U.S. FDA reviewing if weight limits effect of 'morning after' pill

(Reuters) – The U.S. Food and Drug Administration said it was looking into whether morning-after emergency contraceptive pills fail to work in women over a certain weight and will decide whether to add a warning to the drug’s label. The agency was reacting to reports that European health regulators had ordered a label change for the emergency contraceptive product sold there by French drugmaker HRA Pharma under the brand name Norlevo, requiring it to include the drug’s diminishing effectiveness based on weight. The FDA is “currently reviewing the available and related scientific information on this issue, including the publication upon which the Norlevo labeling change was based,” FDA spokeswoman Erica Jefferson said on Monday via an email. “The agency will then determine what, if any, labeling changes to approved emergency contraceptives are warranted.” HRA scientists discovered that its Norlevo began losing effectiveness in women who weigh about 165 pounds (75 kilograms) and was not at all effective in women weighing over 176 pounds (80 kg), according to reports on CNN and elsewhere.