The Problem with The Pill?

25 May

By Executive Producer Dave Manoucheri
SACRAMENTO (CBS13) ―

It’s one of the most popular birth control pills on the market and some believe it’s dangerous. Millions of women are taking the birth control Yaz every day. However, there’s a growing list of lawsuits claiming the side effects can be deadly.

Susan Galinis is one of those people. Susan’s life centers around her husband and her children. So much so that she arranged her work schedule to maximize her time with them.

“So I wouldn’t miss time with my kids I’d get up at three in the morning,” says Susan. That’s when she’d go to work saving animals at the Silicon Valley Humane Society.

“[We'd] do 40 surgeries in a day. . . come home by noon,” Susan said. Those afternoons were spent with her three-year-old twins, taking them out to the park, or even the theme park.

June 8th, 2008, was the last normal day she spent with her family. It was a day spent at Great America, a theme park. She didn’t know her world was about to turn upside down.

“Came home, went to bed, woke up with the worst headache,” says Susan. “Next thing I know, I’m waking up in the hospital paralyzed on my left side.”

Susan suffered a severe stroke. As doctors rushed to remove a blood clot in her neck they had to drill a hole in her head to relieve the growing pressure on her brain.

Susan had taken birth control for years, but her doctor had just prescribed a new pill one month earlier: Yaz.

The new pill is marketed as helping to keep skin clear and control acne. In the TV ads, shots of balloons touting the benefits and information for the drug float by the screen while women saying they’re on the drug talk about the new pill.

“There’s one pill that goes beyond the rest — it’s Yaz,” says the commercial, adding “it also helps keep skin clear…”

“I heard it on the commercial,” says Susan, “how it would clear up acne, so I was surprised they were giving it to me. It was a new drug and they’re expensive, so, ‘yay for me’,” says Susan, remembering her satisfaction with being given the drug. Now, however, she says she’d take that back.

Susan has spent the last two years learning to walk again and learning to move her left arm. Still, she has no short-term memory and can barely read.

“I feel like a different person, a person I don’t really like,” Susan says. “I like my old self,” Susan says, breaking down during our interview. As tears filled her eyes, she added “Yaz took that.”

Susan has now joined 1,100 women nationwide suing Bayer Pharmaceuticals, the maker of Yaz and Yasmin. These women claim multiple maladies, including stroke, pulmonary embolism, heart attack, kidney failure, pancreatitis, and gall bladder disease. One attorney told our sister station in Boston, WBZ-TV, that as many as 50 women have died as a result of taking Yaz.

The pills are made with a synthetic hormone called “Drospirenone”. Susan’s attorney says Bayer did not adequately warn women of its dangerous side-effects.

“All birth control pills pose risks,” says Susan’s attorney, Mike Danko. “In fact the manufacturers warn of those risks but what Bayer isn’t telling us is the risks associated with Yaz are much greater than the risks associated with other birth control pills.”

Last year, two studies in the British Medical Journal showed women on Yaz do have a greater risk of developing blood clots. But two studies paid for by Bayer show that risk is the same as with any other birth control pill.

The discrepancy bothers OB-GYN Doctor Kristen Eckler, who says “I think the studies out there are concerning.”

Bayer insists the product is safe. They sent us this statement, saying “Bayer stands behind the safety of its oral contraceptives, which are safe and effective when used as directed and according to product labeling and good clinical practice.”

Dr. Eckler agrees that most women do fine on Yaz.

“While it may be a somewhat higher risk of causing blood clot[s] than its predecessors,” says Eckler, “that difference or that amount of change is very, very small.”

Still, Susan says those odds didn’t work out for her.

“It feels like your hand is stuck in a freezer,” says Susan, describing what she feels daily in her hand, losing some sensation due to the stroke. “It’s so cold that it burns.”

Susan still has chronic pain in her arm, constant headaches, and the relationship with her kids and husband has dramatically changed.

“They identify me as two different mommies,” Susan says of her children. “What the doctor said basically is that to them I really did die and that he has a new wife and they have to get used to me again as a different person.”

While Susan can’t get her old life back, she says she can warn women not to risk their lives.

“You are taking a huge risk and it’s not worth it if you lose,” Susan says. I’m very fortunate, I lived. There are a lot of people who haven’t.”

