More Information on Yaz, Yasmin, and Ocella Coming Soon....

Yaz® and Yasmin® are oral contraceptive combination drugs, manufactured by Bayer HealthCare Pharmaceuticals, Inc.

Both drugs contain a combination of the hormones estrogen (ethinyl estradiol) and progestin (drospirenone), and both contraceptives are now involved in multiple federal lawsuits.The only difference between Yaz® and Yasmin® is the amount of estrogen that they contain.

Yasmin® contains 30 mcg estrogen, and Yaz® contains 20 mcg. The drugs work by prevention of ovulation and causing changes in the lining of the uterus.

Yaz® and Yasmin® have three FDA-approved uses:

•    Pregnancy prevention
•    alleviation of premenstrual dysphoric disorder (PMDD)
•    treatment of moderate acne

Yasmin® and Yaz® are top-selling birth control pills in the US, with an estimated 25% market share. Yaz® alone is the highest-grossing contraceptive in the United States (2008 figures).

Yaz /Yasmin and the FDA

In October 2008, a warning letter was sent by the Food and Drug Administration to Bayer HealthCare Pharmaceuticals, Inc., in response to claims the company had made for Yaz®, the popular and heavily promoted birth control pill.

The FDA stated that Yaz® has additional risks compared to other birth control pills because it contains drospirenone, a progestin hormone that can increase potassium levels.

Among the debilitating and serious injuries reported from drospirenone in birth control are heart attacks, blood clots, strokes, and pulmonary embolisms. Some people have even died.

Each tablet of Yaz®/Yasmine® contains 3 mg drospirenone, a progestin hormone. The FDA reports that drospirenone can lead to hyperkalemia, a condition caused by excessive amounts of potassium in the blood of high risk patients, resulting in potentially serious heart and health problems.

Yaz® was approved for use in the US market in 2006; Yasmin® had been approved in 2001. The FDA is alleged to have received more reports of serious side effects for Yaz® and Yasmin® than other birth control pills on the market for a much longer time.

Yaz®/Yasmin® Side-Effects

The most commonly reported side-effects to Yaz® and Yasmin® are mild, such as decrease in sex drive, weight gain, nausea and vomiting, headaches, susceptibility to yeast infections, vaginal discharge, and breakthrough spotting or bleeding.

However, very severe and even fatal responses to the drug have been reported, such as:

•    Blood clots
•    Pulmonary embolism (PE)
•    Deep vein thrombosis (DVT)
•    Heart attack
•    Strokes
•    Liver Failure
•    Pancreatitis
•    Gall bladder disease/ gall stone removal
•    Kidney failure
•    Organ failure
•    Dehydration, elevated potassium levels and/or severe cardiac arrhythmias

If you or a loved one have been prescribed Yaz® or Yasmin® and have experienced any of these symptoms, please contact us immediately for a free consultation.

Consult with your physician before you stop taking any medications, including Yaz® and Yasmin®.

Who We Are

Here at DrugRxRecall we provide current and topical information about some of the most commonly prescribed medications today. 

Our intention is to educate and inform people about the benefits and possible dangers associated with many commonly prescribed medications.

We can help you locate difficult to find legal assistance for prescription drug-related accidents, injuries, and deaths;  asbestos cancer and mesothelioma illness and legal issues; and any serious personal injuries.

How to Start the Process

Mass Tort vs.  Class Action:  What is the Difference?

You may find this website because you put “class action” into your search engine, along with a drug name, such as “Yaz Class Action” or "Yasmin Class Action" or "Ocella Class Action."

You might think “class actions” are the way most cases are handled by law firms dealing with prescription drugs that harm people.  However, actually this is not precisely true.  Most pharmaceutical drug claims are handled as “mass torts.” 

You probably did not put “mass tort” into the search engine as the term “mass tort” is far less well known legal term in the public generally.   Therefore, we make sure to help you find us by discussing class actions frequently and explain the difference between class actions and mass torts here.

