ONTD Political

Birth control pills recalled, may not prevent pregnancy

8:00 pm - 01/31/2012
This is more of an FYI post. The tl;dr: Placement of extra placebos means the pill you take might not be contraceptive. If you use Lo/Ovral-28 tablets, Norgestrel, or Ethinyl Estradiol tablets, be aware!

Pfizer Inc. (PFE), the world’s biggest drugmaker, recalled 1 million packs of birth-control pills after discovering a packaging error that may cause women to take the wrong dosages and put them at risk for unintended pregnancies.

The company recalled 14 lots of Lo/Ovral-28 tablets and 14 lots of a generic version of the medicine, New York-based Pfizer said today in an e-mail. About 1 million packs of 28 tablets were withdrawn, Grace Ann Arnold, a Pfizer spokeswoman, said in a separate e-mail.

The tablets, manufactured and packaged by Pfizer, were marketed by closely held Akrimax Rx Products of Cranford, New Jersey under the Akrimax Pharmaceuticals brand. The company hasn’t received any reports of adverse health consequences, Arnold said.

Each pack contains 21 white tablets that contain the synthetic hormones norgestrel and ethinyl estradiol and are taken for 21 consecutive days. The remaining seven tablets are inactive pink pills taken for a week.

“An investigation by Pfizer found that some blister packs may contain an inexact count of inert or active ingredient- tablets and that the tablets may be out of sequence,” the company said. That could cause women to take an incorrect daily dosage and increase the risk of accidental pregnancy.

The error was “identified and corrected immediately,” and doesn’t pose immediate health risks, Pfizer said. “However, consumers exposed to affected packaging should begin using a non-hormonal form of contraception immediately.”

Wyeth Pharmaceuticals won FDA approval of Lo/Ovral-28 in 1976. Watson Pharmaceuticals Inc. (WPI) is among companies that offer generic copies. Pfizer acquired Wyeth in 2009.

source.
blackheart 1st-Feb-2012 06:43 am (UTC)
The article says the active pills are white and inactive ones are pink. So shouldn't the people on this prescription notice there's something wrong when it looks different? Extra pink pills, ones in the wrong spot, etc. I'm pretty sure I'd notice a blue pill in a bottle of white Aspirins. Or are the users just popping whichever one's next in the pack without paying it a second thought?
recorded 1st-Feb-2012 06:54 am (UTC)
According to the recall notice:

"may contain an inexact count of inert or active ingredient tablets and that
the tablets may be out of sequence. "

From the picture, the difference seems to be light pink and dark pink which doesn't really seem like a significant difference. Also, I imagine the people it's going to fuck over are the busy and the people new (ie; young) to birth control.


Really glad I have an IUD right now.
blackheart 1st-Feb-2012 07:03 am (UTC)
Something easily overlooked then, especially if taking the pill is a morning agenda thing. A little forethought could have prevented something like this from affecting so many. Like, say, a higher contrast dye color for the pills. I'm interested in seeing how Pfizer handles this mishap.

IUD? I don't blame you there! But I'm even more thankful for being lazy and just abstaining.
recorded 1st-Feb-2012 08:37 am (UTC)
I just had a round of antibiotics, so I have been abstaining same as you :( Condoms? Noty, I prefer abstinence. lol
blackheart 1st-Feb-2012 03:27 pm (UTC)
I'm asexual. I'd rather claw out my own eyes and eat them than have sex. Which is funny because my mother was a nympho and started sex ed early. She also tried to force me on the pill, which I refused to take.
recorded 2nd-Feb-2012 12:59 am (UTC)
The pill can be beneficial regardless of whether or not you're having sex. Though, I understand why someone would not want to be on something that messes with the natural order of things.

My periods are fairly non-existent with my IUD and I don't have to do anything special to maintain it. I get much less weepy before my period. My periods are light and only occur every 60 days instead of every 28 (not all women have that, some dont get periods anymore some still have regular periods). Ofc, there are risks with an IUD. I lost my IUD strings & had to have an ultrasound to make sure it was still in proper position. Fortunately, it was or I could have needed a minor surgery to remove it.
darsynia 1st-Feb-2012 01:27 pm (UTC)
Yeah usually they're not in a bottle though, they're in a circular thing with a 'poke the pill out' thing, one for every day--I totally wouldn't bother looking at the color of the pill there, if I'm honest about it. I will bet you that if any women do end up suing that they became pregnant while taking this, the company's lawyer will say that it's irresponsible not to look at the pill color, though :(
blackheart 1st-Feb-2012 03:47 pm (UTC)
The company's lawyer is right, to an extent. Consumers that have taken the pills for a while should have an idea of what the things look like. But they also can't expect newbies to recognize something like that, especially when the pills are pink and dark pink. They could be held at fault for not having a higher contrast color scheme and their quality control measures failing. And they can't responsibly blame consumers for trusting the company's product.

