Teenage girls taking low-dose oral contraceptives showed abnormally low levels of bone growth, and sometimes even lost density, compared with teens who took birth control pills with a higher dose of estrogen, Czech researchers found.

In a randomized, crossover trial, bone mineral density (BMD) failed to increase in girls 15 to 19 years old who took pills with a low dose (15 micrograms) of ethinyl estradiol for nine months, while bone density increased normally in participants taking pills with a high dose (30 micrograms) of ethinyl estradiol, according to Dr. Jan Stepan of Charles University in Prague.

In a presentation here at the American Society for Bone and Mineral Research, Stepan said that based on these findings, girls who need oral contraceptives “could be counseled toward preparations with higher estrogen levels.”

The study involved 82 girls in their middle to late teens — a period during which they should be accumulating bone density.

Twenty-eight girls were given no medications and served as controls. The other 54 were randomly assigned to nine months of treatment with oral contraceptives containing either 15 or 30 micrograms of ethinyl estradiol.

After the initial treatment period, those in the treatment group were switched to the other contraceptive dosage for another nine months.

Lumbar spine BMD and whole body bone mineral content were measured at the outset and after each nine-month period. In the control participants, spinal BMD increased by 1 percent during each treatment period, and whole body bone mineral content rose 2 percent in each period.

Those initially assigned to the 30 micrograms ethinyl estradiol dosage also showed a 1 percent increase in spinal BMD, but it returned to baseline levels when they switched to the 15 micrograms dosage.

Participants first receiving the 15 micrograms dose showed virtually no increase in spinal BMD. After switching to the higher dosage, spinal BMD accumulation paralleled that of control participants.

http://www.medpagetoday.com/MeetingCoverage/ASBMR/15944

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Scientists have long known that oral contraceptives, which contain the female hormones estrogen and progestogen, increase the likelihood of deep vein thrombosis of the leg and pulmonary embolism, but new studies in Denmark and the Netherlands determined that some pills are safer than others. Neither study received funding from any companies that make oral contraceptives.

Pills containing a second-generation progestogen — levonorgestrel or norgestrel — and a low dose of estrogen are safest, they concluded.

The overall risk of venous thromboembolism is low, perhaps three for 10,000 woman-years for women in general, said Dr. Ojvind Lidegaard, a professor of obstetrics and gynecology at the Rigshospitalet in Copenhagen, and lead author of one of two reports in the Aug. 14 online issue of BMJ. But older contraceptive pills double or triple that risk, and the newest generation of oral contraceptives increase the risk fourfold or fivefold, he said.

A first message from the studies is that “the risk when you are taking an oral contraceptive depends on both the estrogen dose and the progestogen dose, and the lower the dose, the less risk,” Lidegaard said.

Both studies found that the risk decreases with the length of time a woman takes a combination pill, and that progestogen-only pills and the use of hormone-releasing intrauterine devices are not associated with an increased risk.

The Dutch study, which compared 1,524 women under the age of 50 who had deep venous thromboembolisms with 1,760 women with no such history, found a fivefold increased risk in oral contraceptive users. The risk of an event was highest in the first three months of use and lowest with pills containing levonorgestrel.

Pills with equal doses of estrogen that contained the progestogen desogestrel had double the risk of the pills using levonorgestrel, the researchers found.

The Danish study of all women aged 15 to 49 from 1995 to 2005 found roughly the same association.

Women taking oral contraceptives had a fivefold increased risk of blood clots compared with nonusers, and the risk differed by the type of progestin. “The newer types of oral contraceptives containing drospirenone or cyproterone acetate are associated with an increased risk compared with oral contraceptives containing levonorgestrel,” Van Hylckama Vlieg says. Specifically, the researchers found that:

* Levonorgestrel boosted the risk of blood clots by nearly fourfold compared to nonusers.
* Gestodene boosted risk by 5.6 times.
* Drospirenone boosted risk 6.3 times.
* Cyproterone boosted risk 6.8 times.
* Desogestrel boosted risk 7.3 times.

The risk of blood clots was also associated with the level of estrogen in the pills, with higher estrogen dose linked with higher risk.

Switzerland’s medicines supervisor says it will analyse all birth control pills after a young woman suffered a lung embolism possibly linked to a contraceptive.

A spokesman for the Swiss Agency for Therapeutics (Swissmedic) told Swiss television late on Thursday that it had collected extensive research on various birth control pills and would come to a finding on their health effects in the autumn.

The announcement comes after a 16-year-old woman suffered a lung embolism that left her severely disabled. She had been taking Yasmin birth-control pills produced by Germany’s Bayer company.

Bayer contends the drug presents no more risk for venal thrombosis than other contraceptive pills.

“We assume that Smissmedic’s analysis concerning Yasmin will yield no new findings because Yasmin is one of the most well researched birth-control pills worldwide,” the company said.

Breast cancer and endometrial cancer are increased
Epidemiological studies consistently demonstrate an increased risk of breast cancer in women who used combined menopausal therapy. Largely confined to current or recent users, the risk increases with duration of use and exceeds that in women taking estrogen-only therapy. Endometrial cancer risks depend on the number of days that progestogens are included in the
combined therapy. When progestogens are taken fewer than 10 days per month, the risk of endometrial cancer is increased, but when progestogens are taken daily, the risk is similar to that in women who never used hormonal therapy. There was not sufficient evidence to conclude that hormonal therapy has a protective effect at any cancer site.

