Yaz Lawsuits
First Yaz birth control injury trial in state court is scheduled to commence in January 2012.
Reference
CORRECTING and REPLACING First Yaz Birth Control Injury Trial In State Court Scheduled To Commence In January 2012
Business Wire, September 16, 2011
________________________________________________________________________________
First Yaz birth control injury trial in state court is scheduled to commence in January 2012.
Reference
CORRECTING and REPLACING First Yaz Birth Control Injury Trial In State Court Scheduled To Commence In January 2012
Business Wire, September 16, 2011
________________________________________________________________________________
| Yaz Lawsuit |
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Introduction
Drug must be studied thoroughly and approved before being sold in the market. However, many drugs
cause dangerous side effects and even death. Serious health issue may occur when drugs are not tested
strenuously enough, and unexpected side effects become evident once the drug is on the market.
________________________________________________________________________________
YAZ® (drospirenone and ethinyl estradiol) Tablets - Summary
For a complete information
YAZ® Usage Overview
YAZ® is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive. YAZ is
also indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who
choose to use an oral contraceptive as their method of contraception. YAZ is also indicated for the
treatment of moderate acne vulgaris in women at least 14 years of age. YAZ® provides an oral
contraceptive regimen consisting of 24 active film coated tablets each containing 3 mg of drospirenone and
0.02 mg of ethinyl estradiol stabilized by betadex as a clathrate (molecular inclusion complex) and 4 inert
film coated tablets. Drospirenone is a synthetic progestational compound. Ethinyl estradiol is a synthetic
estrogenic compound. Combination oral contraceptives (COCs) act by suppression of gonadotropins.
Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes
inthe cervical mucus (which increases the difficulty of sperm entry into the uterus) and the endometrium
(which reduces the likelihood of implantation). Drospirenone is a spironolactone analogue with
antimineralocorticoid activity. Preclinical studies in animals have also shown that drospirenone has
antiandrogenic activity.
Acne vulgaris is a skin condition with a multifactorial etiology including androgen stimulation of sebum
production. While the combination of ethinyl estradiol and drospirenone increases sex hormone binding
globulin (SHBG) and decreases free testosterone.
Yaz Warnings
Yaz has a long lists of warnings / side effects. Here are highlights of a few listed in the product insert:
Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This
risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in
women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.
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 and 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 level
checked during the first treatment cycle. Medications that may increase serum potassium include ACE
inhibitors, angiotensin – II receptor antagonists, potassium-sparing diuretics, potassium supplementation,
heparin, aldosterone antagonists, and NSAIDS.
Numerous epidemiological studies have been performed on the incidence of breast, endometrial, ovarian
and cervical cancer in women using oral contraceptives.
Benign hepatic adenomas are associated with oral contraceptive use, although the incidence of benign
tumors is rare in the United States. Indirect calculations have estimated the attributable risk to be in the
range of 3.3 cases/100,000 for users, a risk that increases after four or more years of use.
There have been clinical case reports of retinal thrombosis associated with the use of oral contraceptives,
which may lead to partial or complete loss of vision.
Earlier studies have reported an increased lifetime relative risk of gallbladder surgery in users of oral
contraceptives and estrogens.
Oral contraceptives have been shown to cause glucose intolerance in a significant percentage of users.
An increase in blood pressure has been reported in women taking oral contraceptives and this increase is
more likely in older oral contraceptive users and with continued use.
The onset or exacerbation of migraine or development of headache with a new pattern which is recurrent,
persistent or severe requires discontinuation of oral contraceptives.
Breakthrough bleeding and spotting are sometimes encountered in patients on oral contraceptives,
especially during the first three months of use.
