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FDA Slaps Bayer's Hands as They Mislead the Public about YAZ and Yasmin

 

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The Food and Drug Administration (FDA) has had to intervene on behalf of consumers in regards to misleading advertising for Yasmin, an oral contraceptive approved by the FDA in March 2001 and YAZ which was approved five years later.

These actions were in regards to misleading advertising for the drugs by Berlex and Bayer Healthcare Pharmaceuticals.

In July of 2003, the FDA notified Berlex Laboratories that their Yasmin TV commercial was misleading and in violation of the Federal Food, Drug, and Cosmetic Act. The commercial, “Goodbye Kiss” was cited for implying that Yasmin was clinically superior to other oral contraceptives as well as for minimizing risk information specific to the Yasmin formulation (specifically the progestin component – drospirenone).

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“Goodbye Kiss” utilized the phrase, “...the difference a little chemistry can make” and “different kind of hormone” to emphasize the suggestion that drospirenone is beneficial and superior to progestins used in other oral contraceptives (OCs). There is, in fact, no evidence that Yasmin is clinically superior to OCs that use traditional progestins. The commercial goes on to state that Yasmin “may increase potassium” without communicating that this is a significant health risk. Berlex was ordered to immediately discontinue these ads as well as any other advertising that contained similarly inaccurate claims.

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On October 3, 2008, the FDA sent a warning letter to Bayer Healthcare Pharmaceuticals regarding their deceptive advertising practices for YAZ. The commercials in question were “Not Gonna Take It” and “Balloons”. The FDA stated that these advertisements were misleading because they broaden the drug's indication, overstated the efficacy of YAZ, and minimized the serious risks associated with use.

YAZ was approved by the FDA for pregnancy prevention, treatment of the symptoms of premenstrual dysphoric disorder (PMDD), and treatment of moderate acne in women who wanted to use oral contraceptives. Documentation specifically stated that YAZ was not proven to be effective for treatment of PMS.

“Not Gonna Take It” and “Balloons” used the term PMDD rather than the full phrase “premenstrual dysphoric disorder”, which increased the probability that viewers would mistake PMDD for a condition the same as or very similar to PMS. Both commercials presented symptoms commonly associated with PMS, adding to the confusion. Neither advertisement addressed the fact that YAZ was not indicated in treatment of PMS.

In March of 2009, YAZ was again the focus of an FDA warning. This warning addressed the lack of risk information contained in sponsored internet links for YAZ. The incomplete and misleading statement in the link implies that all patients suffering from acne would benefit from using YAZ. In truth, YAZ is indicated for treating acne vulgaris in women at least 14 years old who are menstruating and desire oral contraceptive birth control. These links also fail to include the full established name of the drugs as well as risk information. Bayer was asked to stop broadcasting promotional materials that were misleading and incomplete.

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Bayer Healthcare Pharmaceuticals seems bent on exaggerating the efficacy and minimizing the side effects of Yasmin and YAZ. The FDA continues to slap their hands for making false and obscure claims. If you, or someone you know, has been taken in by their lies and suffered serious side effects because of them, seek legal advice as soon as possible.

If you would like a free consultation from one of our YAZ attorneys, please fill out the form on this page or call us toll free at 866-761-1385.

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Law Offices of Michael Monheit 1368 Barrowdale Road  Rydal, PA  19046
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