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Subscribe to RSSFederal health experts say Yaz and other widely-used birth control pills should carry stronger labeling information that emphasizes recent evidence that the drugs have a slightly higher risk of blood clots than older drugs.
The Food and Drug Administration's panel of experts voted 21-5 Thursday that labeling on the popular drugs made by Bayer is inadequate and should be updated with information from several recent studies.
Yaz, its predecessor Yasmin and related prescriptions use a manmade hormone called drospirenone, which mimics the naturally occurring female hormone progesterone.
Panelists spent more than nine hours discussing often conflicting data on the blood clot risk of drospirenone-containing drugs compared with older medications. While the group disagreed on the quality of the evidence, the overwhelming majority said it should be made more explicit in the label, including the potentially fatal nature of blood clots.
"Clearly the wording is inadequate and incomplete," said Dr. Richard Bockman of New York's Hospital for Special Surgery. "Adverse events have to be made graphic so physicians and patients are aware of the consequences."
In an earlier vote, panelists voted 15-11 that the pills remain a beneficial option for preventing pregnancy. The majority opinion amounts to a vote of confidence that the drugs should remain on the market, though well over a third of panelists voted against the drug's overall benefit, especially given numerous other oral contraceptives available.
"I can see no real group of patients that this drug benefited over existing alternatives," said Mark Woods of New York University School of Medicine. "Without any clear benefit, and given the potentially catastrophic risk, I voted no."
Approved in 2006, Yaz grew into the best-selling birth control pill in the U.S. by 2008, backed by hundreds of millions of dollars in TV and magazine advertising that emphasized its ability to clear up acne and other hormonal side effects. But prescriptions have fallen more than 80 percent in the last two years amid safety concerns and a consumer backlash against misleading advertisements that regulators said overstated the drug's benefits.
Related stories:
Teen says blood clot after Yaz destroyed her life
FDA favors more risk info on newer birth control pills
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No specific comment on this drug but I as much as I hate government controls, they should ban the advertising of all stinking drugs on TV as a minimum, and in general.
Although patients should be informed on all available treatments in the medical field, manufactures ads will never be the place to obtain good information.
The biggest lobbyist in Washington are drug company representatives outside of the big oil companies! They push the FDA to get their drugs approved, then a year goes by and people seem to get sicker from the drugs! Forget the side effects! I would rather suffer from the original illness and take nothing! The FDA needs a complete colonoscopy to clean out they're bad management!
I'd like to see more warnings stamped on condoms that state possible lose of protection due to inspectors miss handling!
That is on there....haven't you ever unrolled it completely????.......lol
Huh? Has he ever unrolled it completely? Why would he need to?
i wonder if the republicans feel guilty for allowing drugs to hit the market quicker and with less testing?
What is the purpose of the FDA? Does government regulation ever work? They approve drugs, five years later people die, then the FDA pulls it off the shelves, morally corrupt lowlifes like John Edwards collects forty percent of verdicts, and on and on....
I have to laugh. I have been on 3 types of birth control over 10 years. Ortho Novum caused me to develop severe cysts that caused me to become hospitalized. I was 16 at the time. My doc claimed they would prevent them, but I didn't have them before I took them. 3 months after I stop I didn't have another cyst. Then I felt pressured by my doctor after the birth of my 2nd child. They were dead set on Mirena or an IUD. I was like hell no. So they gave me YAZ. I developed a major cyst in my breast a few weeks later that kept growing. I quit the bc after my husband woke up one morning and freaked at the site of the differences in my breasts. I quit it and it took 2 years but it faded away. So I was getting pressured by my new doctor because for 2 years I have refused any contraceptives, but my doctor was pressuring me again. So I gave in and tried this new one (can't remember the name off hand) with folic acid but it was the worst I experienced ever. I shot up 15 lbs in 2 weeks, my doctor claimed I was eating too much. That was crap. Then I kept taking it, and I got scared when I started having shooting pains in my chest again. Well I went back, and odd... I have a cyst back when 1 year ago I had nothing and was told I was good. So I quit because I was bleeding for close to 3 months and sick and had cysts popping up. Well I've been quit 3 months now and I'm still having pain in abdomen and my chest and my periods were irratic afterwards. I will never use any "synthetic" hormones again. I don't trust the gov't and I was more angry when my doctor laughed and "assured" me that everything was safe. He was more concerned about me getting pregnant again then how I felt and side effects. How many people are getting ignored?
Have you considered tubal ligation?
