Doubts have been growing about Yasmin, Yaz and their sister contraceptives for several years now. And those doubts reached full flower at a Food Drug Administration advisory panel on Thursday.

After hours of circular debate about the safety of this family of oral contraceptives, 15 of the FDA’s 26 expert advisors voted that the benefits of these birth control pills outweigh the risk of dangerous blood clots.

But that’s no tub-thumping victory for Bayer. it created this family of contraceptives, which now includes Beyaz and Safyral. They contain a hormone called drospirenone that’s found in none of the other two dozen or so birth control pills available to American women.

And many who voted in favor of Bayer’s drugs expressed serious reservations because of the risks. “I voted yes, but it was a difficult vote,” said Sean Hennessy of the University of Pennsylvania. “I think the drug probably ought to be rarely used.”

Underscoring those doubts, 21 of the 26 panelists voted for strengthening the warnings on labels of Bayer’s contraceptives to reflect the findings of seven studies that the company’s team had spent much of the day trying to discredit.

One of the seven was a 835,000-woman study commissioned by the FDA; it found about a two-fold increase in blood clots for Bayer’s pills compared to competitors’ products.

Nobody’s completely satisfied with the quality of the evidence on the safety of Bayer’s contraceptives containing drospirenone.

But many pointed out that the studies Bayer relies on most to argue for the drugs’ safety were paid for by the company. Bayer makes a bundle on its contraceptives, although U.S. sales have fallen sharply since doubts began to be raised in 2009.

Much of the public comment featured people who urged the FDA to pull Bayer’s contraceptives off the market. “In my opinion, absolutely, these drugs should not be on the market because there are safer alternatives,” said Diana Zuckerman, president of the National Research Center for Women and Families, a consumer group.

The most wrenching testimony came from patients who say they suffered disabling blood clots, and from parents of young women who died after taking these pills.

One of them was Cindy Rippe, whose daughter 20-year-old Elizabeth died three years ago from pulmonary embolisms two months after she switched to Yasmin.

“Elizabeth was a very smart young woman,” Rippe told the panel. “If Elizabeth had been clearly warned that Yasmin had more risk – maybe twice as much risk as other pills – she never would have switched to Yasmin – never. And she would be alive today.”

Rippe is among 10,000 plaintiffs suing Bayer in cases that are to be tried beginning next month.

It doesn’t help Bayer’s case that a former FDA commissioner, Dr. David Kessler, has filed an affidavit in a Chicago federal court accusing Bayer of withholding early reports of blood clots from the federal agency back in 2004. Plaintiffs’ lawyers leaked Kessler’s statement to reporters on the eve of this week’s hearing.

Asked about withholding of data, Bayer executive Dr Leo Plouffe Jr., said:

“We’ve always had a very open communication with the FDA. We’ve responded openly to all requests for information from the FDA. And the information we’re presenting today is in total openness. I hope that puts your mind at rest.”

Bayer’s strongest witness was Dr. Andrea Lukes, a North Carolina gynecologist who said her patients on drospirenone contraceptives often have less bloating, acne and breast tenderness.

“In my experience,” Lukes said, “patients who begin Yaz or Yasmin are less likely to change and are happier with this pill… drospirenone pills provide an important and unique role for contraception.”

That argument had some impact with panel members. Dr, Naomi Tepper of Emory University voted for the proposition that drospirenone contraceptives’ benefits outweigh their risks because she was afraid that a no-vote “would mean pulling them from the market. And if there are women who believe this pill benefits them, that has to be taken into consideration.”

But many were unpersuaded that Yasmin and her sisters confer any special benefits, or at least not enough to outweigh the risks of fatal lung clots or longterm disability from deep-vein thromboses. “I wouldn’t recommend this to my patients and I wouldn’t have my daughter take it,” said Dr. Peter Kaboli of the University of Iowa.

The decision on what to make of all this rests with the FDA. It’s expected to strengthen the warning labels of these birth control pills – although many panel members worried about what consumers and doctors can make of an even-more-complicated litany of conflicting studies.

The agency says it intends to do more definitive studies on the risks of drospirenone contraceptives. but one staffer acknowledged that it hasn’t identified the funds for that yet.

If you have had the cyst removed, how long did it take for your symptoms to disapper or find out if those symptoms were being caused by the cyst?

