Wednesday, February 07, 2007
3G birth control a difficult pill to swallow...

This morning, we reported about a recent petition by Public Citizen about birth control pills. The consumer advocacy group is calling for all third-generation birth control pills (the newest kind) containing desogestrel to be banned. (Full Story) Its concern: These pills can double the risk of life-threatening blood clots. (See the list of medications Public Citizen is concerned about).

The blood clots, besides being painful, can travel to the lung and cause severe shock or death. We found studies dating back to 1995 that validated this increased risk of blood clots. In fact, the FDA publicly announced the higher blood clot risk years ago, yet the drugs still remain on the market.

According to the national prescription drug audit, 7.5 million prescriptions were filled last year. So why are these medications still available? As with most things, you have to dig a little deeper for the answer.

First of all, keep in mind the absolute numbers are very small. The risk of having a blood clot while taking the second-generation birth control pills was about 1 per 1,000 users and went up to around 2 per 1,000 on the third generation (according to a 2001 report in the New England Journal of Medicine). Also, some women find the third-generation pills to be a better pill. They don't get as sick while taking them, compared with some of the older pills.

Public Citizen cites a slightly lower blood clot rate but says there are no additional benefits to the third generation pills compared with the older pills.

So, what is the FDA's role here? Should they remove the pills from the market or is this more a case of buyer beware?

I am on the pill for medical purposes. I still have cramps with my period, but I am not as sick as I was prior to going on the pill. I think the company is blowing this way out of proportion. I am 22 and have been on the pill since I was 17. I am turning 23 in June. I am not pre-disposed to blood clots and I don't smoke.
I saw your report this morning. You also listed ethinyl estradial as an ingredient in these birth control pills that have increased risk of blood clots. My daughters both take Ortho-Tricycien Lo which contains ethinyl estradial. I am planning on having both of my daughters consider an alternate method of birth control. I am looking at the birth control computer as an alternative.
You've shown 5 birth control pills that contain "desogestrel"...what are they?
I am a fit 34-year old woman, and was on a pill which contained these ingredients for over 10 years - until September 2006. In September I was hospitalized with severe blood clots in one leg, and 2 in my lung. After numerous tests which proved no genetic disposition to clots, the Pill was blamed.
I strongly recommend finding other forms of birth control.
What are these pills? I personally am on Tri-Cyclen Lo and would like to know if I am in danger of this.
What are the types of pills that contain desogestrel? I didn't see a list.
Right now my girlfriend is on a newer birthcontrol pill and has been complaining of tenderness and swelling of the breasts. Now that I see this it raises concern that she may be suffering from a blood clot.

As for the role of the FDA, its purpose is to protect consumers, if it feels that risks have risen to a level that is of enough concern, then yes these types of pills should be recalled, and hopefully a newer generation of better pills can be created. The drug companies obviously dont have a need right now to cure the major diseases of the world, but i was under the impression that birth control was big business, why not make products which work better?
Hi Dr.
I am 49 years old. When I was 23 I was on BC pills and had a stroke.
I had a severe headache, tingling in my face and arm.
I was told to stop taking them and never take them again.
I can happen to young women!
Thanks,
Donna
My mother almost died from 1st generation birth control. I have use 2nd gen but I no longer use them. I'm wondering why noone is mentioning the long term side effects of birth control pills. Its becoming apparent, especially in my generation (I am 37), the first to be exposed to synthetic hormones for their entire lives, we are experiencing problems later in life such as endometriosis, ovarian cysts, fibroids, and inferitility. Why doesn't the FDA look at these things. I've lost any faith I had in the FDA and that all birth control pills should be scrutinized.
I think a small risk of a blood clot is far less threatening than a potentially deadly cervix clot.
As a young woman (20) who is on the BC pill, I have to admit that I have some problems with the way they are marketed as a cure all. My doctor prescribed them without asking questions and without noting possible side effects or giving me a choice between medications. I know the side effects, so this wasn't an issue, but many people don't.

For me, the pill is the best option right now, even if I wasn't given another choice. But I do think that it should be marketed as one of many options, not the universal cure.
They should NOT ban that pill. I tried other OTC's, but one only ones that would give me regular periods are the ones with desogestrel. There are other benefits to this hormone as well, which other otc's do not have. (see the indications)
In addition, I, and most people, have no risk factors for blood clots in addion to taking birth control pills.
It should not be used in patients at risk, but should be allowed for the general population.
i WAS 34 YEARS OLD, HEALTHY, AND DID NOT SMOKE. i HAD A SEVERE STROKE AND IT HAS LEFT THE LEFT SIDE OF MY BODY PARALYZED. I WAS IN THE HOSPITAL FOR 3 MONTHS. I BELIEVE THAT MORE RESEARCH NEEDS TO BE DONE ON THE EFFECTS OF BIRTH CONTROL PILLS. THOUGH I AM STILL ALIVE, MY LIFE HAS CHANGED DRAMATICALLY.
Like several other people, I also missed the list of pills that were mentioned today. I wish you had put in this website. Please let me know. Thanks.
I would prefer more studie sto removing them from the market, I have been on 5 different pills trying to find one that stops ovarian cysts without completely messing up my system, the one working best contains desogestrel.

I would hope that before they ban medications that some of us need, they would investigate inmore depth the cause of the increased risks.
I think that consumers need to read the information that is given to them when they receive prescriptions. These side effects are listed everytime that they get a refil. Yes, we need to be notified that there are potential side effects, but we must also take responsibility to read the information given to us. This will allow us to make educated dicisions for ourselves. If we have questions, we should consult our physician and not just assume that we know what we are doing.
How does the Birth Control-Vaginal Ring- compare to oral agents? Is the use of the ring- safer or less safe than the oral agents?? Could Dr. Gupta discuss all of the birth control agents that use hormones to control conception.
I take an OCP regularly for endometriosis. It took several years of working with my physician to identify one that treated this condition properly with few to no side effects. I am under 35 and do not smoke and, although I take a second-generation and not a third-generation OCP, I have educated myself about the potential side effects (including blood clots).

