FDA Warning Letters Sent to Bayer in October 2008 About Problems with TV Advertising For Yaz

The patient information for YAZ includes a BOXED WARNING that states (in pertinent part): “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.”

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. Moreover, YAZ has additional risks because it contains the progestin, drospirenone.

Broadening of Indication—Premenstrual Dvsghoric Disorder (PMDD): "Not Gonna Take It" (ZYRA-6323) & "Balloons" (ZYRA-6567)
The TV Ads misleadingly suggest that YAZ is effective in a broader range of patients and conditions than has been demonstrated by substantial evidence or substantial clinical experience. Specifically, given the overlap in certain symptoms between premenstrual syndrome (PMS) and PMDD, and the material limitation on YAZ's PMDD indication (that it has not been evaluated for the treatment of the less serious condition, PMS), the TV Ads misleadingly suggest that YAZ is appropriate for treating women with PMS, who may not be appropriate candidates for this drug. We note that despite listing certain symptoms of PMDD, nowhere do the TV Ads use the full phrase "premenstrual dysphoric disorder," to more completely distinguish PMDD from PMS, thereby increasing the likelihood that a viewer, in light of the claims and presentations described below, will understand it to be the same as, or substantially similar to, PMS.

The TV Ad " Not Gonna Take It" starts by stating: "We all know that birth control pills are 99% effective and can give you shorter, lighter periods. But did you know there's a Pill that could do more?"

It then displays images of energetic, euphoric, playful women singing "We're Not Gonna Take It" as they kick, punch, and push words describing symptoms such as "IRRITABILITY," "MOODINESS," "BLOATING," and "FEELING ANXIOUS," away from the screen, followed by the claim "It's YAZ! And there's no other birth control like it." The screen then displays a listing of symptoms including: irritability; increased appetite; moodiness; fatigue; feeling anxious; headaches; bloating; and muscle aches.

Similarly, the TV Ad "Balloons" starts by stating: "All birth control pills are 99% effective and can give you shorter, lighter periods. But there's one Pill that goes beyond the rest. It's YAZ." It then displays numerous balloons throughout the ad with symptoms, such as, "IRRITABILITY," "MOODINESS," "FEELING ANXIOUS," "BLOATING," "FATIGUE," "MUSCLE ACHES," "HEADACHES," "INCREASED APPETITE," and "ACNE."

The symptoms displayed in these ads are commonly seen in women with PMS, which is a less serious and more common condition than PMDD.

The TV Ads entirely omit the material limitation from the PI of the drug's PMDD indication - i.e., that "YAZ has not been evaluated for the treatment of premenstrual syndrome (PMS)" and fail to convey that the drug is only indicated for women who experience the symptoms presented to such a degree that they have PMDD, rather than PMS. As a result of the failure to convey these material facts, and the failure to explain what PMDD is, in contrast to PMS, the TV Ads misleadingly suggest that YAZ is approved to treat women with any severity of the symptoms presented, regardless of whether their symptoms are actually severe enough to constitute PMDD.

We note that the list of symptoms displayed in the TV Ads are accompanied by the text "YAZ treats PMDD" along with a SUPER reading "PMDD is a mood disorder related to the menstrual cycle."

However, these disclosures do not suffice to communicate the material fact that YAZ is not approved for treatment of PMS or to overcome the implication created by the totality of the visuals and images in the ads that YAZ is appropriate for any woman who experiences the symptoms presented. We also note that the voiceover states that "YAZ is the only birth control pill proven to treat the emotional and physical premenstrual symptoms that are severe enough to impact your life." However, this claim also fails to communicate that YAZ is not approved for treatment of PMS, and fails to distinguish, between PMS and PMDD.

The totality of the visual and audio presentations in both TV ads suggest that YAZ is approved to treat women with any severity of the symptoms presented, including women with PMS, when this is not the case. Thus, the TV Ads misleadingly broaden the indication of the drug.

Acne
In addition, the TV Ads suggest that YAZ is approved for acne of all severities when this is not the case. Specifically, in "Not Gonna Take it," the word "ACNE" appears in large print in the middle of the screen along with the audio claim "It can also help keep your skin clear," which is accompanied bya close-up visual of a woman with completely clear skin. Similarly, in "Balloons," the "ACNE" balloon is prominently displayed on the screen, as it floats by a smiling woman with obviously clear skin, along with the audio claim that YAZ " ... also helps keep skin clear." These presentations fail to adequately convey that, as noted in the PI, "YAZ is indicated for the treatment of moderate acne vulgaris ..." (emphasis added). While the TV Ads do include a SUPER which refers to "improvement in ... moderate acne" in small, unbolded print, this does not mitigate the misleading impression created by the prominent audio and visual claims in the TV Ads that YAZ is indicated for acne of all severities.

