October 27, 2011

FDA Cites Blood-Clot Risk Tied to Bayer Birth-Control Pills

U.S. regulators warned there may be an increased risk of blood clots connected with birth-control pills made by Bayer AG, and said the issue will be further evaluated in a meeting with advisers in December.
Women taking pills containing the hormone drospirenone were 74 percent more likely to experience clots than those on low- estrogen pills, the Food and Drug Administration said in a report released today. An FDA advisory committee will meet Dec. 8 to discuss the findings.
Sales of the Yaz family of birth-control pills fell 13 percent in 2010 to 1.11 billion euros ($1.57 billion), making them the company’s second-biggest drug. North American revenue from the pills has fallen as the German drugmaker, based in Leverkusen, faces competition from generics made by Teva Pharmaceutical Industries Ltd. The company earlier today said the pill’s risks weren’t higher than that of other oral contraceptives.
“We believe that the overall potential risk that Yaz or Beyaz present to patients is absolutely compared with that of other oral contraceptives,” said Joerg Reinhardt, head of Bayer’s HealthCare unit, in a conference call with analysts today before the FDA released the study results.
After the FDA made its statement, Astrid Kranz, a Bayer spokeswoman, said the company will comment further at the agency’s panel in December.

Similar to Progesterone
Drospirenone is similar to the natural female hormone progesterone. The study evaluated data from 835,826 women ranging in age from 10 to 55 taking pills containing the hormone over time, including Bayer’s Yaz, Beyaz and Angeliq, the FDA report said.
The FDA findings come on top of recent studies suggesting newer birth control pills, including those containing drospirenone, carry twice the risk of potentially deadly blood clots than older contraceptives.
Researchers in Denmark used the country’s health-care data base of women between the ages of 15 and 49 from 2001 through 2009 to find dangerous clots known as venous thromboembolism developed in 4,246 women for the first time during the study. The researchers reported their results in the British Medical Journal this week. by Adriel Bettelheim and Naomi Kresge

SEPTEMBER 28, 2011

FDA Flags Concern on Birth-Control Pill=

The U.S. Food and Drug Administration said Monday it "remains concerned" a certain type of birth-control pill that contains drospirenone could raise the risk of blood clots beyond that of other pills.
In a drug safety communication posted on the agency's website Monday, the FDA said preliminary results of an agency-funded study involving 800,000 women suggest about a 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing birth-control pills, compared to users of other hormonal contraceptives.
Drospirenone is used in pills including Yaz and Yasmin, which are marketed by Bayer AG. Drospirenone is a type of female sex hormone called a progestin. Some drospirenone pills are also available in generic versions.
But the FDA said it hasn't reached a final conclusion that the products raise the risk of blood clots beyond that of other pills, and the agency will convene an outside panel of medical experts on Dec. 8 to discuss the matter.
Most birth-control pills contain two types of hormones, estrogen and progestin. All types of pills increase the risk of blood clots, and product labels warn of such risk.
The FDA said there is conflicting information about the blood-clot risk possibly associated with drospirenone from six other published studies. Some of the studies have reported that the risk of blood clots for women who use birth-control pills containing drospirenone is higher than that for women who use birth-control pills containing levonorgestrel, while other studies haven't found such a risk. While the risk of blood clots is low among women who take birth-control pills, the FDA said it is higher than the risk among women who aren't taking the pills.
Blood clots form inside a vein and are known as deep vein thrombosis, or DVT. The clots usually form in the lower leg or thigh, but can break loose and travel to other areas of the body such as the lungs, where they are called a pulmonary embolism, or PE. The FDA said the symptoms of a DVT include the new onset of persistent leg pain, while those of a PE include severe chest pain and sudden shortness of breath.
Bayer has said its analysis of the available scientific evidence shows that the risk of developing a blood clot associated with taking pills containing drospirenone "is comparable" to that of other birth-control pills studied, but it is working with the FDA on the matter. Sales of Bayer's Yaz product family have been declining, which the company blames on generic competition in the U.S.
In May, the European Medicines Agency said the risk of developing blood clots for oral contraceptives containing drospirenone was higher than that of pills containing levonorgestrel but said the risk for any type of birth-control pill was small. EMA said the product labels of birth-control pills containing drospirenone will be updated.

