The
YASMIN contraceptive secret X FILES !!!
Expediente Secretos X del anticonceptivo YASMIN, !!!
Data-Medicos
Dermagic/Express No. 6-(X-9)
11 Enero 2.004 /11 January 2.004
EDITORIAL ESPAÑOL
=================
La gran pildora anticonceptiva llamada YASMIN, del laboratorio SCHERING ALEMANA
lanzada al mercado en EUROPA en el año 2000 y que recientemente se esta
comercializando en Venezuela, parece que esta comenzando a tener PROBLEMAS, en
estos EXPEDIENTES X del dia de hoy les demuestro de una manera clara y sencilla
que NO TODO LO QUE BRILLA ES ORO. YASMIN esta involucrada en eventos de
TROMBOEMBOLISMO con apenas 17 dias de tratamiento y causo la muerte de una joven
de 17 años de tromboembolismo venoso hace un año en Alemania.
Se han descrito mas de 4O CASOS DE TROMBOEMBOLISMO atribuidos
a YASMIN a nivel de piernas y pulmonares. El colego Medico de Alemania ha
decidido que YASMIN ES UNA PILDORA DE segunda generacion porque se carecen
de datos epidemiologicos sobre sus efectos adversos sobre el TROMBOEMBOLISMO.
Asi que amigos dermagicos esten pendiente de esta droga. !!!
Parece que la pildora del gran bienestar no cumplio con su
"slogan" e incluso hay un grupo de medicos que publicamente ha fijado
posicion en el hecho de que YASMIN NO DEBE SER PROPAGANDEADA COMO TAL ! El nuevo
anticonceptivo es una combinacion de DROSPIRENONA (un progestageno) y
ETINILESTRADIOL
Saludos a todos
Dr. Jose Lapenta R
ENGLISH EDITORIAL
================
The great called birth-control pill YASMIN, of the GERMAN laboratory SCHERING
rushed to the market in EUROPE in the year 2000 and that recently is marketing
in Venezuela, it seems that is beginning to have PROBLEMS, in these FILES X of
today's day demonstrates to all in a clear and simple way that NOT ALL THAT
SHINES is GOLD. YASMIN is involved in events of THROMBOEMBOLISM with hardly 17
days of treatment and I have caused the death of a 17 year-old Dutch last year
in Germany.
They have been described but of 4O CASES OF THROMBOEMBOLISM
attributed to YASMIN, at level of legs and lung. The German Medical school he
has decided that YASMIN is A PILL OF second generation because they are lacked
epidemic data on its adverse effects on the THROMBOEMBOLISM. So dermagics
friends be careful of this drug. !!!
It seems that the pill of the great well-being didn't fulfill
its "slogan" and there is even a group of doctors that openly it has fixed
position in the fact that YASMIN should NOT BE ANNOUNCED LIKE that! The new
contraceptive, is a combination of DROSPIRENONE (a progestogen) and
ETHINYLESTRADIOL.
Greetings to all
Dr. José Lapenta R
=======================================================
REFERENCIAS BIBLIOGRAFICAS/
BIBLIOGRAPHICAL REFERENCES
=======================================================
1.) Dutch GPs warned against new contraceptive pill
News.
2.) Thromboembolism associated with the new contraceptive Yasmin.
3.) [Venous thromboembolism and combined oral contraceptives. Reported adverse
reactions indicate at least similar risk with the most recent contraceptive
pills].
4.) Yasmin advert withdrawn--why and how.
=======================================================
1.) Dutch GPs warned against new contraceptive pill
News
Tony Sheldon, Utrecht
Source:BMJ 2002;324:869 ( 13 April )
Dutch GPs are being advised by their own
professional body not to prescribe a new low dose, monophasic oral contraceptive,
marketed under the trade name Yasmin, until studies have established whether it
is as safe as other contraceptive pills.