Read the entire press release

The attorneys at Morgan & Morgan are warning consumers that Yasmin (also known as Yaz) birth control pills have been linked to serious side effects, including heart attack, stroke, and death. Yaz and Yasmin, as well as the generic equivalent Ocella, are daily oral contraceptives designed to prevent pregnancy.

Yasmin is one of the most popular oral contraceptives on the market, and it is the first type of birth control to contain a different kind of hormone, called drsp or drospirenone. Although the manufacturers of this drug claim that it is as safe as other types of accepted birth control pills on the market, drospirenone can increase the potassium levels of users. Increased potassium levels can cause health problems and are particularly dangerous for people with kidney, liver or adrenal disease. Serious side effects that have been linked to the use of Yaz/Yasmin birth control pills include:

1. Heart attack
2. Cardiac arrhythmia
3. Blood clot
4. Deep Vein Thrombosis (DVT)
5. Pulmonary Embolism (PE)
6. Stroke
7. Gallbladder disease
8. Benign liver tumor
9. Sudden death

Risk factors for these side effects include preexisting heart or cardiovascular problems, diabetes, high blood pressure, and obesity. Less serious side effects of Yaz/Yasmin include upper respiratory infection, headache, nausea, diarrhea, vomiting, vaginitis, urinary tract infection, intermenstrual bleeding, dizziness and pain.

The Food and Drug Administration (FDA) has repeatedly reprimanded Bayer Healthcare Pharmaceuticals (the manufacturers of Yaz/Yasmin) for marketing this drug in a way that minimizes these serious side effects and misleads women about the safety of this new type of birth control. However, the drug has not yet been recalled by the FDA or by its manufacturer.

Is NuvaRing to blame for Jackie Bozicev’s death? Her husband believes so.

Jackie died in December 2007. An autopsy showed she died of a blood clot that traveled from her pelvic area to her lungs. Her husband Rob was baffled. Up until that dreaded day, Jackie was seemingly healthy. She didn’t have a history of clots, nor did she smoke.

When doctors had no answers as to what caused the blood clot that led to his wifes death, Rob turned to Google and found what he believes is the culprit: NuvaRing, a birth control device inserted into the vagina monthly and removed after 3 weeks. A new ring must be inserted no more than 7 days later, according to NuvaRing’s Web site.

The device, made by Organon Pharmaceuticals (now owned by Schering-Plough) is touted as the first-of-its kind contraceptive with magazine ads proclaiming, “Let Freedom Ring.”

More than one million women use NuvaRing. Jackie started using the ring in May 2007, a month after giving birth to her second child.

“Jackie had no indication NuvaRing was any more dangerous than any other contraceptive,” says Carmen Scott, a lawyer representing the family in a civil lawsuit against the drugmaker.

All hormone-based contraceptives raise the risk of blood clots (which can lead to stroke and heart attack) but it is more common with some than others. The riskiest use third-generation hormones, like desogestrel (a similar compound is used in the ring).

Developed in the 1980s, the pills were intended to lessen non-serious side effects of the pill including acne and facial hair. Although largely ineffective in doing so and no better as birth control – which is acknowledged by the FDA – the pills remain on the market, says Mother Jones.

Research has consistently shown that these newer pills nearly double the risk of life-threatening blood clots compared to older forms of birth control pills. In 2007, Public Citizen, a watchdog group, petitioned the FDA to ban third-generation birth control pills. But the agency has yet to take action.

Blood clots can be particularly dangerous because they can travel through the veins and block blood flow at another location, causing a condition known as venous thromboembolism (VTE). Blood clots that travel to the lungs can cause pulmonary embolism, which is often fatal.

The FDA has received reports of 300 or more adverse events including stroke, heart attack, nonfatal blood clots and death, since NuvaRing’s approval in 2001, says Scott. More than 100 pending lawsuits attribute injuries to NuvaRing.

While those numbers may seem low, the pattern within them is relatively similar to those alleged against Johnson & Johnson’s – Ortho Evra, a skin patch approved for birth control. On that brand, 1,500 lawsuits were brought after more than 40 women died from blood clots and stroke.

The problem with both the patch and NuvaRing is one in the same: they deliver a constant stream of the active drug. By contrast, birth control pills enter the body through the digestive tract where much of the chemical is destroyed. Once the drug enters the patient’s blood, it lessens until the next pill is taken. Thus the body gets a rest from the drug whereas the patch/ring-wearer does not.

Injuryboard.com

Women who get pregnant within a few weeks of taking birth-control pills seem much more likely than others to have low birth-weight or premature babies, concludes a new Canadian study that deals with one of the most widely prescribed classes of drugs.

The findings suggest couples should consider using condoms and other “barrier” contraception methods in the month before they try to conceive, say the researchers from the University of Ottawa.

