It’s the same question thousands of woman are asking after suffering serious health problems they say were caused by Yaz and Yasmine birth control pills. The pills are a unique formulation that combine a new hormone called ethinyl estradiol with the diuretic drospirenone. Bayer Healthcare, the company that produces the pills, claimed the formulation not only prevented unwanted pregnancies, but also helped curb symptoms of premenstrual dysphoric disorder (PMDD) and moderate acne.

However, experts say the diuretic causes an increase in potassium levels that can lead to blood clots, which puts women at an increased risk of heart attack, stroke, pulmonary embolism, deep vein thrombosis, and even death. More than 2,000 women have filed suit against Bayer claiming they were not adequately warned that taking Yaz or Yasmin put them at risk for serious and life threatening health problems.

“There are a bunch of people out there (who have fallen ill after taking Yaz),” Mollie writes. “Let’s hope we can find them and make other girls aware just how dangerous Yaz really is.”

SOURCE: Yaz Lawsuit › Yaz blood clot victim hopes to warn others

What doctors discovered on Rose’s arm was a 10-inch blood clot that stretched from the base of her upper arm to her chest. They say it was caused by Rose’s birth control pills. Large clots like Rose’s that form in the veins of the arms or legs are often caused by a condition known as deep vein thrombosis. If left untreated, the clots could break off and travel to the lungs, which can be fatal.

The standard treatment for blood clots is drugs known as blood thinners. However, there is no guarantee the clot will go away and there is always a risk of internal bleeding. In search of a more effective treatment, Portola Valley physician Dr. Thomas Fogarty invented the Trellis Peripheral Infusion System, designed to remove large clots in veins using balloons and blood thinners that are injected into the clot area.

Fogarty’s Trellis device was approved by the Food and Drug Administration (FDA) in 2005, and has since been used on patients at more than 600 hospitals nationwide. The process involves navigating a catheter through the vein and into the clot and then inflating a balloon on either side of the clot. Trapped between the balloons, the blood clot is then injected with a clot-dissolving drug. The clot usually breaks up within an hour and patients are usually able to go home within a day with little more than a centimeter-sized scar.

Rose turned out to be an ideal candidate for the procedure, and she said she is pleased the process went so smoothly. “My Trellis scar is one dot,” she said.

SOURCE: Yaz Lawsuit › Trellis device offers safer and more effective treatment for blood clots

Birth control pills increase a woman’s risk of life-threatening blood clots, a condition obese women are already at greater risk for than normal-weight women. Birth control pills with higher estrogen levels put women at even greater risk for developing blood clots, which can lead to deep vein thrombosis, pulmonary embolism, heart attack, stroke and even death. Thus, prescribing high-dose birth control pills to obese women can be dangerous.

The clinical trial involved 226 normal-weight or obese women who were randomly assigned to take pills with either a lower or higher estrogen dosage. All women underwent blood tests to determine if they were using the pills consistently. After three or four cycles, the women received multiple ultrasounds and blood tests to determine if their ovaries were making eggs. About 90 percent of normal-weight women and 72 percent of obese women had hormone levels that indicated consistent use.

Of the remaining 150 women who used the oral contraceptives regularly, three out of the 96 normal weight women conceived compared to one out of the 54 obese women, leading researchers to determine that obese women were just as protected against unwanted pregnancies while on the pill as normal-weight women.

This fall, the National Institutes of Health will convene a group of experts to investigate whether further research is necessary on obesity and oral contraceptives. Meanwhile, the Food and Drug Administration plans to hear evidence that a new emergency contraceptive pill is less effective in obese women.

SOURCE: Yaz Lawsuit › Study: Birth control pills just as effective for obese women

Despite a court order for the pharmaceutical company to hand over some 10 million pages of documents related to the oral contraceptive and the marketing for it, Bayer is playing hardball. The company is reportedly delivering the documents out of order or without attachments as it issues statements to the media that Yaz and Yasmin are no more dangerous than other birth control pills.

Yet, if that were the case, why did Bayer promote its oral contraceptives with flashy ads that, the Food and Drug Administration (FDA) says, overstated the benefits of the pills and downplayed the risks? The federal agency fined Bayer and ordered the drug company to launch a second campaign that more clearly stated the approved uses for the pills and the risks associated with them.

