Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Wednesday, April 18, 2012

Fundamentals of Dive-Sex class, latex-grab

His condom burst! I’m fertile! I am SO fucked!

Casino dive-moms: Several women working in our casinos came to me asking that I teach a ‘Fundamentals of Dive-Sex’ course during spring break because they have daughters who will be taking courses at the University of Hawaii in Honolulu this summer and want to ensure they know how to protect themselves during an underwater sexual encounter. West coast girls have been taking summer courses at UH almost forever, but until recently there didn’t appear to be a need for gas-guards as underwater intercourse was fairly rare and if there were serious injuries none seemed to make the headlines. The students I taught will be at the University of Hawaii Manoa campus on the north side of H1 inland from Waikiki, but can easily get to the outer islands on weekend trips.

The Fundamentals of Dive-Sex course I taught included: Being fitted for FemCaps or Reflections flat spring latex diaphragms for use as gas-guards or as one student called her FemCap ‘Flood Insurance’, since its needed to prevent water being forced into the uterus if the vagina floods which, as returning readers know, is very common during underwater penetrative sex. I taught how to correctly insert their gas-guards, what lubricants to use and how to apply them and the use of Ben Wa balls for pelvic muscle toning. All the girls were on Yaz or Beyaz so I didn’t stress the normal need to use a spermicide with their cervical barriers, but they will be using DiveGel+ as their lube which has the O9 spermicide Semécide in it so that was covered. I also taught how to use the FC2 female condom – correct insertion technique and to make sure he reenters inside the sheath if he slips out - if for some reason they couldn’t use their cervical barriers for an underwater encounter.

Latex-Grab: Lastly I taught the girls about latex-grab. That’s where, if both partners are wearing barriers, a lot of their natural lubricant is trapped within each barrier and that is especially true for diaphragms since they cover almost the entire anterior wall of the vagina. An additional complication is if the woman is also on hormonal contraceptives. The progestin in hormonal birth control can dry up the normal vaginal lubricant for some women so that even when aroused they are relatively dry. In addition to the pain involved in having sex while not sufficiently lubricated, a potentially more serious problem is that the friction of the condom tip on the dome of the diaphragm can cause the condom to burst or pull the diaphragm off the cervix leaving her unprotected, or both. Latex-grab is particularly common when a couple is using both a latex condom and latex diaphragm though it can also occur with silicone diaphragms and polyurethane condoms.

The supplies: I provided each student with the necessary supplies for the course as well as what each should need for summer school. They were: a primary cervical barrier either the Reflexions latex flat spring diaphragm (because it is especially difficult to under-thrust) or a FemCap; two 25 count boxes of prefilled 10ml DiveGel+ disposable applicators; two doses of Plan B One-Step in case she forgets to take her pills. Plan B is better in their case since they will need to continue taking their regular birth control pills; a package of 10 FC2 female condoms, which are about $.90 each through our clinic. And since the students are dependents of casino employees they are covered under the casino’s reproductive health care insurance so they could be enrolled in the clinical trial to use DiveGel+.; and finally for the class each student was provided a set of (two individual) one inch diameter .6 oz Pyrex glass vaginal training balls.

Several needed to be SCUBA certified first and the five that ended up in the class I taught were very highly motivated and worked hard to get the technique down correctly so that if necessary they could teach their partners what they needed to get the most from the experience. It’s so nice when I’m working with highly motivated young women. The First summer session at UH Manoa is May 21 – June 29, and the second session July 2 – Aug 10, 2012 and my Vegas girls will stay for both sessions.

Label change for birth control pills containing Drospirenone: Birth Control Pills Containing Drospirenone: Label Change-Products may be associated with a higher risk for blood clots

“FDA has completed its review of recent observational (epidemiologic) studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills. Based on this review, FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills.” The full Safety Alert can be found HERE

The FDA Approved Oral Contraceptives containing Drospirenone are:

Drospirenone and ethinyl estradiol: Drospirenone 3 mg and ethinyl estradiol 0.03 mg
Ocella: Drospirenone 3 mg and ethinyl estradiol 0.03 mg
Safyral: Drospirenone 3 mg, ethinyl estradiol 0.03 mg, and levomefolate calcium 0.451 mg
Syeda: Drospirenone 3 mg and ethinyl estradiol 0.03 mg
Yasmin: Drospirenone 3 mg and ethinyl estradiol 0.03 mg
Zarah: Drospirenone 3 mg and ethinyl estradiol 0.03 mg
Beyaz: Drospirenone 3 mg, ethinyl estradiol 0.02 mg and levomefolate calcium 0.451 mg
Drospirenone and ethinyl estradiol: Drospirenone 3 mg and ethinyl estradiol 0.02 mg
Gianvi: Drospirenone 3 mg and ethinyl estradiol 0.02 mg
Loryna: Drospirenone 3 mg and ethinyl estradiol 0.02 mg
Yaz: Drospirenone 3 mg and ethinyl estradiol 0.02 mg

Sunday, March 25, 2012

OTC oral contraceptives in the U.S?

Combined birth control pills dial pack

Reproductive Health Advocates Urge FDA To Allow Nonprescription Access to Birth Control Pills

March 23, 2012 — Women's health advocates at an FDA hearing on Friday will ask agency officials to include oral contraceptives among the medications they are considering for nonprescription access, Bloomberg reports.

The two-day public hearing, which began Thursday, aims to assess whether certain prescription medications can be safely moved to nonprescription status. The changes are intended to reduce costs and increase access to the drugs.

In a statement released last month, FDA focused on four types of drugs related to chronic conditions: asthma, blood pressure, cholesterol and migraine treatments. According to Bloomberg, FDA has not taken a public position on nonprescription access to birth control pills.

Eleanor Schwarz, an associate professor of medicine at the University of Pittsburgh, said that although contraception "has been a politically charged topic," when the issue is considered "within the purely health-and-science realm, we understand it saves people's lives." She added, "All available contraceptives are much safer for women's health than an undesired pregnancy." Schwarz led a research team that tested computerized kiosks to help a woman determine whether she should take birth control pills by assessing factors that might make the pills inadvisable, such as smoking or severe migraines. "This program identifies women who can safely use hormonal contraception as well, or better than, most doctors," Schwarz said (Edney, Bloomberg, 3/23).

Personal comment: I understand wanting to make access easier for women who need and can safely use hormonal birth control. However given the number of law suits against pharmaceutical companies by women who claim to have had serious reactions from using hormonal contraceptives I think it would be a terrible idea to allow sale of oral contraceptives over the counter and go to self-screening rather than screening of patients that is supposed to be performed by a doctor to find medical conditions that would make hormonal contraceptives a bad choice before writing her an Rx for them.

Saturday, October 29, 2011

Increased clot risk for some hormonal birth control

Yaz birth control pills

FDA Details Clot Risk for Birth Control Products
By John Gever, Senior Editor, MedPage Today
Published: October 27, 2011

“Worrisome increases in thrombotic risk associated with hormonal contraceptives are not limited to those containing drospirenone, according to an FDA report issued Thursday.
Compared with hormonal contraceptives with relatively low estrogen doses, norelgestromin/ethinyl estradiol transdermal patch and etonogestrel/estradiol vaginal ring products were both associated with increased risk for venous thromboembolism (VTE), as were birth control pills containing drospirenone, according to the retrospective database analysis.

FDA researchers ran the analysis on records maintained by Kaiser Permanente for members in California and state Medicaid programs in Tennessee and Washington, covering a total of more than 835,000 women who received contraceptive prescriptions from 2001 to 2007.

After adjusting for demographic and other factors, the analysis indicated the following relative risks, with low-estrogen hormonal contraceptives as the reference:

• Drospirenone products: 1.74 (95% CI 1.42 to 2.14)

• Norelgestromin/ethinyl estradiol transdermal patch: 1.55 (95% CI 1.17 to 2.07)

• Etonogestrel/estradiol vaginal ring: 1.56 (95% CI 1.02 to 2.37)

Younger women (those up to age 34) appeared to be at higher risk for VTE for all three product types, the study showed.

And the clotting risk was not limited to VTE -- arterial thromboembolism was significantly increased among women 35 and older taking drospirenone products for the first time.

Thrombosis has long been a concern for hormonal contraceptives of all types and doses. But a number of studies have suggested that the risk differs among the multitude of product types now available.

Drospirenone came into the FDA's crosshairs earlier this year when two studies found that the VTE risk was doubled or tripled relative to levonorgestrel-containing pills.
Previous studies had also identified possible increases in risk associated with the patch and vaginal ring products, although the FDA had not formally announced a safety review, as it had done for the drospirenone products.

All of the previous studies were relatively small and fell short of the quality needed to form the basis for regulatory action, the FDA indicated.

Late last month, after reviewing the preliminary data from the Kaiser/Medicaid analysis, the agency said it still had not reached a conclusion about the degree of risk. That remains the case, according to the FDA this week.

It plans to present all the data to its Reproductive Health Drugs and Drug Safety and Risk Management advisory committees at a joint meeting on Dec. 8.”

Personal comment: Birth-control pills that contain drospirenone include Bayer's Yaz, Yasmin, Beyaz, Safyral; Sandoz's Syeda and Loryna; as well as Barr Laboratories' Ocella, Watson Pharmaceuticals' Zarah and Teva Pharmaceuticals' Loryna. Etonogestrel is also used in the single rod implant Implanon.

It will be interesting to see what the FDA decides because they have known about the problems with Ortho Evra (the patch) – because of the much higher average estrogen dose - for years and have done nothing more than require warning labels for the product.

Tuesday, March 8, 2011

hCG weight loss regimen



Pregnyl injectable hCG available on-line

The New York Times
March 7, 2011
By ANEMONA HARTOCOLLIS

Diet plan with hormone has fans and skeptics

Every morning, Kay Brown engages in a ritual similar to a heroin addict’s, or a diabetic’s: she sticks herself with a syringe. Only hers contains hCG, a pregnancy hormone.

Ms. Brown, 35, is not taking hCG to help her bear a child. She believes that by combining the hormone injections with a 500-calorie-a-day diet, she will achieve a kind of weight-loss nirvana: losing fat in all the right places without feeling tired or hungry. “I had a friend who did it before her wedding,” Ms. Brown said. “She looks great.”

Women like Ms. Brown are streaming into doctors’ offices and weight-loss clinics all over the country, paying upward of $1,000 a month for a consultation, a supply of the hormone and the syringes needed to deliver it. More than 50 years after a doctor at a Roman clinic began promoting hCG as a dieting aid, it is as popular as ever, even though there is scant evidence that it makes any difference.

The regimen combines daily injections with a near-starvation diet, and patients, mostly women, are often enticed by promises that they can lose about a pound a day without feeling hungry. Perhaps even more seductively, they are frequently told that the hCG will prompt their bodies to carry away and metabolize fat that has been stored where they least want it — in their upper arms, bellies and thighs.

In response to inquiries stirred up by the diet’s popularity, the Food and Drug Administration warned in January that “homeopathic” forms of hCG, like lozenges and sprays, sold over the Internet and in some health food stores, are fraudulent and illegal if they claim weight-loss powers.

The injectable, prescription form of hCG, human chorionic gonadotropin, is approved as a treatment for infertility and other uses, and it is legal for doctors to prescribe it “off-label” for weight loss.

But the F.D.A. has also reiterated a warning, first issued in the mid-1970s, that is required on hCG packaging: It has not been shown to increase weight loss, to cause a more “attractive” distribution of fat or to “decrease hunger and discomfort” from low-calorie diets.

The F.D.A. recently received a report of a patient on the hCG diet who had a pulmonary embolism, said Christopher Kelly, a spokesman for the agency. He said the hormone carried risks of blood clots, depression, headaches and breast tenderness or enlargement.

Dr. Pieter Cohen, an assistant professor at Harvard medical school who researches weight-loss supplements, said that aside from the issue of side effects, the use of hCG as a diet tool was “manipulating people to give them the sense that they’re receiving something that’s powerful and potent and effective, and in fact they’re receiving something that’s nothing better than a placebo.”

But unlike other popular diet supplements, hCG, which is derived from the urine of pregnant women, has acquired an aura of respectability because the injections are available only by prescription.

Ms. Brown’s physician, Lionel Bissoon, a well-known society doctor with an office off Central Park West, charges $1,150 for his hCG program, which covers an examination, injection training, a month’s supply of the hormone and syringes, and blood work to monitor for possible trouble.

“From an anecdotal point of view,” Dr. Bissoon said, “physicians all around the country have seen people losing a tremendous amount of weight with this stuff, and you cannot afford to ignore that.”

Another New York doctor, Scott M. Blyer, offers the hCG diet as an adjunct to his cosmetic surgery practice, working with Jacqueline Fulop-Goodling, an orthodontist, out of her office in Midtown. Dr. Fulop-Goodling does not prescribe hCG, but she counsels patients. They charge $800 for a 40-day course of therapy, half-price for repeat rounds; they also require an EKG to make sure the patient has no heart trouble.

One of Dr. Blyer’s patients, a 30-year-old business consultant named May, who asked that her last name not be used because she was embarrassed to be considering the diet, described herself as an “emotional eater.” She is 5-foot-3 and 130 pounds, but said she hoped to shed 20 pounds in time to be a bridesmaid at an April wedding. “So I have just six weeks,” she said.

Dr. Blyer looked uneasy. “Your legs are thin, your face is thin,” he told her. “You’re a very attractive woman.” But he reassured her that she would lose weight where she wanted to, in her stomach. The hCG, Dr. Blyer said, “tricks your body into a state of pregnancy; it burns off fat so the fetus can get enough calories, but it protects muscle.”

May eventually decided that she did not need to lose much weight and did not go through with the diet.

Dr. Blyer’s explanation of how the hCG diet works resembles a theory first popularized in the 1950s by A. T. W. Simeons, a doctor in Rome who said he had used it on more than 500 patients, and published a paper about it in The Lancet, the British medical journal, in 1954.

In 1995, a Dutch study in The British Journal of Clinical Pharmacology tried to resolve the question of whether the hCG diet really worked by analyzing 14 randomized clinical trials of the diet. Only two, including one co-written by an advocate of the diet, found that people on hCG lost more weight, felt less hunger and had an improved body shape, compared with people on the same 500-calorie diet who received a placebo, like saline injections.

But several studies concluded that the ritual of the daily injection and the instant gratification of quick weight loss helped motivate people to stay on the diet.

However arcane the theory, some doctors say it is theoretically plausible that hCG would create a more toned body, because it can induce the production of male hormones and increase muscle mass.

“There’s a reason Manny Ramirez took it,” said Dr. Martin Keltz, director of the division of reproductive endocrinology and infertility at St. Lukes-Roosevelt Hospital Center in Manhattan. Mr. Ramirez, the baseball star, was suspended for 50 games in 2009 after evidence surfaced that he had used hCG, which is banned by Major League Baseball.

Dr. Keltz said he thought it was possible to redistribute fat with hCG, but, he added, “there are risks, like cardiovascular risks.”

“I would shy away from them,” he continued.

Then there are the nutritional concerns about a diet that some say mimics anorexia. “The average person is going to eat 1,800 to 3,000 calories,” said Kristen Smith, a bariatric surgery dietitian at Montefiore Medical Center.

“I don’t think it promotes healthy long-term eating habits,” she added.

Doctors who prescribe hCG for dieting say that experience is in their favor, even if the research is not. They point to women like Guldal Caba, a 53-year-old psychologist from Toledo, Ohio, who traveled to New York for treatment from Dr. Bissoon. “It was the fat that needed to go — you know behind my bra, that back fat, my belly,” Dr. Caba said.

Ms. Brown, a theater administrator who is 5-foot-8, said she was thrilled to lose six pounds in seven days, and hopeful about reaching her goal of losing 30, which would bring her close to her ideal weight of 135. She said she did not feel hungry and did not obsess about food as she had years ago, when suffering from anorexia.

“A lot of people have a lot of opinions,” Ms. Brown said, “but I don’t want to be a person who feels like my weight is not under my control.”

Personal comment: We have society doctors here and in LA who prescribe hCG regimens for weight loss and several of the mom’s (in their late 30s early 40s) of ballet and AST students at St Lucy’s are on the regimen. None of them have had any severe side effects and have managed to eat enough to avoid secondary amenorrhea and are losing or have lost weight and are now on a maintenance level regimen. Even so, my experience with hormones in the pill, Ortho Tri-Cyclen (norgestimate and ethinyl estradiol), taught me to stay away from hormones if possible so if asked I recommend exercise and a healthy diet for weight loss. Weight loss supplements for St Lucy’s students are forbidden except in the most severe cases with St Lucy’s approved physicians and dietitians overseeing a students treatment.

I do take L-Dopa to limit my milk production to control the size of my breasts – to a full B-cup when engorged with milk – and the dopamine has the added side effect of increasing my libido, so that’s a win-win! And I do take Adderall for concentration when I’m on clean-up for the Family, but other than that, recreational sex is my ‘drug’ of choice.

Friday, June 18, 2010

ellaOne closer to U.S availability


ellaOne (ulipristal acetate) another step closer

The New York Times
June 17, 2010
By GARDINER HARRIS

Panel Recommends Approval of After-Sex Pill to Prevent Pregnancy

GAITHERSBURG, Md. — A federal advisory panel voted unanimously Thursday that federal drug regulators should approve a medicine that could help prevent pregnancy if taken as late as five days after unprotected sex.

The pill, called ella, sprang from government labs and appears to be more effective than Plan B, a morning-after pill now available over the counter to women 18 and older that gradually loses efficacy after intercourse and can be taken at latest three days after sex. ella, by contrast, works just as well on the fifth day as the first after sex.

Ella blocks the effects of progesterone, a female hormone that spurs ovulation. It is a chemical relative to RU-486, the abortion pill, and some mystery remains over exactly how it works. That mystery spurred a fierce debate outside the committee over whether it should be considered an abortion drug, a debate that prompted the posting of several uniformed police officers around the meeting room.

The F.D.A. usually follows the advice of its advisory panels but not always.

The dispute is whether the drug works by delaying ovulation (as the pill’s manufacturer claims) or by preventing a fertilized egg from implanting itself in the uterus (as anti-abortion advocates say).

Dr. Jeffrey Bray, a pharmacologist at the Food and Drug Administration, said that ella may do both. And Dr. Scott Emerson, a committee member and professor of biostatistics at the University of Washington, said any drug that can prevent pregnancy if taken five days after unprotected sex must do more than simply delay ovulation.

Animal studies showed that ella had little effect on established pregnancies, suggesting it acts differently than RU-486. Dr. David Archer, a professor of obstetrics and gynecology at Eastern Virginia Medical School who spoke on behalf of ella’s maker, said ella was not an abortion pill. “I just don’t think there is any element here that would allow me to say that this has an abortifacient activity,” Dr. Archer said.

ella is manufactured by HRA Pharma, a tiny French drug maker. If approved, the medicine would be available by prescription only. Born in the United States, ella was approved for sale in Europe last fall. During the meeting, anti-abortion and abortion rights advocates traded salvos. Wendy Wright, president of Concerned Women for America, a conservative group, called ella an unsafe abortion pill that men might slip to unsuspecting women.

“With ella, women will be enticed to buy a poorly tested abortion pill in the guise of a morning-after pill,” she said. Ms. Wright was followed to the microphone by Amy Allina, program director of the National Women’s Health Network, who said abortion questions were distractions intended to prevent “medically safe contraceptive options from becoming available.”

The committee spent the day in a cold discussion of the sobering realities that follow moments of passion, a discussion punctuated by the clacking of knitting needles from Dr. Paula Hilliard, a committee member and professor of gynecologic specialties at the Stanford University School of Medicine. It was a conversation mostly among women. Dr. Erin Gainer, HRA Pharma’s chief executive, is a young woman, and nine of the committee’s 11 members are women. Women’s health advocates say that the need for better contraceptive options is clear.

James Trussell, director of the Office of Population Research at Princeton University, who spoke on behalf of the company, said that more than one million women who do not want to get pregnant are estimated to have unprotected sex every night in the United States, and more than 25,000 become pregnant every year after being sexually assaulted. Half of all pregnancies in the United States are unintended even though contraceptives are almost universally accepted by women.

Even though ella is somewhat more effective and can be taken later than Plan B, the new drug would, if approved, probably do little to solve this epidemic of unplanned pregnancies. Plan B has been available without a prescription since 2006 for women 18 and older, but abortion and unintended-pregnancy rates have remained largely unchanged.

Women who have unprotected sex have about one chance in 20 of becoming pregnant. Those who take Plan B within three days cut that risk to about one chance in 40, and if ella is approved, that risk would be cut further to about one chance in 50. ella is less effective in obese women, studies show.

Dr. Valerie Montgomery Rice, a committee member and dean of Meharry Medical College in Nashville, pressed the company and F.D.A. to make the drug available over the counter, as is Plan B. “Why would we not move to O.T.C. status?” she asked. Dr. Gainer said the medicine was too new to consider such a step.

ella was originally developed by the National Institute of Child Health and Human Development. The institute, now named after Eunice Kennedy Shriver, is part of the National Institutes of Health. It decided in 2002 during the avowedly anti-abortion Bush administration to finance a crucial study to assess the drug’s efficacy as an emergency contraceptive.

Tuesday, June 15, 2010

The FDA and ulipristal acetate


ellaOne pack ulipristal acetate

USA TODAY
By Rita Rubin
Updated 6/7/2010

FDA panel to mull 'morning-after pill' effective 5 days after sex

A Food and Drug Administration advisory committee will meet June 17 to consider whether the agency should approve a new emergency contraceptive that studies show is more effective than Plan B, the only "morning-after pill" on the U.S. market.

HRA Pharma of Paris launched ulipristal acetate in October 2009 and sells it in 21 European countries under the brand name ellaOne. As in Europe, ulipristal would be available only by prescription in the USA. Plan B, the brand name for levonorgestrel, is available without a prescription to women 17 and older, but those under 17 require a prescription.

Plan B is approved for use up to 72 hours after unprotected sex; even within that window, though, it becomes less effective over time. But two company-funded trials involving more than 3,000 women, published in February, found that ulipristal was consistently effective up to 120 hours, or five days, after unprotected sex.

In one randomized study, researchers compared ulipristal to levonorgestrel in women who had sought emergency contraception at family-planning clinics in the USA, Britain and Ireland within five days of having unprotected sex.

About 1,700 of the women received emergency contraception within 72 hours of having unprotected sex. Half got ulipristal and the other half received levonorgestrel. In the ulipristal group, 15 ended up getting pregnant, compared with 22 who took levonorgestrel.

Among 203 women who received emergency contraception 72 hours to 120 hours after unprotected sex, there were three pregnancies, all in women who had been given levonorgestrel.

The other study published in February focused on 1,241 women who had come to Planned Parenthood clinics for emergency contraception 48 to 120 hours after unprotected sex. All of them received ulipristal. About 2%, or 26, still ended up getting pregnant, but those who took the pill five days after unprotected sex were no more likely to get pregnant than those who took it two days afterward.

"If it were my daughter, I'd want her to have ulipristal rather than Plan B in her medicine cabinet," says Paul Fine, co-author of the studies, professor of obstetrics, gynecology and urology at Houston's Baylor College of Medicine and medical director of Planned Parenthood of Houston, southeast Texas and Louisiana.

More safety data are needed before ulipristal could be sold without a prescription, Fine and his co-authors wrote Feb. 13 in The Lancet.

Ulipristal and levonorgestrel work by inhibiting ovulation, Fine says. He disputed comments filed with the FDA on June 1 by Americans United for Life, an anti-abortion group that likened ulipristal to RU-486, the so-called abortion pill, which is its chemical cousin.

But Fine counters that ulipristal did not cause abortions in women who got pregnant after taking it.

Personal comment: In my entry for January 29, 2010 I mentioned that Elke brought along a supply of ellaOne to use after encounters with Adolph, even though she has a GyneFix IUD implanted, because she had heard how fertile he is. Anyway, the FDA will be holding hearings this week to help decide if they should approve ulipristal acetate for use in the U.S. as an emergency contraceptive. There is sure to be a spirited discussion, but I hope it is quickly approved.

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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