The drug Yaz is a new birth control pill that contains drospirenone, a synthetic female sex hormone. Several recent studies have linked drospirenone to serious, life-threatening side effects, such as deep vein thrombosis (DVT) and pulmonary embolism (PE). The FDA has issued a safety announcement because of evidence that Yaz significantly increases a woman’s risk of deadly blood clots.
What is Yaz?
Yaz is an oral medication produced by Bayer HealthCare Pharmaceuticals Inc. It was approved by the FDA in 2001 to prevent pregnancy, treat premenstrual dysphoric disorder (PMDD), and alleviate moderate acne. Yaz contains a chemical called drospirenone, which is a synthetic form of the female sex hormone progestin.
First Warning Letter: FDA Finds Yaz Ads Misleading, Minimize Serious Risks
In 2008, the FDA sent its First Warning Letter that Yaz “TV Ads are misleading because they broaden the drug’s indication, overstate the efficacy … and minimize serious risks, associated with the use of the drug.” The FDA was concerned that Yaz commercials could be misleading, because they implied that the drug could treat PMS and severe acne. In reality, Yaz was only approved to treat PMDD (premenstrual dysphoric disorder) and moderate acne. In response, the makers of Yaz ran a $20 million marketing campaign to comply with the requests of the FDA.
Second Warning Letter: FDA Finds Yaz Ads “Fail to Communicate Any Risk Information”
In 2009, the FDA issued a Second Warning Letter to the makers of Yaz. Again, they were concerned because they advertisements are “misleading because they … fail to communicate any risk information associated with the use of these drugs.”
FDA Study & Safety Announcements
All birth control pills increase a woman’s risk of blood clots. However, five new studies have shown that women who use birth control pills that contain drospirenone, such as Yaz, are at a significantly higher risk of developing blood clots than that for women who use other forms of oral birth control.
The FDA reviewed six studies that evaluated the risk of blood clots in women using birth control pills containing drospirenone, such as Yaz. Two studies from 2009 reported that a woman may be twice as likely to develop a blood clot compared to women using other forms of birth control. The conclusions of these two studies were corroborated by two additional articles published in 2011 in the British Medical Journal, which reported that a woman taking birth control with drospirenone may be up to three times more likely to develop a blood clot.
The FDA conducted its own study, following nearly 800,000 women who were taking forms of birth control with drospirenone, including Yaz. In October 2011, the FDA issued a statement regarding preliminary findings of the study which found that women have at least a 1.5-fold increased chance of developing a blood clot after using drospirenone-containing birth control, such as Yaz. The risk of developing blood clots is greatest for women in their first year of taking Yaz.
Side Effects of Yaz
Yaz has been linked to the formation of blood clots in the extremities, called Deep Vein Thrombosis (DVT). When these blood clots break loose, they may travel to the lungs, heart, or brain, and block the supply of blood to these organs. If a stroke is not treated quickly, it can be fatal.
- Deep vein thrombosis (DVT) is a side effect of using Yaz, causing blood clots to form in the large veins in the lower leg and thigh. The blood clot may block blood flow, causing swelling and pain.
- In the most serious cases, the clot may break away and move through the bloodstream. This is called an embolism. If an embolism travels through the bloodstream, it may become lodged in the heart, lungs, or brain, causing serious injury or death.
- Pulmonary embolism (PE) is when an embolism travels through the body and becomes lodged in the artery leading to the lung. The resulting lack of oxygen can cause serious injury to the internal organs. If untreated, 30% of people who have a PE will die, usually within the first few hours of the event.
Other side effects:
- Cardiovascular events, especially in women who smoke
- Liver disease
- Uterine bleeding
- Pseudotumor Cerebri (PTC)
- Idiopathic Intracranial Hypertension (IIH)