Yaz, Yasmin and Ocella Overview
Millions of women take the popular birth control pills Yaz, Yasmin, and Ocella. Yaz and Yasmin are produced by Bayer Healthcare Pharmaceuticals. Ocella, which is a generic form of Yasmin, is supplied by Bayer to Barr Laboratories and Teva USA Pharmaceuticals for distribution.
The birth control pills are composed of the synthetic hormones drospirenone and ethinyl estradiol. In recent years, drospirenone-containing birth control pills have been linked to serious health complications, including blood clots and stroke.
How do Yaz, Yasmin, and Ocella work?
Yaz, Yasmin, and Ocella primarily prevent pregnancy by suppressing the release of eggs from the woman's ovaries. In addition, the thickening of the cervix mucus helps impede sperm penetration. Changes in the endometrium also prevent egg implantation. In addition to pregnancy prevention, Yaz may be prescribed to treat the following medical conditions:
- Moderate acne in young women age 14 and older who want oral contraceptives
- Premenstrual dysphoric disorder (PMDD) in women who wish to avoid pregnancy
The Food and Drug Administration (FDA) has not approved Yaz to treat premenstrual syndrome (PMS). Like other oral contraceptives, Yaz, Yasmin, and Ocella do not protect against the transmission of sexually transmitted diseases (STDs) or HIV.
Yaz, Yasmin, and Ocella have been linked to serious health complications. Numerous women have reported experiencing the following health issues while taking the birth control pills:
- Blood clots
- Deep vein thrombosis
- Pulmonary embolism
- Heart attack
- Gallbladder injuries and disease
- Vision loss
In the most severe cases, women have reportedly died as a result of these complications. In addition, like other combination oral contraceptives, Yaz, Yasmin, and Ocella may cause serious harm to women who are over 35 and smoke cigarettes. Blood clots, stroke, heart attack, and even death can result.
FDA Warning Letter and Settlement
In October 2008, the FDA issued a warning letter to Bayer Healthcare Pharmaceuticals alleging that its two TV commercials violated FDA law on the following grounds:
- Broadened Yaz's indication: According to the FDA, the TV ads misleadingly suggested that Yaz had been approved to treat PMS and all types of acne.
- Overstated Yaz's efficacy: The TV ads inaccurately suggested that taking Yaz will result in clear, acne-free skin, according to the FDA.
- Minimized the safety risks associated with Yaz : The visuals and music used in the TV ads allegedly distracted viewers from comprehending the serious and life-threatening risks associated with Yaz.
In February 2009, the FDA along with 27 State Attorney Generals entered into a settlement agreement with Bayer Corporation. Bayer agreed to spend $20 million in corrective TV ads for Yaz. In addition, the company promised that for the next six years it would submit Yaz TV ads for FDA approval.
FDA Mandates Changes to Label Warnings
Yaz, Yasmin, and Ocella all contain the progestin hormone drospirenone. An FDA-funded study found that women who took drospirenone-containing birth control pills had a 1.5 times higher risk of developing blood clots than women who took other progestin-containing oral contraceptives. Another study found the risk for blood clots to be high as three times when compared to other types of progestin-containing birth control pills. However, other studies have found no increased incidence of blood clots.
Blood clots can cause deep vein thrombosis, heart attack, stroke, loss of eyesight, pulmonary embolisms, and even death in some cases. Consequently, in April 2012, the FDA issued a safety communication stating that women taking drospirenone-containing birth control pills may have a higher risk for developing a blood clot than women taking other progestin-containing oral contraceptives. The FDA mandated that drospirenone-containing oral contraceptives' labels be updated with warnings reflecting the risk of blood clots along with the findings of the various studies.
Lawsuits Involving Yaz, Yasmin, and Ocella
Numerous product liability lawsuits involving Yaz, Yasmin, and Ocella have been filed in the state and federal courts. So far, more than 11,000 federal lawsuits involving the oral contraceptives have been consolidated into a multidistrict litigation matter in the U.S. District Court for the Southern District of Illinois. Under product liability law, products must meet consumers' ordinary expectations. Products that are manufactured defectively, designed defectively, or that fail to provide adequate warnings about the risks involved can expose manufacturers and sellers to liability.
In the birth control lawsuits, plaintiffs have argued that the pills' design is defective because drospirenone allegedly makes the pills unreasonably dangerous for consumers. The lawsuits also allege that the drug manufacturers failed to provide adequate warnings about the risks associated with the oral contraceptives. In addition, a plaintiff may have a medical malpractice claim if her healthcare provider failed to warn her about the birth control pills' risks or negligently prescribed the oral contraceptive.
Getting Legal Help
If you or a loved one have experienced any dangerous symptoms or unusual medical conditions while taking Yaz, Yasmin, or Ocella, you should first contact your doctor or other healthcare professional. You may also wish to meet with an experienced attorney to discuss your options and to protect your right to a legal remedy for any injuries caused by Yaz or Yasmine use.
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