
References:
FDA Press announcement (12 Aug
2013) (Click here).
Part II of II
NORCB Newsletter
August 2013
National Organization
for Research &
Control of Biologicals
Post Marketing
Surveillance and
Adverse Event
Following
immunization
Department
Inside this issue:
Why Some Don't Respond to Rubella Vaccine?
3
Data show Novartis'
meningitis B vaccine
induces response in
infants
3,4
Can Vaccines Be Delivered Via the Lungs
Instead of by Injection?
4
Brain Cancer Survival
Improved Following
FDA Approval of Bevacizumab
4,5
Novartis' Men B vaccine Bexsero approved
in Australia
5
Volume 4, Issue 8
Why Some Don't Respond to Rubella Vaccine?
Using advanced genetic sequencing technology
and analysis, Mayo Clinic vaccine researchers
have identified 27 genes that respond in very
different ways to the standard rubella vaccine,
making the vaccine less effective for a portion of
the population.
"This study highlighted the genes potentially
responsible for poor response to the rubella vaccine," says Mayo Clinic vaccinologist. "We
found differences in genes responsible for antigen interactions, inflammation and differences
in the gene pathways involved between low and
high vaccine responders. It's another instance of
using individualized medicine approaches to
find potential solutions for patients not benefiting from standard treatments."
Researchers in the Mayo Clinic Vaccine Research Group began with a random sample of
738 healthy children and young adults who had
had two doses of the MMR (measles, mumps,
and rubella) vaccine and then selected 25 individuals who represented either high or low responders. Samples from those participants were
subject to sequencing of messenger RNA, resulting in transcriptional data that was analyzed for differences in gene expression.
This was the first Next Generation (highspeed, high-throughput) gene expression profiling and analysis conducted after rubella vaccination that provided quantitative data. Researchers say the findings will help in efforts to
better understand reactions to the existing
rubella vaccine and be very useful in developing alternative vaccines so individuals in the
low-response group can be adequately protected.
Reference
Science Daily News: (Click here)
Data show Novartis' meningitis B vaccine induces response
in infants
Phase II data presented at the European
Society for Paediatric Infectious Diseases
annual meeting showed that Novartis' experimental meningococcal group B vaccine, MenB, induces a protective immune
response in infants, the drugmaker announced. Novartis noted that the data support the compound's promise of being the
"first potentially broad coverage vaccine
capable of protecting infants against the
meningococcal B strain."
munisations at 2, 4 and 6 months, and a
booster dose at 12 months. The findings
showed that one month after the third
dose, the percentages of subjects who
achieved a protective immune response
against three strains of the virus included
in the vaccine were 89 percent, 96 percent and 85 percent. After the booster,
the percentages of subjects who achieved
a protective immune response were 100
percent, 98 percent and 93 percent.
In the trial, 150 healthy infants were
administered MenB alongside routine im-
Study researcher, the head of the
Oxford Vaccine Group at the University
Part II NORCB
Page 4
of Oxford, commented that “the
problem with producing a vaccine
against meningitis B is that there
are so many different strains." he
added: "These initial results from
the UK show that the vaccine induces an immune response against
strains containing the vaccine
components. The next step is to
find how broad these responses
are against other strains that
cause disease."
Volume 4, Issue 8
First Word Pharma News: (Click here)
The vaccine entered late-stage
testing earlier this year.
Reference:
Can Vaccines Be Delivered Via the Lungs Instead of by Injection?
In addition to the obvious benefit of eliminating the need for an
injection, new vaccine delivery
methods via the lungs offer particular advantages for protecting
against infectious agents that enter the body through the respiratory track.
A comprehensive review article that presents the current status, challenges, and opportunities
of pulmonary vaccine delivery is
published in Journal of Aerosol
Medicine and Pulmonary Drug Delivery, a peer-reviewed journal
from Mary Ann Liebert, Inc.,
publishers.
In "Pulmonary Vaccine Delivery: A Realistic Approach?"
Wouter Tonnis and coauthors
from University of Groningen
and National Institute for Public
Brain Cancer
Bevacizumab
Survival
A new population-based
study has found that patients
with glioblastoma who died in
2010, after the Food and Drug
Administration (FDA) approval
of bevacizumab, had lived significantly longer than patients who
died of the disease in 2008, prior
to the conditional approval of the
drug for the treatment of the
deadly brain cancer. Bevaci-
Health and the Environment
(Bilthoven), The Netherlands,
describe the unique physiology
and immune responsiveness of
the respiratory track that make
pulmonary vaccine delivery such
an attractive alternative to traditional injections. Although pulmonary vaccination is still a
young field, with much more
research needed, evidence suggests administration of a vaccine
to the lungs can induce a local
immune response more effectively than conventional types of
vaccine delivery, in addition to
stimulating antibody production
throughout the body. This could
be especially important for combating pathogens that cause pulmonary diseases.
unexplored. Theoretically we
should be able to avoid needles and
simply inhale our vaccines," says
Professor and Chief, Division of
Pulmonary and Critical Care Medicine at SUNY-Stony Brook.
