Inside The FDA Advisory Committee on Beyaz, Drospirenone

Washington, DCIt's been two years since Beyaz was approved by the US Food and Drug Administration (FDA). And for two years Beyaz, a drospirenone oral contraceptive (OC) manufactured by Bayer, has been included in FDA advisory committee gatherings focusing on Beyaz side effects and those of other drospirenone-based contraceptives.

There have been many, according to briefing notes provided to participants of the most recent panel meeting on September 11th and made available by the FDA in late August, prior to the meeting.

According to the FDA Adverse Event Reporting System (AERS), there were no fewer than 467 reports of adverse events related to Beyaz birth control between September 2010—when Beyaz was approved—and May 1, 2012.

However, the AERS system is voluntary only. That means there is no requirement to report adverse events such as Beyaz blood clots, with the prevailing belief that anywhere from one, to 10 percent of adverse reactions actually get reported. Thus, it is generally held the 467 figure is misleading.

The briefing notes to advisory panelists on the eve of their September meeting concluded that "drospirenone-containing contraceptives have had substantial use by women 10 to 24 years of age and the relative risk of [venous thrombembolic events, VTE] appeared higher for women younger than 30 years of age."

The most compelling comments related to Beyaz drospirenone were delivered by Dr. Sonia Nagda, a physician affiliated with the National Research Center for Women & Families (NRC). Armed with a degree in public health from Harvard, Dr. Nagda addressed the FDA advisory panel and made no bones about her concern over the side effects of Beyaz and DRSP birth control.

While acknowledging that all birth control pills carry risk for blood clot to some degree, "a review of nine recent studies found higher risks from drospirenone in seven of them," she said in comments posted on the official web site of the NRC. "Two studies published in 2009 reported drospirenone contraceptives increase the risk of blood clots by 1.5-to-2 times compared to pills containing levonorgestrel. Two articles published in 2011 in BMJ [British Medical Journal] reported an increased risk of blood clots that was two, to three times higher than other birth control pills."

Dr. Nagda noted the FDA's own review of medical records associated with 800,000 women of varying ages using birth control found that when the review looked at new users, "drospirenone increased the risk of blood clots and heart attacks, especially for females under 35." Her comments reflect the observation contained in the briefing points to panelist, as noted above.

The concerned physician noted that the only two studies which suggested no increased risk in deep vein thrombosis (DVT) blood clots associated with drospirenone contraceptives and Beyaz bleeding, were authored by individuals with financial ties to Bayer, "and they did not separately analyze women younger or older than 35, which could have influenced the results."

Continuing her brief to the FDA safety panelists, Dr. Nagda noted the following.

"Last year, an FDA Advisory Committee voted for stronger warnings about VTE risks of DRSP (drospirenone), and FDA complied. But many on that Advisory Committee wanted to do more to save lives. Unfortunately, they were outnumbered due to the members with financial ties to Beyaz's manufacturer (sic). An Advisory Committee member who had previously expressed concern about the safety of DRSP was NOT [original emphasis] allowed to vote. If the members who had financial ties to Yaz had ALSO [original emphasis] been excluded from voting, the vote would have been different."

She noted that more than 250,000 teens under the age of 18 are using drospirenone-based OCs, with millions of older teens and young women added into the mix. Previous FDA panels, in narrowly allowing Beyaz to remain on the market despite risks associated with Beyaz blood clots, were content with beefing up warning labels.

Dr. Nagda, however, in her remarks to the expert panel on September 11, noted that teens were not going to read the labels. Nor were their busy parents. Most place implicit trust with their doctor. But most doctors are not going to read the studies either, she said, assuming demands on their time with a busy practice.

"They are going to assume that this Advisory Committee will safeguard their loved ones."

Beyaz users (or their parents) who are not aware of the risks and are blindsided by a blood clot or VTE incident, will have little recourse but to file a Beyaz lawsuit to achieve financial and moral compensation.

In the meantime, the noted doctor from the NRC made her point clear to the FDA expert panel where it comes to Beyaz birth control and other drospirenone-based contraceptives:

"Because of the overwhelming evidence in well-designed studies indicating an increased VTE risk of DRSP compared to safer, less expensive contraceptives, we urge the FDA to take these pills off the market."