It seems every week there is another news story about a woman who has died or suffered severe health consequences associated with use of Yaz and Yasmin. That, coupled with the arrival of generic competition from drug maker Teva, has resulted in a 15 percent drop of Yaz sales. One can only wonder how much the legal settlements with Yaz/Yasmin victims will cost Bayer.

SOURCE: Yaz Lawsuit › Lawsuits against Yaz, Yasmin double to 2,000

Acne spurred by hormone changes usually occurs the week before the period and often springs up on the chin. “In that situation, you might prescribe a birth control pill along with their standard regimen,” Dr. Berson told Modern Medicine. Oral contraceptives shouldn’t be looked at as the lone cure-all for acne. “It is something that is given to prevent further breakouts. … You would still give it along with the traditional therapies, whether they are topical or oral.”

But birth control pills are not without risks. “Most of the side effects are due to the estrogen component,” Dr. Berson says, adding that the most common problems associated with the pill include nausea, headaches and breast swelling. But, she adds, “there is still potential for deep vein thrombosis and vascular events.”

Yaz (as well as Yasmin and the generic ocella) is one type of birth control pill that has been singled out for its indication for treating acne as well as taming the symptoms of premenstrual dysphoric disorder (PMDD). Because it has multiple indications, more prescriptions are written for Yaz in the United States than any other birth control pill. But, there have also been more lawsuits filed against Yaz from women who say they suffered serious health problems from the pill, including blood clots, heart attacks, strokes, deep vein thrombosis, pulmonary embolism and even gallbladder problems.

Women who have a history of blood clotting disorders, migraines, high blood pressure, smoking or heart disease should not take oral contraceptives because they are at greater risk for blood clots. But even women who had no prior health problems that would make them a bad candidate for the birth control pills still became ill after taking Yaz.

“You want to make sure that (women) understand the potential risks, such as blood clots,” Dr. Berson says.

SOURCE: Yaz Lawsuit › Should you use the pill to treat acne?

“Our goal is to evaluate objectively the risks and benefits of demedicalizing contraceptive care, with an eye toward improving access to OCs (oral contraceptives) and potentially other hormonal contraceptive methods by making them available without a prescription,” a statement from the nonprofit advocacy group reads.

The group says there is substantial literature available on oral contraceptives that show birth control pills meet most of the Food and Drug Administration’s criteria for OTC status. “The drug’s benefits outweigh the risk for women of reproductive age; the potential for misuse or abuse is low; a consumer can easily self-diagnose the condition for which the pills are indicated; and directions for use are straightforward.”

Birth control pills have a host of minor side effects including vision changes, breast tenderness, fluid retention, weight gain, acne, headaches, depression and anxiety. But women who use estrogen-containing birth control pills are at a 3- to 6-fold increased risk of developing blood clots. Blood clots may lead to deep vein thrombosis, heart attack or stroke.

Some studies suggest that different types of birth control pills can put women at an even greater risk of blood clots. Most notably is Bayer HealthCare’s blockbuster birth control pill Yaz, also known as Yasmin and by the generic ocella. Yaz is the top-selling birth control pill in the country, yet few women realize they are at risk of blood clots until it is too late. To date, more than 1,100 lawsuits have been filed against Bayer by women who allege they were not adequately warned by the drug company that taking Yaz put them at greater risk of serious injury.

Making oral contraceptives available OTC does have benefits. It will give women greater control over their birth control choices, and that could lead to easier access to higher rates of initiation, continuation and fewer gaps in use, thereby “potentially leading to an overall decrease in rates of unintended pregnancy and abortion,” the organization’s statement reads.

For now, the Working Group on Oral Contraceptives Over-the-Counter will carry out several activities, including research, engaging in public education and discussion, and building consensus on key issues. “We will initiate dialogue with professional medical organizations, host a meeting to gauge support for this issue among organizations representing diverse groups of women, and create informational materials on the safety of OCs.”