Overstatement of Efficacy: PMDD "Balloons" (ZYRA-6567)
The TV Ad is misleading because it suggests that YAZ is more effective than has been demonstrated by substantial evidence or substantial clinical experience. The totality of the audio and visual claims and presentations misleadingly suggests that treatment with YAZ will allow women to say "good-bye" to their symptoms completely. For example, the TV Ad's theme song "Good-Bye to you" plays in the background as energetic, euphoric, playful women release balloons into the air displaying certain symptoms (e.g., irritability, moodiness, feeling anxious, bloating, fatigue, muscle aches, headaches, increased appetite, and acne). The balloons then float up and away from the women misleadingly suggesting that these women are saying, " goodbye" to their symptoms and are now symptom-free, when such an elimination of symptoms has not been demonstrated by substantial evidence or substantial clinical experience. According to the PI, in the primary clinical trial that served as the basis for approval of YAZ in the PMDD population, " . . .the average decrease (improvement) from baseline was 37.5 points in women taking YAZ, compared to 30.0 points in women taking placebo" (added emphasis). These results do not support the implication that YAZ will result in a complete cessation of PMDD symptoms.

Acne: "Not Gonna Take It" (ZYRA-6323) & "Balloons" (ZYRA-6567)
The TV Ads include close-up images of women with completely clear, acne-free skin. In the TV Ad " Not Gonna Take It," there is an image of a woman with the word "ACNE" prominently displayed on the screen before the word "ACNE" fades away from view. The woman turns her face to the side showing viewers that she has no visible signs of acne on her face, in conjunction with the audio claim "It can also help keep your skin clear." In "Balloons," a woman with obviously clear skin smiles and acknowledges the " ACNE" balloon as it floats away from the center of the screen and disappears into the sky, in conjunction with, the background song " Good-bye to you" and the audio claim that YAZ " . . .also helps keep skin clear." The overwhelming impression conveyed by the TV Ads is that treatment with YAZ results in clear, acne-free skin for those women suffering from acne when this has not been demonstrated by substantial evidence or substantial clinical experience.

Minimization of Risk: "Not Gonna Take It" (ZYRA-6323) & "Balloons" (ZYRA-6567)
The audio communication of serious risk disclosures during the "major statement" is minimized by distracting visuals, numerous scene changes, and other competing modalities such as the background music which combine to interfere with the presentation of the risk information. In "Not Gonna Take It", the fast-paced visuals depict various women looking at pictures, trying on clothes, chatting at a cafe, stretching/exercising in a park, and walking down the street while the audio component describes the major risks associated with YAZ. Similarly, in "Balloons," the background music plays as fast-paced visuals depict various women running in a park, sitting on a scenic waterfront, smiling, walking out of a coffee shop, driving and singing, walking out on a balcony, using an elevator, walking through the street to join friends, in addition, to a pigeon on a building ledge and balloons being released and floating away. These complex presentations distract from and make it difficult for viewers to process and comprehend the important risks being conveyed. This is particularly troubling as some of the risks being conveyed are serious, even life-threatening. 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.

Conclusion and Requested Action
For the reasons discussed above, the promotional piece misbrands YAZ in violation of the Act, 21 U.S.C. 352(n), 352(f)(1), & 321(n), and FDA implementing regulations. 21 CFR 201.1 00(c)(1); 201.128; 202.1 (e)(5)(iii) & 202.1(e)(6)(i).

DDMAC asks Bayer to immediately cease dissemination of violative promotional materials for YAZ that are the same as or similar to those described above.

Read the FDA warning letter.

How Weitz & Luxenberg Can Help You
If you have experienced serious help problems after taking YAZ, you may be entitled to file a Yaz lawsuit against the manufacturer.

A lawyer with experience in birth control litigation can help evaluate your claim.

Many women around the country have suffered from life-threatening Yasmin pulmonary embolism side effects but are unaware they have a right to seek monetary compensation by filing a claim against Bayer.

For a free no-obligation case review of your possible YAZ lawsuit, please complete the form below. A representative of our firm will be in touch shortly.

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