Yaz/Yasmin: “Remove dangerous contraceptive pills from the market!”
Oct. 14, 2011, ABC News

New Studies Find Yaz More Risky Than Other Leading Birth Control Pills: ABC News Investigates


The blockbuster birth control pill with benefits, Yaz was pitched as the choice for women desperate for relief from severe PMS and acne. But now, new independent studies have found that Yaz carries higher blood clotting risks than other leading birth control pills.
ABC News investigated whether tens of millions of women switched to a more potentially risky pill that, as it turns out, was never proven to treat common PMS.
In 2007, Carissa Ubersox, 24, was fresh out of college and starting her dream job as a pediatric nurse in Madison, Wis. On Christmas day, while working the holiday shift, her boyfriend surprised her at the hospital with a marriage proposal.
Wanting to look and feel her best for her wedding day, Carissa said she switched to Yaz after watching one of its commercials that suggested this pill could help with bloating and acne.
"Yaz is the only birth control proven to treat the physical and emotional premenstrual symptoms that are severe enough to impact your life," claimed the ad.
It "sounds like a miracle drug," Carissa said she remembers thinking.
But just three months later, in February 2008, Carissa's legs started to ache. She didn't pay much attention to it, assuming, she said, that it was just soreness from being on her feet for a 12-hour shift.
By the next evening, she was gasping for air. Blood clots in her legs had traveled through her veins to her lungs, causing a massive double pulmonary embolism.
Her fiance called 911, but on the way to the hospital Carissa's heart stopped. Doctors revived her, but she slipped into a coma for almost two weeks.
Carissa's only memory of that time is something she refers to as an extraordinary dreamlike experience. She said she remembers a big ornate gate and seeing a recently deceased cousin. That cousin, Carissa said, told her, "You can stay here with me or you can go back." But, she recounted, he told her if she goes back she'll end up blind.
"I just remember waking up in the hospital and I was like, 'Oh, I guess I chose to stay,'" Carissa told ABC News. Like her cousin in her dreamlike experience foretold, she actually did wake up blind, and remains blind to this day.
No one can say for sure whether Yaz caused Carissa's blindness, but Yaz contains a unique hormone called drospirenone that some experts say may trigger more blood clots than other birth control pills. Clots can cause serious breathing problems, a stroke or even death.
All birth control pills come with some risk. Two to four women per 10,000 on the pill will suffer blood clots, and some will die as a result. But with Yaz, several new independent studies have put that risk two to three times higher.
"It's a disappointing finding," said Dr. Susan Jick, author of one of those independent studies involving almost a million women. "As a public safety concern that's not what one wants to find."
Made by Bayer HealthCare Pharmaceuticals, Yaz sales rocketed to nearly $2 billion a year after its release in 2006, making it at one time the leading birth control pill on the market and Bayer's top-selling drug.
And there was a lot of buzz surrounding Yaz, from popular women's magazines touting it as "the pill for PMS" and "super pill" to TV news segments, like one in Dallas that called Yaz, "a miracle pill that gets rid of most of the uncomfortable symptoms of PMS."
Some company executives apparently encouraged these exaggerated claims, ABC News has learned. Internal documents obtained by ABC News show their reactions: "[T]his is outstanding!!! can we get good morning america to do the same segment!!!???!! (tee hee)," one executive wrote about the Dallas segment that called Yaz a miracle pill for PMS.
But the Food and Drug Administration wasn't amused. In 2008, the FDA said Yaz was not shown to be effective for common PMS, just a rare and serious form of menstrual symptoms, and that Yaz's success with acne was "misleadingly overstate(d)." State authorities also accused Bayer of deceptive advertising.
Bayer denied any wrongdoing, but in an unusual legal settlement agreed to spend $20 million on corrective TV ads, which said, "Yaz is for the treatment of premenstrual dysphonic disorder, or PMDD, and moderate acne, not for the treatment of PMS or mild acne." But by then, millions of women had already opted for Yaz.
Some experts say there is cause for concern about recent medical findings. Jick found it noteworthy that the studies funded by Bayer found no difference in risk, while all four of the most recent independent studies found increased risk.
Jick added that when she sent her study to Bayer, she was surprised that they never responded or asked to work with her.
"The studies that have found increased risks are not in the best interest of the company," Jick said.
Columbia University medical ethicist David Rothman added that, in general, "We have got to look at drug studies published by the company producing the products with a lot of suspicion. They have too much skin in the game."
Internal Bayer documents obtained by ABC News raise questions about some of the company's research. According to one report, Bayer apparently kept the name of one of two employees off a company-sponsored study because, according to an internal email, "there is a negative value to having a corporate author on the paper."
"It's really nefarious, a basic violation of scientific integrity, when the person who did the research doesn't even appear on the paper," said Rothman.
Thousands of women are now suing Bayer, including Carissa Ubersox, but the company continues to deny any wrongdoing. Citing those lawsuits, Bayer refused to be interviewed for this story and instead sent ABC News a statement saying Yaz is as safe as any other birth control pill when used correctly.
There are no answers yet for Carissa, whose life has changed forever. She is no longer a pediatric nurse, no longer engaged and, she said, "everything that I thought I worked so hard for has disappeared." Yaz, she said, is to blame.
The FDA has re-opened the case on Yaz, conducting its own new review of the drug's safety. If you are considering your birth control options, experts say you should, as always, consult your own doctor.