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.