SOURCE: Yaz Lawsuit › Group advocates to make birth control pills available OTC

Dawn Varrechio

Like many women, Dawn was taking Yaz birth control pills, the most popular oral contraceptive in America. What she didn’t realize is that by taking Yaz she was putting herself at greater risk for life-threatening blood clots. Last year, two studies published in the British Medical Journal found women on Yaz to be at greater risk of developing blood clots than on other forms of birth control. Bayer HealthCare, makers of Yaz, sponsored two previous studies that discount those claims, arguing that Yaz doesn’t increase blood clot risk any more than other brands of birth control pills.

Yaz, also known by the brand name Yasmin and the generic Ocella, is the only birth control pill that contains drospirenone, a diuretic, and ethinyl estradiol. The pills were touted not only for pregnancy prevention but also for the treatment of severe acne and premenstrual dysphoric disorder, or PMDD. Yaz soared in popularity, becoming a blockbuster money maker for Bayer.

But as Bayer began collecting its profits, reports of serious injuries and deaths in women who took the drug began pouring in. Bayer now faces more than a thousand lawsuits from women who say Yaz caused them to suffer from health problems such as heart attacks, strokes, pulmonary embolisms, blood clots, deep vein thrombosis, and gallbladder disease.

Survivors can only hope their problems don’t return. “It’s scary,” said Dawn, who says she now worries about the long-term effects Yaz will have on her. “It’s really scary.”

SOURCE: Yaz Lawsuit › Woman worries about long-term effects of Yaz

Irina Shiryaeva

Blood clots are one of the most common causes of death in the United States, second only to cancer. Despite their prevalence, only six percent of Americans know the symptoms and risk factors of blood clots – including pulmonary embolism and deep vein thrombosis, or blood clots that commonly affect the leg veins.

According to the National Alliance for Thrombosis and Thrombophilia, there are many known causes for blood clots to form. Those factors include prolonged bed rest or inactivity, such as long plane rides. The lack of movement can cause reduced circulation in the legs. Most surgical procedures or physical trauma can also increase one’s risk. Other situations that increase one’s risk of blood clots includes pregnancy, oral contraceptives and hormone replacement therapy.

Estrogen does not cause blood clots, but it does dramatically increase a woman’s risk. Most birth control pills, which include an estrogen and progestin, increase a woman’s risk of blood clots by as much as three- to four-fold. About one woman out of 300 taking oral contraceptives will develop a blood clot. Women on birth control pills who have additional risk factors – such as taking a long-distance trip or flight – are at even greater risk of developing potentially life threatening blood clots.

While manufacturers of birth control pills and even birth control patches have warnings on their label of the increased risk of blood clots, many women who have been harmed by them say the warnings weren’t adequate enough. Several lawsuits have been filed against the makers of Yaz, Yasmin and its generic, Ocella; and Johnson & Johnson, maker of the Ortho Evra birth control patch, has paid millions to settle lawsuits from women who have suffered blood clots after using the patches.

Unfortunately, it’s too late for Irina, who leaves behind a husband and 3-year-old son.

Source: News Observer

SOURCE: Yaz Lawsuit › Birth control pills, long plane flights increase risk of blood clots

Yaz, and Bayer’s equivalent Yasmin, as well as the generic Ocella, are considered fourth-generation birth control pills. They contain a new type of synthetic progestin, drospirenone, that acts as a diuretic. The pills are promoted to not only prevent pregnancies but to also treat severe acne and premenstrual dysphoric disorder, or PMDD.

As of November, the Food and Drug Administration had received 993 reports of pulmonary embolism (blood clots in the lungs), 487 reports of deep vein thrombosis (blood clots in the deep veins), and 229 reports of other blood clots from birth control pills containing drospirenone.

Bayer stands by the safety of its blockbuster birth control pill, saying the pills carry the same health risk as any other type of oral contraceptive. However, two separate studies in the British Medical Journal claimed women were at as much as 6.3 times higher risk of developing blood clots when taking Yaz, Yasmin or Ocella. Recently, Bayer updated the labels of Yaz and Yasmin to include a risk of developing life-threatening blood clots.