Class Action

A class action is a type of legal proceeding where a lawsuit is filed on behalf of a group of people who share a set of circumstances, harms, injuries, sufferings, or potential damages.  Class actions are designed to help promote “judicial economy” and decrease pressure on courts when large numbers of people suffer a harm in the same manner.

For example, class actions are sometimes used in the context of when a bank or large corporation charges fees that are determined unfair to a large number of clients.  In those instances, one harmed person may stand as the single claim that determines the outcome for the entire class of claimants.  Often the recovery is not good for the class of harmed individuals as a whole.

Typically a class action has several criteria that must be met.  The individuals in the class must be notified of the claim and given a chance to “opt in” or “opt out” of the class, or find lawyers of their own.  Prior to the actual class action lawsuit, a motion is filed in court that certifies a particular plaintiff as the acting party on behalf of the larger group or class of plaintiffs.

One of the factors looked at is whether the individual recoveries for each plaintiff are too low to warrant each plaintiff hiring their own attorney;  when this is present a class action may be certified as the best way to proceed.   For example, this is often the case when dealing with small bank fees. 

The representative plaintiff also shows that he or she is typical in that his or her experience with the company or product is typical of the experiences of the other similarly situated plaintiffs, and that this type of class action lawsuit is the most efficient for holding the defendants accountable.  The evidence against the defendants must be typical and represented in a similar manner by all the harmed individuals, and finally, a showing that individual lawsuits against the defendant would never be prudent nor efficient in time and money is part of the process of determining that a class action is the best way to proceed.    It is easy to see that the often massive and very different injuries sustained by people who take prescription drugs do not fit this mold for “class actions.”

Mass Tort Lawsuits

Mass torts are different from class actions despite the fact that they are related in the sense that both share a large group of people who have suffered harms. 

Mass tort claims, like class actions, try to reduce the number of court claims in the legal system and promote judicial economy and efficiency.  However, they cover a much broader range of subjects typically than class actions and they are handled differently.

Perhaps the simplest way to understand the difference is mass torts still involve each plaintiff having their own individual claim.

There is no “representative plaintiff” in mass tort claims.  The mass tort plaintiffs are each receiving their own legal process and individual remedy tailored to their particular circumstances.   

Mass tort claims are the most common way that consumers are provided legal remedies when they are injured on a large scale by defective drugs or defective products.  While drugs and defective medical devices, for example, injure large groups of people, the injuries are often very different among each plaintiff.  All cases in drug defect claims rarely fit neatly into a single class of individuals who share the exact same type of injury.

Mass tort litigation allows one attorney or a group of attorneys to represent several injured parties in individual cases.  The attorneys often share information to help each other and their clients proceed against the defendants in a more powerful manner as a result of the cooperation of the plaintiffs’ attorneys.  Attorneys all over the country, and in fact sometimes internationally, pool resources, research, information, time, financial resources, and their intellectual energy and ideas to make sure that all of the plaintiffs hopefully obtain some measure of justice.

Mass tort claims are often complicated with detailed litigation and numerous plaintiffs and defendants.  Sometimes experts are used just to determine the proper way to award damages to the various parties.

DrugRxRecall and The Mulligan Law Firm are here to listen to your potential mass tort claim and hopefully help as many people as possible find justice.    Please contact us today if you or a loved one have an injury of any type discussed on this website. 

What You Can Do & How We Can Help

http://en.wikipedia.org/wiki/Drospirenone

Drospirenone

From Wikipedia, the free encyclopedia
 
Drospirenone
Systematic (IUPAC) name
(6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-
 1,3',4',6,6a,7,8,9,10,11,12,13,14,15,15a,16-
 hexadecahydro-10,13-dimethylspiro-
 [17H-dicyclopropa-6,7:15,16]cyclopenta
 [a]phenanthrene-17,2'(5H)-furan]-3,5'(2H)-dione)
Clinical data
Pregnancy cat.
X(US)
Legal status
Routes
Oral

Pharmacokinetic data

Bioavailability
 
76%

Protein binding
 
97%
 
Metabolism
 
Hepatic, minor (CYP3A4-mediated)
 
