The story lauded contraceptives for their preventative benefits: “Women on birth control see a 60 percent decreased risk of ovarian cancer. There is also a 50 percent reduction in uterine cancer which has 37,000 new cases each year.” Yet, the story fails to mention the serious risks associated with Yaz, a newer generation birth control pill that combines the hormones ethinyl estradiol and drospirenone, as well as other birth control pills.

All birth control pills carry a slight risk for blood clots. But new studies suggest that some pills, especially those containing drospirenone, may put women at even greater risk for developing the condition. Blood clots are serious health problems that can lead to heart attacks, strokes, and even sudden death.

Last month, based on new studies published in the British Medical Journal, the FDA and Health Canada announced they were reviewing studies on the health risks associated with Yaz, Yasmin (also made with ethinyl estradiol and drospirenone) and their generic equivalents. Early reviews of the studies comparing oral contraceptives containing drospirenone with pills containing another progestin, indicate that drospirenone-containing pills may put women at greater risk for blood clots.

Bayer, the makers of Yaz and Yasmin, have held firm on the message that their pills are no more dangerous than other oral contraceptives. However, the company was ordered by the FDA this summer to add stronger blood clot warnings on the safety labels of both Yaz and Yasmin. Bayer also faces about 2,000 lawsuits from injured women who allege that they were not properly warned by the company that the pills could be deadly.

Still think the benefits of an acne-free face outweigh the risk of life-altering blood clots?

Source: Style Bistro

SOURCE: Yaz Lawsuit › Are birth control pills for acne treatment a good idea?

Generic drugs are what the Food and Drug Administration calls “copies of brand name drugs that have exactly the same dose, intended use, side effects, route of administration, risks, safety, and strength as the original drug.” However, the generic version, by law, is not entirely the same. It may have different colors or inactive ingredients. About half of all generic drugs are produced in the same plants used to manufacture the brand name drugs.

Yaz contains 3mg drospirenone and 20 mcg of ethinyl estradiol. Bayer offers the same formulation in Beyaz, a birth control pill that also contains the B vitamin folic acid. Generic versions of Yaz made by other manufacturers include Gianvi and Loryna.

Yasmin contains 3mg drospirenone and 30 mcg of ethinyl estradiol. Bayer also offers a folic acid-fortified version of Yasmin known by the brand name Safyral. Bayer also offers a generic Yasmin by the name of Ocella. Syeda and Zarah are more generic brands of Yasmin sold by other companies.

While all birth control pills put women at risk for blood clots, new studies show that drospirenone-containing pills put women at even greater risk. This includes Yaz and Yasmin, but also the numerous generic brands. Using a generic version of a medication does not mean, if you have been injured, that you are not eligible for compensation.

However,  a recent Supreme Court ruling determined makers of generic drugs are not required to warn patients if they receive reports of new side effects from the drugs. This ruling can protect generic drug makers from being sued under state liability laws for failing to warn patients of these new dangers. If you have been injured by a generic drug, it is important to talk to your lawyer about how this ruling may affect your rights to justice.

Beasley Allen Law Firm is currently investigating cases of women who have suffered blood clots, heart attacks, strokes or gallbladder damage after using any drospirenone-containing birth control pill.

Source: WebMD

SOURCE: Yaz Lawsuit › Generic versions of Yaz, Yasmin just as dangerous as brand name pills

Cummins believes it was her daughter’s birth control pills, which she also took for the treatment of acne, that caused her death. She has filed suit against the Bayer Corp., makers of the birth control Yaz, and several of its divisions. The lawsuit was filed as part of a national class-action lawsuit against the makers of Yaz.

The lawsuit states that Bayer “knowingly and falsely represented that Yaz was fit to be used for the purpose for which they were intended, when in fact the drugs were defective and dangerous.” It alleges that Bayer and its partners concealed the dangers of their drugs, neglected to warn the public of those dangers, misrepresented the drugs and violated consumer protection laws.

All birth control pills carry warnings of blood clots on their safety labels, but studies show that the formulation of hormones in Yaz, drospirenone and ethinyl estradiol, puts users at even greater risk for blood clots, which can lead to pulmonary embolism, deep vein thrombosis, heart attack, stroke and sudden death.

Bayer has maintained that its popular oral contraceptive is no more dangerous than other birth control pills, and promises to fight the allegations. “Bayer will defend itself vigorously against these lawsuits,” the company said in a statement.

