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New “morning-after” pill effective and safe: FDA staff


3 Star

New “morning-after” pill effective and safe: FDA staff

Our Review Summary

By definition, emergency contraception is meant to be used only when other means of contraception fail. Controversy about emergency contraception typically centers around how it works – whether it prevents ovulation or blocks implantation of a fertilized egg. If emergency contraception works after fertilization, some would consider it an aborting agent. Regardless of its method of action, however, emergency contraception provides a safe and effective alternative to abortion. Although many women experience uncomfortable side effects from the medication, these are temporary and there are very few risks.

In the US, the most commonly used emergency contraceptive is Plan B or levonogestrel. It contains the progestin commonly found in most birth control pills, but in much higher doses. Plan B acts to prevent ovluation. Mifeprex, or RU-486, can be used as an emergency contraceptive or aborting agent depending on when it is used. Last year, the EllaOne was approved for use in Europe and the UK. It has been shown to be effective for up to 5 days after contraceptive failure and has few side effects. Now, the FDA will meet to decide on its approval for use in the US.

This story about EllaOne does not mention costs, does not adequately describe the strength of the available evidence to support the drug and does not provide quantification of the benefits or harms of the drug. And it doesn’t quote any independent sources outside of the FDA or the pharmaceutical company. Quoting independent sources to provide some perspective on what this might mean to women would have greatly improved this story.


Why This Matters

The absence of cost info, of comparisons to the most important alternatives (Plan B or Mifeprex), and of any sense of the scope of the benefits or harms were problems with this story.  It was not clear that any independent vetting of claims took place.


Does the story adequately discuss the costs of the intervention?

Not Satisfactory

The story does not mention costs. Although it is hard to say definitively how much the drug would cost in the US since it is not yet available, the story could have mentioned the cost of the drug in Europe or provide an estimate from the drug manufacturer or even from an analyst.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The story provides no quanitification of benefits from the drug. Ideally, the story would have described the likelihood of pregnancy after uNPRotected sex with or without the drug. According to British sources "It is estimated that for every 100 women who take Ellaone up to five days after uNPRotected sex, approximately two women will become pregnant. The tablet is more effective at preventing pregnancy the earlier it is taken, so it is important to take it as soon as possible after uNPRotected sex, rather than delay it to the fifth day."

Does the story adequately explain/quantify the harms of the intervention?


The story mentions that the FDA found no unexpected adverse events and describes the side effects of the drug including nausea, headache and abdominal pain as "common." The package insert for EllaOne describes these side effects as affecting more than 10% of users. It would have been helpful if the story had cited that stat.

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

The story does not describe the quality of the evidence to support the use of the drug.

Does the story commit disease-mongering?


The story does not engage in disease mongering.

Does the story use independent sources and identify conflicts of interest?

Not Satisfactory

The story quotes no independent sources outside of the FDA or the pharmaceutical company. Quoting independent sources to provide some perspective on what this might mean to women, would have greatly improved this story.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

Although the story mentions other emergency contraceptive options, it does not really describe the pluses and minuses of the new approach compared to the most important alternatives, Plan B or Mifeprex.

Does the story establish the availability of the treatment/test/product/procedure?


The story clearly states that the FDA is now reviewing the drug and that it is not yet available in the US but is available in Europe.

Does the story establish the true novelty of the approach?


Clearly the drug is not new since it is already available in Europe. The FDA is now considering its approval for use in the US.

Does the story appear to rely solely or largely on a news release?

Not Applicable

Not applicable because we can’t be sure if the story relied solely on a press release.

Total Score: 4 of 9 Satisfactory


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