Half-life
30 hours
 
Excretion
 
Renal and fecal
 
Identifiers
 
CAS number
 
67392-87-4
 
ATC code
G03AA12

PubChem
CID 68873
 
DrugBank
DB01395
 
ChemSpider
62105
 
UNII
N295J34A25
 
KEGG
D03917
 
ChEBI
CHEBI:50838
 
ChEMBL
CHEMBL1509
Chemical data
Formula
C24H30O3
Mol. mass
366.493 g/mol
SMILES
eMolecules & PubChem
InChI

Drospirenone is a synthetic progestin that is typically used in birth control. There have been concerns raised regarding its safety and is thus not recommended as a first line agent.[1]
 
Contents
 1 Medical uses
 2 Adverse effects
 3 Chemistry
 4 Litigation
 5 See also
 6 References
 
Medical uses
 
Drospirenone is part of certain birth control formulations. The compound differs from other synthetic progestins in that its pharmacological profile in preclinical studies shows it to be closer to the natural progesterone. As such it has anti-mineralocorticoid properties, counteracts the estrogen-stimulated activity of the renin-angiotensin-aldosterone system, and is not androgenic. With its activities similar to spironolactone it may lead to less water retention and breast tenderness while improving skin appearance (less acne).
 
Drospirenone is taken orally with about 76% bioavailability. It is bound not by sex hormone-binding globulin or corticosteroid binding globulin, but by other serum proteins. Metabolites have not been shown to be biologically active, show up in urine and feces, and are essentially completely excreted within 10 days.
 
The compound is part of certain newer oral contraceptive formulations:
 Yasmin contains 3 mg drospirenone and 30 mcg ethinylestradiol per tablet. It is indicated for the prevention of pregnancy in women who elect an oral contraceptive.
 Yasminelle contains 3 mg drospirenone and 20 mcg ethinylestradiol per tablet and is used for contraception.
 Yaz contains 3 mg drospirenone and 20 mcg ethinylestradiol per tablet and is given for 24/4 days with the same indications.
 
It has also been formulated in medication to manage menopausal symptoms using 0.5 mg drsp and 1 mg estradiol per day by oral application. This medication was introduced in the United States in 2007 as Angeliq.
 
Drospirenone at 3 mg, which can potentially cause hyperkalemia in high-risk patients, is comparable to a 25 mg dose of spironolactone.
 
The medication is contraindicated in patients with hepatic dysfunction, renal insufficiency, adrenal insufficiency, or in whom the use of oral contraceptives is contraindicated, such as smokers and patients with a history of DVT, stroke, or other blood clots. Because of the anti-mineralocorticoid effects care needs to be exercised when other drugs that may increase potassium levels are taken. Such medications include ACE inhibitors, angiotensin-II receptor agonists, potassium-sparing diuretics, potassium supplementation, heparin, aldosterone antagonists, and NSAIDs.
 
  Adverse effects
 
Drospirenone appears to increase the risk of venous thromboembolism more than levonorgestrel.[2]
 

On September 26, 2011 the U.S. Food and Drug Administration (FDA) announced that it has not yet reached a conclusion, but remains concerned, about the potential increased risk of blood clots with the use of drospirenone-containing birth control pills.Preliminary results of the FDA-funded study suggest an approximately 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing birth control pills compared to users of other hormonal contraceptives.[3]
 
  Chemistry
 
It is an analog to spironolactone, with a molecular weight of 366.5 and the molecular formula C24H30O3.
 
  Litigation
 
In 2008, a series of television commercials prompted the FDA to cite Bayer for overstating the approved uses of Yaz while failing to adequately address the risks of the drug. Bayer was required to dispel the inaccurate information contained in those ads by creating new ads that clarified the drug's approved uses.[4]
 On October 8, 2009, Bayer disclosed that 129 lawsuits had been brought against them over the side effects and marketing of Yaz and Yasmin. The allegations include (but are not limited to):
 Glossing over risks associated with the products and overstating their approved uses in an effort to mislead users of Yaz and Yasmin into believing that the drugs were safe.[4][5]
 Failure to properly research the medication.
 Failing to recall the drug after post-marketing reports demonstrated that the risk of potentially life-threatening side effects of Yasmin and Yaz outweighed potential benefits that could be achieved via other available oral contraceptives.
 
