The YASMIN Secret X files  !!!
 
 

 

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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                                                  
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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

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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

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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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Produced by Dr. Jose Lapenta R. Dermatologist 
Maracay Estado Aragua Venezuela 2.004  
  Telf: 0416-6401045- 02432327287-02432328571