Showing posts with label Obesity. Show all posts
Showing posts with label Obesity. Show all posts

Sunday, August 1, 2010

Birth control pills and obesity


Ortho Cyclen 0.25mg norgestimate, 35mcg ethinyl estradiol

The pill equally effective in obese, thin women
Reuters Health
By Anne Harding
Fri Jul 30, 2010

“NEW YORK (Reuters Health) - Despite studies suggesting that birth control pills might not work as well in obese women, a new study suggests that they prevent pregnancy the same no matter what a woman weighs.

As long as a woman-heavy or thin--took the pill consistently, Dr. Carolyn L. Westhoff of Columbia University Medical Center in New York City and her colleagues found, it prevented her ovaries from producing eggs. Westhoff and her team report their findings in the August issue of Obstetrics & Gynecology.

Studies have found that obese women are 30 to 40 percent more likely to get pregnant while taking the pill than were normal-weight women taking it, perhaps because excess weight might blunt its effectiveness. Overall contraception failure rates are estimated between 2 and 8 percent per year.

In their study, Westhoff and her colleagues enrolled 226 normal-weight or obese women, randomly assigning them to take a lower or higher dose version of the pill. After three or four cycles of oral contraceptives, the researchers then had the women undergo multiple ultrasounds and blood tests to determine if their ovaries were making eggs.

The researchers tested women's blood levels several times to determine if they were using the pill consistently; about 90 percent of the normal-weight women had hormone levels indicating consistent use, compared to 72 percent of the obese women.

Ninety-seven percent of the 150 consistent pill users did not ovulate, the researchers found, meaning they would not have gotten pregnant during that cycle. Whether or not a woman was obese didn't affect her likelihood of ovulation; among the consistent pill users, three of the 96 normal-weight women ovulated, and one of the 54 obese women did.

Two ovulations occurred in women taking the higher-dose pill, and two occurred in women on the lower dose.

But more than a third of the 13 women who were inconsistent pill users ovulated, and two-thirds of the 18 non-users produced eggs.

The new findings, along with more recent clinical trials, should put to rest concerns that obese women are more likely to get pregnant while on the pill, Westhoff says. The issue has confounded doctors, she notes, because some companies have pushed physicians to prescribe higher dose formulations to their obese patients based on the idea that lower doses aren't effective.

The problem with this approach, she explains, is that obese women are at increased risk of developing life-threatening blood clots in their veins. Taking the pill-especially at higher doses-further increases the risk these clots will occur.

But according to her findings, Westhoff says, obese women who take lower-dose pill formulations can be reassured that they will be effective in preventing pregnancy.

Westhoff has consulted for drug firms that make oral contraceptives, including Duramed, Schering-Plough, and Bayer.

The problem with previous studies, Westhoff told Reuters Health, was that women were asked to recall unintended pregnancies that had occurred in the past; the women also reported their own weights, rather than being weighed by the research team.

Dr. Victoria Holt of the University of Washington in Seattle, who led the studies finding different failure rates among obese and normal-weight research, said she still believes obese women are more at risk of becoming pregnant while on the pill.

She argues that Westhoff's research suggests obese women are less likely to achieve adequate hormone levels while taking the pill, because just 72 percent had levels indicating consistent oral contraceptive use, compared to 90 percent of the normal-weight women.

"If indeed there is lower effectiveness among obese women, then this does not appear to be the mechanism through which it works," Dr. James Trussell, the director of the Office of Population Research at Princeton University in New Jersey, told Reuters Health. Trussell studies contraceptive failure, but wasn't involved in Westhoff's research. "But nobody has any idea what the other mechanism would be."

This November, the National Institutes of Health will convene a group of experts to investigate whether further research should be done on obesity and oral contraceptives, he noted, while the Food and Drug Administration is also planning a hearing to address evidence that a new emergency contraceptive pill is more likely to fail in obese women.

"It's a particular concern in the United States because obesity is increasing so rapidly," Trussell said. "I would say that the pill is still not going to be the front line, the top tier contraception for obese women."

Methods with a lower risk of failure due to human error, like the IUD, hormonal implants, or vasectomy for the male partner, would likely be a better choice, he said.

"If a woman really doesn't want to become pregnant I would suggest combining oral contraceptives with a barrier method," Holt advised, such as condoms or a diaphragm.

SOURCE: link.reuters.com/wez52n Obstetrics & Gynecology, August 2010.”

Personal comment: Our escort training and service operations don’t employ heavier girls. The classical ballet dancers with Balanchine bodies that are our specialty are the very opposite of heavy; toned sleek and hard-bodied with small firm breasts and high tight buns. Even so I’ve been following this research (still in its early stages) for some time. What we can all agree on is that heavier women are more likely to become preggers while on the pill than are their thinner sisters. That may be due to metabolism subtleties or the fact that heavier girls are noticeably and consistently less compliant (perhaps for psychological reasons) in taking their pills correctly, or both.

The bottom line is that most of the services that supply heavier escorts – it’s a niche market – require the girls to have IUDs inserted for insurance purposes. They use the standard framed versions generally available - Marina or ParaGard - tending more toward Marina because it reduces menstrual flow and sometimes stops the woman’s periods entirely. Heavier escorts tend to offer only vanilla sex options because getting into most fetishwear when heavy is an exhausting process and the weight on their feet in ballet-boots will often lead to severe injuries so at best they only pose sitting down or on their backs when in ballet boots.

