Wednesday, May 20, 2009

Birth Control Pill YAZ Studied for Link to Cardiovascular Side Effects

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,

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posted by Jessica at 11:46 AM

Thursday, April 17, 2008

Newspaper Discusses Schlichter, Bogard & Denton NuvaRing Case involving a Mother who Died After Using NuvaRing for One Month

Dana Jenn began using the NuvaRing in June, 2005. She was a healthy, fit mother of four training to run a marathon. She died suddenly of a pulmonary embolism (a blood clot in the lung) only a month after starting to use the NuvaRing.

Dana's family has chosen to file a lawsuit against the maker of the NuvaRing. Her lawsuit was mentioned in April, 2008 by the Springfield, Missouri newspaper, the News Leader. Dana is represented by Schlichter, Bogard & Denton. Click here to read the article.

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 and Denton for a free consultation.

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

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posted by TammyS at 9:43 AM

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