ADVERSE SIDE EFFECTS
An increased risk of the following serious adverse side effects has been associated with the use of oral
contraceptives (see WARNINGS): Thrombophlebitis, Arterial thromboembolism, Pulmonary embolism,
Myocardial infarction, Cerebral hemorrhage, Cerebral thrombosis, Hypertension, Gallbladder disease,
Hepatic adenomas or benign liver tumors
There is evidence of an association between the following conditions and the use of oral contraceptives
Mesenteric thrombosis, Retinal thrombosis. The following adverse side ffects have been reported in
patients receiving oral contraceptives and are believed to be drug-related: Nausea, Vomiting,
Gastrointestinal symptoms (such as abdominal cramps and bloating), Breakthrough bleeding, Spotting,
Change in menstrual flow, Amenorrhea, Temporary infertility after discontinuation of treatment, Edema,
Melasma which may persist, Breast changes: tenderness, enlargement, secretion, Change in weight or
appetite (increase or decrease), Change in cervical ectropion and secretion, Possible diminution in lactation
when given immediately postpartum, Cholestatic jaundice, Migraine, Rash (allergic), Mood changes,
including depression, Reduced tolerance to carbohydrates, Vaginitis, including candidiasis, Change in
corneal curvature (steepening), lntolerance to contact lenses, Decrease in serum folate levels,
Exacerbation of systemic lupus erythematosus, Exacerbation of porphyria, Exacerbation of chorea,
Aggravation of varicose veins and Anaphylactic/anaphylactoid reactions, including urticaria, angioedema,
and severe reactions with respiratory and circulatory symptoms. This list of Yaz side effects above is
incomplete, for details, please, consult with your medical doctor or review the product insert.
___________________________________________________________________________________
Yaz (drospirenone 3 mg/ethinyl estradiol 0.02 mg) tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research
(CDER) – April 2010
FDA WARNING - YAZ SIDE EFFECTS - VENOUS THROMBO-EMBOLISM
Thromboembolic Disorders and Other Vascular Problems
Thromboembolism
Several studies have investigated the relative risks of thromboembolism in women using a different
drospirenone-containing COC (Yasmin, which contains 0.030 mg of ethinyl estradiol and 3 mg of
drospirenone) compared to those in women using COCs containing other progestins. Two prospective
cohort studies, both evaluating the risk of venous and arterial thromboembolism and death, were initiated at
the time of Yasmin approval. 1, 2 The first (EURAS) showed the risk of thromboembolism (particularly
venous thromboembolism) and death in Yasmin users to be comparable to that of other oral contraceptive
preparations, including those containing levonorgestrel (a so-called second generation COC). The second
prospective cohort study (Ingenix) also showed a comparable risk of thromboembolism in Yasmin users
compared to users of other COCs, including those containing levonorgestrel. In the second study, COC
comparator groups were selected based on their having similar characteristics to those being prescribed
Yasmin.
* Two additional epidemiological studies, one case-control study (van Hylckama Vlieg et al. 3) and one
retrospective cohort study (Lidegaard et al. 4) suggested that the risk of venous thromboembolism
occurring in Yasmin users was higher than that for users of levonorgestrel containing COCs and lower than
that for users of desogestrel/gestodene-containing COCs (socalled third generation COCs). In the case-
control study, however, the number of Yasmin cases was very small (1.2% of all cases) making the risk
estimates unreliable. The relative risk for Yasmin users in the retrospective cohort study was greater than
that for users of other COC products when considering women who used the products for less than one
year. However, these one-year estimates may not be reliable because the analysis may include women of
varying risk levels. Among women who used the product for 1 to 4 years, the relative risk was similar for
users of Yasmin to that for users of other COC products.
Drug must be studied thoroughly and approved before being sold in the market. However, many drugs
cause dangerous side effects and even death. Serious health issue may occur when drugs are not tested
strenuously enough, and unexpected side effects become evident once the drug is on the market.
________________________________________________________________________________
YAZ® (drospirenone and ethinyl estradiol) Tablets - Summary
For a complete information
YAZ® Usage Overview
YAZ® is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive. YAZ is
also indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who
choose to use an oral contraceptive as their method of contraception. YAZ is also indicated for the
treatment of moderate acne vulgaris in women at least 14 years of age. YAZ® provides an oral
contraceptive regimen consisting of 24 active film coated tablets each containing 3 mg of drospirenone and
0.02 mg of ethinyl estradiol stabilized by betadex as a clathrate (molecular inclusion complex) and 4 inert
film coated tablets. Drospirenone is a synthetic progestational compound. Ethinyl estradiol is a synthetic
estrogenic compound. Combination oral contraceptives (COCs) act by suppression of gonadotropins.
Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes
inthe cervical mucus (which increases the difficulty of sperm entry into the uterus) and the endometrium
(which reduces the likelihood of implantation). Drospirenone is a spironolactone analogue with
antimineralocorticoid activity. Preclinical studies in animals have also shown that drospirenone has
antiandrogenic activity.
Acne vulgaris is a skin condition with a multifactorial etiology including androgen stimulation of sebum
production. While the combination of ethinyl estradiol and drospirenone increases sex hormone binding
globulin (SHBG) and decreases free testosterone.
