In December, at the Joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee of the Food and Drug Administration, oral contraceptives containing drospirenone, approved since 2001, were discussed in detail.
Drospirenone is a form of progestin, a synthetic hormone which is different from the older forms of birth control. Called the ‘fourth generation’ of progestin, there is less data available than on the earlier forms of progesterone.
The Division of Pharmacovigilance within the FDA was asked to look at post-marketing reports of complications associated with Beyaz in children age zero to 17.
Ironically, the name of Beyaz means ‘beyond Yaz” and it is Bayer’s latest contraceptive to contain the same dose of estrogen as Yaz, as well as drospirenone; but it also contains folate, important in preventing birth defects if a pregnancy should occur while on the pill.
Beyaz is also prescribed to women as young as age 14 and up to treat moderate acne, however adolescents as young as 10 have been known to take the contraceptive.
There has long been a concern about the risk of cardiovascular combinations in combined hormonal contraceptives because of the prothrombotic effects of estrogen. Deep venous thrombosis (DVT) or blood clots, and venous thromboembolism (VTE), blood clots, as well as pulmonary embolism (PE), which is a blockage of the main artery of the lungs from a blood clot that travelled from elsewhere in the body, have all been reported consistently. PE can lead to collapse, low blood pressure and sudden death.
But there is less information available on the drospirenone/ethinyl estradiol tablets.
While all hormonal birth control can cause a blood clot, drospirenone has an elevated risk.
Most studies have shown a two- to-five-fold increase in the risk of venous thromboembolism (VTE) or blood clots, for those patients taking drospirenone – when compared to contraceptives compared to other progestin-containing products.
Drospirenone is a synthetic steroidal progestin and when combined with an estrogen such as ethinylestradiol is sold as Yaz, Yasmin Beyaz, Zarah, Angeliq, Yasminelle.
But there was little data on youngsters and adolescents who might be taking Beyaz as a contraceptive or to treat acne.
Here are some of the narratives that are coming forward concerning young users:
- A 16-year-old female who had a pulmonary embolism while taking Beyaz who had a 10 cigarette a day habit.
- A 12-year-old experienced deep vein thrombosis (DVT) in her lower extremities while on Yaz or Beyaz.
- A healthy 17-year-old collapsed near death from a pulmonary embolism and coronary artery thrombosis. She did not smoke or have any contributing factors and had been taking Beyaz birth control for a little over two weeks. The blood clot moved from her heart to both lungs when she collapsed.
- A 14-year-old who was taking Beyaz for an acne breakout experienced a venous thromboembolism in the left eye. She began taking Beyaz three months earlier.
These are just some of the “adverse events” reported to the FDA in its Adverse Events Reporting System database; just some of the 19 reports that were identified from the data from September 24, 2010 to May 1, 2012.
However consider this. Reporting to the FDA is a less than perfect snapshot of the actual injuries. The FDA’s database is thought to represent as little as one percent of actual real-life situations since many people do not know about the existence of the database or how to enter a report.
AERS is a computerized database where doctors and patients are supposed to report post-marketing events as part of safety surveillance of drugs and other therapeutic biologic products.
AERS is not used to calculate the actual number of adverse events in the U.S. because it is so unreliable.
The main conclusion of studies so far, is that drospirenone-containing contraceptives are used by women as young as 10 for either contraception or to treat mild acne, and the relative risk of VTE appears to be higher for women under the age of 30.
Again the studies provide no specific information on the safety of Beyaz among adolescent users, though the theory is that it carries the same risk as other drospirenone containing oral contraceptives. And when you consider the up to five-fold increased risk of blood clots injuries, you must remember something else – there appears to be no significant increased benefit to offset this risk.
The ‘fourth generation” does not necessarily mean newer and better.