The Judicial Panel of Multidistrict Litigation assigned the Yasmin And Yaz MDL to Judge David R. Herndon of the Southern District of Illinois. The Yaz/Yasmin/Ocella MDL, docket number 2100 was created for the purposes of consolidating all federal Yaz/Yasmin lawsuits alleging personal injury and wrongful death. The cases are now under the heading IN RE: Yasmin and Yaz (Drospirenone) Marketing and Sales Practices and Products Liability Litigation.

The Judicial Panel found the Southern District of Illinois will serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation. U.S. District Court Judge David R. Herndon will preside over these Yaz and Yasmin cases for coordinated or consolidated pretrial proceedings. All consolidated actions share factual questions relating to at least one of the drospirenone-containing oral contraceptives Yaz and Yasmin, which are manufactured by Bayer. Plaintiffs in the products liability actions challenge the safety of those oral contraceptives and bring claims for personal injuries or wrongful death stemming from use of the drugs.

Yaz and Yasmin, as well as the generic Ocella, have been associated with various serious side effects, including Blood Clots, Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Stroke, Cerebrovascular Accidents (CVA), Heart Attack, Myocardial Infarction, Gallbladder Disease / Injury, Gallbladder Removal (cholecystectomy), Kidney Failure or Renal Failure, Pancreatitis and even Death.

Labels: death, DVT, MDL, PE, yasmin, 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