After a much publicized hearing, federal health experts said that drug labeling for Yaz and other drospirenone containing birth control pills should be updated to highlight recent data suggesting a higher risk of blood clots with these drugs than older contraceptive pills.
Expectations were heightened and many experts felt that the FDA may put a restriction on the sale of these drugs, but according to many, the FDA's findings was very disappointing.
The FDA's panel of experts voted 21-5 Thursday that labeling on the popular drugs made by Bayer is inadequate and needs more information about the potential risk of blood clots in the legs and lungs, known as deep vein thrombosis and pulmonary embolism.
Yaz, its predecessor Yasmin and others use a synthetic progestin hormone called drospirenone. Yaz was approved in 2006, and quickly became the best-selling birth control pill in the U.S. by 2008. But prescriptions have fallen more than 80 percent in the last two years over safety concerns and mounting lawsuits.
Medical experts debated more than nine hours discussing the blood clot risk of drospirenone-containing drugs. The overwhelming majority said it should be clearly stated in the medication label the potentially fatal nature of blood clots.
"Clearly the wording is inadequate and incomplete," said Dr. Richard Bockman of New York's Hospital for Special Surgery. "Adverse events have to be made graphic so physicians and patients are aware of the consequences."
The panelists voted 15-11 that the pills remain a beneficial option for preventing pregnancy. This ruling amounts to a vote of confidence for keeping the drugs on the market, over a third of panelists voted against the drug's overall benefit, citing numerous alternatives available.
"I can see no real group of patients that this drug benefited over existing alternatives," said Mark Woods of New York University School of Medicine. "Without any clear benefit, and given the potentially catastrophic risk, I voted no."
The most recent study by the FDA found women taking Yasmin had a 75 percent higher chance of suffering a blood clot than patients taking a combination of older drugs.
Panelists heard more than a half-dozen patients or their family members who blame Yaz or Yasmin for sometimes deadly blood clots.
Cindy Rippee spoke about her last conversation with her 20-year-old daughter Elizabeth Rippee, who died Christmas Eve 2008 when a blood clot traveled to her lung. Rippee said her daughter had been taking Yasmin for about two months, after taking another birth control pill, Tri-Sprintec, for a year previously.
"My daughter was a very smart young woman. If Elizabeth had been clearly told that Yasmin had more risk, maybe twice as much risk, as other pills she never would have switched to Yasmin and would be here today," said Rippee, of Escondido, Calif.
Rippee is among 10,000 plaintiffs suing Bayer in personal injury lawsuits pending throughout the U.S. federal court system.
The FDA has not set a timetable for any changes in Yaz's labeling. For now, many doctors say they don't expect to stop prescribing the drugs anytime soon.
The FDA convened the panel to consider additional safety measures for newer contraceptives based on recent studies that show a higher risk of blood clots with the drugs.
The panel is now scheduled to discuss adding new warning information to the drugs' labeling about the potential risks of blood clots.
Shezad Malik is an Internal Medicine and Cardiology specialist, a Texas Medical Doctor (retired) and Defective Medical Device and Dangerous Drug Attorney. Dr. Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.