DIANE 35
CONTRACEPTION
DIANE 35 (21 TABLETS) / box
Generic Name: Cyproterone Acetate, Ethinylestradiol
Manufacturer: Schering
Diane 35 are wellknow is most famous birthcontrol pills and
also know as this generic can do an acne treatment.That why many people looking
buy diane 35 and cut some medicine off the package.
But many knid are not looklike please consult to your doctor
brfore using this control pills.Some side effect of diane will caus you less or
much depend on you body.
Below are informaito to preview of diane 35.This information
come from public www we can n ot garantee this is excatly corect and you can
not use this information for you prescription.
1 tablet contains:
2,000 mg of cyproterone acetate
Ethinyl estradiol 0.035 mg tablets
The tablets should be taken in order to pass the package
every day at the same time, liquid, if necessary. An active tablet taken daily
for 21 consecutive days. Each additional package is started after an interval
of 7 days or free compressed period of 7 days of placebo tablets, in which a
withdrawal bleed usually occurs. This usually starts 2-3 days after the last
tablet and may not finish before the next group starts.
Issue
As part of Health Canada's efforts to minimize health risk
factors to Canadians, a safety review was initiated to evaluate the currently
available information regarding the potential risk of blood clots with
DIANE-35. The review was prompted by a French medicines regulatory agency
announcement on January 30th, 2013 indicating its intention to suspend the
marketing authorizations for DIANE-35 and its generics for acne treatment in
France within 3 months. The French decision was triggered by reports of deaths
caused by blood clots associated with the use of DIANE-35 in France.Footnote 1
The Health Canada review includes the consideration of strategies that would
minimize potential risks to Canadians with the use of DIANE-35.
Background
Approved use of DIANE-35 and its generics in Canada
DIANE-35 and its generics are approved in Canada for the
treatment of severe acne with accompanying symptoms of androgenisation (male
characteristics) including excessively oily skin as well as facial and body
hair growth, after topical therapy or systemic antibiotic treatments have
failed. It is to be used only after other acne treatments have not worked. In
discussion with a woman's health care provider, the use of these medicines
should be discontinued when signs of acne have cleared.
Blood clot-related side effects
Blood clots are a rare but well-known side effect associated
with the use of DIANE-35 and other hormonal products containing progestins and
estrogens. The risk of blood clot formation is less common in young, healthy,
non-pregnant women than in those on hormonal products. Other issues that may
increase a woman's chance of developing a clot include older age, smoking,
obesity and periods of immobility such as those associated with long-distance
travel or hospitalization. Some evidence indicates that the chance of
developing clots may be higher during the first year of use with hormonal
products. The risk of blood clots is outlined in the product information
available to the public.
Objective
To assess the available evidence that dealt with a woman's
chance of developing a blood clot while taking DIANE-35. The evidence
considered Canadian patient reports, scientific and medical literature, and
what is known about the use of this medicine both in Canada and
internationally. The currently existing strategies to minimize this risk were
also considered, including a review of the product information available to
health care professionals and patients.
Use of DIANE-35 in Canada
Health Canada estimates the number of prescriptions for
DIANE-35 and generics to be stable over the last five years at approximately
450,000 prescriptions per year, which corresponds to about 40,000 women using this drug each year
in Canada. The major reason for prescribing this medicine is for the treatment
of severe acne, but the data also indicates its usage as a means of birth
control (estimated at 35-40% of prescriptions given by general practitioners
and obstetrician/gynecologists), which is considered an unapproved use of this
drug. However, due to the relatively low number of overall prescriptions for
DIANE-35 in Canada, these figures on use as a means of birth control can only
be used as guidance for estimation.
Canadian reports of blood clots associated with DIANE-35 use
The Canada Vigilance database was searched for reports that
implicated both cyproterone acetate and ethinyl estradiol products and a blood
clot-related incident or any report of death. Reports from the point of
DIANE-35 becoming available in Canada, in 1998, up to May 1, 2013, were
collected. The search retrieved 95 unique reports. A total of 12 reports of
death were identified and were further investigated. In 10 out of the 12 cases,
the likelihood of the drug causing the death was considered to be at least
"possible," with the other two reports containing not enough
information to determine whether or not the drug caused the death. However, in
nine out of these possible 10 cases, the patients had additional risk factors
that would predispose or make it possible for them to have blood clots, such as
obesity, smoking, previous trauma and decreased mobility. The case reports do
not indicate a change in the known safety profile of DIANE-35 for blood clots
in Canada.
Scientific Reports
The review considered the scientific and medical literature.
Several scientific studies addressed the risk of blood clots with different
types of hormonal products such as DIANE-35 and birth control pills. The risk
of blood clots with these products was compared to the risk of blood clots in
women that do not use these products. It was found that the occurrence of blood
clots in users of DIANE-35 was higher than non-users but similar to some of the
hormonal birth control products currently available on the Canadian market. It
was concluded that this information does not point to a higher risk of blood
clots than what is already known about DIANE-35 and outlined in the product
information.
Usage of DIANE-35 in France and internationally
It was important to determine how DIANE-35 was being used in
other countries to better understand the French medicines regulatory agency's
decision. At that time, the approved use of the drug in France was for treating
acne, potentially exposing a greater number of French patients to the risk of
blood clots than in Canada. In comparison, the approved use in the United
Kingdom is similar to Canada: for treatment of moderate to severe acne and
after used topical therapy or systemic antibiotic treatments have failed.
Conclusions and Actions
The current prescribing information for DIANE-35 already
contained warnings about the risk of blood clots. This information is supported
by evidence from key scientific studies. Considering the current evidence and
discussions that have taken place internationally, Health Canada is adopting a
precautionary approach and has updated the prescribing information to provide
further clarity regarding this rare but known risk. The completion of the
review was communicated in the form of an advisory, to inform the public and
health care professionals about the safe use of this product in the appropriate
patient population. Health Canada's review of the safety of the anti-acne
medication DIANE-35 has found that the drug's benefits continue to outweigh the
risks, when used as authorized.
Full Review Reports
Full review reports are available upon request to Marketed
Health Products Directorate. These reports are subject to redactions of
personal and confidential information.
References
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(dated June 17, 2010)
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