Yaz Warning Letter

In a warning letter from the Department Of Health & Human Services

“The Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed two 60-second direct-to-consumer (DTC) broadcast television advertisements (TV Ads) entitled “Not Gonna Take it” and “Balloons” for YAZ Tablets submitted by Bayer HealthCare Pharmaceuticals, Inc. under cover of separate Forms.  The TV Ads are misleading because they broaden the drug’s indication, overstate the efficacy of YAZ, and minimize serious risks associated with the use of the drug.  Thus, the TV Ads misbrand the drug in violation of the Federal Food, Drug, and Cosmetic Act (the Act), and FDA’s implementing regulations.  These violations are concerning from a public health perspective because they encourage use of YAZ in circumstances other than those in which the drug has been approved, over-promise the benefits and minimize the risks associated with YAZ.”

The warning letter proceeds to state:

“Additionally, 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 infraction, 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.”

To read the complete warning letter from the Department Of Health & Human Services, click here. 

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