This isn't someone getting burned by hot coffee. It's a contraceptive that failed and created a life. The blame can't entirely be pushed onto the victim when it was the company's mistake.
darsynia 1st-Feb-2012 03:49 pm (UTC)
Agreed! I shouldn't have read the comments at Consumerist about this, though. Basically all blame the women (with a bonus 'now the liberals have more excuses to abort!!' nonsense), even though they've said it's not a case of mislabeling, there are incorrect numbers of active pills and whatnot.

I think it'll be complete bullshit if they claim that because even perfect use isn't 100%, it doesn't matter what they did. I almost guarantee that the % of women who turn up pregnant while on this during the period of time they were incorrect will be higher than even typical use % failure.
huit 1st-Feb-2012 04:20 pm (UTC)
Aren't some birth controls in packaging with a dispensing unit so that you HAVE to take them in a certain order? (or maybe I'm thinking of something else that comes packaged like that, like asthma medication...)
eien_herrison 1st-Feb-2012 04:28 pm (UTC)
This isn't someone getting burned by hot coffee.

Can we (generally) please stop using that case as an example of a frivilous lawsuit? Third degree burns on 6% of the body (including genital regions) is nothing minor at all (nor are 200 other previous similar cases, or McD offering $800 when she asked for her medical expenses to be paid).
rjdaae 1st-Feb-2012 07:50 pm (UTC)
Thank you!
blackheart 1st-Feb-2012 11:08 pm (UTC)
I HOPE THIS COMMENT WORKS. Omfg I had to download an app to comment with my tablet. Tried, failed with replying via website and email.

I was misinformed about the coffee case and was not aware it was that traumatic. That's horrible. Again, I had no idea there were serious burns and...man wtf. OW.
darsynia 1st-Feb-2012 06:58 pm (UTC)
Just adding my voice to hope that you're not trying to claim that hot coffee lawsuit was frivolous. The woman involved had burns that were extremely fast, that fused her skin together in her crotch (trying to avoid overly illustrative imagery, because, well. OW). Think of how long it takes you to try to mitigate a spilled hot beverage on your lap, and how long the liquid had to burn her--definitely NOT frivolous. She even only sued for her medical bills, and was awarded a lot more when McD decided to be asses about it.

Both the hot coffee woman and the women who are now pregnant thanks to this company's negligence have long-lasting, perhaps lifelong changes as a result.
blackheart 1st-Feb-2012 11:09 pm (UTC)
See above comment. I was misinformed about the severity of the burns. D:
darsynia 1st-Feb-2012 11:27 pm (UTC)
NP! I had a similar reaction to yours when I first looked into the case. Now I feel like somewhat of an evangelist when it comes to anyone calling it other than it is, lol.
blackheart 1st-Feb-2012 11:50 pm (UTC)
Lol I don't blame you. I'm sure plenty of folks think what I did, thanks to the media and bad jokes. But it's good to know what really happened.
angelus7988 1st-Feb-2012 10:11 pm (UTC)
This isn't someone getting burned by hot coffee.

The lawsuit to which you are referring to was not about hot coffee, it was about scalding hot coffee that caused third degree burns which fused Stella Liebeck's labia shut. I've spilled hot coffee on myself, so I can attest to the fact that hot coffee does not nor should it do that. I'm sorry, but I really hate it when people cite that as a "frivolous" lawsuit.
blackheart 1st-Feb-2012 11:11 pm (UTC)
And round 3! I was misinformed and did not know the burns were that severe. Thank you for the correction. Man what happened to her was awful D:
angelus7988 1st-Feb-2012 11:28 pm (UTC)
Sorry for dog-piling. I hadn't seen that two other people pointed that out. I just get really annoyed when that case is brought up.
breexbree 1st-Feb-2012 06:21 pm (UTC)
But by issuing a recall, aren't they indirectly claiming responsibility?
darsynia 1st-Feb-2012 06:54 pm (UTC)
I'd hope so!

What I'm curious about is how long the company spent assessing the risks of speaking up before they did. If it was over a month, could that be considered extra negligence? Imagining a woman who has been on that medication for 3 months, living in Ohio, who is now ineligible for an abortion because of their heartbeat law, for example.
sesmo 2nd-Feb-2012 01:23 am (UTC)
Courts have held that recalls cannot be held against the company as an admission of guilt. This is a really good thing, otherwise companies would be fighting recalls tooth & nail, instead of publicizing them early.
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