Yaz Birth Control FDA & Black Box Warnings

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Since birth control pill, Yaz was introduced, numerous FDA warnings have been issued to its manufacturer, Bayer.  FDA warnings about Yaz, Yasmin and Ocella have included manufacturing concerns, illegal marketing and serious concerns about health risks of the birth control pills.

Yaz Birth Control FDA Warnings

Since 2003, the Food and Drug Administration (FDA) has sent multiple warning letters to Bayer Healthcare regarding its birth control products which contain the hormones drospirenone and ethinyl estradiol.

The Bayer oral contraceptives affected by Yaz FDA warnings include:

  • Yaz
  • Yasmin
  • Beyaz
  • Safyral

The FDA, a government agency within the Department of Health and Human Services, is responsible for regulating and supervising the safety of all new and existing medicines, especially keeping unsafe drugs off the market. The FDA prevents most unsafe drugs from ever making it to the general public. In most cases, the FDA works to make sure every patient is aware of the risks associated with taking certain unsafe drugs. In rare cases, the FDA will completely recall an unsafe drug, when it proves to be too dangerous.

Bayer’s FDA warnings for Yaz included three letters which ordered them to discontinue false advertising practices, one which condemned unsanitary conditions at a Bayer plant where Yaz and Yasmin were manufactured, and two additional warnings about the risks of blood clot formation which the drug can cause and the dangers it poses.

Yaz and Yasmin Black Box Warnings

All medications containing drospirenone as the progesterone ingredient carry a black box warning mandated by the FDA.  Black box warnings are also called boxed statement warnings and notify prescribers of a significant risk fo severe and life-threatening side effects.  The black box warning for Yaz states:

“Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke. 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 infarction, thromboembolism, stroke), hepatic neoplasia, gallbladder disease, and hypertension.”

This black box warning is also included on all oral contraceptives which are similar to Yaz including:

Drospirenone/Ethinyl Estradiol Oral Contraceptives
BrandDoseManufacturer
Yazdrospirenone 3mg / ethinyl estradiol 0.02mgBayer Healthcare
Gianvidrospirenone 3mg / ethinyl estradiol 0.02mgTeva Pharmaceuticals
Lorynadrospirenone 3mg / ethinyl estradiol 0.02mgSandoz Pharmaceuticals
Nikkidrospirenone 3mg / ethinyl estradiol 0.02mgNurx Pharmaceuticals
Yasmindrospirenone 3mg / ethinyl estradiol 0.03mgBayer Healthcare
Ocelladrospirenone 3mg / ethinyl estradiol 0.03mgTeva Pharmaceuticals
Syedadrospirenone 3mg / ethinyl estradiol 0.03mgSandoz Pharmaceuticals
Zarahdrospirenone 3mg / ethinyl estradiol 0.03mgMayne Pharma International
Beyazdrospirenone 3mg / ethinyl estradiol 0.02mg / levomefolate 0.451mgBayer Healthcare
Safyraldrospirenone 3mg / ethinyl estradiol 0.02mg / levomefolate 0.451mg and 0.451mg levomefolateBayer Healthcare

Read more about Yaz birth control lawsuits and warnings

Yaz Warning Letters

Since 2003, the following FDA warning have been issued to Bayer Healthcare or about Yaz and drospirenone oral contraceptive agents:

  • July 10, 2003 – FDA warns Bayer to correct its television commercials for misleading claims that exaggerate the efficacy and diminish the risks of taking Yasmin.
  • October 3, 2008 – FDA warns Bayer to correct its television commercials for misleading claims that exaggerate the efficacy, diminish the risks of taking Yaz, and that suggest its use for conditions the FDA not approve it for. Bayer is forced to spend $20 million on commercials that correction their former.
  • March 26, 2009 – FDA warns Bayer to correct its sponsored links on internet search engines for misleading claims that exaggerate the efficacy, diminish the risks of taking Yaz, and that suggest its use for conditions the FDA not approve it for.
  • August 5, 2009 – FDA warns Bayer that the German facility where the Drospirenone found in Yaz and Yasmin is manufactured falls dramatically short of US standards.
  • May 31, 2011 – FDA issues safety warning about possible increased risk of blood clots with birth control pills containing drospirenone.
  • September 26,2011 – FDA issues safety review update on possible increased risk blood clots with birth control pills containing drospirenone.
  • April 10, 2012 – FDA issues additional updated information on possible increased risk blood clots with birth control pills containing drospirenone and begins requiring new information be added to prescribing instructions.

After the FDA guidance, all prescribing information and labelling for drospirenone products was required to be updated by manufacturers.

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