Yaz Warnings
Yaz has a long lists of warnings / side effects. Here are highlights of a few listed in the product insert:
Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This
risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in
women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.
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 and 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 level
checked during the first treatment cycle. Medications that may increase serum potassium include ACE
inhibitors, angiotensin – II receptor antagonists, potassium-sparing diuretics, potassium supplementation,
heparin, aldosterone antagonists, and NSAIDS.
Numerous epidemiological studies have been performed on the incidence of breast, endometrial, ovarian
and cervical cancer in women using oral contraceptives.
Benign hepatic adenomas are associated with oral contraceptive use, although the incidence of benign
tumors is rare in the United States. Indirect calculations have estimated the attributable risk to be in the
range of 3.3 cases/100,000 for users, a risk that increases after four or more years of use.
There have been clinical case reports of retinal thrombosis associated with the use of oral contraceptives,
which may lead to partial or complete loss of vision.
Earlier studies have reported an increased lifetime relative risk of gallbladder surgery in users of oral
contraceptives and estrogens.
Oral contraceptives have been shown to cause glucose intolerance in a significant percentage of users.
An increase in blood pressure has been reported in women taking oral contraceptives and this increase is
more likely in older oral contraceptive users and with continued use.
The onset or exacerbation of migraine or development of headache with a new pattern which is recurrent,
persistent or severe requires discontinuation of oral contraceptives.
Breakthrough bleeding and spotting are sometimes encountered in patients on oral contraceptives,
especially during the first three months of use.
ADVERSE SIDE EFFECTS
An increased risk of the following serious adverse side effects has been associated with the use of oral
contraceptives (see WARNINGS): Thrombophlebitis, Arterial thromboembolism, Pulmonary embolism,
Myocardial infarction, Cerebral hemorrhage, Cerebral thrombosis, Hypertension, Gallbladder disease,
Hepatic adenomas or benign liver tumors
There is evidence of an association between the following conditions and the use of oral contraceptives
Mesenteric thrombosis, Retinal thrombosis. The following adverse side ffects have been reported in
patients receiving oral contraceptives and are believed to be drug-related: Nausea, Vomiting,
Gastrointestinal symptoms (such as abdominal cramps and bloating), Breakthrough bleeding, Spotting,
Change in menstrual flow, Amenorrhea, Temporary infertility after discontinuation of treatment, Edema,
Melasma which may persist, Breast changes: tenderness, enlargement, secretion, Change in weight or
appetite (increase or decrease), Change in cervical ectropion and secretion, Possible diminution in lactation
when given immediately postpartum, Cholestatic jaundice, Migraine, Rash (allergic), Mood changes,
including depression, Reduced tolerance to carbohydrates, Vaginitis, including candidiasis, Change in
corneal curvature (steepening), lntolerance to contact lenses, Decrease in serum folate levels,
Exacerbation of systemic lupus erythematosus, Exacerbation of porphyria, Exacerbation of chorea,
Aggravation of varicose veins and Anaphylactic/anaphylactoid reactions, including urticaria, angioedema,
and severe reactions with respiratory and circulatory symptoms. This list of Yaz side effects above is
incomplete, for details, please, consult with your medical doctor or review the product insert.
___________________________________________________________________________________
Yaz (drospirenone 3 mg/ethinyl estradiol 0.02 mg) tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research
(CDER) – April 2010
FDA WARNING - YAZ SIDE EFFECTS - VENOUS THROMBO-EMBOLISM
Thromboembolic Disorders and Other Vascular Problems
Thromboembolism
Several studies have investigated the relative risks of thromboembolism in women using a different
drospirenone-containing COC (Yasmin, which contains 0.030 mg of ethinyl estradiol and 3 mg of
drospirenone) compared to those in women using COCs containing other progestins. Two prospective
cohort studies, both evaluating the risk of venous and arterial thromboembolism and death, were initiated at
the time of Yasmin approval. 1, 2 The first (EURAS) showed the risk of thromboembolism (particularly
venous thromboembolism) and death in Yasmin users to be comparable to that of other oral contraceptive
preparations, including those containing levonorgestrel (a so-called second generation COC). The second
prospective cohort study (Ingenix) also showed a comparable risk of thromboembolism in Yasmin users
compared to users of other COCs, including those containing levonorgestrel. In the second study, COC
comparator groups were selected based on their having similar characteristics to those being prescribed
Yasmin.