Each woman's body chemistry is different, and an OCP that works well for one may not work as well for another. I believe the above-mentioned is a case of "buyer beware." As long as the pharmaceutical companies that produce these OCPs make a concerted effort to warn patients of the potential risks involved, the patient and her physician should have an opportunity to confer and decide whether or not to utilize them.
I was put on Ortho-Cept 28 in 1996. Having no available genetic history, as I am adopted, I had no clue of a propensity to form clots. I almost died a few months after taking the pill, lost a large portion of my digestive tract and other organs to clots. I believe testing for these disorders should be done before considering taking any hormones, specifically, women who don't know their family history.
One brand that contains desogestrel is Desogen, which I currently take. I have 7 packs left and because of this report, I'm not sure if I want to continue the BC once I finish what I have. I've been on this BC for 3 years. The thought of the possibility of having a clot now looms in my mind.
i know the patch is different than the pill, but i was wondering how much more of a risk they are. I got a bloodclot 2 years ago when I was 18years old, healthy and a non-smoker. It can happen to ANYONE. Now my only option is an IUD which gives me severe cramps and heavier, longer periods.
Good day DOctor i don't use pills before but i was introduce to LUTERA by my Doctor i want to know if it part of the ones that as the risk.
Thank you all for your comments and personal stories. To answer one of the more frequent questions, the nine drugs that Public Citizen is taking issue with, and that Dr. Gupta listed this morning on CNN are as follows:

- Kariva (Duramed/Barr)

- Desogen (Organon)

- Mircette (Duramed/Barr)

- Velivet(Duramed)

- Apri-28 (Duramed/Barr)

- Ortho-Cept (Ortho-McNeil)

- Reclipsen (Watson)

- Cyclessa (Organon)

- Desogestrel and Ethinyl Estradiol (Duramed/Barr and Watson Pharmaceuticals)



It's important to remember though, that all types of birth control pills contain a risk and a written warning about increased risk of blood clots and those containing desogesterol have an additional warning that the risk for blood clots may be even greater.

In addition, the drug companies say their drugs are safe when taken as directed. Two manufacturers issued statements to CNN:


"The labeling that accompanies the company's oral contraceptive product provides all the necessary warnings and precautions for the appropriate use of the products."

-Statement from Barr Pharmaceuticals


"When used as labeled, Ortho-Cept is a safe and effective birth control choice."

-Statement from Ortho Women's Health & Urology
Who would go bareback in these days with AIDS everywhere? Ban the pill, use condoms!
I have been on various birth control pills for over 19 years. I have always been counseled on the side effect of taking the pills including blood clots with each prescription. I make it a point to read the information provided with my prescription. Blood clot risks while taking any hormone has existed as long as I have been on them, this should not be news to anyone taking the pill. Any birth control pill has higher risks if you are a smoker (which I am not), but how many people stop smoking as a result. As with any medicine, you need to inform yourself of the side effects and make the desicion for yourself if the benefits outway the risks. I do not feel some outside organization should have the right to restrict peoples choices. How many of you know the risks of taking Over-the-counter medicine like Tylenol or Advil? They can cause serious side effects as well, but do you want them taken off the market also?? I would rather this group push for a ban on Cigarettes, I think that would save more lives than banning a womens choice to birth control products.
I think the FDA should re- evaluate alot of birth controls. I had a friend that died right before christmas that had a blod clot affect her intestine, caused by birth control, ortha tri cyclen, the pill. She weighed 82 lbs when she died and she was only 24 years old.
I developed a 10-inch DVT 10 years ago while taking Orthocept (desogestrel). I was lucky I didn't die. The valves in my leg were destroyed and I now have serious complications as a result. If there's no additional benefit, get them off the market!
If doctors would use discretion in prescribing birth control to smokers, or better educate women about lifestyle choices that contribute to the risk of serious side effects of hormonal contraceptives, this would be a non-issue. Just because a serious side effect is a possibility does not mean the pills should be removed from the market--like everything, this is a cost-benefit analysis, and the benefits (i.e. reproductive integrity, reduced risk of certain cancers, and improvement in quality of life by reduction of negative menstrual symptoms) clearly outweigh the risks for most women.
Where can I find a list of the pills that contain this drug? I have been on birth control pills for 11 years.
Double the risk and no significant difference in outcome/effectiveness? Just say no to the "low dose" pill!
There's no reason to take these riskier pills, since there are so many other low-dose varieties available. I've tried many kinds, and every one has some sort of side-effects, including Mircette and Desogen. It's just a question of finding the best fit for your own biochemistry. I finally settled on Lo-Estrin FE. No side effects to speak of. I'm 47, and I plan to keep taking it as long as I can.

Note to DN in St. Louis: Some of us are in long-term relationships with extremely low risk of contracting AIDS. Who'd want to deal with condoms (ugh!) in those circumstances? The pill is far more effective as birth control, prevents cramps, has other worthwhile health benefits (as well as risks), and best of all - it isn't made out of latex!
This is just another ploy by the religious right to limit women's reproductive choices.

Women need to educate themselves about all of the benefits and risks of any type of birth control. Find out the facts and decide for yourselves. Don't let the government, consumer groups, or the religious right do it for you.
I took regular BCP for 3 years in early 90's for birth control with no side effects. Starting taking Yazmin 8/2002 to control hormones and fight migraines. DVTs in right leg in 1/2003 that moved to both lungs. I'm lucky to be alive. I strongly believe birth control must be accessible and know the risks are small, but after only 5 months? Come on. There's a problem!
These poor women on here are scared to death. Asking which pills contain the hormone in question. Instead of turning to an accessible medical professional, they ask a doctor on CNN.com who is not going to give them the time of day. That's why this scare tactic should be put to rest. Ladies, get on the phone and call your doctor or pharmacists to get the information you seek. Seek REAL medical advice before and weigh your options before you make a decision. Don't rely on the article on this page alone.
How can I find a list of the pills that contain this drug? Can you put up a list for us?
Personally, I use the patch. As I recall, my doctor did make note of the increased risk of blod clots. I am not a smoker, and in generally good health. Additioanlly, I have had lots of problems with other BC pills...older pills give me debilitating morning-sickness (the kind so bad I couldn't function). I love the patch. It's been the easiest for me to tolerate--including other low-dose pills. I would hate to have to give it up. I am aware of the risk, am an informed patient, and realize all prescriptions come with the possibility of a side effect.
I am a healthy 30-year old female who took birth control in prior years without an issue. I started the 3rd generation pills in December and was in the hospital by the end of February with a massive clot in my leg and several in both lungs.

