Yaz Injuries, Warnings & Consumer Advocate Pleas

There have been numerous FDA (U.S. Food & Drug Administration) warnings related to Bayer Pharmaceutical's Yaz and Yasmin following thousands of reported injuries around the world such as blood clots, heart problems and more. Consumer advocate groups are pleading with the FDA to remove these "fourth generation" of oral contraceptives containing diospironone from the market as they can increase the risk of blood clots by an astounding 75%.

Yaz Cause Blood Clots, Heart Attacks, Strokes & More

Both Yaz and Yasmin, which contain drospirenone & ethinyl estradiol (estrogen), are thought to dangerously increase potassium levels. While this can result in the formulation of blood clots and lead to strokes and pulmonary embolisms, other side effects have been reported such as depression, heart attacks, kidney damage, liver damage and a host of others.

Yaz FDA Black Box Warning

Yaz and Yasmin currently contain a "black box" warning against smoking and taking the medication. The warning states that women over the age of 35 will increase their risk of serious cardiovascular side effects by smoking and using Yaz or Yasmin. The warning further indicates that the risk increases with age and number of cigarettes smoked per day, particularly if over 15 cigarettes per day.

Black box warnings have also been added to Yaz and Yasmin notifying the user that the medication should not be taken if there is a history of kidney, liver, or adrenal disease. The warning also advises the user to check her potassium levels frequently if taking Yaz or Yasmin in conjunction with certain cardiovascular or chronic inflammatory drugs, including: non-steroidal anti-inflammatory drugs (ibuprofen, Motrin, Advil, etc.), potassium sparing diuretics, potassium supplements, ACE inhibitors, Angiotensin-II receptor antagonists, Heparin, and aldosterone antagonists.

Yasmin FDA Warning Letters To Bayer

The FDA has sent Bayer three warning letters over its Yaz & Yasmin birth control pill advertisements – basically telling the German-based drug manufacturer to stop misleading consumers. Here's what each letter said:

  • 2003 FDA Letter to Bayer Re: Yasmin's "Goodbye Kiss" Ad.The FDA notified Berlex Laboratories, a Bayer subsidiary, that its advertisement entitled "Goodbye Kiss" was not only misleading because it "makes implied clinical superiority claims to other combination oral contraceptives and minimizes the important risk information that distinguishes Yasmin from other combination oral contraceptives," but that it also violated the Federal Food, Drug and Cosmetic Act.

  • 2008 FDA Letter to Bayer Re: Yaz's "Not Gonna Take It" & "Balloons" Ads.The FDA notified Bayer that its Yaz "Not Gonna Take It" and "Balloons" advertisements are "misleading because they broaden the drug's indication, overstate the efficacy of [the drug], 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."

  • 2009 FDA Letter to Bayer Re: YAZ Ads. The FDA notified Bayer again that its Yaz advertisements are "incomplete and misleading, suggesting that YAZ is useful in a broader range of conditions or patients than has been demonstrated by substantial evidence or substantial clinical experience."

The FDA also warned Bayer that its claims that all patients with moderate acne are candidates for Yaz is simply not true. It said:

    ...Yaz's indication is limited to the treatment of moderate acne vulgaris in women at least 14 years of age who have achieved menarche (their first menstrual cycle), and it should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.

Bayer has spent $20 million to correct its advertising campaign.

In addition, the FDA warned Bayer about substantial problems and its failure to conform to good manufacturingprocesses in one of its German plants which makes the key ingredients for both Yaz and Yasmin. In particular, the FDA accuses Bayer of hiding data which should have kept several batches of the drugs from being shipped to the United States.

U.S. Drug Watchdog Says Yaz & Yasmin Birth Control Pills More Dangerous Than Others

The U.S. Drug Watchdog, a non-profit consumer advocate group committed to safety and protection with respect to all pharmaceuticals and prescription drugs, has said that Bayer's Yaz and Yasmin birth control drugs are more dangerous than others . However, the group says that the drug company has done little to warn consumers about the serious and dangerous side effects of Yaz and Yasmin oral contraceptives.

In a 2012 statement, the group reported that Yaz birth control injuries have become its most important women's health initiative ever as oral contraceptives which contain diospironone increase the risk of blood clotsby an astounding 75%.

If you believe you or a loved one has suffered harm as a result of taking Yaz or Yasmin, seek legal advice right away to protect your rights. There is no fee and no other obligation. If you delay, however, you may lose your right to seek compensation for your injuries caused by Yaz or Yasmin due to state-imposed time limits for filing a Yaz lawsuit, called the statute of limitations.