What Makes It Different and the FDA’s Involvement
The popular birth control, Yaz and Yasmin (generically known as Ocella), differ from other oral contraceptives in that they contain a unique progestin component known as drospirenone. Drospirenone, only recently approved for use in the drug in 2001, is not used in any other birth control pill approved in the United States.
Drospirenone creates a risk of increased potassium levels which can lead to hyperkalemia—a condition that, in many people, disrupts normal heart rhythms. Disrupting normal heart rhythms can be fatal: disruption can slow the blood flow through the heart to the point that blood clots form. Blood clots in the heart can lead to heart attack or can travel to other parts of the body—such as the lungs or the brain—thus causing pulmonary emboli or strokes. Therefore, because the birth control pill contains drospirenone, Yaz and Yasmin pose new and additional risks to young women who use oral contraceptives.
The risks associated with this popular birth control pill are severe; many women who took Yaz or Yasmin have died or been seriously injured because of the serious health risks associated with the drug. In fact, the FDA received over fifty reports of Yaz and Yasmin-related deaths between 2004 and 2008, most involving increased levels of potassium and occurring in women as young as 17 years old. Imagine how many went unreported! A growing number of lawsuits have been filed by or on behalf of these women, charging the drug manufacturer with inadequately warning them of the increased risks Yaz and Yasmin pose to those women who use the oral contraceptive.
While the public-at-large and many physicians may not recognize an adverse reaction to drospirenone, the health risks have been known for longer than many realize. In 2002, the British Medical Journal reported some practitioners’ concern about the drug as a result of 40 cases of venous thrombosis among women taking it. Also, in 2003, the Journal published a paper that detailed reports of thromboembolism deaths and injuries thought to be caused by Yaz and Yasmin.
The FDA has been reprimanding Yaz and Yasmin manufacturers for misleading and inadequate television advertising for the drug for quite some time.
In one warning letter to the pill manufacturer, the FDA stated that the 2003 Yaz and Yasmin commercial entitled “Goodbye Kiss” was misleading to consumers. The ad implied to consumers that the drug was clinically superior to other oral contraceptives. The FDA stated that it was unaware of any evidence demonstrating that the drug was superior to other oral contraceptives or that drospirenone was clinically beneficial. More correctly, the FDA was only aware of the added clinical risks associated with Yasmin and Yaz. Second, while the ad noted drospirenone’s tendency to increase potassium, that effect was portrayed as a benefit of the drug rather than its true nature as a significant health risk. The FDA stated “by failing to add the necessary context to clarify that increased blood potassium is a safety risk rather than a clinical benefit, the ad misleadingly represents or suggests that Yasmin is safer than has been demonstrated by substantial evidence or substantial clinical experience.” As a result of the FDA’s 2003 warning letter, the drug manufacturer was ordered to immediately discontinue the television ads and all other similar promotions.
Since then, new commercials for the popular birth control have aired, but not without further FDA involvement. Last October, the FDA again admonished Yaz and Yasmin manufacturers for television advertising for the drug, finding that the ads, again, misled consumers. This time, two separate ads were found to be misleading in violation of numerous regulations because they “encourage[d] 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.” The ads broadened the indications of the drug by implying that it treated not only symptoms of premenstrual dysphoric disorder (PMDD) but also symptoms of PMS, a less serious condition. This was problematic considering the fact that the drug had never been evaluated for treatment of PMS. The most startling aspect of these commercials is the downplaying of the risks involved with taking Yaz and Yasmin: There were distracting visuals, numerous scene changes, and background music playing as the serious health risks were being communicated. The FDA stated “The overall effect of the distracting visuals, graphics, concurrent supers and background music is to undermine 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.” As a result of this warning letter, the FDA required Bayer, the Yaz and Yasmin manufacturer, to cease running these ads and any similar misleading promotions. Bayer was also required to run correction ads, an uncharacteristic move for the FDA. The new corrective ad is meant to clear up the misconceptions conveyed in Yaz’s previous advertising campaigns. Correcting these misleading ads cost Bayer upwards of $20 million and will hopefully curtail further misleading information about this popular birth control pill.
Discouraging Bayer from running misleading ads may not, however, be as easy as originally thought. Bayer has received yet another warning from the FDA, this time for its sponsored links on internet search engines. The FDA found the Yaz sponsored link to violate various regulations because it omitted risk information associated with the use of the drug, overstated its indications, and did not use the full established name of the drug being promoted. Promotional materials are required to disclose risk and other information about the drug but the sponsored link for Yaz merely states “YAZ Prevents Pregnancy, May Help Moderate Acne and PMDD” and provides a link to the Yaz website. Such a listing is misleading because it fails to mention any risk information, thus implying the drug is safer than it has been shown to be.
If you, or someone you love, have experienced birth control side effects from using Yasmin, YAZ or Ocella, and would like the attorneys at Nolan Law Group to review your case, please contact us.