The scariest part of the side effects of birth control is that while there are warning labels no one tells you what to look for. I would get small cramps in my legs or feet occasionally, assuming I bumped into something or pulled a muscle. I began having trouble breathing and thought it was an upper respiratory infection...tis was the season. When I had a cramp so severe in my leg I couldn't walk I was told my lungs sounded clear and one look at my leg sent me straight to a hospital where I was admitted for over a week. I will never be off of the blood thinners because of the number of clots I passed to my lungs. The worst part is that my ankles will never be the same again and swell with the slightest amounts of activity.
Why isn't there an alternative for men that disables the sperm's potency? Most women don't object to condoms, but if men won't use them, let the men find a way to modify their own chemistry for a change.
There are a lot worse drugs out there than the birth control pill, with far greater risks, and far more side effects. There is already a warning label on both the old and the new form of pill that shows how they have a potential risk factor for clots. I don't believe it is necessary to completely pull off the pills from the market, but that doctors themselves need to figure out what would be best for their patients, not consumer groups, nor the FDA. It's not an experimental drug, it's already out there on the market, and there is a warning for it. Right to choice?
The risk is so small. We need to keep the govt from regulating everything.
When I was 17 years old I was on the orthrotricylen? If that's how you spell it. I developed a massive blood clot in both of my lungs. If I hadn't gotten to the hospital when I did I would have died. I was lucky that I was so young. So now because of that I will be on blood thinners for the rest of my life. I'm definitely for this ban and I have been warning friends about the horrible risks of this drug. Yes it's good for the prevention of pregnancy but I think that plain old condoms would do just as well and less risk of getting yourself killed. That's just my two cents.
An above poster says to use condoms rather than BC? Not everyone is taking Birth Control for Contraception purposes... some are on it to regulate their cycles and other menstral irregularities... Also... this should be more of a beware... most people if provided the right information are capable of making their own informed decision!
I agree that BCP's should be more widely regulated-unfortunately, its easier to get Viagra than it is to get a decent BCP that works. As a young woman with enodmetriosis, I understand the constant struggle that is needed to find the right pill to work for each woman's body. I am hoping for a hysterectomy so I can finally stop paying for and suffering from the side effects of these medications. BCP's are not a joke, and if they do not work or make you feel ill-stop taking them and find a doctor who will work with you! Taking care of our bodies is the most important thing we can do to protect ourselves-do not trust the pharmaceutical companies to do it for you!
I am 39 and have been on low dose birth control -- I was taking LoEstrin for years, until last March when I awoke from a nap unable to speak. I knew it was a vascular event & had my husband rush me to the hospital. It took them 9 hours to figure out the right cocktail of medications to bring about a change. I had a CT scan in the ER which was normal, and an MRI & 2 MRAs also normal, but my neurologist refuses to allow me back on those pills. I honestly don't want to take them either. It's the only thing that could have been a risk factor, I'm healthy in all other ways. I am just glad the loss of speech was not permanent.
Taking them off the market seems extreme. The risks are low and we don't need to encourage the people out there who want the pill banned altogether. I do think there needs to be more research into the risks of certain birth control pills. For instance, did you know Yasmin increases the levels of potassium in the blood? I had no warning when I took it. Did it occur to anyone that increased levels of potassium might not be good for the user's heart? Also, what is going on with Ortho Evra?

Personally, I've tried several pills and found I am very sensitive to the side effects. All of them made me nauseous. Most caused headaches. With Triphasil, I had breakthrough bleeding for four months straight. With Yasmin, I had such extreme bodily swelling that I was in tears from the pain. The only hormonal birth control I can take is Nuvaring.
I am on Birth Control pills in order to aid in fighting my Polycistic Ovarian Syndrome. I've had migranes so bad that they have paralyzed the left side of my body. I've resorted to new birth control, and I still have major headaches.
If the amount of people dying can be reduced it should be done.
Would you like to explain to the families that if the pill had been banned they wouldn't have lost someone they loved dearly?
There is is no difference in effectiveness th 2G birth control still does what it is suppose to.
It seems to me all the 3G birth control is doing, is killing more women.
Get real! This is a very low incidence of blood clot formation, and the mortality due to unwanted child birth is far, far higher. Perhaps the risk might be offset by a "baby" aspirin along with the birth control pill.
Getting pregnant while not financially prepared and or married can lead to depression, poverty, abuse, and abortion. For the one in thousands chance I will stay with birth-control.
I've been using a low dose bc pill for almost a year now. My doctor made it abundantly clear that blood clots were a risk and gave me information on what signs of blood clots are. For me, the benefits outweigh the risk and there has been no sign of blood clots.
I think the thing to keep in mind is that any medicine can have a negative result. Even something as simple as aspirin can cause harm. If patients are educated by their doctors, then it is their choice, and should remain their choice, to take this risk.
I personally was on the pill for over 15 years and decided to stop in my mid-thirties because of the fear of blood clots. Even though my doctor has told me on numerous occasions that the chances are small because I am a non-smoker, life is just to precious at this point in time to take any chances. I think that the drug companies need to do more long-term research before putting a new product on the market (especially when young girls may be their target group).
And I think that the doctors that prescribe these particular medications need to do their homework about the long-term effects (or lack of data) before letting the drug companies dictate what drugs they prescribe to these young women. I am not taking any chances and am hormone-free at the present time.
Isn't this why we have doctors and pharmacists? Isn't my doctor the one that is responsible for knowing the risks, communicating them to me, and helping me make an informed decision? Like so many mental health medications, some hormone meds that seem to do the same thing as others on paper simply work differently in different bodies. With an overall risk rate for blood clots still very low, shoudln't I be allowed to make the decision to take the risk if the 30 per 100,000 drug works better or has fewer side effects for me?
Each person should take responsibility for what they do to their body. Do your research, talk to your doctor, if you are already at a high risk of blood clots then don't take the pill. Mass banning of anything is the cause of a few idiots who ruin it for everyone else who has common sense.
One would think each subsequent-generation medication would be better with fewer risks. I think the increase risk of harm (or death) however small is unacceptable and the drug companies should go back to the drawing board for a better birth control pill.
People who use birth control know the risks involved or should. It is a personal decision, made with your physician's assistance, not the government's regarding which form of birth control to use. If a woman does not want to use the pill, she can seek out an alternative form of birth control, accept the risk of pregnancy, or simply be celibate. The risk for the pill is still very low, especially when compared to the normal risks present for pregnancy.
I think these pills should remain on the market. The physician should assess the patient's risk factors for blood clots and weigh that with other factors in considering which birth control pill is best for that patient. All medications have side effects.
"Who would go bareback in these days with AIDS everywhere? Ban the pill, use condoms!
Posted By DN, St. Louis, MO : 3:12 PM ET "