SOURCE: Yaz Lawsuit › Yaz, Yasmin can be dangerous to your health

Bayer HealthCare

Yaz and Yasmin, as well as the generic Ocella, contain drospirenone, a diuretic that the plaintiffs claim elevated potassium in their bloodstream, which put them at greater risk for serious and sometimes fatal complications from blood clots, such as heart attack, pulmonary embolism, deep vein thrombosis and stroke. Diuretics can also cause significant problems with the gallbladder and may lead to gallbladder removal.

The lawsuits allege Bayer’s birth control pills put users at greater risk for serious adverse events; however, the company maintains that a woman’s risk of developing blood clots while taking Yaz or Yasmin is similar to other oral contraceptives.

Yaz and Yasmin were Bayer’s top-selling pharmaceutical last year, ringing in sales of $1.64 billion.

SOURCE: Yaz Lawsuit › Bayer adds new information about blood clot risk to Yaz, Yasmin labels

According to the Southeastern Texas Record, three east Texas women filed lawsuits against Merck & Co. Inc., alleging that they relied on misrepresentations of the device and as a result suffered injuries. All claim the manufacturers failed to warn them of the greater risk of venous thromboembolism, including deep vein thrombosis and pulmonary embolism.

The Nuvaring controversy is just another incident in which women claim that makers of contraceptives failed to adequately warn them of the increased risk of serious injury when using the birth control. Johnson & Johnson recently paid $68 million to settle thousands of cases against women who say they suffered from blood clots and other serious events after using the Ortho Evra birth control patch. As a result, the company no longer actively markets the patch.

Bayer Healthcare has found itself in a similar mess with its biggest money-maker, Yaz, a birth control pill also known by the brand name Yasmin. Plaintiffs claim the hormone-plus-diuretic formulation is more dangerous than other oral contraceptives, causing life-threatening blood clots and gallbladder problems.

SOURCE: Yaz Lawsuit › Lawsuits claim Nuvaring is just as dangerous as Ortho Evra patch, Yaz

Schwoob was one of two million Canadian women in 2009 prescribed Bayer Pharmaceutical’s blockbuster oral contraceptive Yasmin, according to TheSpec.com. Yasmin is also sold under the brand name Yaz and the generic brand ocella. Three months after starting on the meds, Schwoob suffered the chest pains. She says she was never warned that by taking Yasmin, she was at greater risk of suffering blood clots and other serious health problems. She is now a vocal representative of a class action lawsuit against Bayer filed by women, like her, who have been harmed by Yasmin. Bayer also faces hundreds of similar lawsuits in the United States.

Schwoob’s lawsuit claims Yasmin and Yaz carry a four times greater risk of deep vein thrombosis and pulmonary embolism compared to other contraceptives, yet the company failed to adequately warn the public of those risks. Bayer contests that notion, arguing that its birth control pills are safe and effective.

The class action lawsuit seeks damages of $500,000 for every woman who was prescribed Yasmin, as well as $20 million in punitive damages.

SOURCE: Yaz Lawsuit › Canadian women sue makers of Yasmin over health problems

Deep vein thrombosis (DVT)

DVT is a common disorder, but it is highly preventable, says Gary Raskob, Ph.D. and lead author of the AJPM Paper. “That’s why spreading the word about who’s at risk and the steps one can take to prevent these dangerous clots is so important,” he said.

The paper recommends strengthening surveillance of DVT and PE, and increasing public awareness of risk factors through a national campaign. For example, recent studies have identified that people who travel by airplane are at three times greater risk of developing DVT or PE. The campaign would advise air travelers to reduce their risk by staying active on the plane and staying hydrated by drinking plenty of water and avoiding alcoholic beverages.

Other risk factors include surgery or trauma, hospitalization for medical illness, cancer, obesity, smoking, pregnancy, age over 60, and a family history of blood clots. Oral contraceptives can also put users at greater risk of blood clots. To date, 59 deaths have been linked to the popular birth control pill, Yaz, also known as Yasmin or Ocella.

Symptoms of DVT include sudden pain, swelling and tenderness. PE symptoms include chest pain, shortness of breath, and sweating. For more information about these blood clotting disorders, visit the American Society of Hematology Web site at www.BloodTheVitalConnection.org.