I had a vasectomy @ age 18 and have never regretted it.
That's ridiculous. Have no one here ever heard of Natural Family Planning (NFP)??? Seriously, look it up. There are NO harmful side effects whatsoever, it's easy to do, and it treats women like they deserve to be treated - with complete respect for their fertility and their bodies. Couples who use Natural Family Planning can use it to either abstain from or achieve pregnancy. MIght I suggest starting with Googling "The Couple to Couple League"? WAY better than continuing to treat your fertility like a disease and wreck it with unnecessary drugs.
NO ONE can "force" you to use any birth control. Pressure or not, it you can't advocate for yourself then I suggest you abstain from sex. It is called personal responsibility...YOU are ultimately in control of your health care and the meds you take.
Greg, natural family planning doesn't work for every one. There are many of us gals out here with irregular cycles. I started using Bcps to get a regular cycle... big mistake. Blood clots... pulmonary embolism... details below in another post.
Natural family planning isn't a bad idea, but like everything else, it doesn't necessarily work for everyone.
How about you get sterilized. That way (from the way it sounds... being on birth control at 16) I will not have to pay for any more of your offspring!... through the taxes that I pay. ***Note the period***
Your doctor has no business pressuring you or any other patient to use hormonal birth control. That was one of the reasons I quit using OBGYNs for my health care. I now go to a practice that is run by certified nurse midwives for my well-woman care (and hopefully my prenatal care and birth of my children when the time comes). Many doctors are unfamiliar with birth control outside of hormonal birth control. If neither you nor your partner are willing or ready to think about sterilization, have you considered using a barrier method such as a diaphragm or a cervical cap as method of birth control?
Get off all birth control - it's mortally sinful for your soul - use NFP (natural family planning).
Please tell me that you're being sarcastic, BigD. (About the moral implications of using birth control, not NFP, that is.)
Women (and men) simply need to adopt morals and ethics and not see sex merely as conjugal (it's also the mechanism for reproduction, yes -- a human baby).
The fact that the Plan B pill was restricted to prescription only to girls under 17 is one of teh few logical, sane things coming out of this administration. To have female doctors, experts and feminists loathe the fact they can bear children through sex say that "teenagers who could get Plan B off the shelf are 'well aware of the risks and won't use it regularly' " are as naive as the teenagers themselves.
You can't think back to when you were a teenager and knew how (or learned how) to manipulate rules, procedures and stories to suit your real intentions? Please. Teenage girls would use any product to "get around" being made to look like an idiot, or pregnant, or fat, or ugly, etc.
I agree with you on that one! What teen can afford a $50 pill anyway?
Adopt moral and ethics....you must be talking about the congress and senate.....we just have sex because we enjoy it and it feels good...GIVE THEM THE PILL!!!!
people also see chocolate as tasty, but it's also a mechanism for hyperglycemia and obesity. yet it's still being eaten all over the world...
now i know this is a stretch, but people can just accept that sex has been around for quite some time. it's fun, it feels good, and in this day and age there are ways to prevent things like unwanted pregnancy and cut down the risk of STIs and still have fun.
if you're at risk for throwing clots, don't take the pill. if you're not all that enthused about a ligation or vasectomy, there are other options available. there are these little latex things that cost about 50 cents a pop, are available at pretty much every Rite Aid or 7-11, and when used properly are pretty good at keeping buns from growing in the oven. no one really likes wearing one, but hey, they're pretty handy for when you don't quite want an 18 year commitment.
if you can't take the pills or handle the surgeries, there isn't really an excuse for teens to not have a rubber ready in this day and age in this country. they're sold everywhere, easy to hide, store relatively well, and most importantly they drastically cut the risk of a baby falling out of one of the sex-ees nine months later.
teaching abstinence is a horrible idea when the time comes to actually being responsible in the heat of the moment. ("what? you put this where?"). all drugs carry risks of side effects, and no birth control therapy can prevent STIs. just buy your kids condoms. they'll be happy, you'll know they'll probably be responsible, and you won't be holding grand kids at bobby or susie's high school graduation.
To dblhelix - I don't disagree, but I just wanted to make a note:
"if you're at risk for throwing clots, don't take the pill." I had no prior bleeding/clotting issues and I developed a cerebral venous thrombosis after a month on the Nuva Ring. It took 5 months and a gazillion different specialists (as well as a seziure, vision loss, and light-sensitive headaches so bad I'd puke) to get a diagnosis, after which I went to a hematologist. My work-up was completely normal. The point of this whole ramble was just to say...there's no way to know if you're "at risk," and EVERYONE on hormone-based contraceptives should be very careful. Definitely pay attention to your body, and if you notice anything odd, see a doctor.