That is a narrow view don't you think? I don't take BC so I can have sex, I take them so I have a period and don't develop uterine cancer from not shedding my uterine lining due to PCOS. There are a lot of medical reasons women take the pill. Yes, we should use condoms if we are having sex with a new partner, but those in committed monagomous relationships that have been tested and disease free may choose to take the pill rather than deal with condoms. It is up to each individual to determine if the benefits justify the risks with BC or any other medication. I have concerns about continuing on the pill due to possibility of clots, but at this time the small chance of clots is less of a worry to me than why I started and continue to take the pill.
I am 44 years old. I started taking the pill when I was about 17 years old. During my child bearing years, I was off the pill and used a diaphragm or sponge (no longer on the market). It seems I do have a mild case of endometriosis now though exercise helps. I had leg cramps when I first started taking the pill but that was when the pill was in a high dose form. I have otherwise, not had any problems. Regarding the comment about condoms, I have been with my husband only (and he just with me) for about 25 years making no need for condoms. Also, many people don't like them so I don't view them as a great answer. Despite risks, I will continue taking BC because I don't want any more children, don't feel I can afford to raise them properly, would not give a child up for adoption and don't want an abortion. I think BC needs to be made available at no cost to all women (and men) because there are too many children brought into this world who are not properly cared for and the cost to birth a baby is much more to the healthcare system than the cost of BC. I don't understand why people do not see this. Let's provide BC to all and then let people who want children have them.
I was on the pill (several versions) for 5 years before i developed a very serious clot. At the time of the clot i believe i was on either Apri-28 or Ortho-Cept. While doctors SUSPECT the pill was to blame, they don't really know for sure. As a result, i have been advised to avoid hormones of any kind. With all this being said, i DO NOT believe 3G BC pills should be pulled from the market. There are many drugs with very serious side effects that people take on a regular basis (OTC pain medication), and no one is calling for the removal of these drugs from the market. Viagra is another good example of a drug that has serious consequences, yet no one is advocating it's removal either. I feel people should be well informed before taking ANY medication, and weigh the benefits against the risk. While doctors should let us know exactly what we may be getting ourselves into, we should strive to be as informed as possible on our own. One would not buy a house or car without doing all the necessary research before hand, why would you ingest medication without doing the same. It's time we behave like responsible adults, and I'd appreciate if the FDA would treat us as such. At a risk that is this low (relatively), there is no need to pull 3G pills.
I think it's a combination responsibility of the consumer doing their research and the drug administration testing, retesting and properly/clearly labeling products. When deciding to persue use of any birth control pill or really any medication at all, the consumer has a responsibility to their own bodies to research the medication they use and ask their doctor what options they have. Doctors should give the information out when prescribing the medication, in my opinion, but they're human just like the rest of us. If you don't go in prepared to ask questions, how will you learn?

I've heard horror stories about certain types of BCPs making people sick, whereas I've had no problems with the one I'm on - Ortho Tricyclene. I tried the Lo version for a year and switched back due to some other side effects, but to use it as an example, everybody is different and therefore will react differently to the medication. As a BCP user, I'm aware that there could be serious side effects later in life, but that's because I did my research before choosing to persue use of BCPs and asked questions when I spoke with my doctor. At the same time, no matter how informed we are before-hand, there's no way to be 100% sure of the exact effect it'll have on our bodies. Only we, as individuals, are
responsible for the choices we make. However, as technologies advance, I do think the FDA has a responsibility to periodically re-evaluate approved medications regardless of how many people have run into serious side effects.
The difference in risk, while double, does not seem irresponsible enough to be pulled from the market.

Any time someone is putting their life in the hands of pharmeceutical companies, un-necessarily, they know (or should), that there is a trade-off. Pill 'X' provides (fill in blank) effect you're looking for, *but* (fill in the blank) bad thing can happen.

We can't expect to chemically manipulate our bodies without negative side effects.
As with all medicines - even as with all products whatsoever - these pills have both risks and benefits. The argument should not be about whether to allow them on the market, but rather how to ensure that the decision to use them or not is rational and informed for everyone involved - doctors and patients alike. As it stands, the marketers of the drug will naturally downplay the risks, and the advocacy group will naturally overstress them to compensate. Only by eliminating vagueness entirely can the problem be solved fairly; users should be told the precise risk of blood clots as established by the study and how that compares to the risk of similar drugs, preferably by having that all printed explicitly on the packaging. They should also know exactly what a blood clot is and what it implies given their own personal risk factors, knowledge which can be imparted to them by the prescribing physician or, in a world that made sense, by an education system which prepares them with such important, practical knowledge of their physiology.