Mike Danko now represents more than 300 women in this growing lawsuit. Susan was his first client. With hundreds of other women around the country, represented by other attorneys, Mr. Danko believes when he finally goes to trial in a year or two there could be as many as 25,000 women.

Women Safe On Birth Control Pill Yaz? Bayer says, “Yes.” Independent Studies Demonstrate the Answer is: NO

6 May

 

Millions of women take birth control pills every day, and all of these medications carry a small risk of serious health complications. 

But some women believe the most widely prescribed pill on the market is more dangerous than the rest.

Leanne Letendre is like any other mom, greeting her kids after school and helping with homework.

But a year ago, those simple chores were more than she could manage. 

“I couldn’t even make it up a flight of stairs.  I had to go up three stairs, stop and then finish,” she said.  “I was so sick, I couldn’t even think.”

TICKING TIME BOMB

Doctors discovered the Hudson, New Hampshire mom had been living with a ticking time bomb inside her lungs; blood clots, dozens of them. 

“They were just everywhere,” she said.  “It was shocking because blood clots can kill you.”

Doctors told Letendre they believe the clots were caused by Yaz, the latest generation of birth control pills made with a new, synthetic hormone. 

Letendre thought she was just one of the rare, unlucky few but it didn’t take long to find dozens of women with similar stories online.

LAWSUITS

More than 1,000 lawsuits have been filed against Bayer, the maker of Yaz and Yasmin, a similar pill.  

The suits claim Bayer did not adequately warn women of the dangerous side effects.  

One attorney claims as many as 50 women died as a result of taking Yaz.

So is Yaz riskier than other birth control pills?

CONFLICTING STUDIES

“That’s a question under great debate right now,” explained Massachusetts General Hospital OB/GYN Dr. Kristen Eckler.   

There have been conflicting studies on the safety of the drug. 

Last year, two studies published in the British Medical Journal found women on Yaz do, in fact, have a higher risk of developing potentially deadly blood clots. 

Two other studies, conducted by Bayer, said the risk is similar to other birth control pills. 

It’s a discrepancy that doesn’t sit well with Dr. Eckler. 

“The studies are concerning,” she said.

Bayer continues to stand by the safety of its product. 

In a statement the company said, “We are convinced that Yaz and Yasmin are good choices for women seeking safe and effective contraception if they use the products as directed.”

“MOST WILL BE FINE”

Dr. Eckler agrees that most women do fine on Yaz. 

“So while it may be a somewhat higher risk of causing blood clot than its predecessors, that difference or that amount of chance is still very, very small,” she explained. 

Dr. Eckler also pointed out that pregnancy carries a much higher risk of developing a blood clot than being on Yaz or any birth control pill.

For Letendre, it’s a lottery she didn’t want to win. 

ONE WOMAN’S BATTLE

She still has blood clots in her lungs, shortness of breath, and she has to take powerful blood thinners.  

Those drugs raise her risk of bleeding, so she has to be really careful about hurting herself. 

She says she used to love to roller skate with the kids, but now she’s worried about falling and getting cut or bruised. 

“It limits the activities I can do with my children,” she said. 

Doctors have also told Letendre there’s a chance she could have to stay on the blood thinners for the rest of her life.

Letendre knows she’s lucky to be alive, but she can’t help thinking “what if.”

“I’m very, very angry because I might not ever be 100 percent, and it could have been avoided,” she said.

Bayer is conducting a new study on Yaz and the results are expected sometime next year.

(© MMX, CBS Broadcasting Inc. All Rights Reserved.)

Indiana Women Target Bayer

18 Feb

As reported by Bruce Smith @ IndyStar last week (click here for full story), over 50 women have filed lawsuits in Indianapolis against Bayer, alleging that its birth control drugs Yasmin and Yaz caused them serious injuries, including strokes, heart attacks, gallbladder problems and DVT.  These follow hundreds of similar lawsuits filed across the country.

Yasmin, which has been marketed since 2001, and Yaz, since 2006, contain “fourth generation” steroidal formulations for oral contraceptives. They contain drospirenone, which the suits claim may lead to very high levels of potassium.

That medical condition, or hyperkalemia, may cause arterial blood clots, gallbladder disease, pancreatitis, liver and kidney failure, rapid heartbeat, arrhythmias and other conditions, including death, according to the suits.

