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FDA Forces Pharma Company To Admit That Its Birth Control Pill Isn't Miraculous

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Bayer, the company that makes the popular birth control pill, Yaz, is being forced to run ads that "correct" some of the claims that it made in commercials touting the pill's "proven" ability to rid women of acne and PMS. The company settled with the FDA, promising to spend $20 million on the corrections, warning women that they shouldn't take Yaz hoping to cure their pimples and irritability.

From the NYT:

Regulators say the ads overstated the drug's ability to improve women's moods and clear up acne, while playing down its potential health risks. Under a settlement with the states, Bayer agreed last Friday to spend at least $20 million on the campaign and for the next six years to submit all Yaz ads for federal screening before they appear.

"You may have seen some Yaz commercials recently that were not clear," an actress says in the new corrective television spot, as she looks into the camera. "The F.D.A. wants us to correct a few points in those ads."

The offending ads can still be found on YouTube. Wow, look at all of our problems floating away in happy balloons.


A Birth Control Pill That Promised Too Much [NYT]

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58
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You know, I hate big pharma as much as anyone, but being a guy even I understood that Yaz isn't a cure-all.

This is like those ads for Guess Who? where they say "Game pieces do not actually talk."

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@concordia: If the game pieces do not actually talk then you are playing it far less intoxicated than you should be.

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I wanted to embed the Annuale skit from SNL, but YouTube took it down...8^C

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I always found that it was nice anyways for Bayer to repackage and resell after Yasmin went generic, so I feel no sympathy.

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They must have a doctor outreach program like no one's business, because every ob/gyn I've spoken to since Yaz came out goes all glassy-eyed and pushes Yaz as some sort of second coming of pharmaceuticals.

I acquiesced and found out that there are some women who've taken it who get a nasty all-day fatigue side effect. Yaz proponents online swear that "it goes away after a couple of months", and I assume those women don't have jobs or kids to chase around and can spend a couple months feeling lethargic and vaguely ill before they return to something in the normal range.

So if you get talked into taking this thing and have trouble scraping yourself out of bed and getting through the day, do yourself a favor and just switch right away.

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@morgasco: Yaz is not the same as Yasmin. They contain the same hormones, but in different formulations. I was taking Yasmin and had nothing but problems, and switched to Yaz and everything has been great.

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@concordia: For a birth control pill that claims to reduce symptoms of PMS, it kind of ignores the fact that it's a hormone in pill form that CREATES emotional fluctuations. Kind of a big deal, especially when Gynecologists act like birth control pills are the holy grail of women's medicine.

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I'll bet most women were too busy rocking out to the pop-punk cover in the background to even HEAR the list of side effects. Wow, pretty balloons!

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@kathyl: If your doctor prescribes you ANY brand-name drug, it's well worth asking what goodies he or she got from the drug's manufacturer.

Pharma has always been a huge bonanza for doctors. You may have seen the articles on Consumerist where doctor-office employees are whining about how the new ethics rules are taking away their free pens and lunches.

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i can speak from personal experience of my spouse and many of my friends spouses.. Yaz makes women batshit crazy. my wife tried it and i was looking for a shovel and a place to dig less than a week into it. she dropped it after a month and went back to the cheap, non-mood-altering variety.

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This was discussed earlier this week on Jezebel.

Birth control pills are a crapshoot with all women. Sure, it might keep you from getting knocked up but the side effects differ from woman to woman because each pill is a little different. Plus, you have to be on a pill for at least 3 months before you can say, with certainty, whether it's really good or really wrong for you.

I was on Ortho Cept for a year - which sucked - and then Ortho Tri-Cyclen Lo for almost 6 years and it was awesome for me - but unfortunately expensive as well. Lots of other women have gone batshit crazy on it. I've since switched to the generic form of Alysse (sticking with the low-dose pills) and so far it seems to be doing ok for me, but it hasn't been 3 months yet so I can't say with certainty.

Every woman's chemistry is different, but the only cure-all for a ridiculous period and preventing you from getting knocked up is removing the equipment - but then you still might be batshit crazy b/c of the hormonal imbalance.

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@valsharess1: The difference is fairly minor. I'm not sure why if you had issues taking Yasmin that your OB/GYN would try another medication with the same hormones just in varying amounts on you before trying the hundred or so other, cheaper alternatives.