If a product is too risky for anyone to decide, without being misled, to use, then it should and will disappear from the market. If not, it should and will remain. Accurate, reliable information and the training to put it to use is the key to making the market serve humanity rather than visa versa.
It has become more and more clear to me as I get older (32) that there is a severe lack of research and study that is going into women's health, especially as it relates to hormones. One day we are told we will die if we take hormones or birth control and the next we are told it will save our lives. I would just emplore the medical and scientific community to truly provide us with better answers. While I realize that is an enormous request and not that easy, it is simply time that women receive better treatment and answers. Not everything related to women's health complaints is IBS and there has to be better answers and solutions for hormone replacement/birth control.
Teresa from Denver, I couldn't agree with you more. I am a 30 year old active, non-smoker and I was hospitalized for 6 days due to clotting in my leg and severe lung clots. It was awful. All of my genetic tests came back negative of any clotting disorders so I was told to stay away from the pill. What others may not know is that if this happens to you, you will most likely be on a blood thinner for 6 mos which is no walk in the park either.
I don't necessarily think birth control pills should be banned, but doctors need to make the risks more clear to patients. And this goes for ALL drugs, not just birth control. I've never had a doctor go over possible side effects of any drug I've been prescribed. Doctors also need to do their own research on medications rather than rely on biased sales reps who provide them with only favorable studies.

My doctor never warned me of possible tendonitis or tendon rupture from fluoroquinolone antibiotics. I have been trying to recover from both of these effects for the last 2+ years since I took a fluoroquinolone.

Fluoroquinolone antibiotics (Levaquin, Cipro, Avelox, etc.) were prescribed ~33.5million times in the US in 2004 (according to DHHS) and have also been the subject of petitions to the FDA by Public Citizen - petitions that were ignored by the media.
This is a question of acceptable risk. There are risks involved in thousands of different procedures and drugs currently on the market today, and it is up to the consumer to make a choice. Some drugs have been banned in the name of safety while equally risky drugs are deemed acceptable by the FDA. What, I wonder, guides the FDA's decisions?
It would be very helpful to see what the FDA says about desogestrel. I feel that many of these Groups are just pushing to slowly take each and every birth control form off the shelves. Until I see proof I will not believe them. Also they need to conduct a study on whether or not these ladies suffering blood clots are smokers, if they exercise, and other variables
It's all about the money. The first contraceptive pills out were (?????). Miscarriages were common place after stopping the pill back in those days. My wife was on the "pill" and miscarried after she stopped taking the pill. She was 4-5 months pregnant. In 1967 England published an expose on that type of birth control pill saying it caused cancer.
An investigative reporter found out that the research was financed by the Trojan Condom manufacturer in England. Keep in mind when reading about controversial issues its still ALL ABOUT THE MONEY.
Yes, they should remove these pills from the market. Young women are woefully ignorant when it comes to the birth control pills they take and do not realize that low androgen pills, for example, can have a negative effect on libido. Older pills such as Lo-Ovral can do as good a job with less risk.
Wouldn't it be smarter to just have kids and enjoy them Loving you back down the road... no blood clots, no PARALYZED body and no DEATH risks guarenteed!
From a man that truely loves his women and want's her healthy... :)
I AM A 35 YEAR OLD TRIATHLETE. I WAS ON THE NUVA RING FOR EIGHT MONTHS. I HAVE NEVER SMOKED AND HAVE NO FAMILY HISTORY OF ANYTHING.

I WAS HOSPITALIZED IN SEPTEMBER OF 2005 WITH MULTIPLE CLOTS IN BOTH MY RIGHT AND LEFT LUNGS.

AFTER MULTITUDES OF TESTS ORDERED BY THE HEAD OF PULMONOLOGY AT EMORY UNIVERSITY HOSPITAL IT WAS CONCLUDED THAT MY CLOTS WERE THE RESULT OF THE BIRTH CONTROL I WAS ON.

THE NUVA RING CONTAINS ETHINYL ESTRADOL. "LOW DOSE" IS MISLEADING. THOSE ARE THE WORST KINDS AND DOCTORS ARE GIVING THEM OUT LIKE CANDY.

I AM HAPPY THE FDA IS FINALLY SITTING UP TO TAKE NOTICE OF THIS. BUT I ALSO WONDER HOW MANY OTHER WOMEN HAVE TO GET SICK AND/OR DIE BEFORE SOMETHING DRASTIC IS DONE.

IT DOESN'T MATTER HOW OLD YOU ARE, IT DOESN'T MATTER IF YOU HAVE A FAMILY HISTORY OF BLOOD CLOTS OR WHATEVER; THIS CAN HAPPEN TO ANYONE AT ANY AGE AND IT SEEMS LIKE THERE IS PLENTY OF EVIDENCE TO SUPPORT IT.

THANK YOU TO DR. GUPTA FOR HELPING TO BRING AWARENESS TO THIS DEADLY ISSUE.
My non-smoking athletic 30 year old wife came very close to dieing because of a blood clot in her lung. If it was not for the quick diagnosis and intervention of a couple of Doctors at the hospital in Missoula Montana, she would not be alive today. Doctors who prescribe the pill need to be much more diligent in discussing the possible side effects and what they will feel like. The clot could have been caught in her leg but it was thought to be a strained muscle due to a mountain climb the previous weekend. A Doctor even massaged it and prescribed a muscle relaxer! Now she is on a blood thinner for the rest of her life. We have since heard of several people with similar stories. So be careful, it could happen to you.
my daughter is 17 years old and had a pulmonary embolism after taking birth control for one month. It was Yaz. I believe this birth control pill almost killed her.
I agree with Christian, San Jose, Ca: birth control pills are big businss. Why do we not have pills that work better? I was part of a study group that took these pills before they were on the market. i'm 34 and have never had a problem with them, or any others, besides nausea from the older higer dosages. I am always in favor of birth control study and availability, but with out education- doctors informing patients what exactly they are taking, and the risks involved- we might as well be in the dark ages.
Please, more availability and more education. Take the time to learn and be informed. Ask questions. Make the right choices for yourself.
Did you know your risk of a blood clot when you are pregnant is 60 out of 100,000 women? This makes even a birth control pill with desogestrol a safer option than pregnancy.
This is a "consumer" protection group representing a religious-right ideology of taking away a woman's right to control their reproductive issues.

