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.
According to a review by Health Canada, women taking Bayer’s popular birth control pills, Yaz and Yasmin, may be up to three times more likely to develop a serious blood clot, compared to those taking older-generation oral contraceptives.
On Monday, Health Canada announced it had completed a safety review of drospirenone-containing birth control pills. As part of its release, Health Canada said that, “Overall, the body of current evidence suggests that the risk of blood clots in 1.5 to 3 times higher with oral contraceptives that contain drospirenone relative to those that contain levonorgestrel, a different hormone.”
While the labels for these drospirenone-containging drugs have been updated to reflect the new information regarding the increased risk for blood clots, the U.S. Food and Drug Administration’s reproductive health drugs advisory committee will still meet on Thursday in order to further discuss the safety and efficacy of these products.
Source: CBCnews Health (Online)
The U.S. Food and Drug Administration recently issued an updated safety communication regarding Bayer Pharmaceutical’s widely-used birth control pills, Yaz and Yasmin, citing that women using these drugs are 75 percent more likely to develop blood clots compared to those who use older-generation pills.
As a result of the FDA’s study, which followed 800,000 women between the years 2001 and 2007, researchers from the FDA, Kaiser Permanente, Vanderbilt University and the University of Washington ultimately found that drospirenone-containing birth control pills increased the risk of blood clots, otherwise known as venous thromboembolic events (VTE), by 75 percent over pills containing progestin levonorgestrel.
Additionally, the study’s findings backed several claims raised by thousands of women who have filed Yaz-related lawsuits, all of whom experienced serious blood clots as a result of using drospirenone-containing birth control pills like Yaz, Yasmin, Beyaz, Gianvi, Loryna, Safyral, Syeda Zarah and/or Ocella.
The FDA will present the new data at a December 8th meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.