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@rtmccormick: Exactly... my wife is a pharmacist also, and after a few weeks of her taking and the constant craziness she was able to call and get an alternative medication prescribed.

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@mythago: Exactly on the brand name thing, there are literally a hundred or so generic BC medications out there for you to try, why would you want to pay an crazy amount more for a brand name medication? And for those of you who say, well, it's only twice as much with my insurance, think about why health care costs are crazy expensive, people are taking brand name medications BEFORE ruling out generic medications in the same class. And yes, I know this doesn't apply to all so don't try to make it about that. :)

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@shorty63136: Good point. Seriously, Yaz gave my fiancee the worst freakin migraines in the world.

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@Applekid:

I prefer playing the game on hallucinogenic substances - shrooms, PCP, or even plain ol' LSD.

"Does your guy have, like a big horn sticking out of the middle of his left cheek?"

...

"FUCKHOWDIDYOUKNOWITWASMYFATHER YOU SONOFABITCH I'LL KILL YOU"

...

*drools uncontrollably*

...

board game night at my dad's house was always interesting...

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I saw the new commercials and was like, wow, FDA must have come down on them for something. Then, because my migraine med magically makes all birth control useless, proceeded to ignore the commercial since they are all irrelevant for me.

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@rtmccormick: from my personal experience, Yaz was like a godsend... as shorty63136 said below -- it's different for every woman.

Yasmin screwed with my eyesight (aside from other things) -- to the point where I was looking into prescription glasses. I switched to Yaz to deal with PMDD and my hormonal issues improved tremendously and suddenly my eyesight was fine.

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"Blue-eyed dressed for every situation
Moving through the doorway of a nation"

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THANK FREAKIN' GAWD!

I read the headline and was worried that my wife was gonna have a surprise for me when I got home...

Acne and PMS I can deal with. So long as Yaz still prevents baby-making, I'm cool.

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Either way, that pill has been a miracle for me. Instead of wanting to kill everyone on earth for 2 weeks, now I only sort of want to kill people for 4 days, tops.

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@shorty63136: Interesting and good point. My very first BC was Ortho-Cept, which perfect for my body chemistry, and I never had any crazy side effects. But my other friends were hopping from pill to pill to find something that worked.


I've since switched to Nuvaring, and once again, zero side effects. Maybe I'm just lucky.

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It only said treat, not cure. Personally, I never saw them "overstate" it's effectiveness. It did understate the increased risk of blood clots and stroke, which could have used correcting.

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@shorty63136:


I believe that Alysse is the one that my girlfriend takes, and so far it works great for her, she is no crazier than normal. Also this month she hit 6 months on it and it is working even better than she expected, to the point she thought she might be pregnant instead and freaked the hell out (I never said she wasnt crazy in the first place)

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@Parapraxis: Now show the court on this doll where the talking game pieces touched you.

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I don't know a thing about Yaz (wasn't that a band in the '80s, anyway?), but I have to admit that the HBC I take is like something out of a fairy tale. It's solved every problem caused by my ridiculously uneven naturally-made levels of hormones and then some. If it could only clean the house for me, it would be perfect. Funny thing is, I found it through trial and error and have never, ever seen it advertised anywhere.

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I dunno, Yaz actually DID cure my acne and my PMS. I used to have horrible cystic acne that showed up everytime I got my period, and I'd be flat-out crying it hurt so badly. Not to mention which, the Friday before my period, like clockwork, I'd have a fight with the boyfriend.

After hmm, four months: No cystic acne and the boyfriend has actually commented on how balanced I seem.

I've actually asked my doctor why the hell this is - it's something about how it's a non-mood altering chemical unlike Ortho Tri-cyclen, which is, estrogen/progesterin or something.

But as far as I'm concerned, Yaz is 100% the commercials.

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@JulesNoctambule: It was the name of Alison Moyet's band in England, though in the US they used the name "Yazoo" for legal reasons.


Too bad she can't sue to stop them from using it. I wonder if she's doing that over in Ol' Blighty?

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I don't feel like the doctors I've visited explain the implication of birth control pills thoroughly enough. I think they take them too lightly and just expect all women to use them.

I had a bad experience. The pill evened out my moods, but I didn't have problems in that area, so it just made me feel flat all the time. It also messed with my sex drive and had other sexual side affects. My side affects weren't severe and I guess some people wouldn't mind living that way, but it wasn't for me.

