The FDA is investigating thousands of reports that link the Yaz, Yasmin, and Ocella to blood clots, breathing issues, heart attacks, strokes, and other serious health issues.
Yaz, Yasmin and Ocella are oral birth contraceptives, made with a combination of two different types of hormones: estrogen and progestin. Unlike other contraceptives, Yasmin includes a common form of estrogen called ethinyl estradiol, as well as a unique, uncommon progestin known as drospirenone. Drospirenone can work against the body’s normal mechanism for regulating salt and water balance, which can lead to hyperkalemia in high risk patients, and can also result in many other potentially serious heart and health problems.
- Deep vein thrombosis (DVT): This is a blood clot within a deep vein, usually in the legs, the pelvis, and sometimes the arms. This is a very painful condition that can lead to a pulmonary embolism (PE) and can ultimately cause death in some cases, if not cause further painful complications.
- Pulmonary embolism (PE): This blockage of the pulmonary artery is usually a result of deep vein thrombosis. One will experience complications when breathing, heart palpitations, and chest pain. If left untreated, PE can cause circulatory issues, collapse, and even sudden death.
- Hyperkalemia: a condition caused by higher than normal levels of potassium in the bloodstream and can cause abnormal heart rhythms (also referred to as cardiac arrhythmias and heart palpitations). Severe hyperkalemia can lead to cardiac arrest and even death.
- Numbness, weakness, or confusion. One may also experience a sinus-like headache that can also lead to speech, balance, and vision problems.
- Heart Attack
- Gallbladder disease
- Migraine headaches that may change in severity and pattern.
- Chest pain and nausea may suddenly develop.
- Breast lumps that suddenly appear, as do stomach pain, jaundice (skin or eyes become yellowish in color), or loss of appetite.
- Mood changes, depression, or changes in sleep pattern
- Sudden Death
On May 31, 2011, the U.S. Food and Drug Administration (FDA) issued a safety announcement in regards to birth control pills that contain drospirenone. According to the FDA, several epidemiological studies have reported that the risk of blood clots for women who use birth control pills containing drospirenone is higher than that for women who use birth control pills containing the progestin levonorgestrel.
Not only has this warning been announced in the U.S., the European Medicines Agency also made the same announcement in May of 2011. Seven epidemiological studies were performed, evaluating the association between combined oral contraceptives (COCs) that contained drospirenone and venous thromboembolism (VTE). After review, the European Medicines Agency found that although the risk of VTE with any COC is small, the results from the studies still show that drospirenone-containing COCs are associated with a higher risk of VTE than levonorgestrel-containing COCs.
FDA Drug Safety Communication: Safety Review of possible increased risk of blood clots with birth control pills containing drospirenone
European Medicines Agency: safety announcement