This is an issue between a doctor and his or her patient. Full informational disclosure by the doctor to the patient must be paramount so that the patient can make an informed decision as to the best course of action.
A simple blood test to see if my daughter had 'factor V lieden' before the dr prescribed bc pills would have notified the dr that my daughter was suseptible to blood clotting. 'Factor V Lieden' is in %5 of all woman and puts them at higher risk. No dr ever tests for this before prescribing bc pills. My daughter had a Pulmonary Embolism.
I am on Desogen by Organon and have finally found a pill that works with my body. I used to suffer from ovarian cysts, cramps, and bleeding for 7 to 10 days even on birth control pills. This was the first pill that worked for me. Was I aware of the risk of blood clots? Of course I was, I read the complete Detailed Patient Labeling that comes with each pack of 28 Day Regimen. Under the heading Risk of Taking Oral Contraceptives: 1. Risk of developing blood clots (Number 1, not 4 or 5). The complete entry for the Risk of developing blood clots is three paragraphs long. It even outlines what is suggested to do in the event of an elected surgery, need to stay in bed for a prolonged illness in regards to when to stop taking the pills and when to start again. Of course you should always consult your health care provider first.
I currently have 4 clots in my lungs and am very lucky to be alive because of mircette. I have never smoked and have no genetic dispositions. My doctor did not advise me about the increased risk for clots when he switched me to the low dosage pills. Women are not being properly advised about the risk - it's about what ever drug company gives the doctor to push their products to the patients. My life is forever changed because of their greed!
I have a friend that almost died of a blood clut because of the pills...please stop them
Taking any birth control pill puts women at risk of estrogen dominance which later in life contributes to osteoperosis, extreme meopause symptoms and increased risks of cancer. This latest is just one more reason why I am no longer on birth contol and am looking for safer alternatives.
Interesting topic...I think that taking these off the market is extreme. The risks are manageable and to a degree we should be responsible for taking an active role in our own health care. I have taken birth control now for 20 years and am on a combination pill containing norethindrone/ethinyl estradiol. However, I do not take it for birth control but as part of a hormone therapy... I would be concerned that those out there with a similar condition will be without.
A few months ago I spent a week in the hospital with bilateral pulmonary emboli (blood clots in each lung). Not to mention the severe pain and difficulty breathing, the clots probably should have killed me as I had symptoms for a week before seeing a doctor. I am 21 years old, non-smoker, in perfect health- it never crossed my mind anything serious could be wrong with me. I was on Yasmin for a year. I'm not saying these drugs should be taken off the market, because most people don't have any problems beyond perhaps a little weight gain. However, I agree that doctors shouldn't just hand you a package that lists possible side affects. They should go over them with each patient and discuss what these side affects might feel like. Had I known that shortness of breath and back pain can mean a blood clot in the lung, I probably would have gone to the hospital sooner. I am very lucky, but this could have been avoided.
It seems to me that the answer to this question is an obvious one. The article mentions that the number of users who got blood clots from the "third-generation" pills is double the number of the users who got blood clots while using the "second-generation" pills. Personally, this seems like a very serious statistic, and if the FDA is considering taking it off the market, then I think it very worthwhile to do so. After all, what is the worse that could come of that?
I think the FDA has a right to make sure that all of the information is available in the packaging and to doctor's prescribing these pills, both the pros and the cons of each choice. But those side effect statistics are still lower than some side effects of other drugs that are allowed, so information and education is the key.

After that, it is up to the woman to decide. We have to stop letting the government make our choices for us and take responsibility of our own decisions.

My heart goes out to those with problems, but the risks were told to you before you began birth control and that was the choice you made. I have been on birth control for 5 years now (17-22) to treat cramps and I am well aware of the issues and consider this a personal decision.
I too am the victim of the side effects of low dose birth control pills. I was on Ortho Cept for 10 years and developed multiple clots in my left leg. Two very large clots traveled to my right lung and needless to say, I am very fortunate to be here today. My life has forever been changed since this happened.
I was warned of the side effects of the pill but I never thought it would happen to me. I was taking the pill to regulate my period and help with the severe cramps. Since being off the pill, I am back to severe cramping, extremely heavy periods, etc. Since I have been off the pill for the past 3 years, there are many times I have pondered benefits v. risk. I don't think pulling these drugs from the market is the solution to the problem.
I was on ortho-tricyclen lo when I got a blood clot that made it hard to see in my right field of vision! It's a real threat, people! Please be careful, ladies.
As a registered nurse, I thought I was well educated about the issues directly related to women's health. So, when my OB/GYn prescribed Ortho Tri-Cyclen Lo, for the treatment of endometriosis, I agreed. One month later, one pack later, I almost died of a massive Pulmonary Embolism. The message for all women: be educated about birth control pills and seek alternative methods. And while the risk of blood clots is statistically small with BC pills, just ask a "statistic" how it feels to almost die...
Let the doctors and patients decide--"advocacy groups" who want a blanket ban are more interested in promoting narrow policies than the health of individuals who may or may not be at risk. Sure, more research may be necessary to determine risk factors, but preventing doctors and patients from pursuing what works best for them is short-sighted and unnecessary.
I am very disappointed in the CNN coverage on this - multiple posts have requested a list of pills containing desogestrel ... but yet nothing has been posted with this information. Come on, CNN, give us the news that's relevant to us and don't just scare us by not giving us the full story!
I just had surgery Dec 20 to remove 2 ft of my small intestine and ileum which was full of blood clots and turned gangrene. My pain started in Nov but doctors could not find the problem. I finally went to a great hospital St. Mary's in Knoxville, throwing up, passing out, and blood pressure out of this world. They run tests for hours, said my platelet count was very high and they did a CT scan with contrast found my problem and within an hour I was having emergency surgery. I had went on birth control pills in June of 2006, was having VERY bad periods they said was hormonal I had been switched on different ones because of spotting. I cannot remember all of the names I know one was new that had the DSRP (i think) the one with the party commercial and the last ones was APRI. The hemotologist have tested me and I do have a heriditory blood clotting problem PAI-1 or that maybe the test. I know I was in a lot of pain for 2 months, could not eat, sleep, move and barely lived. All the doctors said it was something you find in older people, who smoke, and drank all the time. They said if I had not been 37 I would not have made it. I feel the birth control pills helped in my blood clots but I am not a doctor.
Yes, the AVERAGE numbers are small - but.... for those individuals (the 3-16% of Caucasians with a Leiden mutation in Factor V), the progestin in 3G OCs increases their risk of a clot not 2-fold, but SEVEN-fold. Hanging in there helps though - the risk of a clot halves after the first year of taking a 3G OC.

