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The oral contraceptive that combines the estrogen ethinyl estradiol with the new progestin drospirenone (YASMIN) was approved by the Food and Drug Administration (FDA) in April 2001. In the April 2002 issue of Worst Pills, Best Pills News we listed Yasmin as a Do Not Use drug for two reasons: 1) drospirenone causes elevated blood levels of potassium that may cause serious heart and other health problems such as a change in acid balance of the blood and muscle weakness, and 2) there is no...
The oral contraceptive that combines the estrogen ethinyl estradiol with the new progestin drospirenone (YASMIN) was approved by the Food and Drug Administration (FDA) in April 2001. In the April 2002 issue of Worst Pills, Best Pills News we listed Yasmin as a Do Not Use drug for two reasons: 1) drospirenone causes elevated blood levels of potassium that may cause serious heart and other health problems such as a change in acid balance of the blood and muscle weakness, and 2) there is no evidence that Yasmin is superior in any way to older contraceptive products.
The FDA-approved patient information leaflet for Yasmin carries the standard warning about the risk of developing blood clots that is the same as that for the other combination oral contraceptives on the market:
Blood clots and blockage of blood vessels are the most serious side effects of taking oral contraceptives and can be fatal. ln particular, a clot in the legs can cause thrombophlebitis [blood clots] and a clot that travels to the lungs can cause sudden blocking of the vessel carrying blood to the lungs. Rarely, clots occur in the blood vessels of the eye and may cause blindness, double vision or impaired vision.
Oral contraceptives are one of the few families of drugs that are required by FDA regulation to be dispensed with information written specifically for patients.
A communication from the Dutch adverse drug reaction reporting system, The Netherlands Pharmacovigilance Centre, published in the February 6, 2003 issue of the British Medical Journal, reported five cases of blood clots possibly being linked to the use of Yasmin.
The first case was a 17-year-old woman who suddenly collapsed and died after taking Yasmin for six months. An autopsy showed that she suffered a massive pulmonary embolism (blood clot in the lungs). She had no obvious risk factors for developing blood clots such as smoking, a period of long immobilization, air flights or taking other drugs that might cause blood clots.
A 28-year-old woman was changed from an oral contraceptive containing ethinyl estradiol with desogestrel, a pill similar to the U.S. products DESOGEN or ORTHOCEPT (that we also list as Do Not Use), to Yasmin. After four months on Yasmin, she developed a blood clot in one leg and was treated with an anticoagulant (blood thinner).
A 45-year-old woman had a blood clot in one leg after taking Yasmin for two months, as did a 50-year-old woman who took the oral contraceptive for three months. A 35-year-old woman had a lung clot 17 days after she started taking Yasmin. She had given birth four months earlier.
What You Can Do
You should not use Yasmin for the reasons we stated in the April 2002 newsletter. Some physicians may believe that Yasmin is less likely to cause blood clots than older oral contraceptives; however, there is no research to support such a belief.
