Yaz Advertising and the FDA
Let’s say for the sake of argument that we decided to get into the car wax business. Let us further say that we spent millions of dollars on an advertising campaign in which we claimed that not only would our wax make your car extremely shiny, but would also make it run better.
If we ran ads making this claim in newspapers, on television, the radio and the internet, we would be in serious trouble, regardless of the accuracy of our claims about the ability of our wax to make cars shine. The sticking point is that we claimed that our car wax can do something which it most certainly cannot, which is improving the function of your cars motor.
No reputable business would market a product by claiming that it does something it wouldn’t do, yet many pharmaceutical companies seem to have no problems doing exactly that. Just this past year, Bayer has been cited for misleading advertising by the Food and Drug Administration, which forced the pharmaceutical giant to spend even more money to adjust its marketing campaign.
The advertising in question involved a birth control pill called Yaz, which was marketed as not only a contraceptive but as a cure for both acne and premenstrual dysphoric disorder, or PMDD. You shouldn’t confuse PMDD with premenstrual syndrome (PMS,) as the symptoms of PMS are much less severe then the symptoms of PMDD. PMS brings with it mild mood swings, irritability and cramps, while PMDD is associated with severe depression, panic attacks and insomnia, among other symptoms. One of the many problems that the FDA had with the Yaz advertising campaign was that Bayer actually did mistaken the symptoms for PMS with PMDD in order to increase the appeal of the drug.
On the actual FDA-approved labeling of the drug, the supposed PMDD benefits were listed as:
(F)or the prevention of pregnancy in women who elect to use an oral
contraceptive.
(F)or the treatment of symptoms of premenstrual dysphoric disorder, in women who choose to use an oral contraceptive as their method of contraception. The effectiveness of YAZ for PMDD when used for more than three menstrual cycles has not been evaluated.
YAZ has not been evaluated for the treatment of premenstrual
syndrome (PMS).
In addition to the labeling, Bayer also added a package insert that essentially re-iterated the same thing:
YAZ has not been shown to be effective for the treatment of premenstrual syndrome (PMS), a less serious cluster of symptoms occurring before menstruation. If you or your healthcare provider believes you have PMS, you should only take YAZ if you want to prevent pregnancy; and not for the treatment of PMS.
This brings us to the television ads, in which the term “Premenstrual Dysphoric Disorder” is never actually mentioned. Instead they just use “PMDD,” which could very easily be confused for PMS. And when you consider the “We’re Not Gonna Take It” themed advertisements, in which women are seen punching away words like “Bloating,” “Irritability,” and “Feeling Anxious,” what is implied is that PMDD is exactly the same thing as PMS, which it most certainly is not. This could lead women to take Yaz in the hopes that it will prevent them from undergoing the minor symptoms of PMS when in fact the pills have no real effect on PMS symptoms at all, but are in fact intended for the much heavier PMDD symptoms. The equivalent for this would be a commercial for Vicodin in which women are punching away words like “Mild Headache” or “Sore Knees.”
Another problem that the FDA had with the Bayer advertisements was the fact that one of the words that was punched away was “Acne,” which implied that simply taking Yaz would clear away any acne that you might have. According to the labeling of the product, Yaz has been shown to have some success treating mild forms of acne, but you wouldn’t know that by watching the advertisement.
Some of you might be thinking that this is nothing to really get angry over. It seems that Bayer is guilty of nothing more than overstating or engaging in mild misdirection in their advertisements in order to get more sales. And if it weren’t for the fact that Yaz, Yasmin and the generic version Oscella contain an ingredient called drispirenone, we would agree with you.
Drispirenone is a synthetic variant of progestin, which is one of the two major ingredients of practically every birth control pill on the market. Bayer found that this variant did in fact produce some of the reductions of the side effects that make birth control pills a sometime unpleasant experience for the women who take them. But considering that drispirenone increases potassium levels in the blood stream, and therefore increases the risk of blood clotts among users, we don’t think that helping with mild acne is much of a trade-off.
Since Yaz and Yasmin have been on the market, the FDA has been inundated with hundreds of complaints regarding women suffering strokes, heart attacks and pulmonary embolisms. There have been more than a few cases of otherwise perfectly healthy women dying after taking these pills for no more than a month. It is for this reason that we think Bayer needs to be held responsible for a little more than misleading advertising.
Greenberg and Bederman is currently offering legal help to women in the Washington, D.C. area who have been injured due to the use of Bayer’s line of birth control pills. If you or a loved one has been seriously hurt or hospitalized after using Yaz, Yasmin or Oscella, contact Greenberg & Bederman for a free yaz legal consultation today.
To learn more about yaz, yasmin, or oscella dangers, please vist our website and click on the yaz page, or go to our youtube site and watch our yaz attorney video.
To learn more about yaz side effects, please read our yaz page. To learn more abour our yaz lawyer, Andy Bederman, please read yaz bio or watch his yaz lawyer video.
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