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Yaz is an oral contraceptive developed by Bayer pharmaceuticals. Like other forms of oral birth control, Yaz was promoted to prevent pregnancy. However, Yaz was also approved to treat moderate acne and premenstrual dysphoric disorder. Thousands of patients and their families filed legal claims against Bayer alleging Yaz caused blood clots, heart attacks, gallbladder injuries, and strokes.
Yaz, Yasmin, Jasmine, and Yarina Oral Contraceptives
The oral contraceptive Yaz was marketed under many names. The drug formula is a compound containing 3 mg drospirenone and 0.02 mg to 0.03 mg ethinylestradiol, depending on the brand name. Drospirenone is a steroidal progestin used in birth control and post-menopausal hormone therapy treatment. Ethinylestradiol is an active estrogen and derivative of estradiol. Combined these pills were marketed under a number of names, including:
- Safyral (with folate)
- Beyaz (with folate)
FDA Approval of Yaz
On November 18, 2004, the Food and Drug Administration (FDA) issued an approvable letter to Berlex, Inc., for its new oral contraceptive called Yaz.
On March 17, 2006, the FDA approved Yaz for the treatment for prevention of pregnancy.
On October 4, 2006, the FDA approved Yaz for the treatment for prevention of pregnancy and premenstrual dysphoric disorder (PMDD).
On January 30, 2007, the FDA approved Yaz to treat acne.
On September 26, 2011, the FDA issued a Drug Safety Communication Safety review update on the possible increased risk of blood clots with birth control pills containing drospirenone.
On April 10, 2012, the FDA issued an update to the safety communication to warn patients of the increased risk of blood clots in women taking Yaz.
The Intended Use of Yaz
Yaz is indicated for the prevention of pregnancy in women for use as an oral contraceptive. In addition to use as an oral contraceptive, Yaz is also indicated for the treatment of premenstrual dysphoric disorder (PMDD). The FDA has also indicated Yaz for the treatment of moderate acne vulgaris in women at least 14 years of age or older, who have no known contraindications to oral contraceptive therapy.
PMDD can be a severe form of premenstrual syndrome (PMS). However, the FDA has not been evaluated for the treatment of PMS.
How Yaz Treats These Conditions
Combined oral contraceptive pills lower the risk of becoming pregnant primarily by suppressing ovulation. Birth control pills may also result in cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.
General Side Effects of Using Yaz
There are a number of possible side effects which may be related to taking Yaz. Most side effects of birth control are not serious. Minor side effects may include:
- Bleeding between menstrual periods
- Weight gain
- Breast tenderness
- Difficulty wearing contact lenses
Contraindications refer to situations or conditions where a drug should not be used on patients. Contraindications involving Yaz include:
- Renal insufficiency
- Hepatic dysfunction
- Adrenal Insufficiency
- Thrombophlebitis or thromboembolic disorders
- A past history of deep-vein thrombophlebitis or thromboembolic disorders
- Cerebral-vascular or coronary-artery disease (current or history)
- Valvular heart disease with thrombogenic complications
- Severe hypertension
- Diabetes with vascular involvement
- Headaches with focal neurological symptoms
- Major surgery with prolonged immobilization
- Known or suspected carcinoma of the breast
- Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
- Undiagnosed abnormal genital bleeding
- Cholestatic jaundice of pregnancy or jaundice with prior Pill use
- Known or suspected pregnancy
- Liver tumor (benign or malignant) or active liver disease
- Heavy smoking (≥15 cigarettes per day) and over age 35
- Hypersensitivity to any component of this product
An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives, such as Yaz. This includes:
- Arterial thromboembolism
- Pulmonary embolism
- Myocardial infarction
- Cerebral hemorrhage
- Cerebral thrombosis
- Gallbladder disease
- Hepatic adenomas or benign liver tumors
There is evidence of an association between the following conditions and the use of oral contraceptives, such as Yaz:
- Mesenteric thrombosis
- Retinal thrombosis
The following adverse reactions have been reported in patients receiving oral contraceptives, such as Yaz, and are believed to be drug-related:
- Gastrointestinal symptoms (such as abdominal cramps and bloating)
- Breakthrough bleeding
- Change in menstrual flow
- Temporary infertility after discontinuation of treatment
- 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
- Rash (allergic)
- Mood changes, including depression
- Reduced tolerance to carbohydrates
- Vaginitis, including candidiasis
- Change in corneal curvature (steepening)
- intolerance to contact lenses
- Decrease in serum folate levels
- Exacerbation of systemic lupus erythematosus
- Exacerbation of porphyria
- Exacerbation of chorea
- Aggravation of varicose veins
- Anaphylactic/anaphylactoid reactions, including urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms
The following adverse reactions have been reported in users of oral contraceptives, such as Yaz, and a causal association has been neither confirmed nor refuted:
- Budd-Chiari syndrome
- Changes in libido
- Cystitis-like syndrome
- Erythema multiforme
- Erythema nodosum
- Hemolytic uremic syndrome
- Hemorrhagic eruption
- Impaired renal function
- Loss of scalp hair
- Optic neuritis, which may lead to partial or complete loss of vision
- Premenstrual syndrome
Risks for Specific Populations
Certain individuals may face additional or increased risks when using prescription drugs. Risks of Yaz for specific populations include:
- Nursing mothers. When possible, nursing mothers are advised to use other forms of birth control until she has weaned her child. Estrogen-containing oral contraceptives can reduce milk production in breastfeeding mothers.