I switched to the withdrawal method and like it much more than the pill. Of course, it has its own drawbacks.

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@Jeremy82465: There's always room for a little crazy in your life. :)

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@lannister80: The difference is not minor. Females are very responsive to estrogen. Both drugs have 3mg of drospirenone in them which is a type of diuretic that spares potassium. Yaz contains 0.02mg (20 mcg) of Ethinyl Estradiol (EE) and Yasmin contains 0.03 (30 mcg) of EE. That is a 50% increase in the amount of estrogen you receive from your birth control tablet. This can make a huge difference. Women can be affected from as little as a 2-3 mcg difference in EE.

-Phex
-3rd Year PharmD/MBA Candidate

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@morgasco: It is a good idea to ask that question. Now I am all for cheap medicine but it is sometimes better to get certain brand names rather than generics. EG Lipitor is much better than Zocor IMHO.

It can also depend on the situation. Eg. You start off on a generic ACE inhibitor like lisinopril for high blood pressure but you cant take the nasty coughing side effect. Doctor then puts you on an ARB which is the next best thing which is a brand name medication. This happens quite often, especially in certain populations of patients and in some disease states like renal dysfunction.

But, you are correct to ask for a reason why.

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@lannister80: Yes, because placebo's are so effective on hormonal issues.

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@Phexerian: Not going to go against you by any means, so don't take it that way :), but the impression given by the PharmD's I have worked/dealt with that it was just an attempt to slightly alter the dosing of the medication to allow Bayer to repackage and sell it under the brand still, just before they lost Yasmin to the generic side (I believe on compared it to GSK upping Flonase to 110 mcg and repacking as Veramyst after Flonase went generic, and I'm sure the sensitivity levels for that can be in the lower realms also) As for sensitivity levels with any medication can be very minute, but the normal sensitivity levels usually don't rest on the bottom of the spectrum.
But I guess that has nothing to do with the whole point of the posting and I take blame for being a pirate and hijacking this thread.

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@Rey: Glad I'm not the only one who thought that when I read the headline. :)

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I dunno, they did say at the bottom of the advert that "Yaz is for women seeking a birth control pill."


Pretty clear to me....

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@Phexerian: Come now, I even said it doesn't apply to all :) There's always populations that have exceptions, but if it works for the vast majority I say keep the optimism alive.

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@PantheaCleite: I don't feel like the doctors I've visited explain the implication of birth control pills thoroughly enough.

Same! I have had quite a few women's heath-related issues and every doctor I have spoken to has done nothing but push cure-all wonder drugs at me. No questions asked, no mention of side effects, lots of condom-bashing, and a lecture on why I need to be a guinea pig for "protect myself" with Guardasil. Every visit, every doctor. Now I even get ads in the mail for the products from various doctors. No mention of side effects, just lots of pitches.

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@SableHemlock: Usually I zone out when commercials come on - esp pharmaceuticals. They have some special 'drug sales' voice tone or background music or something similar.... this one grabbed my attention. How often do you see any ad where the company says 'we just got federally smacked, so here's a modified sales pitch'?

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@shorty63136:

Oh, yeah. Very true. I used to take Ortho products and the Tri-cyclen had the lovely side effect of ZERO libido, coupled with fatigue. Actually quite effective for a BC pill! After about a month, my ex-BF and I decided I needed to go back to the doctor.

I went on a low-dose pill l after I got a blood clot. It's awesome because my period has disappeared.

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@morgasco: Veramyst is a different chemical. Fluticasone furoate, as opposed to Flonase's luticasone propionate.

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@PantheaCleite: Withdrawal method: also known as the "So, when are you due?" method...

However, newer forms of the "rhythm" method, I think it's also known as fertility awareness, can work pretty well if you don't mind taking your temperature and checking your cervical mucus every day...

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@alexawesome: What's your problem with hormonal birth control? You do know that a woman's body does naturally have hormonal fluctuations that lead to sometimes quite severe emotional fluctuations? Every fertile woman has some form of PMS.

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As a woman who reacted horribly to several birth control pills, I quit those bastards after a year of messing around with different ones.


My sister had some pretty severe side effects while on Yaz, too.


I don't care HOW long they've been on the market and HOW many tests show they're safe. I think it's a dangerous business to be messing with hormones. Especially in women of childbearing age. And call me crazy, but I would like to see some stats on infertility in women who have taken birth control pills over a long period of time.