Source: The Times News

SOURCE: Yaz Lawsuit › Mother files lawsuit against Yaz on behalf of deceased daughter

A Swiss appeals court has recently rejected Bayer’s request to punish a Swiss television station that reported there were about 190 deaths associated with Yaz and Yasmin in the Food and Drug Administration (FDA) database of adverse reactions. The database includes both confirmed and unconfirmed drug reports, and Bayer argued that it was not a true indicator of how dangerous the drug really is.

Yet, thousands of lawsuits levied against Bayer by women and their family members injured or killed after using the pills speak otherwise.

All birth control pills carry a risk for blood clots, but lawsuits contend that Yaz and Yasmin, both of which contain the hormones ethinyl estradiol and drospirenone, put women at even greater risk for blood clots. The disorder can lead to heart attacks, strokes and sudden death. Some lawsuits allege that Yaz and Yasmin also can damage the gallbladder, requiring surgery. Bayer faces more than 2,000 lawsuits over injuries and deaths caused by Yaz and Yasmin.

Bayer remains unwavering in its defense of its popular oral contraceptives. While the pharmaceutical company can’t fight the claims made in the U.S., it recently took on Swiss TV, alleging that the station’s report on deaths associated with the pills were “manipulative” and by reporting the story the station breached its “statutory requirement of factual accuracy.” Bayer first lost a ruling in lower court and earlier this month lost an appeal to a Swiss federal court on the basis that while the news story contained critical viewpoints, those views were correctly identified as such.

SOURCE: Yaz Lawsuit › Bayer loses case to silence media reporting dangers of Yaz, Yasmin

Bayer

“Given the already large and robust scientific body of evidence, in Bayer’s opinion, these studies do not change the overall assessment about the safety of Bayer’s oral contraceptives,” the company said in a statement.

Yaz and Yasmin are considered “fourth generation” birth control pills and use the hormones ethinyl estradiol and drospirenone. Bayer heavily marketed the pills, even touting Yaz as a cure-all of sorts for bothersome PMS symptoms and acne. The Food and Drug Administration ordered Bayer to rerun the ads, toning down its PMS claims (the drug was approved to also help ease symptoms of the more serious premenstrual dysphoric disorder, PMDD, but not PMS) and specifically outlining the risks associated with the pills, including the risk for life threatening blood clots.

Bayer has since been slapped with lawsuits from women and their families who have suffered from blood clots, heart attacks, strokes, gallbladder damage, and even death after using the pills. Bayer has long argued that Yaz and Yasmin are no more dangerous than other birth control pills.

All oral contraceptives carry a risk for blood clots, and lawsuits have maintained that Bayer’s pills put women at even greater risk. Previous studies that suggested as much were dismissed by Bayer. But two new studies back up plaintiffs’ claims, showing women who took contraceptives with drospirenone had more than twice the risk of developing blood clots than women on a hormone used in older generation pills, levonorgestrel.

Bayer still refuses to accept the blame. According to its statement, “Bayer’s assessment, (of the studies) based on its review to date, is that the manner in which the authors applied the study methodology reported in these two publications show significant flaws and the databases used provide less reliable conclusions than are available from existing scientific evidence around the risk of developing venous thromboembolism (VTE), or blood clots, with combination oral contraceptives (COCs).”

SOURCE: Yaz Lawsuit › Bayer dismisses new studies showing higher blood clot risk with Yaz, Yasmin

Bayer

Levonorgestrel is a progestogen that is used in both combination hormone pills and progestogen-only formulations. It is known by the brand names Escapelle, Plan B, Levonelle, NorLevo, Postinor-2, i-pill, Next Choice, and 72-HOURS. It is also the active ingredient in the Mirena-brand intrauterine device (IUD).

Blood clots have always been a risk factor with birth control pills, but mounting lawsuits against Bayer argue that Bayer’s formulation of drospirenone and ethinyl estradiol in Yaz and Yasmin puts women at greater risk. The same formulation of hormones is also in the generic oral contraceptive Ocella, as well as Bayer’s newly introduced folic acid-fortified pills Bayaz and Safyral.

Researchers from the Boston Collaborative Drug Surveillance Program at Boston University School of Medicine studied about 900 women on birth control since 2002. The blood clot risk for women taking Yaz or Yasmin was 30.8 per 100,000 person-years. Women on pills containing levonorgestrel had a rate of only 12.5 per 100,000 person-years.

Most alarming, researchers also found that women younger than 30 who used Yaz or Yasmin were at even greater risk for blood clots than women on second-generation pills. These young women had an incidence rate of 24.8 per 100,000 compared to only 5.39 per 100,000 if they took pills containing levonorgestrel.

