Posted on 11/05/2010 2:12:23 PM PDT by NYer
It's an investigation every woman should see. Thousands are coming forward about Yaz, a popular birth control pill.
Blood clots, gall bladder disease, heart attacks and even strokes -- in each case, the women say their decline in health is directly linked to the contraceptive they chose.
Where you see advertisements for Yaz, you'll see bright colors and smiling faces. But now there's also an added emphasis on the serious side effects of this contraceptive -- results of a $20 million corrective marketing campaign by its manufacturer, Bayer, getting a message out that thousands of women now claim was missing when their pills were prescribed.
Here is what Katie Ketner says she was told by her gynecologist at the age of 15:
"It helped people regulate their menstruation, helped people control their acne and things like that."
In addition to preventing pregnancy, Yaz (introduced in 2006 as going 'beyond birth control') is only approved for treating moderate acne and a disabling mood disorder called PMDD or Premenstrual Dysphoric Disorder from which few women suffer.
Katie had never taken any type of birth control before. She said Yaz was the only prescription she was on for the next three years, but by the time she was getting ready to head to college, she was in the midst of a much different type of life-changing event.
"I didn't go out. I didn't go see friends. I just laid in bed for the most part, and I was sick all the time. I was vomiting constantly. Eventually, I was vomiting bile," Ketner said.
For months, doctors tried to figure out what was wrong with what had been a perfectly healthy young woman. It turned out she had gall bladder disease.
"I found out that my gall bladder function was at about 64 percent, and it should be between 98 and 100 percent," she said.
Ketner stopped taking Yaz. Her gall bladder was removed in October 2009, and she has been fine ever since.
"I was not predisposed to this condition. I have none of the risk factors. The only thing was Yaz," she said.
Four weeks and one day after Susan Gallenos began taking Yaz, her health was in jeopardy, too. She suffered a stroke. Surgeons had to remove part of her skull because of swelling to the brain.
"My IQ plummeted to 77, borderline mentally retarded," Gallenos said.
She lived to tell her story, but when she came home to her children ...
"To them, their mom did die because she was there one day, and the next day she was gone, and I was gone for six months," Gallenos said.
She suffers chronic pain, has no short-term memory and can't drive. Both Kate and Susan's doctors believe that Yaz caused their health problems. Now, they -- like nearly 4,000 other women with similar stories -- have filed suit in a multi-district litigation, similar to a class-action lawsuit against Bayer.
"We've seen anywhere from pulmonary embolism, strokes, blood clots, gall bladder disease and also kidney failure," said Melissa Hedrick with the Atkins and Markoff law firm.
They're also handling more than 100 other complaints about Yaz, its sister contraceptive, Yadmin, and its generic version, Ocella, from across the nation.
"The issue really is in these cases' warnings. The doctors weren't aware that Yaz, Yasmin and Ocella had any greater risks than other birth control pills," Hedrick said.
Dr. Eli Reshef, medical director of the Integris Bennett Fertility Institute agrees with legal experts' assessment about the misleading advertising.
"The ads were a bit misleading because, basically, they show that the medication is or imply that the medication is approved for any type of menstrual syndrome like PMS and for any case of acne," Reshef said.
The FDA even sent Bayer this warning letter in 2008, clearly stating that the TV ads were misleading, broadening the drug's indications, overstating the efficacy and minimizing serious risks. It says the ads misbrand the drug in violation of the Federal Food, Drug and Cosmetic Act.
In response to the FDA, Bayer made immediate marketing adjustments, and doctors have continued to prescribe Yaz now with Bayer's increased warnings to their patients.
Dr. Reshef says some women may not have any problems from taking it at all.
"The deaths from aspirin, combined with the deaths from penicillin, are clearly higher than the deaths from birth control pills, but obviously it's very difficult to sue the makers of penicillin or aspirin because those medication have been around for a long time," Reshef said.
He feels Yaz still has more benefits than risks. We contacted the manufacturer, Bayer, and although they have changed their advertisement, they're vigorously defending the overall safety of their product and the lawsuits. They issued this statement saying:
"Data confirm that the benefit-risk profiles for Yaz and Yasmin remain unchanged. We are convinced that Yaz and Yasmin are good choices for women seeking safe and effective contraception if they use the products as directed."
Bayer is currently supporting another independently conducted study in the United States and Europe. Results are expected in 2011, but for many women like Katie ...
"I did a bunch of research about it, read my whole pamphlet to see if there's anything in it about gall bladder, and obviously it wasn't there," she said.
They say all of this is coming too late.
The attorneys at Atkins and Markoff say Bayer has turned over millions of pages of documents. They're reviewing that paperwork as they prepare for the first trials to begin in September.
Some legal experts are anticipating 20,000 to 30,000 complaints to have come in by then.
They say a resolution could be two years down the road.
No more dangerous than asperin.
We Fenway fans, we stop and clap our hands, at Yaz’s jazz.
Blood clots and contraception risks have been known for 30 years.
Best Birth Control is DON’T HAVE SEX
I have never understood why women would take the pill. It changes your whole body chemistry. I even think breast cancer is a part of this whole thing. I never took it. Yes, you have to have some self control but there are other methods that don’t change your whole hormone system. It’s common sense! People think if a dr gives something to you, it’s safe. Well, not always!
I'm a biochemist, and I would say to avoid taking anything unless it's absolutely necessary to treat a diagnosed condition. This includes "natural" supplements as well as drugs (which in many cases are "natural" extracts, but they are standardized as far as dosage and effectiveness are concerned). It's amazing to me to see what people will put into their bodies just because it's "natural." Simply, if there isn't a compelling reason to take a pharmaceutically active drug or supplement, don't take it!
< /off soapbox >
It's amazing to me to see what people will put into their bodies ...
And what goes in, must also come out. What impact doe all of these drugs have on our water supply and ecosystem.
Woemn put sh!+ in their bodies they wouldn’t put in their compost piles. I don’t know if radioisotope decay products are any more dangerous than hormonal contraceptive effluents in the groundwater— and that’s the absolute truth.
Exactly. While there is an effort to create mass hysteria over a naturally occurring gas that also happens to be vital for life, real environmental problems like this are completely ignored. It drives me nuts.
A little bit of radiation never hurt anyone. Prolonged exposure to chemical cocktails--not to mention the accumulation of those drugs in the water and their effect on animals depending on that water, OTOH...
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