The European Medicines Agency (EMA) will take a deep dive into whether over-the-counter emergency contraceptives--the so-called "morning-after pill"--don't work well in heavier women. It will review a handful of the approved products in Europe. The FDA is doing the same with the Plan B drug sold in the U.S. by Teva Pharmaceutical Industries ($TEVA).
The chain reaction review process began last fall after scientists with French drugmaker HRA Pharma discovered its own drug, Norlevo, doesn't really work in women who weigh more than 176 pounds, and is less effective at 165 pounds. Regulators in Europe responded by having the drugmaker make labeling changes to warn women. The FDA then decided it was going to investigate the question of effectiveness itself.
"The agency will then determine what, if any, labeling changes to approved emergency contraceptives are warranted," an FDA spokeswoman told Reuters at the time.
The EMA today said that the emergency contraceptives being reviewed include a number of medicines that are approved at the national level that contain the progestogen (hormone) levonorgestrel, including Norlevo, Levonelle/Postinor and Levodonna. It also is roping in a review of ellaOne, which contains ulipristal acetate and was granted a marketing authorization in Europe in 2009.
In the U.S., the FDA and the White House went through a pitched political battle--which it eventually lost--to limit access to Teva's Plan B One-Step and other similar birth control drugs to women who were at least 17 years old. A federal court had ordered the drugs available, over-the-counter and without restrictions to females of all ages.
- here's the release