Plan B doesnt work if you weigh more than 165

[Raptor]

Sorry if this shouldnt be in snark but its big news

motherjones.com/environment/2013/11/plan-b-morning-after-pill-weight-limit-pounds

The European manufacturer of an emergency contraceptive pill identical to Plan B, also known as the morning-after pill, will warn women that the drug is completely ineffective for women who weigh more than 176 pounds and begins to lose effectiveness in women who weigh more than 165 pounds. HRA Pharma, the French manufacturer of the European drug, Norlevo, is changing its packaging information to reflect the weight limits. European pharmaceutical regulators approved the change on November 10, but it has not been previously reported.

This development has implications for American women. Some of the most popular emergency contraceptive pills sold over the counter in the United States—including the one-pill drugs Plan B One-Step, Next Choice One Dose, and My Way, and a number of generic two-pill emergency contraceptives—have a dosage and chemical makeup identical to the European drug. Weight data from the Centers for Disease Control and Prevention (CDC) suggests that, at 166 pounds, the average American woman is too heavy to use these pills effectively.

It also seems that most pills wont be allowed to change their packaging to show the new studies

But American manufacturers do not currently advise American customers of weight limits for levonorgestrel-based emergency contraceptives.

Because 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. (The FDA has proposed a rule change that would allow generic manufacturers to update drug information independently.) A spokeswoman for Teva declined to comment for this article.

It is not clear whether drugmakers can formulate an effective levonorgestrel pill for women who weigh more than 165 pounds. "A dose increase of levonorgestrel is not proven to be a solution for this problem," notes Gajek, the HRA Pharma spokeswoman. "However, women with higher weight are advised to discuss alternative emergency contraceptive options with their physician: IUD or alternative oral emergency contraceptive." In the United States, IUD insertion can cost anywhere from $500 to $900.

I'm assuming that there will not be a recommendation to take two pills depending on your weight.

[Mama Mia]

That's incredibly immoral if the manufacturer knows its ineffective for a large segment of the population but doesn't prominently warn people!

[Dysfundamental]

One thing that's bugging me a lot about this is that "weighing more than 165" is being equated with "being overweight" in the coverage of this as though women are all one height. I read the original paper, and it's an issue there, too.

[Trynn]

One thing that's bugging me a lot about this is that "weighing more than 165" is being equated with "being overweight" in the coverage of this as though women are all one height. I read the original paper, and it's an issue there, too.

That's what I was thinking.. not all women who are 165 are overweight. In fact, that actually sounds about right for certain women I know who are taller.

I thought this thread was going to be some stupid fundy pulling bs out of her butt. This is worse.

[Rita]

This is bad, ethically and for business. I've posted the article on my Fb, and I think it's something everyone should read. And we shouldn't have to say this, either, but yes, it's fat-shaming, and that's wrong, too.

[singsingsing]

I'm 5'8", which is fairly tall but not like OMG GIANT, and according to the BMI I'd be just barely overweight if I weighed 165 LBS. If you're 6'0" and 165 LBS you'd be right in the middle of the normal/healthy range. It's too bad that Plan B won't work for women over a certain weight, it's really skeezy that the company won't put that on its labels, and it's ridiculous that people are assuming that everyone over 165 LBS is overweight (and so what is someone is?).

[Ariel]

Did they state why it won't work for women over 165? It is it just that there isn't enough hormone in one pill for larger women?

I agree that you can just choose a number and apply it to all women. As a 5'8 woman, 165 is overweight for me according to BMI, but I'm a medium and don't "look" overweight.

[SPHASH]

This is the first time I've heard you can't be overweight to take Plan B.

[LeopardLady]

According to the original study abstract (I couldn't get to the actual full article), it isn't a certain weight cut off, but a certain BMI that causes the ineffectiveness. I'd guess that there was some decision made by the European manufacturer using an assumption of average height because people are much more likely to know (or easily measure) their weight as opposed to BMI.

http://www.ncbi.nlm.nih.gov/pubmed/21920190

[thekate]

Did they state why it won't work for women over 165? It is it just that there isn't enough hormone in one pill for larger women?

I agree that you can just choose a number and apply it to all women. As a 5'8 woman, 165 is overweight for me according to BMI, but I'm a medium and don't "look" overweight.

No, they said increasing the dosage doesn't increase effectiveness.

I've read a couple articles and none seem to address whether it's the actual lbs. or the BMI that reduces effectiveness.

x-post w/ LeopardLady - Thanks for the link...it answers my 2nd comment.

[doggie]

weight is accurate BMI is a made up term that is about as accurate as a fundy is with evolution quit a lot of the time. it was formula made up in the 1800's if I remember right.

[LeopardLady]

weight is accurate BMI is a made up term that is about as accurate as a fundy is with evolution quit a lot of the time. it was formula made up in the 1800's if I remember right.

Sadly the researchers used BMI as their measurement, despite it not being accurate. I wish they had taken the time to do the study using % body fat as that's what the study seems to be implying. However, modern medicine has sadly decided BMI is a close-enough approximation of body fat.

[Khiwanean]

Sadly the researchers used BMI as their measurement, despite it not being accurate. I wish they had taken the time to do the study using % body fat as that's what the study seems to be implying. However, modern medicine has sadly decided BMI is a close-enough approximation of body fat.

Which is especially ridiculous when you consider that when we studied BMI in my high school health class, a significant number of the athletes scored as obese, even though they clearly weren't.