SOURCE: Yaz Lawsuit › Young women at even greater risk for blood clots with Yaz, Yasmin

Drospirenone is a hormone that works like a diuretic. It is used in combination with another hormone, ethinyl estradiol, in Bayer HealthCare’s Yaz and Yasmin. Bayer recently released Beyaz and Safyral, two more birth control pills identical to Yaz and Yasmin, respectively, but with added folate. There are also generic versions of Yaz and Yasmin available, such as Ocella.

Diuretics can cause significant problems with the gallbladder that in some cases can lead to gallbladder removal. Some studies suggest that drospirenone can also increase potassium levels in the blood and lead to hyperkalemia, a condition which causes heart rhythm disturbances that can cause blood clots and lead to sudden cardiac death, heart attacks, or strokes.

Bayer has long fought allegations that its popular birth control pills can put women’s lives at risk, but with more than 2,000 lawsuits filed against the company from women who say they were harmed by the pills, Bayer’s defense looks weak.

The new study was funded by the Fonds de la recherché en sante du Quebec, a government-financed research agency, and is in the current issue of the Canadian Medical Association Journal.

SOURCE: Yaz Lawsuit › Yaz, Yasmin puts women at greater risk for gallbladder damage

The data involved more than 3 million women from 2002 to 2009. The women ranged in age from 13 to 33 with at least six months of enrollment in insurance and prescription drug coverage. The study found that 18 percent of teenage girls ages 13 to 18 filled prescriptions for birth control pills in 2009, up year after year since 2002. This was a 50 percent increase among commercially insured teenagers and a 29 percent increase among teenagers on Medicaid. The No. 1 choice in birth control pills among teenaged women was Yaz.

When Yaz was first approved for marketing in the United States it was touted as more than for pregnancy prevention. Bayer’s ads said the oral contraceptive could quell irritability caused by premenstrual syndrome (PMS) and manage breakouts of acne. It wasn’t long before women began asking for the pill by name, and it became the top selling birth control pill in America.

But the Food and Drug Administration (FDA) soon caught wind of those ads, and ordered Bayer to run a series of commercials to clarify that the pill was not approved for PMS, but for the more serious premenstrual dysphoric disorder, or PMDD. Bayer was also told to clearly state the risks associated with the drug, including the risk for blood clots, heart attacks, strokes and gallbladder damage.

While all birth control pills carry a risk for blood clots, studies began to suggest that Yaz, a combination of ethinyl estradiol and drospirenone, put women at an even greater risk for the serious side effects. As a result, thousands of women and their loved ones have filed lawsuits against Bayer arguing they were not warned of the dangerous and life-threatening risks associated with Yaz.

SOURCE: Yaz Lawsuit › Yaz is most popular birth control pill among teenagers

Yasmin is part of Bayer’s “four sisters” of oral contraceptives that include Yaz and Yasmin as well as the recently introduced folic acid-fortified pills Beyaz and Safyral. All four use a combination of the hormones ethinyl estradiol and drospirenone. The pills brought in more than $1.5 billion, a 13 percent drop from 2009.

Yaz was approved by the Food and Drug Administration (FDA) in 2006, and was marketed as a new kind of birth control pill that not only prevented pregnancy but also tackled PMS symptoms such as irritability and helped clear up acne. The marketing campaign launched Yaz into the best-seller category among birth control pills, with many women asking their doctors for it by name.

The FDA soon penalized Bayer for running ads that overstated the drug’s benefits and downplayed the serious risks, including the risk of blood clots, heart attack and strokes. The FDA also ordered the drug company to run a series of clarification ads.

Soon after, Bayer was hit with thousands of lawsuits from women who claim they suffered serious health problems from the pills and that Bayer knew the risks but did not adequately warn consumers.

The bad press surrounding Yaz and Yasmin have contributed to the drugs’ lagging sales over the past year, which may explain why the company is fighting generic competition that would devour more of its waning profits.

SOURCE: Yaz Lawsuit › UK blocks sales of generic Yasmin

Most women who become pregnant are typically tested for gestational diabetes by their obstetricians. It is caused by high blood sugar (glucose) levels. Most women with gestational diabetes are able to control their blood sugar and avoid harm to themselves or their baby. Once the baby is delivered, the mother’s blood sugar usually goes back to normal. But these women are at risk for developing type 2 diabetes within five to 10 years of delivery. The new study suggests these women are at an even greater risk if they take the mini pill following pregnancy.

On a more positive note, another recent study found that women on mini-pills are at no greater risk for developing heart disease compared to women who were not taking oral contraceptives. The mini pills are also less likely to cause blood clots than the traditional estrogen-plus-progestin pills.