The point is that the decision to take, or not take a medication is a balance of the benefit vs the risks for THAT INDIVIDUAL. If I had a family history of estrogen-dependent cancers, or frequently had PAP results showing dysplasias, I'd want a 3G OC. But if I had a Leiden V mutation, was obsese or smoked, and often took long-haul flights, I'd decline a 3G OC.

As a nation, we tend each small patch in our corn fields with greater precision and tailored solutions than we do our people's health. Farmers invest in science because they get a better outcome (more high quality corn); medicine should do the same.

Isn't it time to reject the "one size fits all" mentality that demands simplistically that a drug be ON or OFF the market? C'mon CNN, it's easy to generate heat, what's needed is a little more light.
Its about time. I sometimes wonder what they do and dont tell you when you sign Reading the fine print of a pill pack mentions an increased chance of breast cancer, blood clots, and other problems but these never seem to come up in the offices of reputable doctors. I am interested to see where this goes and what this does for the pharmaceuticals.
I have recently recovered from a pulmonary embalism that was a complete shock to me. I had been on the same birth control pill since my 13 year old daughter was born. When I had knee surgery, there was no additional concerns that blood clots would be a problem(I had 5 major surgeries in the past 10 years). To my surprise, the doctors said that the ESTROGEN in my blood combined with my age(37) caused this deadly situation. So I believe that if something is going to be banned, ALL birth control pills need to be examined, not just the new ones with the new hormone combination!
haha this is crazy i wouldnt want that to happen to me or anyone i know.
After two months on third generation, I had to have emergency surgery to remove my gall bladder and after surgery developed multiple blood clots in my leg and lungs. The damage to my leg is irreversible. The risks of birth control are understated and the pharmaceutical companies should not be allowed to hide behind the warnings. No amount of education and warnings can prepare a woman for these types of risks and complications that can long term affect your quality of life. I don't advocate that birth control pills be removed from the market (the benefits still outway the risks) but I do feel the pharmaceutical companies should be held accountable for marketing products that are unsafe for the sake of greater profits.
Ralph Nader's Public Citizen is a non-scientific worry group that accepts epidemiological studies that fail to perform multifactorial analyses. That's the source of the blood clot theories, which my own publications have shown to be false. See www.witnesss.net/data/fmsturtevant.doc.for papers. -F.M. Sturtevant, Ph.D.
I'm the outlier--as usual. I tried a low-dose combination pill (Ortho tri-cyclen) to reduce my heavy anemia-causing periods. Not only did it fail to reduce my periods, but I was continuously nauseous and had more headaches. I didn't have any issues with blood clots in spite of high blood pressure, perhaps in part because of the iron-deficiency anemia and partly because of my genetic makeup.

Depo-Provera injections at what amounts to 6 times the normal contraceptive dose, on the other hand, not only reduced my periods but STOPPED them. The only downside to the Depo was that it may have caused bone loss in my spine and hips. More likely, it simply contributed to bone loss because I also have problems with too much epinephrine (adrenaline) in my system, which caused too much cortisol to be synthesized and released. A more recent study indicates that the SSRI I'm taking for anxiety and depression (all SSRI's are guilty of this) may have also contributed to bone loss as well.

Since I'm hypertensive, the doctor has added propranolol, a beta-blocker, to my regimen in the hopes that it will help to elevate my potassium levels (I wasn't taking a diuretic, so the cause of my hypokalemia is unknown), lower my blood pressure and, if a current study can be extrapolated from rodents to humans, help to rebuild the lost bone in my spine.

I'd really LIKE to return to the Depo-Provera injections because I felt so much better during that treatment, but that will depend on the results of my next bone scan in about 6 months.
I think the one thing that people are forgetting is that some women due to a family history of breast cancer cannot or should not be taking high estrogen pills. It is all a personal trade off that should be discussed with your health provider about your personal history and make the choices based on that rather than any thing else.
Here's what I KNOW, not what I think -
These 3rd generation BCP's are not worth the increased risks, especially considering the fact that they are in no way a more effective alternative. It was just a year ago that I started taking a 3GP. I'm a single mom who put myself through school, put my life on hold to raise my own children. As blessed as I was to have the opportunity to have someone in my life, I never would have imagined I would be where I am now. 6 months after starting the pill, I found myself in the emergency room with a blood clot that extended from my armpit to my wrist. I'm a dental hygienist and it was my dominant arm (of course). After a month of several daily self injections, missing almost a month of work, and going on 6 months of coumadin - I am STILL riding out the "risks" that this option entailed. Is it worth it? NO! Should you or your daughters, sisters, wives be on these with the added risks and no added benefit? Again, take it from me personally - I'm saying emphatically - NO!!
This was the first pill I was ever tried on to try and curb my mood swings and cramping. It's the least expensive on the market, or at least that's what I was told when it was first prescribed to me, and I haven't had a single problem while on it. I'll be rather upset if they take it off the market - if nothing else because evreyone around me will have to go into hiding for that month I'll have to take off to switch pills. I don't think anybody wants to see me with the PMS symptoms I had before I started taking Desogestrel.
I was 23 and had been on Mircette (a 3G pill) for a year when I went into the hospital with bilateral pulmonary emboli. While I was hospitalized, we found out I have a genetic clotting disorder, factor V Leiden. My disorder is not that rare among Caucasians: about 5% have it (it's about 1.2% for African Americans).

