FDA Warnings about Yaz and Yasmin

In 2003, the FDA wrote a letter to Berlex Laboratories (who was the manufacturer of Yaz in 2003) requesting that it take Yasmin’s television ad entitled “Goodbye Kiss” off the air because it was misleading.

According to the FDA’s letter:

“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. The unifying theme of the ad, typified by the tagline “Ask about Yasmin, and the difference a little chemistry can make” (emphasis added by FDA) suggests that Yasmin is better than other birth control pills because of drospirenone and the way in which it is metabolized in the body.

This “chemistry” difference is presented as a product benefit. FDA is not aware of substantial evidence or substantial clinical experience demonstrating that Yasmin is superior to other COCs or that the drospirenone in Yasmin is clinically beneficial. On the contrary, FDA is aware of the added clinical risks associated with drospirenone… (emphasis added by us)”

Despite the above warning from the FDA, Bayer (who bought Berlex Laboratories, and is now the manufacturer of Yasmin and Yaz) continued to mislead the public about the benefits and risks of the drugs. They were warned by the FDA in 2008, this time for ads regarding Yaz.

From the 2008 letter from the FDA:

“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.

Drospirenone has antimineralocorticoid properties which can lead to hyperkalemia in high risk patients, which may result in potentially serious heart and health problems. Women taking Yaz must be concerned about the drug interactions that could increase potassium, in addition to the drug interactions common to all combination oral contraceptives…

The overall effect of the distracting visuals, graphics, concurrent supers and background music [in the ad] 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.”

Click here to read the full letter from FDA in 2003 to Berlex about the misleading Yasmin tv ad

Click here to read the full letter from FDA in 2008 to Bayer about the misleading Yaz tv ad