And perhaps a slightly relevant note...I was 21, athletic and at a healthy weight, and had never smoked when I got the clot. So much for risk factors!
I know there are cases such as those, that was just a massive oversimplification on my part. That's the thing about hormonal treatments, when they work they're great but when they don't the effects can be disastrous.
It's one of those "people are like snow flakes, no one has the same biochemistry" sort of deals that come along with drugs. What may work just fine for most might not for some.
on a side note, just out of curiosity - how was the CVT eventually found?
I note the LIPITOR atorvastatin calciam .....Ad beside me! ...LOL
Caution: The improper use of contraceptives may lead to birth defects such as conservatism or republicanism.
Caution: The liberal push for abortion on demand may, I mean, WILL, lead to the death of millions of baby (over 50 million since Roe v. Wade). Better to be "defective" than dead.
Please ignore the paid shills.
I am conservative, and Republican affiliated, but I have no objection to you LIBS controlling your own herd. (Darwin Award) Keep it up Leftists. Don't push it on me though, I am responsible for my actions.
I hope you have a good lawyer when you get to the pearly gates :-)
The risks associated with the use of the pill have been known since the pill was brought on the market. It's no secret that blood clots are very real risk, especially in women over 30 who smoke. There are risks with any medication, even such benign over the counter meds like acetaminophen and ibuprofen. There is no such thing as a completely safe with no side effects drug. I get a complete print out of all pertinent information with every prescription I have filled and there is complete information with every over the counter medication. If you the consumer fail to read the information, or if you are confused about a certain medication the pharmacist will be glad to help you. And yes, I speak to my pharmacist not my M.D. the pharmacist knows way more than your average M.D., hence the name Pharmacist. I think to avoid any further confusion regarding medications that we the consumer be made to sign a form saying that we have read, understand and have asked any questions we may have, before we are handed the medication. That way you'll be making an informed choice as to whether or not you wish to take that particular medication.
Excellent post, lorakittle!
I agree with you, Lorakittle...
However, Yaz and a few other newer b.c. pills have generated significantly more negative incidents than other types of hormonal contraception. The debate that ensues isn't necessarily regarding the patient's inability to grasp the risk of side-effects, but rather if the frequency of negative outcomes negates the drug's overall safety. That's the money question.
On a side note though, I would argue that drowsiness, mild nausea, or possible weight gain are side-effects; while pulmonary embolisms, anuerisms (sp?), and strokes in healthy teenagers are much more than a side-effect.
Why does this surprise anyone? The other commenters are correct. This almost parrallels the current issue regarding the "morning after" pill controversy, and Obama's decision NOT to allow it sold to under 17-year olds, without permission. He's a Dem, but taking a rather "conservative" stance. Good for Obama. He has daughters, and is obviously NOT in big pharma's back pocket. I am Pro-choice, yet I side with our President on this one. FDA approves all kinds of dangerous drugs and says they are okay...until AFTER the deaths and problems occur.
If you're pro-choice, why in the world would you be against the morning after pill? Abortion and Plan B both kill an innocent human life. If you're for that in some circumstances, why aren't you for it in others...? (By the way, be sure and thank your mom for being pro-life)
Greg - Grow a uterus and then perhaps I will consider your opinion. Whilst you do so, consider properly researching Plan B. A little knowledge may spare you further embarassment in such forums. Plan B in no way "kills" human life. And though I am absolutely for Plan B, I am against the notion that a 17 year old should be able to obtain the medication (or any medication) without parental notification. Note that I specifically said notification and not consent. I am all about zero population growth. Especially when the parents are children themselves.
It also causes bad dark facial splotches! No warning about that, either!
Yes, the risks associated with the pill have been known since the pill was brought on the market, especially in women over 35 and in women who smoked. However, note that with Yaz and Yasmin, the risk of VTEs were especially higher in women UNDER 35. And I know MANY young women who take or have taken these birth control pills. Birth control pills make up at least half of the business at certain college pharmacies. So females need to know that there are many other birth control pill options available that do not carry the increased risk of blood clots. To learn more, read
I had a pulmonary embolism due to blood clots from the pill. I can't say that I would have not taken it had my doctor been clear about the possibility of this happening, but perhaps I would have been more aware during the lead up to... how else can I put it... almost dying. Charlie horses that don't go away quickly are a sure sign of trouble that I was not even aware of.
