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US panel rules that warnings on two birth control pills be strengthened

BMJ 2011; 343 doi: https://doi.org/10.1136/bmj.d8104 (Published 13 December 2011) Cite this as: BMJ 2011;343:d8104
  1. Jeanne Lenzer
  1. 1New York

Labels on the popular birth control pills Yasmin and Yaz should be strengthened to include more information about the possibility that they could increase the risk of blood clots, an advisory committee to the Food and Drug Administration said on Thursday 8 December.

The panel, which voted 21 to five in favour of changing the labels, stopped short of recommending that the labels should warn that the drugs, whose main active ingredient is drospirenone, are more likely than other contraceptive pills to cause blood clots. Instead the experts suggested that the labels say that the evidence about blood clots is conflicting. The panel also decided by 15-11 that the drug’s benefits outweighed its risks.

The panel reached its decision after reviewing a number of studies of drospirenone, some of which found an increased risk of thromboembolic events.

However, the panel was not shown documents that are at the heart of a report by David Kessler, a former …

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