- Patients with Renal Impairment. Yaz is contraindicated in patients with renal impairment.
- Patients with Hepatic Impairment. Yaz is contraindicated in patients with hepatic disease.
Talk to Your Doctor Before Taking Yaz
Before taking Yaz, patients should tell their doctor if they have or ever had:
- Blood clots in the legs (deep vein thrombosis), lungs (pulmonary embolism), or eyes (retinal thrombosis)
- Ever had a stroke
- Ever had a heart attack
- Have certain heart valve problems or heart rhythm abnormalities that can cause blood clots to form in the heart
- Have an inherited problem with your blood that makes it clot more than normal
- Have high blood pressure that medicine can’t control
- Have diabetes with kidney, eye, nerve, or blood vessel damage
- Ever had certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision
- Ever had breast cancer or any cancer that is sensitive to female hormones
- Have liver disease, including liver tumors
- Have kidney disease
- Have adrenal disease
- Smoke and are over 35 years old
- Are or suspect you are pregnant
- Have ever had jaundice caused by pregnancy
Patients should also tell their doctor about all their prescription and nonprescription drugs, medicines, vitamins, and herbal supplements. Patients who are considering taking Yaz should be especially aware if they take:
- NSAIDs (ibuprofen, naproxen, and others)
- Potassium-sparing diuretics (spironolactone and others)
- Potassium supplementation
- ACE inhibitors (captopril, enalapril, lisinopril, and others)
- Angiotensin-II receptor antagonists (Cozaar, Diovan, Avapro, and others)
- Aldosterone antagonists
- Carbamazepine (Carbatrol, Equetro, Tegretol, Tegretol-XR, Teril, Epitol)
- Phenytoin (Dilantin-125, Dilantin)
- Rifampin (Rifater, Rifamate, Rimactane, Rifadin)
- St. John’s wort (Hypericum perforatum)
Complications from Using Yaz
Warnings and Precautions
- Thromboembolic Disorders and Other Vascular Problems. Stop Yaz if an arterial or venous thrombotic (VTE) event occurs
- Hyperkalemia. Yaz should not be used in patients with conditions that predispose to hyperkalemia.
- Carcinoma of the Breasts and Reproductive Organs. Women who currently have or have had breast cancer should not use Yaz because breast cancer is a hormonally-sensitive tumor.
- High Blood Pressure. For women with well-controlled hypertension, monitor blood pressure and stop Yaz if blood pressure rises significantly. Women with uncontrolled hypertension or hypertension with vascular disease should not use combined oral contraceptives (COCs).
- Gallbladder Disease. Studies suggest a small increased relative risk of developing gallbladder disease among COC users.
- Carbohydrate and Lipid Metabolic Effects. Carefully monitor prediabetic and diabetic women who are taking Yaz.
- Headache. If a woman taking Yaz develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue Yaz if indicated.
- Bleeding Irregularities. Unscheduled (breakthrough or intracyclic) bleeding and spotting sometimes occur in patients on COCs, especially during the first three months of use. If bleeding persists or occurs after previously regular cycles, check for causes such as pregnancy or malignancy.
- COC Use Before or During Early Pregnancy. Extensive epidemiological studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy.
- Depression. Women with a history of depression should be carefully observed and Yaz discontinued if depression recurs to a serious degree.
Interference with Laboratory Tests. The use of COCs may change the results of some laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins.
- Monitoring. A woman who is taking COCs should have a yearly visit with her healthcare provider for a blood pressure check and for other indicated healthcare.
- Other Conditions. In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema. Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation while taking COCs.
Black Box Warning
A black box warning is the most serious and important warning on a prescription drug label. It is designed to call attention to the most serious or life-threatening risks of using a prescription drug.