Thank God for Heparin.
It's about time for this!!!
I support any birth control method that keeps incompetent idiots from procreating.
Like the song says: "Only stupid people are breeding".
What constitutes an "incompetent idiot"? That's incredibly vague. And if "Only stupid people are breeding", then how did YOU get on this earth? Are you suggesting your own parents should have birth controlled you out of existence as well? If you're going to try and stomp on some vague class of idiots, at least do some more explaining and back up your claims with more than a few lyrics from a song.
He's just parroting the growing eliteist mentality that some people don't deserve to breed. It's all part of the fascade of socialism... Poor guy is already the victim of double-speak and the attack on our very language. Any real conservative values life and liberty for all.
I think planned parenthood founder and eugenicist Margaret Sangar had a similar philosophy...I think it also got picked up by Adolph Hitler...
hello Godwin's Law. i knew it'd hit eventually.
Condoms...Anyone?
Birth control pills cause blood clots. So do kids. Six of one; half-a-dozen of another.
These pills are awful! I was put on Yasmin (against my better judgement) to help control the side effects of ovarian cysts. After some minor side effects with that, I was then put on Yaz. I have been off of this pill for over 4 years and I am still not "normal". While on the pill, it elevated my thyroid level and I had to go on medication to control that. I did some research and found that birth control pills can spike TSH levels. I contacted my general physician and asked if I could stop taking both pills because ob/gyn said she had never heard of any side effects of birth control. My sex drive has been completely depleted since I started the pill and I have spent the last four years trying to get it back. Nothing has worked. I would not recommend any birth control pill to anyone. I have an appt. in January to go see a specialist about my thyroid. Now, if I could only find someone to help me get my sex drive back!
Have you ever gone to a endocrinologist for for your Poly Cystic Ovarian Syndrome? BCPs do not treat PCOS, they only mask the symptoms. The problem is actually elevated insulin, something that is easy to check with a simple blood test, but often isn't. Most women go to the OBGYN because they think this is a reproductive issue... its not. THe elevated insulin is messing up your estrogen and progesterone... along with alot of other things and as a side effect you have the cysts. I would suggest you find a reproductive endocrinologist that is familiar with PCOS. BE thorough and check the doctor out. Talk to the nurse before you schedule your appointment and ask if the doctor prescribes insulin sensitizers such as Glucophage. IF they don't keep looking.
Election fodder to confound and confuse the masses...
This is exactly why the morning after pill should not be available over the counter for girls under a certain age. These drugs are dangerous, no matter what the freakin FDA says. Girls under 15 years are not old enough to appreciate the dangers.
but they're old enough to have kids?
Conebone 69
I'm almost 23 and I've never been on the pill, and I'm not sure if I'll ever use any oral contraceptive, the side effects can be both unexplained and life threatening.
I am extremely hormone sensitive as well. Went to my OBGYN last week to discuss ways to help my severe PMS and the only thing she could offer was more birth control pills and antidepressants. THAT answer made me depressed. I refused and am trying 3 months of acupuncture. If that doesn't work I will be going to an Endo. I want to trust my docs but they are not earning it lately.
Contraception masculinzes women and effeminizes men. It is enslavement just to have sexual pleasure but not think of the life sex is meant to create.
You want "enslavement", David?
Have about 6 kids and you will think "enslavement"!
Unless you are the type who impregnates and runs.
I have six kids - all with my wife (yes, one woman) - what a blessing! You people are at the heart of the "selfish generation" - it's all about ME...grow up!
Great, I am debating going on birth control to relieve cysts. I only need it for that as my husband has been sniped...but now I am afraid of getting something else.
Ugh, to live with the monthly pain and constant headaches or to try Ortho Lo and possibly get some relief. At least he decided not to give me Yas at originally planned.
I went on Seasonale (it's now called Seasonique... same stuff but the 'white pills' have hormone now) to help with cysts. It worked - MUCH less pain/cramping and reduced cysts - and I didn't have any appreciable side effects... maybe some moodiness but that might just be my personality LOL
I would remind people that birth control is not just for just that - birth control. There are women out there, myself included, who are not in sexual relationships whatsoever but need some relief from PMS or PMDD. For me at least, I take birth control not because I don't want to have a child, but because my PMDD is so bad that I would be missing class every day for a week each month.
I'm not saying that birth control is the answer. I'm just reminding people that there is more than one reason to take birth control.