Sometimes small cysts can be resolved by either taking birth control pills or getting an IUD like Mirena(which has hormones in the IUD). you have to catch the cysts early, though, or you can end up like the first person who posted. Talk to your doctor right away; If you ignore your symptoms, you could end up infertile.
Good luck

I have had ovarian cyst surgery three times and they were all different. One took only a week or two to recover fully and the last, most serious surgery where they removed multiple cysts, eight on one ovary alone, was much more lengthy. a solid month to recover from that. Like the other answer you got pay attention to the symptoms, if it's a real problem, get a good gynecologist and get care immediately. My cysts use to rupture and cause me terrible pain. unfortunately it's a common female issue that's not well researched or has a non invasive cure in the medical community. for more information look up poly-ovarian cystic disease. Be well.

Are there Treatments That can Reduce the Symptoms associated with Perimenopause? many women experience relief from hot flashes after taking low-dose birth control pills for a short period of time. other options that may control hot flashes include the birth control skin patch, vaginal ring, and progesterone injections. But, certain women should not use birth control hormones, so talk to your doctor to see if they are right for you. you may also feel better if you do things that enhance your general well-being, such as: * Exercise. * Stop smoking if you smoke. * Get more sleep and try going to sleep and waking up at the same time each day. * Decrease the amount of alcohol you drink. * Get to a healthy weight and stay there. * take a multivitamin supplement and ingest enough calcium. * Drink at least eight glasses of water each day. Talk to your doctor if you are experiencing problems with your sex drive. he or she may be able to recommend a counselor or therapist to help you and your partner work through this issue. Vaginal lubricants may also be recommended, if vaginal dryness is a problem. Additional treatments available to help with the various symptoms of perimenopause may include antidepressant medications for mood swings. Talk to your doctor about your specific symptoms and goals of treatment. This will help him or her in developing the plan that is right for you.

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Dr. Harvey D. Cohen is board certified in both internal medicine and geriatric medicine. He has been in private practice in Rancho Cucamonga since 1979.

For this week’s Focus on 5, Cohen answers questions on deep vein thrombosis.

Blood clots can result from many factors

Q. what is a deep vein thrombosis (DVT)?

A. Deep Vein Thrombosis is a clot formed in the venous system. it mainly affects large veins in the lower legs and thighs; however, it may affect other veins as well. The clot can block blood flow. if the clot breaks off and moves through the blood stream, it can get stuck in the lung, the brain or the heart. if the clot ends up in the lung, it is called a pulmonary embolism. if it ends up in the brain, the result is either a cerebral vascular accident “CVA” or transient ischemic attack “TIA.” if it affects the heart, it can block the outflow of blood to the lung.

Q. what causes deep vein thrombosis?

A. Bed rest, cigarette smoking, fractures, medications such as estrogen and birth control pills, recent surgery, especially in the hip, knee and female reproductive system, obesity, and sitting for long periods of time such as on long plane or car trips. there are also congenital abnormalities of blood clotting such as factor V mutation, anti-thrombin 3 deficiency, and pro-thrombin mutation. these can increase the risk of getting a deep vein thrombosis. Deep vein thrombosis also may appear as the first sign of cancer, particularly colon cancer or pancreatic cancer. Finally, there are illnesses that may thicken the blood and lead to DVT.

Q. I hurt my calf when I fell off my bicycle two days ago and now my calf is swelling and painful. do you think I have a deep vein thrombosis?

A. maybe. you may have swelling just because of the damage to the effected tissues; however, I agree with your thoughts that swelling and tenderness in one leg with increased warmth and/or changes in skin color, such as redness, may be the signs of deep vein thrombosis.

This should be quickly evaluated by your physician. An ultrasound doppler of the lower extremity should be performed. if the clot is above the popliteal area (behind the knee) then treatment with anti-coagulation (blood thinners) should be started. if, however, the clot is below the popliteal area, you should repeat the ultrasound in three to five days to evaluate for progression of the clot into or beyond the popliteal area. if the blood clot stays beneath the popliteal area there is usually no reason for starting anti-coagulation.

Q. three days ago I returned from Australia and I became short of breath and felt a rapid heart beat. I went to the emergency department and I was told I had a pulmonary embolism. what does all of this mean?

A. Long airplane or car trips without walking may cause a stagnation of blood in your lower extremities. A blood clot can form without showing any symptoms such as swelling, pain, or redness in the legs. after the trip, when you got up and out of the plane and walked around, part of this clot broke off and went upstream into your heart, then into the pulmonary artery and finally into your lung. The size of the clot and the underlying condition of your lungs will determine the symptoms you will have. Difficulty breathing, chest pain, especially when you inhale, and heart pounding may be your only symptoms; however, if the blood clot is very large or you have severe underlying lung disease, this could lead to sudden death. To diagnose pulmonary embolism, we utilize a CT pulmonary angiogram or, in some cases, if the patient has kidney disease, a ventilation perfusion scan. Infrequently, we also may utilize pulmonary angiogram where a catheter is placed into your pulmonary artery and a contrast material is injected. if there is a very severe pulmonary embolism causing a significant drop in blood pressure and an inability to get adequate oxygen in your blood, then thrombolysis with medications such as TPA (tissue plasminogen activator) may be utilized to break down the clot. in some cases, surgical intervention to remove the clot is necessary.

Q. I have a blood clot in my lower extremity from below the knee into my groin; however, two months ago I had a bleeding gastric ulcer. I am afraid to take a blood thinner since my stomach ulcer might start to bleed again.

A. you are right on target. it would be contra-indicated to give you an anti-coagulant for at least six months, if not more, after having a gastric ulcer bleed. in order to prevent a blood clot going from your leg into your lung, your physician will advise you to have an inferior vena cava (IVC) filter. This device is placed into your inferior vena cava via a catheter. The vena cava is one of the largest veins in your body. A large blood clot would not be able to go to the lung since it would be stopped by this filter. at times the IVC filter may only be a temporary device that could be removed in the near future. you should speak to your physician regarding these options.

I stopped using my birth control pills (Yasmin) in April of this year. My LMP was on May 21st. I suspect that I am pregnant, but the pregnancy test I took on Monday was negative (maybe I've tested too soon?) I've researched that stopping the use of birth control pills may irregulate your menstral cycle, but it seems that I clearly am having most of the symptoms of being pregnant (nausea, exhaustion). could I be pregnant or am I just experiencing symptoms of being off the pill?

I had those symptoms when i got off of Yasmin, also. However.. go to your OG/BYN just incase. Pregnancy tests are not always right. I have had first hand experience. I took a pregnancy test 4 weeks after inter course .. and it tested negative. I was never experiencing nausea or exhaustion. So about 3 months into my pregnancy.. im growing a belly. Im like.. what the *****. So i take another pregnancy test–negative. then i went to the OG/BYN. Uh.. yeah your pregnant, he told me. I was like…. god damn.

Doctor is the best way to go!!

the best time to take a pregnacy test is in the morning it even says it on the directions. but if you really think you could be go to a clinc or your family doctor just to be sure.

My gyno told me that after stoping yasmin it would take about three months to be able to conceive. your symptoms sound like mine after stopping. I also has spotting and headaches.wait another few days or a week if you have the patience and take another test or go to the gyno for a proper test.

I definitely think that they are just symptoms of coming off the pill.
I stop getting the Depo Shot (birth control in November). I experienced those symptoms for 2 complete months. let me tell you it is horrible.
I would feel sick at night …. even get sick.
tenderness of the chest…. even growing of the chest
My family and friends would state i had a pregnancy glow… (like i really don't know what that means)
So I was nervous… every week for a month i went to the doctors and it was negative. Every-time I went.

So i don't know if you want to or don't… but i really think that you are probably not like me.

It could be either ways. The best thing to do would be to consult a doctor.

You could be pregnant. if you suspect that you are I would recommend going to the dr they can do a blood or urine pregnancy test. Good Luck!

i think maby you have tested to soon wait a couple more days and retest if its still negative you might want to go and get a blood test done much quicker and if your not pregnant the test will show up anything else GOODLUCK and with the symptoms again it could be either ways its just to hard to tell

could go either way take a test in a few days, and see your doctor soon

If you are the test should have come back positive if your last cycle was May21st.I think you should go to the doctor's just to be on the safe side,it could be something else going on with you,although birth control is known to throw you off a little.Goodluck!

go to the doc just in case. they say that you can't get pregnant within a year after you stopped using birth control. i was on depo provera and i got pregnant about a year or two years after. but anything is possible

go to obgyne, sometimes pregnancy test is not accurate, to be sure GOOD LUCK…….

Take another test or go to the doctor. if you are, you need prenatal care.

depends,did you have sex with anyone,if you did then you're pregnant if not you're like me when i got of my miasma pill