[LESS INFO] 10 VIEWS | ADDED 14:00:42 10/17/11
Mike Papatonio on Ring of Fire , February, 2011
Do you remember a few years ago the ads for the contraceptive Yaz, featuring empowered women punching away at balloons labeled "bloating," "irritability" and other common symptoms of PMS to the tune of Twisted Sister's " We're Not Gonna Take It ?" It also was offered up as a treatment for acne. The FDA really didn't like those ads for their upbeat promising of a wholesale cures for all those lady problems without the caveat that the drug was not appropriate for treatment in all cases. T hey cited parent company Bayer for those ads : >
The F.D.A. says that Yaz is approved to treat a more serious condition called premenstrual dysphoric disorder, known to cause anxiety, tension, persistent anger and other symptoms and no evidence that Yaz eliminates PMS symptoms as the ads describe. "The TV ads misleadingly suggest that Yaz is approved to treat women with any severity of the symptoms presented, regardless of whether their symptoms are actually severe enough to constitute PMDD," the FDA letter said.
Both the ads also "suggest that Yaz is approved for acne of all severities when this is not the case," the agency said it is only approved to treat moderate acne.
Another objection by the F.D.A. was the fast-moving images and background music that might be distracting to viewers while information about potential side effects, some potentially life-threatening blood clots, was described. “These complex presentations distract from and make it difficult for viewers to process and comprehend the important risks being conveyed. This is particularly troubling as some of the risks being conveyed are serious, even life-threatening,” the agency said.
But besides this hand-slap, Yaz went on to be one of the most popular brands with millions of women switching to the brand, including Carissa Ubersox: >
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.
While there's careful legalspeak to say that no one can absolutely point to Yaz as the cause of Ubersox's blindness, the fact remains that the only studies that say that Yaz and its sister Yazmin do not pose higher risks are ...wait for it.. .funded by BAYER . >
One large-scale study in Europe, sponsored by Bayer, reported that there was no difference in the risk of cardiovascular problems or death in women taking drospirenone birth control pills compared to women who took pills that contained levonorgestrel, a progestin that has been used since the 1970s.
But two other studies on Danish and Dutch women, published last month in The British Medical Journal, found a higher risk of venous blood clots for women taking newer progestins, including drospirenone.
Mike Papatonio's Florida law firm is leading the suit against Bayer on behalf of women who say they've been harmed by taking Yaz. I'm sure that Republican candidates like Ron Paul would say that this is an issue for the "Free Market" to suss out, but how many more women must suffer like Ubersox before that invisible hand intercedes? What do we tell those casualties before it does, "Sorry, you got hurt, but thems the breaks, don't look for the government to help you."?
Hopefully with a little more exposure, like this Nightline segment from ABC News, we'll get these women some relief:
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