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Gynecology  Contraception
 
 
Birth control patch

Birth control
patch 'riskier
than the Pill'
 


A contraceptive patch used by thousands of British women releases much higher levels of a hormone known to cause blood clots than the Pill, say safety watchdogs.

 
 

12/11/05

The discovery has led to new labelling for the Evra patch in the US, where it was developed.

But it is unclear whether British users will get the same warning or if those using the once-a-week patch are at greater risk of life-threatening blood clots.

Other side effects linked to the self-adhesive patch include strokes and heart attacks, with increased risks for smokers.

Women who use the patch are exposed to 60 per cent more oestrogen than a typical oral contraceptive, according to the US Food and Drug Administration, which ordered the change in labelling.

The product is made by Ortho McNeil Pharmaceuticals, a subsidiary of Johnson & Johnson, which said in a statement that it was currently not known whether there would be changes in the "risk of serious adverse events" as a result of the higher levels.

The company said the patch remained a "safe and effective" birth control option for many women, when used according to the product's label.

Most side effects were minor, with "infrequent" serious adverse events reported by users, it said.

Certain women should not use the patch, including those with blood clots, certain cancers and a history of heart attack or stroke.

In the US, however, the patch has been linked to more than a dozen deaths. It has also been linked to several 'life-threatening' complications, including two British women who suffered problems caused by blood clots.

When it was launched here in June 2003, Evra was hailed as the biggest revolution in family planning since the Pill. It is believed that around 10,000 British women a year use it.

The patch, which also releases the hormone progestogen, provides virtually guaranteed protection against unwanted pregnancy.

Trials of 3,319 women found that only 15 became pregnant - about 0.4 per cent. Women were urged last night not suddenly to remove the patch, which is put on once a week with a break every fourth week. The fpa (formerly the Family Planning Association) advised them to discuss the options with their doctor before stopping use.

Toni Belfield, director of information at the fpa, said: "Any new information about how a method works, its advantages and disadvantages is useful as it enables women to make a more informed choice about their contraception.

"Women should not suddenly stop using the patch as they would risk pregnancy, but if concerned should seek advice from their health professional."

The European Medical Evaluation Agency is due to consider the US move, which might affect labelling in the UK.

In the US, the patch was promoted by supermodel Naomi Campbell and the Norwegian Olympic beach volleyball players. It has been used by more than five million women worldwide.


Source: Daily Mail

© 2005 Associated New Media