Taking a family history isn't always enough to screen out women prone to clots: I had no family history of blood clots, even though I inherited my disorder from both parents.

3G pills add risk to all women, but they are especially dangerous to women who are unaware that they are predisposed to clots. These pills should be removed from the market because they add risk without adding benefit. At the very least, doctors and the FDA need to warn women of the added risks and offer simple blood tests to identify clotting disorders before prescribing.
I was on Ortho Tri-Cyclen for about 5 years in my late teens/early twenties and decided that a low dose may be better for me so I switched to Ortho Tri-Cyclen Lo for few months. Then I realized that I started having problems with the vision in my right eye. After seeing an eye specialist they found that I had a blood clot that formed and diagnosed it as a Central Retinal Vein Occlusion (CRVO). They immediately had me stop taking the pill and the CRVO cleared up, but I am still left with problems with the vision in my right eye that may never go away. I understood the risks associated with the pill, but was under the impression that someone who is healthy and a non smoker with no family history of clots would not be at major risk. It really can happen to anyone.
I belong to a Deep Vein Thrombosis(DVT) chat group composed of people who have/had blood clots. Almost every single woman in the group has singled out the new generation of birth control pills as the cause of their blood clots. Many of them have survived the clot breaking free and lodging in their lungs as a pulmonary embolism which is a highly dangerous, life threatening condition. The FDA must re-evaluate the new birth control pills immediately. Too many women have been seriously injured because of the DVT caused by these birth control pills. My understanding is that many European countries have banned the new generation birth control pills because of the high incidence of DVT and strokes caused by them however the US medical community and the FDA have closed their ears and eyes to the European medical reports. I personally got my DVT from taking Prempro, a hormone replacement therapy (HRT) for women going through perimenopause. Because of this, I must take Warfarin (anti coagulating drug) for the next year to make sure that no new clots develop. I believe that both the new generation birth control pills and HRT must be re-evaluated regarding ther high incidence of DVT by the FDA. The US pharmaceutical companies care more about their bottom line than they do about patient safety and wellness.
Thank you very very much for covering this story. I am involved with some of the online support groups, which were started out of frustration with the lack of information and sheer misinformation that thrombosis patients typicially get and we have been trying very hard to get the word out about this.

My medical provider, a large teaching hospital with a good reputation. persists in trying to prescribe 3rd generation pills for my irregular periods even though I have had a pulmonary embolism and subsequently a DVT in my arm. My reluctance to fill the prescription is ascribed to anxiety....

Names are omitted to protect the ignorant, though you can find even worse stories if you look through our archive.

My thought is that the Pill obviously has a purpose, but that the risks are possibly underestimated and their severity definitely does not appear to be understood by the doctors let alone the patients.

Screening for factor v leiden and perhaps some of the less common genetic disorders would be a step in the right direction, though the cotting process is not yet completely understood and many people repeatedly clot for unknown reasons and such screening would not prevented mine.
my wife was taken those pills. she had a 5cm syst removed and possible a hepatic adenoma (I hope not carcenoma).
Would anyone in their right mind mix these BCP's, Depo Provera, etc. into the soil of their vegetable garden and then eat the vegetables and serve them to the rest of the family? No. If yes, then what is the point of trying to eat chemical- additive free food? These are dangerous drugs and HARMFUL fo women. Now when will women wake up and realize that men are behind the effort to get women on BCPS in order to avoid the responsiblity of fatherhood and all that it entails?

Take cayenne pepper and chlorophyll tablets for heavy bleeding. Don't kill yourself by taking dangerous chemicals like BCPs.
Motherhood is healthful and beneficial, especially when a woman informs herself about the importance of proper nutrition and vitamin, mineral and fish or flaxseed oil supplementation before and after the baby is conceived. Cancer is prevented by longterm (a year or more) breastfeeding and multiple pregnancies, not by taking BCPs.
Also, all chemical birth control cause s changes in the uteran lining which make it unwelcoming to a newly-conceived baby. (Human life begins in the Fallopian tube, when fertilization is complete.) So they also cause the starvation of a baby, since BCPs do not always prevent ovulation. About once every three months, socalled 'breakthrough ovulation' occurs.
Yes, get the BCPs off the market. We need more children since they are the future. Few chidren means a limited future both personally and nationally.
I wanted to comment about the "third generation" birth control. I am 34 years old and I have never smoked a day in my life or had any other illnesses. Yaz caused a blot clot to form in the right hemisphere of my brain, resulting in a stroke. I was hospiltalized for three weeks and I am looking at many months of rehabilitation. I want to warn all the women out there that if it happened to me it can happen to them.
M Morelli (Philadelphia, PA)
Just out of the hospital having had a blood clot in each lung. I'm 41, athletic, thin, non-smoker. My OB probably thought Yaz was a good fit for me despite my age. She prescribed it 6 months ago to help with excessive menstrual bleeding issues.

I had a strange leg cramp about 3 months ago and I went to my primary care physician. He told me it was just a muscle cramp and that if it was a blood clot I'd have swelling and redness. I didn't have either. But over the last few months I've experienced two or more of the same kind of cramps that eventually went away.

After my leg cramp last week I ended up in the hospital with what I thought were abdominal pains and pain from coughing. So glad I went to the ER because they caught the clots and, after a 5-day hospital stay, I'm alive to tell the tale.

Yaz was bad news for me. No clotting issues in my family. And my primary physician was dead wrong about my "leg cramps."
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