SOURCE: Yaz Lawsuit › Medical community wants to raise awareness of preventable blood clots

Yaz incorporates a unique progestin, drospirenone, with ethinyl estradiol, a more common ingredient used in birth control drugs. Many women who have been injured after starting a Yaz regimen allege that the drug poses a multitude of serious risks, which Bayer downplayed in its Yaz marketing campaigns.

The U.S. Food and Drug Administration admonished Bayer in October 2008, citing the company for “significant deviations” in its promotion of Yaz. The complaint largely centered on the understatement of the drug’s risks and the overstatement of its benefits, including the treatment of conditions for which the drug was not approved. The misleading marketing campaign is frequently cited in lawsuits brought against Bayer by former Yaz users.

Some of the most serious side effects associated with Yaz include stroke, heart arrhythmia cardiac arrest, deep vein thrombosis and other forms of blood clotting, pulmonary embolism, gallbladder disease, kidney damage or failure, and sudden death.

Judge Herndon told Southwestern Illinois’ Belleville News-Democrat that he may also conduct bellwether trials, a cluster of cases selected because they reflect the charges and allegations of the other lawsuits. The outcome of bellwether trials helps establish guidelines for other cases.

When a significant number of similar lawsuits, such as those being brought against Bayer over Yaz injuries, accumulate in federal courts, the Judicial Panel on Multidistrict Litigation normally moves to consolidate them in one U.S. District Court to avoid redundant efforts and inconsistent pre-trial rulings. The dynamics of these representative trials will then be considered in the evaluation of other cases.

SOURCE: Yaz Lawsuit › Southern Illinois district court to handle Yaz lawsuits

The plaintiff, who resides in Belpre, Ohio, had been taking Yaz for about a year when she developed deep vein thrombosis in her leg. She spent three days in the hospital, where like many other women who use Yaz, she was put on a regimen of blood thinners to dissolve the clot and reduce the swelling in her leg.

Deep vein thrombosis (DVT) is a very serious type of blood clot that can lead to serious complications and death if not treated properly. Clots that form a DVT can become dislodged, traveling through the bloodstream to the lungs and causing a pulmonary embolism, resulting in permanent damage to the lung. DVT can also cause stroke, cardiac arrest, and other potentially deadly conditions.

Yaz contains drospirenone, a synthetic progestin used in Yaz, Yasmin, and Ocella, which is a generic form of Yasmin. Drospirenone has been shown to increase potassium levels in some women who take the drug, which can lead to DVT and affect the function of several organs, including the heart.

The Ohio plaintiff’s lawsuit was filed in New Jersey Superior Court. The suit alleges that the plaintiff’s injuries were the result of Bayer’s failure to adequately warn consumers of the drug’s risks. Her attorney claims that Bayer knew Yaz to be more dangerous than other birth-control pills, but chose to downplay the drug’s hazards.

SOURCE: Yaz Lawsuit › Ohio mother sues Bayer, alleging Yaz caused blood clot

Yaz

All of the lawsuits allege that Yaz and Yasmin caused adverse events attributable to the ingredient drospirenone (DRSP), which has been linked to blood clots, strokes, heart attacks, gall bladder disease, deep vein thrombosis, pulmonary embolism, and other serious reactions, including sudden death. The suits assert that Bayer knew about the risks but failed to disclose them to consumers while at the same time aggressively marketing the drug.

Last year, the U.S. Food and Drug Administration warned Bayer that its television advertisements for Yaz were misleading and failed to disclose all of the drug’s risks.

Traditional birth control drugs do not contain DRSP, which is a new type of progestin that influences the body’s natural ability to balance salt and water, which could adversely lead to elevated potassium levels. Excessive potassium levels in the body may trigger fatal cardiac arrhythmia and other serious health problems.

The FDA received more than 50 reports of deaths linked to Yaz and Yasmin between 2004 and 2008. The fatalities involved heart attacks, pulmonary embolisms, and strokes. Excessive blood potassium levels were found in many of the cases.

A U.S. Judicial Panel on Multidistrict Litigation has scheduled a hearing for September 24 to decide if the Yaz and Yasmin lawsuits currently pending in federal courts are similar enough to be consolidated into an MDL (multi-district litigation).

SOURCE: Yaz Lawsuit › Yaz lawsuits consolidated in Pennsylvania