The new contraceptive, which is a combination of drospirenone (a progestogen)
and ethinylestradiol, has been available in several European countries since
2000 and was approved by the US Food and Drug Administration last May. It is
licensed for use in the United Kingdom, where it is being launched next week.
Last year a 17 year old Dutch girl who had been taking Yasmin died from a venous
thrombosis. Although no direct link with Yasmin has ever been shown, 40 cases of
venous thrombosis among women taking Yasmin, two of which were fatal, have now
been reported in Europe.
The Dutch College of General Practitioners has now reiterated its position that
GPs should continue to choose the second generation pill, because of the lack of
epidemiological data on the risk of thrombosis from Yasmin.
The Dutch Medicines Evaluation Agency, which has a leading role in the European
Union in assessing the safety of Yasmin, has as a result of the two deaths asked
that the drug carry a warning that the risk of venous thrombosis from using it
remains unknown. Before licensing Yasmin the agency had also asked for more
research into side effects and coagulation. Final results from a comparative
study over three years involving 3000 women have yet to be published.
The agency said: "The impression exists that GPs are inclined to prescribe the
new pill earlier in the assumption that the risk of venous thrombosis is smaller
than with the second and third generation of contraceptive pill," but added that
this cannot be concluded from the available data.
Speaking on a Dutch radio station, Frits Rosendaal, professor of clinical
epidemiology at Leiden University Medical Centre, called for GPs not to
prescribe Yasmin until the risk of venous thrombosis was known.
He said: "I am not satisfied it is absolutely safe." He was alarmed that as many
as 40 cases have been reported voluntarily by doctors so soon after Yasmin was
registered. "Doctors seem to believe it is safer, but we don't know. We are
making the same mistake as with the third generation contraceptive pill."
Yasmin's manufacturer, the German pharmaceutical company Schering, is "absolutely
convinced of the safety of Yasmin." It has written to all Dutch GPs,
gynaecologists, and pharmacists, saying that the 40 reported cases of venous
thrombosis among a million users of Yasmin, mainly in Europe, do "absolutely not
indicate an increased risk of venous thrombosis."
A Schering senior medical adviser, Dr Egbert Klaassen, said the company had
conducted all the necessary research acceptable to the Medicines Evaluation
Agency and the FDA. Interim results from Schering's post-marketing surveillance
study of a million cycles show that, after one year, one venous thrombosis
occurred among Yasmin users, compared with five among users of other oral
contraceptives.
Yasmin has been licensed in Europe since November 2000. Schering estimates that
about 35000 women are using it in the Netherlands and 500000 throughout 17
countries in Europe
=======================================================
2.) Thromboembolism associated with the new contraceptive
Yasmin.
Kees van Grootheest, Tom Vrieling
Source: BMJ. 2003 February 1; 326 (7383): 257
Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH 's-Hertogenbosch,
Netherlands
Correspondence to: K van Grootheest [email protected]
Our centre, the Dutch spontaneous reporting system for adverse drug reactions,
recently received five reports of thromboembolism as a suspected adverse drug
reaction to the new oral contraceptive Yasmin (ethinylestradiol and drospirenone).
A 17 year old woman suddenly collapsed and died after taking the contraceptive
for six months. Autopsy showed that she had had a massive pulmonary embolism. No
obvious risk factors for thromboembolism, such as smoking, a period of long
immobilisation, air flights, or concomitant medication, were evident.1 Because
she died suddenly no blood sample was taken. Blood taken from her parents did
not test positive for any of the known risk factors: concentrations of protein C
and antithrombin III were normal. The activated partial thromboplastin time and
partial thromboplastin time were normal, and the existence of factor V Leiden
mutation was excluded.
A 28 year old woman changed her oral contraceptive from ethinylestradiol with
desogestrel (Marvelon) to ethinylestradiol with drospirenone. Four months later
she had thrombosis in one leg and was treated with acenocoumarol. Risk factors
or concomitant drugs were unknown.