[LeopardLady]

Which is especially ridiculous when you consider that when we studied BMI in my high school health class, a significant number of the athletes scored as obese, even though they clearly weren't.

I feel like it would be important to tease out at some point those who have high BMI due to muscle or those who have high BMI due to fat. The difference could be important in determining the mechanism of why it doesn't work.

[LeopardLady]

Which is especially ridiculous when you consider that when we studied BMI in my high school health class, a significant number of the athletes scored as obese, even though they clearly weren't.

I feel like it would be important to tease out at some point those who have high BMI due to muscle or those who have high BMI due to fat. The difference could be important in determining the mechanism of why it doesn't work.

[Raptor]

http://planbonestep.com/faqs.aspx

Whats amazing is that there is nothing about anything regarding weight, height, BMI etc anywhere on their site. No mention if its a fat soluble issue, a dosage issue, a delivery issue. I'm absolutely flummoxed that I've kept something in my home assuming that it would protect me for the past few years should I ever, g-d forbid, need it and they knew all along that it would not.

This needs to be on the nightly news.

[singsingsing]

I know that BMI isn't the most accurate tool out there, but it's not complete bullshit either. Yes, there is some leeway, but let's face it, if you are 5'2" and 200 LBS you ARE overweight, and if you're 6'3" and 120 LBS you ARE underweight.

[mg78]

This is not surprising. I think that the study is talking about BMI because that is data easy accesible than actually having to measure the body fat percentage of each participants.

We are talking about a medication that has to override your own body physiology in a major way. It is not uncommon for many drugs to be prescribe based on how much a person weights. As I remember, accutane dosage depends on your weight and many other drugs as well, independent of your BMI. would not be surprise if the amount of active ingredient in plan B is not enough if your weight is over 165. And it would make things worse if part of that weight is fat because this is a fat soluble drug as It would tend to partitionate in that tissue.

I cannot say much without looking at the pharmacokinetic data, but I think the just set up the minimal amount require for the average population and now people are noticing that this could not be enough amount for some people. I personally I would just done the study based on weight but as I say before BMI is an cheap way to estimate body type and in a population setting, the exception may not provide enough error to change the study design.

[ADoyle90815]

Which is especially ridiculous when you consider that when we studied BMI in my high school health class, a significant number of the athletes scored as obese, even though they clearly weren't.

That's true, since BMI doesn't take into account muscle mass which is why athletes sometimes score as overweight or obese through BMI.

[freedomjesusfootball]

This is why I have my youngest nephew. My 5'10 muscular sister took plan B after her husband's condom broke, but it obviously didn't work and she had a 4.5 year old, a 2 year old, and a newborn all at once. It's amazing to me that she has one shred of sanity left. I don't think she has had a decent night of sleep in 6 years.

[boxerlover24]

I am very surprised they dont have anything on the package. Don't doctors write your dosage for hormonal bc based on your weight? Why would plan B be any different?

Plan B is only 95% effective (per webmd) if you take it in 24 hours. after that it is only 89% effective. You're kind of rolling the dice already, so maybe that is how they got around the whole weight issue?

[Coconut Flan]

Plus it also seems to depend on where the woman is in her cycle and one seemed more effective than the other. Apparently there are several variables involved in the effectiveness.

[defraudingjezebel]

Holy Moses. I'm glad I came across this on freejinger because I haven't heard a whisper of this ANYWHERE else, which is totally frightening. As someone over 165 lbs, I'll definitely keep in mind that Plan B isn't really a good Plan B after all. Jesus Christ, can't a woman ever get a break?

This is frightening news, especially considering how many states are making it even harder to get an abortion.

[coleslaw74]

I was able to get the full article, thanks to my school VPN.I can send it if people wish. Here's a quote from the Data: "The variable with the most highly significant impact on

the risk of pregnancy was BMI. Compared with women with

a BMI under 25 kg/m2 [normal weight or underweight

according to the World Health Organization (WHO) [17]],

the risk of pregnancy was more than three times greater (OR,

3.60; 95% CI, 1.96–6.53; pb.0001) for obese women (BMI

of 30 kg/m2 and above according to WHO) and 1.5 times

greater (OR, 1.53; 95% CI, 0.75–2.95) for overweight

women (BMI between 25 and 30 kg/m2

), whichever EC drug

was taken (Table 1). When the pregnancy rates were

compared within the two treatment groups, the effect of

BMI was more pronounced in women treated with LNG than

with UPA. The relative risk of becoming pregnant was

doubled when overweight women taking LNG were

compared with normal-weight or underweight women (OR,

2.09; 95% CI, 0.86–4.87; ns) using LNG, whereas the risk

was not different when women taking UPA were compared

(OR, 0.97; 95% CI, 0.27–2.83)."

it also says later that you'll be 4 times more likely to conceive if you have sex the day before/on ovulation (Though that seems a bit obvious)

tl;dr- you're 1.5 times more likely to get pregnant after taking EC if your BMI is 25-30, and you're 3 times more likely if your BMI is 30+

[erastus25]

I know that BMI isn't the most accurate tool out there, but it's not complete bullshit either. Yes, there is some leeway, but let's face it, if you are 5'2" and 200 LBS you ARE overweight, and if you're 6'3" and 120 LBS you ARE underweight.

EXACTLY. The vast majority of people are simply not elite athletes with so much muscle that it throws off their measurement. Many people are also in denial. At a population level, BMI is a good tool.