Yaz Birth Control Alert
If you take Yaz birth control pills, you need to know about an important warning letter issued by the Food and Drug Administration. The FDA has determined that the manufacturer of Yaz has over-promised the benefits of this drug while minimizing its risks. The manufacturer has also encouraged use of Yaz beyond the limits of what has been approved by the FDA.
What does that mean for you and your health? You may have been persuaded to take Yaz to treat a condition, including premenstrual syndrome or PMS, for which the drug has not been approved -- and that may have exposed you to serious side effects, including heart problems.
If you have been harmed by the use of Yaz, you may be eligible to recover money damages for your injuries. At Gordon & Doner, we have experience with drug injury claims, and we can help you determine if you have a case. For more information or to schedule a free case evaluation, contact the lawyers of Gordon & Doner today at 1-800-659-1159.
Manufactured by Bayer HealthCare Pharmaceuticals, the oral contraceptive drug Yaz is a combination drug that contains the hormones estrogen (ethinyl estradiol) and progestin (drospirenone). Yaz was approved for use in 2006.
Yasmin, another birth control pill now made by Bayer, was approved for use in the United States in 2001. The only difference between these two drugs is the amount of estrogen: Yasmin contains 30 mcg while Yaz contains a lower dose of 20 mcg. Both drugs have three FDA approved uses:
- Pregnancy prevention;
- Treating the symptoms of premenstrual dysphoric disorder (PMDD) in women who are using Yasmin or Yaz as their contraceptive;
- Treating moderate acne in women who desire an oral contraceptive for birth control.
These two products dominate the U.S. oral contraceptive market. In 2008, Yasmin had 11 percent market share while Yaz had 18 percent, making Yaz the top-selling birth control pill in the United States.
The popularity of Yaz was boosted in part by an aggressive marketing program. However, a series of television commercials advertising Yaz prompted the FDA to issue a warning letter to Bayer.
For instance, one TV ad dubbed "Balloons" by the FDA featured distracting visuals, graphics, concurrent supers and background music that undermined "the communication of important risk information, minimizing these risks and misleadingly suggesting that Yaz is safer than has been demonstrated by substantial evidence or substantial clinical experience," according to the warning letter.
"The TV ads are misleading because they broaden the drug's indication, overstate the efficacy of Yaz, and minimize serious risks associated with the use of the drug," the FDA warning letter stated. " These violations are concerning from a public health perspective because they encourage use of Yaz in circumstances other than those in which the drug has been approved, over-promise the benefits and minimize the risks associated with Yaz."
While Yaz has not been evaluated for the treatment of premenstrual syndrome, the ads misleadingly suggested that the drug could be used to treat that condition, the FDA said. The TV ads also misleadingly broadened the use of Yaz for acne of all severities, "when this is not the case," according to the warning letter.
The warning letter noted that Yaz actually carried additional risks compared to other birth control pills because it contains drospirenone, a progestin that can cause excess potassium production in some patients. Side effects include an increased risk of serious heart problems.
"Additionally, there are numerous warnings associated with the use of Yaz including, but not limited to, venous and arterial thrombotic and thromboembolic events (such as myocardial infarction, thromboembolism, stroke), hepatic neoplasia, gallbladder disease, and hypertension," the FDA said.
In response, Bayer agreed to run a $20 million advertising campaign to correct the impressions that were created by the initial advertising campaign. Bayer also agreed for the next six years to submit all Yaz ads for federal screening before they appear.
Bayer is now facing federal lawsuits about the safety of Yaz birth control pills. Lawsuits filed in July 2009 allege that Bayer over-promoted the birth control pills while failing to warn of their increased risks of injury.
At Gordon & Doner, we are investigating claims of women who have been injured by the use of Yaz. If you or a loved one has been harmed by the use of Yasmin or Yaz, you may be eligible to seek compensation for your injuries -- but you need to explore your legal options before it is too late. Our qualified pharmaceutical lawyers can help you determine if you have a case.
For more information or to schedule a free case evaluation, contact the lawyers of Gordon & Doner today at 1-800-659-1159.
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