New research shows that oral contraceptives may behave differently in the bodies of women who are obese, than in normal-weight women, thus suggesting that birth control pills may not work well in preventing pregnancy. According to the study published in the journal, Contraception, researchers say that there has been some evidence to suggest that the birth control pills may be less effective in obese women, but finding have not been consistent.

Researchers assigned twenty 18 to 35- year- old women, none of whom were using oral contraceptives, to take birth control for two cycles. Half of the women were obese, with body mass indexes above 30, while the other half were normal weight and had body mass indexes below 25. The women took pills containing ethinyl estradiol and levonorgestrel, which is a synthetic hormone used to regulate ovulation.

For the obese women, it took about 10 days of taking the pill for their blood levels of levonorgestrel to reach the optimum steady-state concentration for suppressing ovulation compared to about 5 days for the normal-weight women.

“The longer time to reach steady-state levels of levonorgestrel may represent a window of opportunity for the ovary to prepare to release an egg”, said research overseer Dr. Allison B. Edelman of Oregon Health and Science University in Portland. She further added that for one of the obese women it took 20 days to reach the steady state level, suggesting that ovulation may never have been adequately suppressed.

In spite of these findings, according to Edelman, “Additional studies are needed before [researchers can] recommend a change in clinical practice regarding the use of oral contraceptives in obese women.

Labels: birth control, body mass index, hormones, obesity, pregnancy, pregnant

We have previously posted about some of the dangers of the Yaz birth control pill. Even more information has come out since. Yaz has recently been under heavy scrutiny for possible dangerous side effects such as stroke, pulmonary embolism, and deep vein thrombosis (DVT). Additionally, the FDA and many states’ attorney general have been on Yaz’ case for a different problem: misleading advertising.

The first time Yaz was admonished for misleading the public was through an FDA warning letter in 2003. The letter was in regards to misleading ads that stated that Yaz was “unique” because it contained progestin drospirenone, therefore leading people to believe that Yaz was superior to other birth control pills. Then in 2008, the FDA sent another warning letter concerning two separate television commercials that publicized treatments for which Yaz was not approved. In February of 2009, attorney generals from 27 different states reached a settlement with Yaz to correct misleading information that Yaz put in tv ads that suggested that Yaz was approved for the treatment of PMS and acne. As a result, Yaz is now required to get FDA approval for all ads before they can air on tv.

Yaz was first released in May 2001 and has since become one of the best selling oral contraceptives, with sales over $616 million in 2008. Neither the FDA nor the manufacturer, Bayer, have yet to recall the drug for its serious side effects. Many of the people that take Yaz may have been induced to take it through Yaz’s misleading advertising, and in turn, suffering serious side effects.

For more information, see:
The FDA’s warning letter concerning Yaz:
http://origin.www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm053993.pdf

Wall Street Journal article concerning new ad campaign:
http://www.nytimes.com/2009/02/11/business/11pill.html

Labels: advertising, Air France, birth control, DVT, FDA, NCAA, stroke, Susan Boyle, YAZ

YAZ is the first birth control pill to combine 20 mcg of ethinyl estradiol (EE) with the so-called "fourth generation" progestin drospirenone (DRSP). Fourth generation progestin drospirenone has antimineralocorticoid properties, which means that it can work against the body's normal mechanism for regulating salt and water balance, a situation that can lead to hyperkalemia in high risk patients, resulting in potentially serious heart and health problems. YAZ was approved by the FDA in March 2006.
A company press release, "FDA Approves YAZ(R), The First Oral Contraceptive To Offer Drospirenone In A 24-Day, Active-Pill Regimen", regarding approval of the drug suggests cardiovascular events are not a concern when using YAZ. The press release states:
YAZ contains 3 mg of the progestin drospirenone that has antimineralocorticoid activity, including the potential for hyperkalemia in high-risk patients, comparable to a 25-mg dose of spironolactone. YAZ should not be used in patients with conditions that predispose to hyperkalemia (i.e., renal insufficiency, hepatic dysfunction, or adrenal insufficiency). Women receiving daily, long-term treatment for chronic conditions or diseases with medications that may increase serum potassium should have their serum potassium levels checked during the first treatment cycle. Medications that may increase serum potassium include ACE inhibitors, angiotensin-ll receptor antagonists, potassium-sparing diuretics, potassium supplementation medications, aldosterone antagonists and NSAIDs.
In YAZ’s current package insert, the warning above is bolded while serious cardiovascular side effects like deep vein thrombosis (DVT), pulmonary embolism (PE), heart attack, and stroke are not emphasized.
The FDA now has some concerns about an association between YAZ and DVT, PE, heart attack, and stroke as demonstrated in the International Active Surveillance Study of Women Taking Oral Contraceptives (INAS-OC) study.
WebMD even lists blood clots such as pulmonary embolism, stroke or heart attacks as rare but very serious side effects of using YAZ.
There are numerous reports of women suffering from a DVT or a PE while using YAZ pills.
The safety concerns surrounding YAZ are similar to the serious and at times fatal side effects of unsafe birth control like Ortho Evra and NuvaRing.
For more information please see: http://www.fda.gov/medwatch/SAFETY/2007/Jan_PI/Yaz_PI.pdf,
http://origin.www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm053993.pdf
http://www.medicalnewstoday.com/articles/39844.php, http://clinicaltrials.gov/ct2/show/NCT00335257,
http://www.webmd.com/drugs/mono-656-ETHINYL+ESTRADIOL%2FDROSPIRENONE+24%2F4+-+ORAL.aspx?drugid=95358&drugname=YAZ+28+Oral,

Labels: birth control, cardiovascular, death, Deep Vein Thrombosis, DVT, heart attack, PE, pulmonary embolism, stroke, YAZ

Hundreds of women throughout the country are the victims of serious injuries caused by the NuvaRing. They have suffered strokes and blood clots, and many of them died. 150 or more women or their families have filed lawsuits against Organon, the maker of the NuvaRing, for the injuries and deaths it has caused.

The NuvaRing is a vaginal contraceptive ring that provides monthly birth control by inserting it against the cervix. It uses a type of synthetic hormone that is different from the one used in traditional birth control pills and is more dangerous.

If you or someone you love has been hurt by the NuvaRing, you may be entitled to compensation. Contact the expert attorneys at Schlichter, Bogard & Denton for a free consultation.

nuvaring@uselaws.com
nationalinjuryattorneys@uselaws.com
314-621-6115

For more information, see the following links:

Woman warns others not to use NuvaRing

Schering-Plough, Akzo Nobel sued over NuvaRing contraceptive device

Wrongful Death Lawsuit Filed Over NuvaRing

Labels: attorney, birth control, blood clot, contraception, death, DVT, lawyer, Nuva Ring, NuvaRing, stroke, thrombosis