Yasmin® does not cause more side-effects than other contraceptive pills

There is an increased risk of blood clots in women taking contraceptive pills. This risk has been known since contraceptive pills entered the market in the 1960s, which was an important step in the development of contraception for women. The contraceptive pill Yasmin® entered the Danish market in 2001. Since then, the Danish Medicines Agency has monitored adverse reactions from Yasmin® and assessed Yasmin®'s adverse drug reaction profile in relation to other contraceptive pills of the combination type. The Danish Medicines Agency assesses that there are not more adverse reactions, including blood clots, associated with Yasmin® compared with other contraceptive pills of the same type.

Our assessment is based on a sizeable volume of adverse reactions reports and European studies. In Denmark , a higher number of adverse reactions has been reported for Yasmin® compared with other contraceptive pills of the same type. However, the volume of reported adverse reactions in Denmark only offers an extremely small basis on which to assess the adverse drug reactions profile, and the Danish Medicines Agency therefore bases its assessment on European studies, which show that the risk of side-effects is on a par with that of other contractive pills of the combination type.

When the contraceptive pill was introduced on the market, the manufacturer of Yasmin® was required to perform further studies of the adverse reactions profile. Consequently, Yasmin® is thoroughly tested today. The risk of blood clots appears from the summary of product characteristics; see the factbox to the right (in Danish only). The summary of product characteristics has changed during Yasmin®'s life on the market in line with new information about adverse reactions.

The Danish Medicines Agency requests doctors to report adverse reactions

It is important that adverse reactions are reported to the Danish Medicines Agency. Doctors and medicine users are therefore requested to report adverse reactions to the Danish Medicines Agency, see the factbox to the right.

Also keep in mind that

• all medicinal products have side-effects,
• side-effects are monitored throughout the life of the medicinal products,
• unknown side effects may emerge.

Follow-up on TV documentary featuring Yasmin ® on 3 June 2007 : Follow-up actions by the Danish Medicines Agency

The Danish Medicines Agency is investigating whether the information from the TV documentary by TV2 on 3 June 2007 represents new knowledge, e.g. whether the side-effects referred to have been reported to the Danish Medicines Agency.

For further information, please contact Chief Medical Officer Doris Irene Stenver, telephone +45 4488 9247.

The Danish Medicines Agency, 6 June 2007