Yaz birth control, the use of his predecessors Yasmin and related provisions of an artificial hormone called drospirenone, which mimics the natural hormone progesterone for women. Approved Yaz in 2006 became the most pickups sold in the U.S. for 2008, with the support of hundreds of millions of dollars advertising on television and magazines, their ability to resolve tensions and other effects secondary hormonal acne. However, revenues fell by more than 80 percent over the last two years because of security fears.
The panelists spent more than nine hours of discussion, often contradictory data on the risk of blood clots drug containing drospirenone compared to older drugs. While the group did not agree on the quality of the evidence, the vast majority said it should be clearly indicated on the label, including potentially fatal blood clots.
"Obviously, the text is inadequate and incomplete," said Dr. Richard Bockman New York Hospital for Special Surgery. "Adverse events should be taken to doctors and patients are aware of the consequences graphics."In a vote earlier panelists voted 15-11 that the Yaz birth control pills are still a useful option for preventing pregnancy. The majority decision amounts to a vote of confidence for the storage of drugs on the market, but also about a third of panel members voted against the drug system as a whole, based on a set of alternatives available .
"I can not really a group of patients with drug benefits compared to existing alternatives," said Mark Woods of the New York University School of Medicine. "Without a clear advantage, and taking account of the potentially catastrophic I have not. "Two major studies by the German pharmaceutical company Bayer, no difference in blood clots in patients taking the drug companies and patients who have shown the older drugs.However, since 2009, five major studies have suggested that pills containing drospirenone have a slightly increased risk of blood clots than older birth control pills, even if the events are very rare in both groups. Even a small increase in risk can be critical, because blood clots can cause heart attack, stroke and blockages in the lungs or blood vessels.
Find the latest study by the FDA, women who have had the opportunity to Yasmin 75 percent more likely to have a blood clot that patients who received a combination of older drugs. The absolute risk of a blood clot is still much less than a fraction of a percent.
FDA scientists found flaws in all existing studies of Yaz birth control pills and Yasmin, including the lack of information about the patient's weight and smoking habits, which may increase the risk of blood clots. Although they are not definitive, the participants said the information clear and must be declared on the label of doctors and patients.
"I think we can do a much better job than I saw the labels," said Dr. Valerie Montgomery Rice, Morehouse School of Medicine.
Panelists said they consider trials with patients in the future of life, race and family to meet in order to accurately detect the risk of blood clots.
With the slogan "beyond Yaz birth control", launched the publication of Bayer, Yaz to women in their 20 years as a drug with a lifestyle advantages over older contraceptives. A screen young women sing Twisted Sister anthem, "We will not stand" while popping balloons with the words "bad mood", "swelling" and "acne".
In the two years following marketing approval Yaz was raised in the bestselling pill in the U.S. with sales potential of $ 781 million in 2009, according to IMS Health. However, sales fell by one million per month to about 200,000 a month, after the company information on studies that found an increased risk of blood clots.In addition, Bayer was forced to publish corrective advertisements after the FDA said the marketing campaign exaggerated the effectiveness of Yaz in the treatment of premenstrual mood swings, and divert attention from the music and images used to minimize medication side effects.
Earlier in the day, panelists heard more than a dozen patients or their relatives, the Yaz or Yasmin sometimes blamed for fatal blood clots.
Cindy ripped talked about his last conversation with his 20-year-old daughter Elisabeth ripped, died on Christmas Eve 2008, when a blood clot travels to the lungs. Ripped said her daughter taking Yaz birth control for about two months after he took a different pill that Tri-Sprintec for one year was.
"It was my daughter a very intelligent young man. If Elizabeth had clearly said that Yasmin has a higher risk, the risk may be twice as much as the other pills, which has never changed and Yasmin to be here today, "said ripped, Escondido, California
Bayer pulled ripped 4000-6000 applicants pending personal injury claims in the American judicial system.
Yaz birth control pills and other pills containing drospirenone accounted for 16 percent of the use of hormonal contraceptives in the United States last year, behind Warner Chilcott Loestren, Johnson & Johnson, Ortho Tri-Cyclen and several other oral contraceptives.
The FDA does not have a timetable for the changes in the general labeling Yaz. For now, many doctors say they do not expect to stop prescribing drugs in the short term. They note that the risk of blood clots in each pill is still much lower than with pregnancy and childbirth, when hormone levels and emerging reduced blood flow connected to dramatically increase the chances of blood clotting .
Studies indicate that 10 of 10,000 women, the last control pill will conduct a blood clot, compared to 20 in 10,000 women who are pregnant or given birth.
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