Big pharma’s latest secret: the morning after pill may not work if you weigh over 165 pounds

nm_plan_b_070914_msThe morning after pill may be less effective on women who weigh 165 pounds or more; it may be totally ineffective on women who weigh 176 pounds or more; in Europe, the morning after pill is not recommended for women who weigh 165 pounds or more. So why doesn’t the average American woman know that her emergency contraception might not work? 

HRA Pharma, the French manufacturer of the European drug, Norlevo, is changing its packaging, big time. It will now warn users that the drug is ineffective in women weighing over 176 pounds and less effective in women who weigh more than 165 pounds. It will even recommend that women who weigh 165 pounds not take the pill. But why does that matter to women in the U.S. of A? Because, as Molly Redden points out in Mother Jones,  Norvelo, is chemically identical to Plan B One-Step, Next Choice One Dose, My Way, and several generic emergency contraceptives. Given that the average American woman weighs 166.2 pounds, this is especially significant: “There’s a whole swath of American women for whom (these pills) are not effective,” explains James Trussell, a professor of public affairs at Princeton University and a senior fellow with the Guttmacher Institute. But unlike their sisters overseas, American women won’t be getting any warnings about this risk.

In Europe, it works and worked like this: in 2011 a professor of obstetrics and gynecology at the University of Edinborough published research showing that emergency contraceptive pills were less effective on women who weighed more. In 2012, HRA Pharma started reviewing this data and got permission from the European Union to update its warning. In 2014, every single box of Norlevo will say ”Studies suggest that Norlevo is less effective in women weighing [165 pounds] or more and not effective in women weighing [176 pounds] or more” and that Norlevo “is not recommended…if you weigh [165 pounds] or more.”

In the U.S., however, as Redden explains,

the Food and Drug Administration prohibits generic drug manufacturers from changing product information unless the brand name manufacturer makes a change, companies that manufacture generic versions of Plan B One-Step cannot update their packaging information unless Teva Pharmaceutical Industries, the exclusive manufacturer of Plan B One-Step, acts first.

You mean, the FDA and pharmaceutical companies aren’t doing everything they possible can to ensure the health and safety of women? I can’t believe it! (If you can’t believe it, check out Dallas Buyers’ Club)

And, of course, as the comments posted in response to the Mother Jones article demonstrate, this news is being met with a beautiful combination of fat-shaming and slut-shaming.

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  1. Posted November 25, 2013 at 3:33 pm | Permalink

    A couple important considerations:

    1) Is the effectiveness truly based on weight, or on bodyfat percentage? While I can’t confirm this, I believe it’s the latter because I have heard that the medication is lipophilic, so the decrease in effectiveness is based on binding easily to fat. So perhaps it could still work for, say, a particularly tall or muscular 176-pound woman even if it doesn’t work for a short, not-so-muscular 176 pound woman…?

    2) If the above is true, why do these studies specify a weight instead of a bodyfat percentage? Weight itself doesn’t mean very much when you consider different heights and muscularity.

    3) I’ve read that increasing the dosage isn’t PROVEN to change the effectiveness, but is that only because no formal studies have been done?

    • Posted November 28, 2013 at 12:06 pm | Permalink

      According to the actual study, there was a correlation between both BMI and weight.

      I may be naive, but I don’t think this is some grand cover-up by evil big pharma. This is one statistical analysis of two studies. The results are certainly interesting, but I would need to see the methodology of the first studies. Frankly the paper isn’t very in depth. And I want to know how this works. Is it a dosing effect? Is it because of the lipophilic mechanism? How did they control for other factors in the original study? Is there any consensus in the field?

      I know that it may seem like the US is not well regulated because the only thing people hear about are the mistakes. But as a researcher, (on the academic side, but still) I do see the other side of things. The amount of regulation that goes into all this is extremely high. Honestly, it’s completely overwhelming. And frankly, I don’t want companies to have to change their labels bases on one study. That would be [redacted for ableism], the labels would never be the same. But they should follow up on this and see if this is valid.

  2. Posted November 25, 2013 at 9:03 pm | Permalink

    That is so frustrating! As a plus sized woman, this would definitely effect me if I needed to use Plan B. FDA needs to prioritize women’s health and the misconceptions they are portraying than caring about the politics of it all. Health needs to come first.

  3. Posted November 25, 2013 at 11:18 pm | Permalink

    What about the original two-pill version of Plan B? Do we know if there are the same issues with effectiveness in women over 165 pounds?

    • Posted November 27, 2013 at 1:27 am | Permalink

      It probably has the same problems. It is the same ingredient just taken in 2 doses instead of 1

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