Injuries specifically suffered amongst these women included blood clots, pulmonary embolisms in their legs or lungs, removal of gallbladders, and strokes.

Bayer officials said they are gathering information about the lawsuits.

According to a statement from company spokeswoman Rose Talarie, “Bayer’s oral contraceptives are safe and effective when used according to product labeling.”

We at YazAwareness obviously disagree with that sentiment.  What do you think?

Over 25,000 Yaz lawsuits headed to St. Louis court

11 Jan

The federal courthouse in East St. Louis will see some extra lawyer traffic after a panel assigned lawsuits against a huge pharmaceutical company here.

U.S. District Chief Judge David Herndon will handle the pre-trial proceedings in lawsuits filed against Bayer Corp., makers of the contraceptive pill, Yaz.

The suits, which could number as many as 25,000, are filed all over the country but will be handled by Herndon as part of the largest multidistrict litigation ever assigned to the district.

Herndon will preside over discovery in those cases, he said, and may later conduct “bellwether” trials that will serve as examples for other trials around the country.

“These trials will serve as a guideline for other cases,” Herndon said. “There will be a variety of dynamics which will be taken into account in the evaluation of cases.”

The Judicial Panel on Multidistrict Litigation in Washington, D.C., determines whether civil cases filed in different federal districts involving common facts should be transferred to one district to avoid duplication in fact-finding efforts and inconsistent pretrial rulings.

The panel is composed of seven federal judges who are appointed by U.S. Supreme Court Chief Justice John Roberts.
When the Judicial Panel on Multidistrict Litigation handed the cases to Herndon in October, there were 40 or 50 cases filed in the district, the judge said.

The panel considers whether the forum is centrally located for all plaintiffs, whether the judge and court clerk has experience in handling multidistrict cases and the agreement of a majority of lawyers handling the cases when deciding where to send a multidistrict case, Herndon said.

Herndon handled a case against telephone company MCI that resulted in an $88 million settlement. Plaintiffs accused MCI of charging subscribers a higher rate for direct-dialed long distance calls.

The birth control pill Yaz combines ethinyl estradiol, an ingredient commonly used in oral contraceptives, and dropspirenone, a new type of progestin that is not used in other birth control pills in the country. Plaintiffs allege that the drug, that goes under Yaz and Yasmin, causes women to suffer strokes, heart attacks, pulmonary embolism, thrombosis, cardiac arrhythmia, gallbladder disease, kidney failure and sudden death.

Bayer will defend itself vigorously against these lawsuits, according to a Bayer’s statement released to the News-Democrat on Saturday.  ”Bayer’s oral contraceptives are safe and effective when used according to product labeling. Health care professionals prescribe oral contraceptives following a comprehensive evaluation of the risks and benefits for the individual woman,” stated the release.

Herndon said Friday he hired a law clerk to help manage the cases. He said the clerk’s office will also hire a clerk to help with the increased caseload.  The Yaz case could spend more than two years on Herndon’s docket.

Source: http://www.bnd.com/179/story/1082686.html?storylink=omni_popular

A Yaz Blood Clot Experience.

20 Dec

YazAwareness.com would like to bring attention to the experiences of a young college student (Caitlyn), who has had to deal with the terrible side effects of Yaz. The full post is available at her blog. We send her our best wishes.

On January 2nd, I woke up at 4:30 in the morning with a searing pain in my left lung and back. It felt like two cinderblocks were pushing on either side of me and every breath felt like a knife going through my lung. I have a low pain tolerance, but this was the worst pain I’ve ever felt in my entire life. I managed to walk to my parents’ room to wake them up as I was gasping for air. My mom helped me back into my room while my dad furiously researched the new medication my dermatologist put me on, convinced it was a side effect. I eventually fell back asleep, but when I woke up again I was greeted by pain that was even worse than before. My mom came in to check on me, and I told her I needed to go to the hospital.

In the emergency room, one of the doctors listened to my symptoms and said “I think you may have a blood clot in your lung.” What? A blood clot? In an 18-year old? [Read the rest at CollegeCandy.com]

Source: http://collegecandy.com/2009/01/26/birth-control-has-side-effects-i-should-know/