Some studies suggest that specific types of combination birth control pills, such as Yaz, which combines ethinyl estradiol and drospirenone, put women at an even greater risk for blood clots. To date, more than 2,000 lawsuits have been filed against Bayer, the makers of Yaz, from women who say they suffered heart attacks, strokes, blood clots and even gallbladder damage after taking Yaz.

SOURCE: Yaz Lawsuit › Mini pills may increase chances of developing type 2 diabetes

Generic drugs must still be approved by the FDA but the process is different than with brand-name medications. Emoquette was approved through the agency’s abbreviated new drug application process, which requires drug makers prove their drug is comparable to an approved medication in dosage, route of administration, quality, performance and intended use.

Drugs are not allowed to be marketed and sold in the United States without FDA approval. This process requires proof from clinical trials the medication is both safe and effective. But the FDA’s seal doesn’t guarantee there will be no problems.

In the early 2000s, the FDA approved Bayer’s Yaz birth control pills. The pills combined the hormones ethinyl estradiol and drospirenone, which also works as a diuretic. Bayer launched a massive marketing campaign that sent sales of Yaz skyrocketing.

It wasn’t long, however, before reports of blood clots, heart attacks, and strokes in young women taking Yaz began to surface. While oral contraceptives carry a risk for blood clots, the problem seemed to more often affect women taking Yaz. As lawsuits against Bayer began to mount, the pharmaceutical company responded by seeking – and obtaining – FDA approval for three more birth control pills with the same hormone combination as Yaz – Yasmin, Beyaz and Safyral.

SOURCE: Yaz Lawsuit › FDA approves generic birth control pill

Two years later her doctor made a connection. Lana had been taking Yaz or Yasmin birth control pills for seven years, since 2001. The pills have been linked to gallbladder damage, yet Lana says she was never warned of those risks by the pills’ manufacturer, Bayer Corp. Lana is now one of more than 2,000 women who have filed lawsuits against Bayer. The plaintiffs claim that Bayer was fully aware of the risks associated with use of the pills, yet the company did nothing to warn users.

Yaz and Yasmin are known as fourth generation birth control pills. They contain the hormones ethinyl estradiol and drospirenone. Drospirenone also works as a diuretic, which can cause an increase in potassium levels in the blood and lead to hyperkalemia, which can cause heart rhythm abnormalities that can cause life threatening blood clots.

Lana is no longer taking the pills, but she still experiences problems and was diagnosed with post-cholecystectomy syndrome. The condition causes persistent pain I the upper right abdomen, nausea, vomiting, gas, bloating and diarrhea. Symptoms of the syndrome occur in about 5 to 40 percent of patients who undergo cholecystectomy.

Lana’s lawsuit seeks unspecified damages. The case has been assigned to Galveston County Court in Texas.

SOURCE: Yaz Lawsuit › Woman blames gallbladder problems on Yaz, Yasmin

The study is the first to provide a comprehensive review of diagnosing, imaging and treating CVT. Researchers found that CVT disproportionately affects pregnant women or women taking birth control pills, as well as people 45 years of age and younger. Oral contraceptives put women at an even greater risk, and researchers recommend that patients with suspected CVT undergo blood tests to determine if they have an inherited or acquired factor in the blood that predisposes them to blood clots.

The safety labels of all birth control pills warn users of a risk for blood clots. However, studies suggest that some birth control pills put users at an even greater risk. Yaz and Yasmin are a type of “fourth generation” birth control pill that combines the hormones ethinyl estradiol and drospirenone. Propelled by pricy marketing campaigns, the pills quickly became the most popular type of oral contraceptive in the country, with many women asking their doctors for the pills by name.

Since the pills were introduced, the Food and Drug Administration (FDA) has received hundreds of reports of women who have been seriously injured while using Yaz and Yasmin. Problems include blood clots, heart attacks, strokes and even gallbladder damage. Bayer HealthCare, makers of Yaz and Yasmin, now face thousands of lawsuits from women claiming they were not adequately warned that using the pills could put their lives in danger.

SOURCE: Yaz Lawsuit › Birth control pills can cause rare form of stroke

Yaz is considered a fourth-generation birth control pill and contains a combination of hormones known as ethinyl estradiol and drospirenone. Drospirenone also works as a diuretic.

Since Bayer Healthcare introduced Yaz to the market in the early 2000s, the company has launched three other birth control bills with similar formulations. The pills have become a favorite among young American and Canadian women, thanks to a massive marketing campaign claiming the pills help fight the symptoms of premenstrual syndrome and clear up acne.

