The US Food and Drug Administration is looking into whether morning-after 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 — sold in Europe 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 labelling change was based”, said FDA spokeswoman Erica Jefferson.
“The agency will then determine what, if any, labelling changes to approved emergency contraceptives are warranted.”
HRA scientists found Norlevo began losing effectiveness in women who weigh about 165lb (75kg) and was not at all effective in those weighing over 176lb (80kg), CNN and others reported.
HRA was conducting research on another topic related to Norlevo when scientists realised there was “a clear impact of weight” on the drug’s effectiveness, HRA chief executive, Erin Gainer said, according to the CNN report.
Weight restrictions on Plan B. Apparently if you're over 176 pounds (quiet specific weight) the pill will not work on you.— SweetNeesey (@Sweetneese) November 25, 2013
The Irish Medicines Board said: “Like the FDA, the IMB together with its EU counterparts is also currently reviewing the available data on this issue, to consider the need for updates to the product information and subsequent communication to healthcare professionals.
“As with all medicines the IMB continuously monitors their safety to ensure that an appropriate balance exists between the benefits of a particular medicine against the potential risks.”
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