The study does not definitively prove a cause-and-effect relationship and needs to be confirmed by more research, said the lead investigator. It is also unclear why oral contraceptives might affect the development of the fetus, added Xi-Kuan Chen, an epidemiologist.

The findings should not be ignored, though, he said.

“Doctors should be bringing this to the attention of patients,” said Mr. Chen, who is also a senior analyst with the Canadian Institute for Health Information. “When they consult with some patients, they should suggest there might be some effect for them.”

Babies born with a low birth weight or prematurely — a growing problem in Canada whose cause is not always clear — are more likely to suffer health problems.

One of Canada’s leading experts on threats to pregnancy, however, said he is skeptical about the team’s results, saying that most previous research has found no link between the pill and such birth problems.

Also, the study could not consider some factors that might have skewed the findings, like whether the women smoked, a leading cause of low-birth weight and prematurity, said Dr. Gideon Koren, head of the Mother-Risk program at Toronto’s Sick Kids Hospital.

It is possible, for instance, that a woman who gets pregnant soon after she was taking the pill had simply forgotten to take the drugs, indicating a careless type who might also smoke, he said.

“This clearly should not be a reason to change practices or change counselling,” said Dr. Koren of the study. “Contraceptives have been in use now for more than four decades and this issue has not come up.”

Tapping into Saskatchewan drug plan and medicare databases — among the most comprehensive in the country — the University of Ottawa researchers looked at three groups of women using oral contraceptives — those who had taken them within 30 days, 31-60 days and 61-90 days of their last period before getting pregnant –1,500 in total.

They were compared to 6,100 women who had not used birth-control pills for at least a year before they gave birth.

Outcomes were similar for most of the contraceptive users and the non-users.

Those who had taken the pill within 30 days of getting pregnant, however, were more than three times more likely to have a very low-weight newborn — under 1,500 grams (3.3 pounds) — and almost two times as likely to have a low-weight baby — under 2,500 grams (5.5 pounds). They were also twice as apt to have a baby born at least six weeks premature. The results means, for instance, that one in 42 of the oral contraceptive users had very low-weight babies, compared to one in 148 of the non-users.

The researchers say their study was unlike previous research in the area in that it isolated out women who had taken the pill very close to the time they got pregnant — where the birth effects were noticed.

But they concede the data had no information on smoking or obesity among the mothers, and that those in the 30-day group may have included a disproportionate number of unplanned pregnancies, a factor that itself might have affected the outcome.

According to researchers at Texas A&M University and University of Pittsburgh women who take oral contraceptives (OC) will find any muscle which might be gained from resistance exercise training is impaired.

The researchers from Texas A&M and the University of Pittsburgh say they have identified a potential new factor that may be independently associated with the characteristics and variability of muscle responses to a controlled resistance exercise training program.
For the study, 73 generally healthy women between the ages of 18-31 were assigned to two groups and completed a 10-week whole-body resistance exercise training (RET).
Group 1 consisted of 34 women who used oral contraceptives (OC). Group 2 consisted of 39 women who did not take birth control pills (non-OC).

The women were encouraged to consume at least 0.5 grams of protein per pound of body weight per day (a third more than is called for by the U.S. government nutritional guidelines) to make sure they consumed enough calories and protein to promote muscle growth.

The participants exercised three times per week for ten weeks under the supervision of exercise physiologists. They performed a variety of exercises to include chest press, lat pull down, leg extension, triceps extension, arm curl and abdominal crunch.

Exercise was done using standard exercise machines and each volunteer performed three sets of 6-10 repetitions per exercise at 75 percent of their maximum strength. Body composition was determined using hydrostatic weighing.

Blood samples were taken before and after the training and assessed to measure anabolic (muscle building) and catabolic (muscle breaking) hormone levels in blood. Resting and fasting blood concentrations were measured for three anabolic hormones: DHEA, DHEAS and IGF1.

Women not taking oral contraceptives gained more than 60 percent more muscle mass than those on the pill.

There were other changes noted in participants on the pill, including reduced concentrations of the hormone DHEA, which Lee explained, is an anabolic hormone and therefore builds muscle.

The team presented their findings at the American Physiological Society meeting, part of the Experimental Biology 2009 scientific conference currently underway in New Orleans.

A 24-year-old Haifa woman who was planning to get married in two months died suddenly this week after a blood clot was discovered in her lungs. Physicians believe that her death was partly due to the hormones in the birth control pills she was taking.

Though death in such instances is rare, another young woman from the Haifa area also died of an embolism several weeks ago.
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Doctors said Tamar Golan’s death Wednesday was caused by a combination of the pills and her tendency to develop blood clots.

“We know that taking birth-control pills makes blood clots four to eight times as likely,” said Dr. Benjamin Brenner, a specialist at the hematology department of Rambam Medical Center, where Golan was treated.

Critical condition

Golan arrived at the hospital in critical condition after losing consciousness in the apartment she shared with her fiance.

She was suffering from excess fluid in her brain and blood clots in her lungs, and died several hours later.

Although Israel has dozens of cases every year of blood clots caused by birth control pills, the clots rarely result in death, said Brenner.

He said it was possible to test for potential blood clot problems, which affect about 20 percent of the population.