* Two additional epidemiological studies, one case-control study (van Hylckama Vlieg et al. 3) and one
retrospective cohort study (Lidegaard et al. 4) suggested that the risk of venous thromboembolism
occurring in Yasmin users was higher than that for users of levonorgestrel containing COCs and lower than
that for users of desogestrel/gestodene-containing COCs (socalled third generation COCs). In the case-
control study, however, the number of Yasmin cases was very small (1.2% of all cases) making the risk
estimates unreliable. The relative risk for Yasmin users in the retrospective cohort study was greater than
that for users of other COC products when considering women who used the products for less than one
year. However, these one-year estimates may not be reliable because the analysis may include women of
varying risk levels. Among women who used the product for 1 to 4 years, the relative risk was similar for
users of Yasmin to that for users of other COC products.
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This website discusses the benefits and side effects of various supplements, herbs and drug products.
Different people may experience different side effects and benefits of a product. You are encouraged to
report adverse side effects to FDA, its website is www.fda.gov., or report the adverse side effects to the
manufacturer, you should be able to find the contact information on the label.
There are always new information. Please, send me an email (zhion@zhion.com) to correct my mistake(s).
Reasonable care has been taken in preparing this document and the information provided herein is believed
to be accurate. The information is not intended to be a substitute for professional advice. It is important to
seek the advice of a physician about any medical condition or symptom or the benefits and side effects of a
supplement or a drug product, it is also important to seek the lawyer's advice on any legal claim.
ALL RIGHTS RESERVED 2011
Different people may experience different side effects and benefits of a product. You are encouraged to
report adverse side effects to FDA, its website is www.fda.gov., or report the adverse side effects to the
manufacturer, you should be able to find the contact information on the label.
There are always new information. Please, send me an email (zhion@zhion.com) to correct my mistake(s).
Reasonable care has been taken in preparing this document and the information provided herein is believed
to be accurate. The information is not intended to be a substitute for professional advice. It is important to
seek the advice of a physician about any medical condition or symptom or the benefits and side effects of a
supplement or a drug product, it is also important to seek the lawyer's advice on any legal claim.
ALL RIGHTS RESERVED 2011
Drug Lawsuits- Do you have a case?
Drug lawsuits are personal injury cases in which drug users injured after taking the drug seek compensation
from the drug manufacturer. Drug lawsuits can win settlements for affected users by proving that:
[A] An user's injuries were actually caused by taking the drug.
[B] The manufacturer knew about the severe drug side effects but they failed to disclose them to the FDA
and the general public.
Users who develop one or more of the unexpected side effect(s) will likely have a viable legal claim and will
be entitled to compensation for their injuries. Families of users who have died due to the drug side effects
may also be entitled to monetary settlements for their loss. Injured patients should meet with a personal
injury lawyer for an initial consultation. During this meeting, injured patients should be able to find out if they
have a provable case against the manufacturer. Most drug lawyers work on contingency – meaning that
plaintiffs won't have to pay for legal services until (or, in some cases, unless) they win a settlement. Injured
users should consult with a lawyer to see if they can start a drug lawsuit and if it is better to file an individual
lawsuit or join a class action case.
______________________________________________________________________________
Lawsuits are being evaluated nationwide for injuries caused as a result of the following drugs:
Drug lawsuits are personal injury cases in which drug users injured after taking the drug seek compensation
from the drug manufacturer. Drug lawsuits can win settlements for affected users by proving that:
[A] An user's injuries were actually caused by taking the drug.
[B] The manufacturer knew about the severe drug side effects but they failed to disclose them to the FDA
and the general public.
Users who develop one or more of the unexpected side effect(s) will likely have a viable legal claim and will
be entitled to compensation for their injuries. Families of users who have died due to the drug side effects
may also be entitled to monetary settlements for their loss. Injured patients should meet with a personal
injury lawyer for an initial consultation. During this meeting, injured patients should be able to find out if they
have a provable case against the manufacturer. Most drug lawyers work on contingency – meaning that
plaintiffs won't have to pay for legal services until (or, in some cases, unless) they win a settlement. Injured
users should consult with a lawyer to see if they can start a drug lawsuit and if it is better to file an individual
lawsuit or join a class action case.
______________________________________________________________________________
Lawsuits are being evaluated nationwide for injuries caused as a result of the following drugs: