Sunday, April 18, 2010

Yaz and drospirenone, Caesar’s farewell

Yaz oral contraceptive pills
By Tammy Worth
Special to the Los Angeles Times
April 19, 2010

Birth control pill concerns bring lawsuits but few solid answers

Yaz and Yasmin complaints focus on the synthetic progestin, drospirenone. Studies have not found an increased risk with these pills, though.

When the oral contraceptives Yasmin and Yaz came on the market in 2001 and 2006, respectively, they were thought to be safer than other birth control pills because they contained a different kind of synthetic progestin.

But in a flurry of lawsuits against the pills' maker, Bayer HealthCare, attorneys claim that the progestin contained in the pills, drospirenone, is the cause of health problems, including deep vein thrombosis (blood clots in the deep veins), strokes, heart attacks and gallbladder disease.

As of mid-February, about 1,100 lawsuits had been filed in the United States against Bayer, which stands behind the safety of the pills.

Research on the issue is divided. Some studies have found drospirenone to pose no greater health risk than other birth control pills; some studies show a sixfold greater risk of getting blood clots, even in young, healthy women. More research is being performed on the safety of the contraceptives, but for now, women considering taking the pills will need to weigh the contradictory information themselves

"There is reason to be concerned, I believe, about both of them [Yaz and Yasmin]," said Dr. Sidney Wolfe, founder and director of Public Citizen's Health Research Group, a nonprofit advocacy organization based in Washington, D.C. "When evidence like that comes up, people should pay attention to it."

Oral contraceptives control unwanted pregnancies by using hormones that block ovulation.

The first of these pills, introduced in the United States in the early 1960s, contained high doses of estrogen. They were quickly found to raise the risk of stroke, blood clots and heart attacks.

Second-generation pills introduced in the 1970s contained lower amounts of estrogen combined with synthetic progestins, including one called levonorgestrel. These reduced the risk of blood clots but caused side effects such as weight gain and acne in many women.

The 1980s brought third-generation pills containing different synthetic progestins, such as one called desogestrel. These were later found to be associated with a higher risk of deep vein thrombosis and pulmonary embolism.

The fourth-generation pills — Yaz, Yasmin and Ocella, a generic version — contain estrogen and yet another progestin, drospirenone. They were created not just to prevent pregnancy but to also reduce the side effects of previous pills and to treat premenstrual dysphoric disorder (severe cases of depression, anxiety, headaches and other symptoms).

Yaz is now the No. 1-selling birth control in the United States, grossing more than $391 million in the first half of 2009, up 44% from the same time period in 2008, according to health data provider IMS Health. Bayer received a warning from the FDA last year for overstating Yaz's effectiveness in treating PMDD and acne while minimizing the risks of the medication on its website and television commercials. In response, the company altered its advertising.

Now the contraceptives are not just the subject of lawsuits, they're also under scrutiny by groups such as Public Citizen over their safety. The FDA is testing the safety of Yaz and other pills in an ongoing study.

Two 2009 reports helped raise alarms. Published in the British Medical Journal, both assessed whether drospirenone is more likely to cause blood clots than other types of synthetic progestins.

One study looked at blood clot rates in Danish women ages 15 to 49 with no history of cardiovascular disease. From 1995 to 2005, there were 4,213 cases of various kinds of blood clots including in the heart, kidney, lungs and liver, 2,045 of which occurred in users of oral contraceptives. Researchers found that pills containing the progestins desogestrel, gestodene and drospirenone (the one found in Yasmin, Yaz and Ocella) were associated with a higher risk of blood clots than those containing levonorgestrel.

A second studied more than 3,200 women from the Netherlands. In this case, participants taking birth control pills containing levonorgestrel had a four times higher risk of getting blood clots than women taking no birth control, and for other progestins the risk was higher still: 5.6 times greater for gestodene, 6.3 times greater for drospirenone and 7.3 times greater for desogestrel. The greatest risk occurred during the first three months of oral contraceptive use.

"It clearly concludes that the safest thing to do is take the older [birth control pills], not the third generation or Yaz," Wolfe said.

Public Citizen had already placed Yasmin on its "Do Not Use" list because it can raise blood potassium levels, Wolfe added.

Rose Talarico, deputy director of external product communications for Bayer, said in an e-mail that Bayer "will defend itself vigorously against these lawsuits" and that patient safety is important to the company. She said the company's drospirenone-containing oral contraceptives "are safe and effective when used according to the product labeling."

Two studies, both sponsored by Bayer, found drospirenone to be as safe as other progestins.

In one, scientists at the Center for Epidemiology and Health Research in Berlin tracked for over a year more than 58,000 European women who had been prescribed various forms of birth control pills. They concluded that there was no greater risk of mortality, cancer or cardiovascular problems from pills with drospirenone than other oral contraceptives.

In the other, i3 Drug Safety, a company that provides pharmaceutical services to drug companies, followed for seven months almost 70,000 U.S. women taking various kinds of oral contraceptives, including ones containing drospirenone. The researchers concluded that more than 9,000 women would need to take Yaz or Yasmin for one extra case of deep vein thrombosis to occur.

Attorney A.J. de Bartolomeo, a partner at the San Francisco law firm Girard Gibbs who is helping shepherd lawsuits against Bayer, said women should be warned if there is even a slightly greater risk.

"We believe it's a dangerous drug, and the most important thing here is to allow women to make an informed choice and know what the comparable risks are before they put a drug in their body," De Bartolomeo said.

As of November, the Food and Drug Administration had received reports of 993 cases of pulmonary embolism (blood clots in the lungs), 487 of deep vein thrombosis (clots in the deep veins) and 229 of other blood clots for the two medications combined.

Some physicians think the attention the medications have received serves only to frighten women.

"Patients get hurt with these types of lawsuits," said Dr. Andrew Kaunitz, a professor of obstetrics and gynecology at the University of Florida's College of Medicine who has consulted with pharmaceutical companies, including Bayer. "They get scared not only with this one pill but all types of contraceptives."

Kaunitz said all types of oral contraceptives increase the risk of blot clots three- to fourfold. But, he added, pregnancy increases the risk of blood clots six- to 10-fold. He said he wouldn't recommend patients change their pills if Yaz or Yasmin are working well for them.

Dr. Anitra Beasley, a physician at the Leadership Training Academy of Physicians for Reproductive Choice and Health and a fellow at Columbia University in New York, has been telling her patients the same thing. She said many come in with worries after seeing commercials questioning the pills' safety — and that some have stopped taking Yaz only to return with an unwanted pregnancy.

"We've got great news from the FDA, that has looked at all of these studies and assures us that the best-done study shows that the risk of clots with Yaz is not greater than on any other birth control pill," she said. "And we have read all of the same literature and have come to the same conclusions — we didn't change our practices."

Dr. Anita Nelson, a professor of obstetrics and gynecology at UCLA's David Geffen School of Medicine who serves on the advisory board of Bayer, said the litigation runs the risk of "scaring the heck out of women."

"I have noticed a pattern, that every time a method of birth control gets popular it gets sued," she said. "The same thing happened for the patch; and we lost Norplant [for the same reason] even though it was very safe and effective."

Personal comment: Yaz is the pill most often prescribed for St Lucy’s girls on hormones. Our Gyns have found that with proper screening it is as safe as other pills with older progestins and it has fewer side effects as well as decreasing severe menstrual cramps other pills hardly touch. Our screening process is very thorough and encompasses a student’s parents and grandparents as well. St Lucy’s girls haven’t had any severe side effects from taking Yaz.

Caesar’s last campaign: It’s been a sad week. I’ve had to send my male tiger, Caesar, to a wildlife sanctuary. He was such a wonderful bedmate; warm, soft and cuddly, unless he rolled over on you. For a cat his size his purr or snoring was relaxing and could put me right to sleep, even if we hadn’t had sex. In the last several months it got so that his behavior was becoming erratic. He was cranky and wouldn’t eat and snapped at his keepers and his Vet could find nothing physically wrong except old age. He was always gentle with me. Well, in the context of what a woman experiences when having an intense sexual encounter with a 300 pound tiger which at best is always risky. But the adrenaline rush when he ejaculated in me was fantastic! Afterward I was always amazed that he didn’t break my neck while thrusting into me. He was just the most amazing lover! I was fortunate to experience in real life what most women can only fantasize about.


  1. Sorry to see Caesar go, but it's for the best.

  2. are you going to get a new tiger?

  3. As sweet as he was Caesar was a one-off for me. I understand how lucky I was that he wanted to play with me not have me for a meal, though we were careful to feed him before he and I were together. Getting fucked by a tiger and living to tell about it was a huge thrill each time it happened, but I'm not going there again.

  4. did you ever ripple grip any of the animals you had and if so, to what effect/affect?

