The FDA has issued a safety announcement to warn that contraceptives like Yasmin significantly increases a woman’s risk of thromboembolic disorders.
What is Yasmin?
Yasmin is a birth control pill created by Berlex Laboratories, which has since been acquired by Bayer HealthCare Pharmaceuticals Inc. It is approved to prevent pregnancy. When used correctly, it is 99% effective at preventing pregnancy. Yasmin is a daily oral regimen consisting of 21 active tablets, each containing 3 mg of drospirenone and 0.03 mg of ethinyl estradiol. It also contains 7 inert tablets, which help a woman stay in the habit of taking the pill regularly.
FDA Issues First Warning: Yasmin Ads “Misleading”
In October 2003, the FDA issued its first warning regarding Yasmin advertisements. The FDA found that the advertisements were misleading to consumers, because they falsely represented Yasmin as a safer alternative to other birth control methods, while minimizing the risk factors associated with its use.
The risk factors from using Yasmin are serious, and may cause death. The FDA said that “women and their healthcare providers must weigh Yasmin’s additional health risks when considering Yasmin over [other contraceptives] without drospirenone.”
Yasmin and Drospirenone
Yasmin contains drospirenone, a synthetic form of the female sex hormone progestin. Drospirenone affects the amount of potassium in a woman’s body, which may lead to the formation of blood clots. Women who are sensitive to potassium, or have liver or kidney issues, are advised not to take Yasmin. Even in healthy women, the risk of developing a blood clot is increased when they are taking drospirenone. Five recent studies have linked the use of birth control containing drospirenone to an increased risk of developing blood clots and other life-threatening thromboembolic disorders.
Studies of Drospirenone
- Two studies published in 2009 reported that a woman using birth control containing drospirenone may be twice as likely to develop a blood clot compared to women using other forms of birth control.
- Two additional articles published in 2011 in the British Medical Journal reported that a woman taking birth control with drospirenone may be up to three times more likely to develop a blood clot.
The FDA recently conducted its own study, following nearly 800,000 women who were taking forms of birth control with drospirenone, including Yasmin. In October 2011, the FDA issued a statement regarding preliminary findings of the study. The FDA found that women have at least a 1.5-fold increased chance of developing a blood clot after using drospirenone-containing contraceptives, such as Yasmin. The risk is greatest for women in their first year of taking Yasmin.
Side Effects of Yasmin
Yasmin 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 Yasmin, 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:
- Arterial thromboembolism
- Myocardial infarction
- Cerebral hemorrhage
- Cerebral thrombosis
- Gallbladder disease
- Hepatic adenomas or benign liver tumors