The black box warning for Yaz includes the risks associated with smoking cigarettes, patients with a predisposition to hyperkalemia, and venous and arterio thrombotic and thromboembolic events.
“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.”
“The use of oral contraceptives is associated with increased risks of several serious conditions including venous and arterial thrombotic and thromboembolic events (such as myocardial infarction, thromboembolism, stroke), hepatic neoplasia, gallbladder disease, and hypertension. The risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity, and diabetes.”
Yaz Warnings and Recall Notices
FDA Drug Safety Communications
On September 26, 2011, the FDA issued a Drug Safety Communication Safety review update on the possible increased risk of blood clots with birth control pills containing drospirenone. On April 10, 2012, the FDA issued an update to the safety communication.
After a review of observational studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills, the FDA concluded the pills may be associated with a higher risk for blood clots than other progestin-containing pills. The FDA has added information about the studies to the birth control pill labels.
“The revised drug labels (Beyaz, Safyral, Yasmin and Yaz) will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins, whereas other epidemiological studies found no additional risk of blood clots with drospirenone-containing products. The labels also will include a summary of the previously released results of an FDA-funded study of the blood clot risk.”
In 2009, the FDA issued a recall of more than 30,000 packages of Yaz and more than 120,000 packages of Ocella. The reason for the recall was that the analytical value for chemical assays of drospirenone and ethinyl estradiol were averaged with another analytical value to provide a reported result that was within specification. These averaging practices can give an inaccurate indication of the amount of active drug.
False Advertising Settlement
Attorney generals from almost half of the states in the U.S. have reached a settlement with Bayer over claims of misleading advertisements to promote Yaz for off-label uses. The advertisements allegedly promoted Yaz for PMS and exaggerated the impact on patient’s acne.
Under the settlement agreement, Yaz must comply with FDA requirements before airing TV commercials. Bayer was also ordered to spend more than $20 million on a campaign to provide accurate information and address the claims.
Patients Legal Rights
There are many ways that drugs and pharmaceuticals are defective as used by patients and consumers. This could include a design defect where the drug is not safe for the intended use, or the drug manufacturer failed to properly warn the patient about dangers involved with taking the drug.
Patients who are injured by defective prescription medications may be able to seek damages from the drug company. Damages can include medical costs, lost income, and pain and suffering. Individuals who lose a loved one because of a drug defect may be able to file a wrongful death claim against the drug company.
Current Yaz Cases
Tens of thousands of claims have been filed against Bayer Healthcare involving Yaz injuries and deaths. Claims include injuries related to blood clots, gallbladder injuries, heart attacks, and strokes. The plaintiffs claims include that Bayer knew or should have known of the risks associated with Yaz and failed to properly warn users of Yaz. Plaintiffs also allege Bayer did not adequately research the life-threatening consequences associated with Yaz.
Yaz Settlements and Verdicts
Bayer has settled thousands of Yaz lawsuits. This includes class action lawsuits and individual negligence and liability claims. However, there are still thousands more Yaz lawsuits pending against Bayer.
In 2012, Bayer settled about 500 lawsuits involving Yaz and Yasmin involving claims the company marketed the drugs as safer alternatives than other birth control options, knowing there was a risk of fatal blood clots. Bayer agreed to settle the cases for about $110 million.
In 2013, Bayer settled a lawsuit brought by Maggie Yunker of Illinois. Yunker began taking Yaz after her doctor suggested the new pill could help her acne and reduce symptoms associated with her period. After beginning Yaz, Yunker developed multiple blood clots and suffered a stroke. Bayer settled the claim for $237,000.
In March 2013, Bayer set aside $24 million for more than 8,000 plaintiffs with gallbladder injury claims involving Yaz.
By March of 2014, Bayer had settled more than 8,000 Yaz cases for approximately $1.7 billion.
By 2016, Bayer has paid out approximately $2.04 billion to settle more than 10,000 Yaz cases involving blood clot claims.
Yaz Drug Defect Lawyers Gilman & Bedigian
If you were injured by after taking Yaz or another defective medication, you may have a legal claim for medical bills, lost wages, and other damages. If a loved one died as the result of taking Yaz, you should talk to experienced drug defect attorneys about your claim. You should not have to suffer due to the drug company’s negligence.
At Gilman & Bedigian, we will use our experience, knowledge, and dedication to fight for you to receive the compensation you and your family deserve. Our aggressive trial lawyers have helped our clients recover millions of dollars in compensation for medical and defective drug injuries. Contact us online or call our law office at (800) 529-6162 for a free consultation.