Tuesday, July 13, 2010

Obesity and birth control


The weight loss drug Qnexa

The Wall Street Journal - Business
July 13, 2010
By Jennifer Corbett Dooren Of DOW JONES NEWSWIRES

FDA Says Obesity Drug Works But With Side Effects

“WASHINGTON (Dow Jones)--The U.S. Food and Drug Administration said Tuesday that a proposed Vivus Inc. (VVUS) weight-loss drug resulted in "significant" weight loss, but the agency raised questions about the drug's long-term side effects.

The questions from the FDA aren't related to Qnexa's effectiveness, which has been proved in multiple clinical trials, but rather to the side effects of a drug that the agency is assuming may be taken indefinitely. Specifically, the panel pointed to increases in anxiety, sleep disturbances and depression, and debated usage by pregnant women.

Qnexa faces a review by the FDA's endocrinologic and metabolic drugs advisory committee Thursday. The panel of non-FDA medical experts will vote then on whether it thinks Qnexa should be approved by the larger FDA in a decision expected by late October.

Tuesday, the FDA posted its review of the product, which totaled 248 pages, on the agency's website.

Shares of Vivus rose 12.4% to $11.98 in early trading Tuesday. Wall Street analysts said the documents weren't particularly negative in their tone or content, but they warned that there remains a great deal of uncertainty about the panel's ultimate outcome.

A Vivus spokesman said the company looks forward to answering the FDA's questions at the panel, but he declined to comment further.

In its safety review of Qnexa, the FDA said it saw increases in heart rate among patients taking the drug but that the clinical significance of the finding is unknown.

The agency also said it saw increases in anxiety, sleep disturbances and depression among patients taking Qnexa compared to placebo but said the overall incidence of such side effects were low. The agency noted, however, that four to seven times as many patients taking the highest dose of Qnexa dropped out of the study because of anxiety-, sleep-, or depression-related side effects.

The FDA's review of Qnexa and the advisory committee meeting are being watched carefully by other companies with obesity drugs in development. Arena Pharmaceuticals Inc.'s (ARNA) lorcaserin will face an FDA panel in September, and Orexigen Therapeutics Inc.'s (OREX) Contrave is tentatively scheduled for a December panel review. The three drugs use different methods of damping appetite.

The other two stocks also rose Tuesday. Arena added 9.2% to $4.14, while Orexigen jumped 19% to $4.94.

The development of obesity compounds has been a tough area for companies since the fen-phen drug combination was taken off the U.S. market in 1997 after one of the medication's components was linked to heart-valve damage.

In 2007, an FDA panel unanimously rejected Sanofi Aventis SA's (SNY, SAN.FR) obesity drug Acomplia on concerns that the drug increased the number of psychiatric events, such as depression and suicidal thinking, among users. Sanofi later withdrew its application seeking FDA approval for the drug, and Pfizer Inc. (PFE) and Merck & Co. (MRK) scrapped plans in 2008 to continue developing similar drugs.

However, given that one-third of Americans are considered obese, companies successful at gaining FDA approval could tap a large market.

Qnexa is a controlled-release formulation that combines low doses of two older drugs: the stimulant phentermine, which cuts appetite, and topiramate, which increases the sense of feeling full. Topiramate is sold under the brand name Topamax by Johnson & Johnson (JNJ) to treat migraines and seizures.

Said the FDA: "Both drugs have reasonably well-established safety profiles because of their widespread use."

But because of the heart problems seen among patients taking fen-phen, the FDA looked at such side effects that might be attributed to phentermine and whether psychiatric side effects and birth defects potentially linked to topiramate would be seen among patients taken Qnexa. The agency noted that current evidence indicates the increased risk for heart-valve problems was attributable to fenfluramine and not to phentermine, one of Qnexa's components.

The FDA said heart palpitations were seen among 1.8% of Qnexa patients compared to 0.8% of patients taking a placebo. Patients taking Qnexa also experienced an increased heart rate. The agency said the clinical significance of the events "in terms of hard cardiovascular outcomes in the overweight and obese population is unknown."

The agency said it was concerned about a "large potential" for women to become pregnant while taking the drug as 34 pregnancies were seen in clinical trials despite instructions to use birth control and obtain a pregnancy test at each doctor visit. Of the 19 pregnancies carried to term, no birth defects were seen, although studies of topiramate in animals have shown it can cause birth defects.

Vivus is seeking a more relaxed birth-defects designation in its application, but FDA documents said the proposed labeling could be confusing to physicians and patients of child-bearing age. The FDA recommended that Qnexa be labeled as pregnancy category X, which means that the risk of using of the drug during pregnancy "clearly outweighs any possible benefit."

Two main clinical studies involving Qnexa were submitted to the FDA. The studies compared about 2,200 patients taking three doses of Qnexa to about 1,500 patients on a placebo, or fake drug, for 56 weeks.

The FDA said patients in the highest dose of Qnexa lost an average of 10.6% of their starting body weight, compared to an 8.6% loss for the middle-dose of Qnexa, 5.1% for the lowest dose and 1.7% for patients on placebo.”

Personal comment: My circle has no problem with obesity. Actually, with the calories we burn our problem is to keep our weight up healthily. I posted this article because we are seeing a lot of women coming into the clinic for help with weight reduction. And obesity and weight loss meds can decrease the effectiveness of hormonal birth control. In addition some weight-loss medications can cause birth defects. Weight loss can also decrease the effectiveness of cervical barrier methods of birth control because a woman’s reproductive anatomy changes with weight gain or loss. A diaphragm should be checked for correct size for every +/- 7 to 10 pounds of weight change and a cervical cap should be checked for every +/- 14 to 20 pounds of weight change. That’s why if a woman plans to lose a lot of weight our clinic recommends she use FC2 condoms until her weight stabilizes because they are safe, effective, aren’t weight sensitive and better tolerated by male partners.

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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