Posted on October 23, 2009 by A.J. De Bartolomeo

FDA Again Warns the Makers of Yaz and Yasmin

Earlier this year, the Food and Drug Administration (FDA), wrote a warning letter to the makers of Yaz about their advertising campaigns, which the FDA characterized as “misleading” because, among other things, many of the Yaz ads “fail[ed] to communicate any risk information” about use of the drug.

Interestingly, this was not the first time the makers of Yaz and Yasmin had received such warnings. In both 2003 and 2008, the FDA sent similar warning letters. Despite all of the FDA’s warnings, the drug manufacturers continued to use the same questionable marketing strategies to promote Yaz.

In the 2009 warning letter, the FDA told Bayer that:

...for promotional materials to be truthful and non-misleading, they must contain risk information in each part as necessary to qualify any claims made about the drug.

According to the FDA, these Yaz ads did not contain that important risk information. The letter warns that the manufacturers overstated both the benefits of Yaz and the conditions that Yaz was approved to treat, making the ads “incomplete and misleading."

The FDA warning letter concluded that Bayer should immediately pull the ads and discontinue the use of any other similar materials.

Even after receiving two previous warning letters from the FDA about their misleading advertisements, the makers of Yaz and Yasmin continued to use these questionable advertising practices. These ads incorrectly led some women to believe that Yaz was safer than it really is.

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Posted on October 19, 2009 by A.J. De Bartolomeo

FDA to Yaz: Stop Misleading Consumers!

Have you seen the new Yaz commercial? You know, the one that begins with the main actress saying:

You may have seen some Yaz commercials recently that were not clear. The F.D.A. wants us to correct a few points in those ads.

It turns out that the “Yaz commercials” the actress is talking about are the very ads that were the subject of an FDA warning letter (PDF) in 2008 to Bayer (the manufacturer of Yaz and Yasmin). The FDA’s letter addressed two of Bayer’s Yaz commercials, entitled "Not Gonna Take it" and "Balloons.”

The warning letter stated that these commercials were “misleading” and “over-promised the benefits while minimizing the risks associated with Yaz.” The FDA also said that the ads were misleading because they implied that Yaz could treat PMS and “help keep skin clear.” In fact, Yaz was only approved to treat the more severe symptoms of PMDD (Premenstrual Dysphoric Disorder) and moderate acne, as opposed to more severe or less severe forms of acne..

The FDA also noted that, in addition to overstating the benefits of Yaz, Bayer also minimized the risks, which the FDA said was “particularly troubling as some of the risks being conveyed are serious, even life-threatening.”

The warning letter concluded that Bayer should stop running the ads immediately, and work on putting together a corrective campaign about the real uses and risks of Yaz that were both truthful and non-misleading.

So, it was actually in response to this warning letter that the makers of Yaz and Yasmin began to air the new commercial to “clear up” misconceptions! Check out that commercial below.

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Posted on October 10, 2009 by A.J. De Bartolomeo

The First Warning: FDA Warns Makers of Yasmin

You might have read about some of the warning letters the FDA sent to the makers of Yaz and Yasmin for misleading advertising – maybe you’ve even seen the Yaz commercial that clarifies the risks of Yaz at the FDA’s request – but did you know that the FDA has actually been warning the makers of Yaz and Yasmin about this sort of advertising since 2003?

In 2003, the FDA sent the first of three warning letters (PDF) to the manufacturer of Yasmin for its advertisements, stating that the:

TV ad misleadingly overstates the efficacy and safety of Yasmin by suggesting that Yasmin is unique and therefore clinically superior to other birth control pills because it contains the chemically different progestin drospirenone.

Yasmin was the first in a line of birth control pills to contain the hormone drospirenone. The FDA’s letter said that the commercial, named “Goodbye Kiss,” over-promoted the effectiveness and safety of Yasmin. Check out this excerpt from the letter:

[The] FDA is not aware of substantial evidence or substantial clinical experience demonstrating that Yasmin is superior to other [oral contraceptives] or that the drospirenone in Yasmin is clinically beneficial. On the contrary, FDA is aware of the added clinical risks associated with drospirenone.

The FDA's warning letter concluded that the makers of Yasmin should remove the ad immediately and stop the use of any other similar promotional materials.

The trend of misleading advertising by the makers of Yasmin, and eventually Yaz, dates all the way back to 2003! It’s been more than five years since the FDA first called them out for minimizing the risks associated with the Yaz/Yasmin hormone drsp. Yet, despite many FDA warning letters about this issue, the makers of Yaz and Yasmin continued to use these questionable advertising practices well into 2009.

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