  5. Hi Anon... I ripple gripped Caesar because I took him often enough that I got to see what the difference was between when I was passive or not. And he was just faster, and I thought a bit more urgent (if that was possible) planting his seed into me. Great Danes were the same… faster getting off, but not as much fun as there is no danger fucking a Great Dane.

    With dolphins I was always so busy enjoying what they were doing in me (the penis is flexible and gets to a woman’s G-spot with apparent ease) and trying to prevent the male I was with from pinning me on the bottom… that I never really got to ripple grip a dolphin all that effectively. So it is near the top of my to-do list when I next go to my place on Virgin Gorda.

  6. have you ever run into a dolphin on a open water dive and had sex with it or have your encounters with dolphins in that aspect been in a controlled environment? do you wear scuba gear and in that case why would it matter if he pinned you to the bottom unless it was very deep i can see how that would be problematic and sandy i suppose unless in a pool, also how does courtship of a dolphin go in an open water scenario, easy? thanks for sharing

  7. do men ballet boot fight? and where can i find footage of said fighting seems much more interesting to watch vs mma where its dudes sweating on each other on the ground and ballet fighting seems to be primarily girls not to mention blades :). much appreciated

  8. Hi anon. I’ve never seen men fight in standard ballet boots. A few have tried to train with bladed heels. I’ve seen one or two start training, but they all had women trainers who were faster (not stronger) and with more precise with footwork – the result of years of pointe training - than they were able to attain and no men made it past the first 6 weeks of training.

    We try hard to prevent any footage of knife-pointe fights. I can’t say there isn’t any out there somewhere but we hope not. Knife-pointe fighting is a very expensive sport because backers have to subsidize fighters with custom made titanium or ceramic armor, training and medical expenses all of which can be wildly expensive. Women sweat a lot too, but if you are into men or boys then it’s not the same as seeing a girl have her breast sliced open because of faulty armor.

  9. Hi Anon. All my encounters with dolphins have been while using SCUBA. When I lived on the East Coast I worked briefly for a very wealthy woman who had several dolphins in a large all weather tank. She wanted to see if I could consistently have ‘safe’ sex (a relative term when used regarding inter-species sex) with the male because she wanted to use that sort of an encounter in a nightclub act. That was my first sexual encounter with a male dolphin and he apparently liked me. Curiously, he was vicious with other women divers and two other divers were injured when he dragged them along the bottom of the tank and slammed them into the walls. My backer gave up on the idea, though I think perhaps with a different male it might have worked.

    My other encounters have been in open water in a cove off my property in the BVIs. I’ve had sex with several over the years, but it’s complicated. The males are all sexually assertive, but there is a pecking order and the older larger males get their pick of females. The young males are around the edges of the pod so I try to pick a relatively young one or swim close enough that he initiates contact. That’s because they are smaller 300 rather than 600 lbs and the younger ones are more likely to have smooth skin. The old ones sometimes have marine growths that can slit a wetsuit, breast or belly when he glides over you so picking one with a smooth belly is important. The standard tactic by a male when he thinks his mate isn’t being receptive to his advances is to roll her on to her back and force her on to the bottom where he can hold her until he penetrates and inseminates her. It is fairly quick and it can be very rough. What I don’t want to have happen is have a more senior male take me away from the younger one who I am trying to mate with, for all the reasons above, plus then he is an a bad mood and wants to get really rough. I had that happen once and he penetrated me and took me way out into the open ocean and I thought I’d been screwed for sure, but when he finished in me he turned around and brought me back! I’m not sure what that was about, but I was very lucky!

    Most of the cove is 110 feet or less and on Nitrox depth is not a problem. Dolphin’s usually mate in relatively shallow water so being taken too deep shouldn’t be a problem. Being forced on to the bottom beneath a 300 lbs. or larger animal is really dangerous as you can be crushed or dragged into or across sharp coral or at best be nearly buried in the sand. And if you are harnessed to a tank that is plowing up the bottom a girl can easily have her pelvis or collar bones broken. That much sand stirred up and there is a good chance of a grain or two getting into your reg and causing equipment problems that either block your oxygen or cause it to free flow and exhaust it very quickly neither of which is good. But when I’m penetrated by a 300 lb animal in his environment it’s awesome!


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Powys , Wales, United Kingdom
I'm a classically trained dancer and SAB grad. A Dance Captain and go-to girl overseeing high-roller entertainment for a major casino/resort