In September 2009, the FDA cited Bayer for sending out potentially low-quality batches of drosperinone. Bayer justified the shipments by explaining that they monitor the "average" quality of all shipments, not the quality of each individual batch.
 
In October 2011 the CBC TV program Market Place ran a segment discussing issues involved with the usage of Yaz/Yasmin [6]
 
  See also
 Progestins
 Combined oral contraceptive pill
 Oral contraceptive formulations
 Hormone replacement therapy
 
  References
 
1.http://www.bmj.com/content/342/bmj.d2519.extract
 2.Dunn, N (2011 Apr 21). "The risk of deep venous thrombosis with oral contraceptives containing drospirenone.". BMJ (Clinical research ed.) 342: d2519. PMID 21511807.
 3.http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm257337.htm
 4.a b http://www.courthousenews.com/2009/10/15/Yasmin_YAZ_Claims_Against_Bayer_Mount_Up.htm
 5."Nurse Charges Dangerous Yaz Birth Control Drug "Altered My Life"". Reuters. October 21, 2009.
 6. http://www.cbc.ca/news/health/story/2011/01/20/yasmin-marketplace.html
 Krattenmacher R (2000). "Drospirenone: pharmacology and pharmacokinetics of a unique progestogen". Contraception 62 (1): 29–38. doi:10.1016/S0010-7824(00)00133-5. PMID 11024226.
 Yasmin product information
 Yaz product information
 Angeliq product information
 
v · d · eEstrogens and progestogens (G03C-D, L02)
 
Progestogens/
 progestins
 (progesterone)
 Agonist
 1st
 Norpregnene (Norethisterone#/Norethisterone acetate • Ethynodiol diacetate)
 
2nd
Norpregnene (Levonorgestrel#/Norgestrel/Norelgestromin)
 
3rd
19-nortestosterone (Desogestrel/Etonogestrel • Gestodene • Norgestimate)
 
4th
Androstene (Drospirenone) • 19-norprogesterone (Nomegestrol • Promegestone • Trimegestone) • 19-nortestosterone (Dienogest)
 
17-OH
Chlormadinone • Cyproterone • Medroxyprogesterone/Medroxyprogesterone 17-acetate# • Megestrol


Pregnenedione (Gestonorone) • Pregnene (Ethisterone) • Pregnadiene (Medrogestone • Melengestrol) • Norpregnane (Norgestrienone) • Lynestrenol • Norethynodrel • Tibolone • Dydrogesterone • Quingestanol
 
Antiprogestin/
 SPRM
 
antagonist: Mifepristone
 
Asoprisnil • CDB-4124  • Ulipristal acetate
 
Estrogens
Agonist
 
Steroidal
 

Diosgenin • Estradiol (Ethinylestradiol#/Mestranol • Estradiol 17 beta-cypionate# • Polyestradiol phosphate) • Estrone (Estrone sulfate) • Estriol • Promestriene • Equilenin • Equilin
 
Nonsteroidal
 
Chlorotrianisene • Dienestrol • Fosfestrol • Diethylstilbestrol • Zeranol
Antiestrogen/
 SERM
 Afimoxifene • Arzoxifene • Bazedoxifene • Cyclofenil • Lasofoxifene • Ormeloxifene • Raloxifene • Tamoxifen • Toremifene
 
Clomifene# • Mepitiostane • Nafoxidine
 
pure antagonist: Fulvestrant
Aromatase inhibitors
nonselective: Aminoglutethimide • Testolactone
selective: Anastrozole • Atamestane • Exemestane • Fadrozole • Formestane • Letrozole • Vorozole

#WHO-EM. ‡Withdrawn from market. Clinical trials: †Phase III. §Never to phase III