Another patient, a 45 year old woman, had deep vein thrombosis in one leg after
taking ethinylestradiol with drospirenone for two months, as did a 50 year old
woman who took the contraceptive for three months. A 35 year old woman had
pulmonary thrombosis 17 days after she started taking the contraceptive. She had
given birth four months earlier.
Ethinylestradiol with drospirenone has been approved as an oral contraceptive in
all European Union countries since 2000 and has recently been launched in the
United Kingdom.2 The public assessment report of the contraceptive gives only
one suspected case of pulmonary embolism but also says that the number of cases
in the preregistration studies are too low for a reliable conclusion on this
matter.3
The risk of thromboembolism for women using the third generation (combined) pill
has long been debated. Physicians therefore may prefer a new type of combined
pill, like ethinylestradiol with drospirenone, assuming that these are safer.
However, an association of these drugs with a lower risk of thromboembolism has
not been proved by research, and our cases show that newer contraceptive pills
may have a risk of thromboembolism. At present, insufficient data on the
superiority of ethinylestradiol with drospirenone are available.
References
1.) Winkler, UH. Oral contraception in women at risk of venous disease. Gynaecol
Forum 2001; 6: 2328 .
2.) Sheldon, T. Dutch GPs warned against new contraceptive pill. BMJ 2002; 324:
869 . [PubMed][Free Full Text]
3.) Official site of Dutch medicines evaluation board. http://www.pubmedcentral.nih.gov/redirect.cgi?&&reftype=other&artid=140765&&http://www.cbg-meb.nl/nl/docs/gnsmiddl/par-yasmin.pdf
(accessed 21 October 2002).
3.) [Venous thromboembolism and combined oral contraceptives.
Reported adverse reactions indicate at least similar risk with the most recent
contraceptive pills]
Lakartidningen. 2003 Sep 25;100(39):3050-2.
[Article in Swedish]
Kieler H, Persson I, Odlind V.
Lakemedelsverket, Uppsala. [email protected]
Rare adverse drug reactions (ADRs) to combined oral contraceptives (COCs), such
as venous thromboembolism (VTE), are seldom disclosed until a COC has been on
the market for some time. Two new COCs, Yasmin and Cilest have recently been
launched in several European countries with expectations of being safer than
older COCs. Utilising data from spontaneous reporting of ADRs to the Medical
Products Agency in Sweden and sales data, VTE incidence for Yasmin and Cilest
was estimated and compared with VTE incidence for a second (Follimin) and a
third generation (Desolett) COC. The reported VTE incidence for Yasmin and
Cilest was higher 4.6, and 3.7 per 10,000 users per year, respectively than the
corresponding VTE incidences for Follimin and Desolett of 1.9 and 2.9 per 10,000
users per year, respectively. The differences were, however, not statistically
significant. We conclude that the risk of VTE associated with the most recent
COCs is at least similar to that of older COCs.
4.) Yasmin advert withdrawn--why and how.
Drug Ther Bull. 2003 Mar;41(3):17-8.
[No authors listed]
In April 2002, Schering Health Care launched its combined oral contraceptive (COC)
pill Yasmin in the UK with an advertising campaign that centred on claimed 'lifestyle'
advantages of the product. In our August 2002 article 'Is Yasmin a "truly
different" pill?', we concluded that the company's claim that Yasmin is "the
pill for wellbeing" was unjustified and misleading and should be withdrawn. We
also argued that there was no compelling published evidence that Yasmin offered
any advantages over other, longer-established, COCs with regards to weight gain,
skin condition or premenstrual symptoms. In September, we received a letter from
Schering's solicitors threatening to sue us for defamation on the grounds that "the
article has damaged the reputation of Yasmin and the Company". In December, we
learned that the company had withdrawn the advertising. Here, we summarise the
events that led to the withdrawal. We also consider the weaknesses this episode
reveals about current procedures for controlling medicines promotion in the UK.
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DATA-MEDICOS/DERMAGIC-EXPRESS No 6-(X-09) 11/01/2.004 DR. JOSE
LAPENTA R.
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