Safyral: Is There a Link between Drospirenone and Strokes?

Seattle, WAStrokes in any age group are a cause for concern, but when young women who are relatively healthy suffer a stroke, red flags tend to be raised, particularly when some drugs used primarily by young women have been linked in studies to an increased risk of stroke. This is true of Safyral and other, similar birth control pills. Safyral side effects, according to the US Food and Drug Administration, include an increased risk of blood clots and stroke. Although Safyral is similar to other drugs such as Yasmin and Yaz, it has not received nearly the media attention of those other drugs.

According to a report from the FDA, the risk of cardiovascular complications linked to the use of combined hormonal contraceptives (CHCs) has long been a source of concern. Combined hormonal contraceptives are contraceptives that combine two different female hormones, an estrogen and a progestin. Safyral is a combined hormonal contraceptive because it contains ethinyl estradiol (estrogen) and drospirenone (progestin).

The FDA’s report, “Combined Hormonal Contraceptives (CHCs) and the Risk of Cardiovascular Disease Endpoints,” notes that the side effects of concern are serious, including venous thromboembolism, pulmonary embolism, acute myocardial infarction and stroke. Furthermore, the FDA report raised the concern that even with an increased risk of cardiovascular events associated with combined hormonal contraceptives, those CHCs that contained drospirenone might have an even further increased risk of heart-related problems.

“DRSP [drospirenone/ethinyl estradiol tablets] may increase cardiac arrhythmia risks and sudden deaths among users because it has anti-mineralocorticoid activity that may increase potassium levels,” the report’s authors wrote.

Studies have not always agreed on the risks associated with DRSP-combined hormonal contraceptives. Some studies have found no increased risk associated with drospirenone, while others have found an increased risk of venous thrombosis when compared with other contraceptives that contained levonorgestrel.

Researchers for the FDA found that the use of drospirenone in a combined hormonal contraceptive was linked to an increased risk of venous thromboembolism.

Lawsuits have been filed against the makers of Yasmin and Yaz, both of which contain drospirenone, alleging women suffered serious health problems, including blood clots and strokes, following their use of the contraceptives. Despite some concerns about the risks associated with drospirenone-containing birth control, the FDA has elected to keep such contraceptives on the market, finding that their benefits outweigh the risks.