Reference:
Science Daily News: (Click here)
"The lung is an immunologic
powerhouse that remains largely
Improved
Following
FDA
Approval
of
zumab is used to treat patients
with certain cancers whose cancer has spread.
strategies involving bevacizumab
prolonged survival in patients
with progressive glioblastoma."
"There has been a great deal of
debate about the effectiveness of
bevacizumab in treating patients
with glioblastoma," says a neurooncologist at Mayo Clinic Cancer
Center. "Our study found that, at
the population level, treatment
Researchers analyzed data on
5,607 adult patients from the National Cancer Institute (NCI) Surveillance, Epidemiology and End
Results (SEER) database before
and after the conditional approval
of bevacizumab for the treatment
Volume 4, Issue 8
of glioblastoma in 2009. The SEER database covers 18 geographic areas of the U.S., which collectively represent 28 percent of the U.S. population.
Part II NORCB
Reference:
Science Daily News: (Click here)
Researchers studied survival in 1,715 patients
with glioblastoma who died in 2006, 1,924 who
died in 2008 and 1,968 who died in 2010. "The
difference in survival between 2008 and 2010 was
highly significant and likely unrelated to any advancements in supportive care," the neurooncologist at Mayo Clinic Cancer Center says.
"This study provides the strongest evidence to date
that bevacizumab therapy improves survival in
patients with glioblastoma."
Glioblastoma, is an aggressive cancer in which
tumors grow rapidly and spread rapidly to new
sites. It is the most common malignant brain tumor in adults and accounts for about 22 percent of
all brain cancers. About 3,000 people develop a
glioblastoma each year in the U.S.
Novartis' Men B vaccine Bexsero approved in Australia
Novartis announced that Australia's Therapeutic Goods Administration approved the meningococcal B (MenB) vaccine Bexsero for use in individuals from two months of age and older. The
company noted that the immunisation "is the first
and only broad coverage vaccine to help protect all
age groups against MenB disease."
According to the drugmaker, the safety and efficacy of Bexsero was studied in trials involving
more than 8000 people, including infants, children,
adolescents and adults. Prior to approval of Bexsero, vaccines were only available against meningococcal bacteria A, C, W-135 and Y. Novartis
said it will now work with Australian authorities to
make Bexsero available in the private market in the
coming months. In addition, the Pharmaceutical
Benefits Advisory Committee is expected to make
recommendations regarding reimbursement and
potential inclusion of Bexsero in the country's immunisation programme.
Bexsero was approved in Europe in January,
while regulatory filings in other markets are under
way. Last month, the UK's Joint Committee on
Vaccination and Immunisation (JCVI) adopted an
interim position against including Bexsero on routine immunisation programmes after determining
the product was unlikely to be cost-effective. At the
time, Novartis said it would supply information on
pricing before the JCVI's decision is finalised..
Reference:
First Word Pharma News: (Click here)
Page 5
What is Pharmacovigilance
According to the WHO, Pharmacovigilance is
A call for reporting
the science and activities relating to the de-
Please remember that you can report suspected adverse
tection, assessment, understanding and pre-
reaction of medicines to EPVC, and adverse reaction
vention of adverse effects or any other medicine-related problem.
following immunization to NORCB using the following communication information
What is the Egyptian Pharmaceutical Vigilance Center
With the increasing demand for patient's
safety which is becoming more stringent, the
Communications information
regulatory authorities are facing an increased demand for patient welfare and
Central Administration of Pharmaceutical Affairs
safety. Thus, The Egyptian Pharmaceutical
Egyptian Pharmaceutical Vigilance Center
Vigilance Center (EPVC) is constructed within
Pharmacovigilance Department
The Central Administration of Pharmaceutical Affairs (CAPA) Ministry of Health to be
21 Abd El Aziz Al Soud Street. El-Manial, Cairo, Egypt, PO Box: 11451
Phone: +202 – 23684288,
responsible for the collection and evaluation
Fax: +202 – 23610497
of information on pharmaceutical products
Email: [email protected]
marketed in Egypt with particular reference
to adverse reactions. Furthermore, EPVC is
taking all appropriate measures to:
1.Encourage physicians and other healthcare
www.epvc.gov.eg
professionals to report the suspected adverse reactions to EPVC.
2.Necessitate the pharmaceutical companies to systematically collect information
on risks related to their medical products
National Organization for Research & Control of Biologicals
and to transmit them to EPVC.
Post Marketing Surveillance and Adverse Event Following
3.Provide information to end-users through
immunization Department
adverse drug reaction news bulletins, drug
51 Wezaret El Zeraa Street, Agouza, Giza P.O. Box: 354 Dokki
alerts and seminars.
Phone: +202 – 37 480 478
Fax: +202 – 37480472
Email: [email protected]
ext. 118