The ads also effectively downplayed the serious side effects associated with the drug, which include blood clots, pulmonary embolism, deep vein thrombosis, heart attack, stroke and gallbladder damage. Soon after the commercials hit the airwaves, the Food and Drug Administration (FDA) ordered Bayer to rerun ads clearly stating the serious side effects that the drugs could cause.

Some experts question the use of drospirenone in the pills, claiming the diuretic can cause a condition that leads to irregular heart rhythms. Those arrhythmias can cause serious health problems, including blood clots, heart attacks and strokes.

The revision ads from Bayer came too late for thousands of women, including Amie and Lauren. Both women have joined the more than 2,000 other women who claim they were injured by Yaz and filed a lawsuit against Bayer.

SOURCE: Yaz Lawsuit › Deceptive ads lead to two more lawsuits against makers of Yaz

Oral contraceptives marketed today that contain ethinyl estradiol and drospirenone in varying doses as their major ingredients include Bayer HealthCare’s Yaz, Yasmin, Yasminelle, Beyaz and Safyral; Teva Pharamaceutical’s generic Gianvi; and the generic ocella. The fourth-generation pills have grown to become one of the most prescribed birth control pills in the country.

What makes these pills work differently is drospirenone. The compound is different from other synthetic progestins in that it appears to be closer to the natural progesterone. Because of this, drospirenone may lead to less water retention and breast tenderness and could help reduce acne. But it also means that the drug may cause an increase in potassium levels which can potentially cause hyperkalemia, a serious condition that may result in death. Thus, the pills are not recommended in patients with hepatic dysfunction, renal insufficiency, or adrenal insufficiency.

Drospirenone-containing pills also carry a risk for blood clots, and it is not recommended for use in patients who are smokers, or have a history of deep vein thrombosis, stroke or other blood clots.

Since the pills became available, more than 4,000 lawsuits have been filed against the makers of the pills alleging that the ethinyl estradiol/drospirenone formulation oral contraceptives put them at greater risk for serious injury and death.

SOURCE: Yaz Lawsuit › Ethinyl estradiol + drospirenone – a deadly combination?

Yaz was marketed heavily across the globe, making it one of the best selling birth control pills and earning it more than $600 in sales in 2008. It is a combination of the hormones drospirenone and ethinyl estradiol. Drospirenone also works as a diuretic. Yaz is also touted as a treatment for acne and PMDD.

Bayer also sells Yasmin, a birth control pill with the same combined hormones but in different doses.

In 2010, Bayer also launched two other oral contraceptives with the same formulation but with added folic acid, known by the brand names Beyaz and Safyral. All four pills are considered to have the same side effects.

Despite the mounting lawsuits, Bayer stands by its defense that Yaz and its sister pills are no more dangerous than other birth control pills. The women who have filed lawsuits against Bayer say that the notion that Yaz is safe is simply a hard pill to swallow.

SOURCE: Yaz Lawsuit › Blood clots a serious side effect of Yaz birth control pills

Researchers collected data by studying a group of rhesus macaque monkeys at the OHSU Oregon National Primate Research Center for eight months. The specific breed of monkeys were used because their reproductive system is nearly identical to humans’. But unlike studies involving humans, the variables in the monkey studies could be controlled and measured, such as exact food consumed.

At the beginning of the study, half the monkeys were obese and half were of normal weight. During the treatment period, the monkeys received doses of oral contraceptives, which were adjusted according to the animals’ weight so that the effects would match those of humans. Weight, food intake, activity levels, body fat and lean muscle mass were all recorded. At the end of the study, the monkeys of normal weight maintained a stable weight, whereas the obese monkeys lost a significant amount of weight and body fat due to an increase in basal metabolic rate.

While the news is encouraging, women who choose to take birth control pills should heed warnings of serious side effects. All birth control pills carry a risk for blood clots, but some studies suggest pills that combine the hormones ethinyl estradiol and drospirenone can put users at even greater risk of blood clots. Brand-name pills with this formulation of hormones include Yaz, Yasmin, Bayaz, and Sayfral.

SOURCE: Yaz Lawsuit › Birth control pills do not cause weight gain, but can cause blood clots

Bayer faces more than 3,000 lawsuits claiming the company’s blockbuster birth control pills caused serious side effects, including strokes, heart attacks, gallbladder problems and even death.

In August, Bayer filed a protective injunction to keep plaintiffs from looking into the company’s marketing strategies for Natazia, a new birth control pill by Bayer that combines the same diuretic as in Yaz and Yasmin, drospirenone, with a different hormone, ethinyl estradiol. Plaintiffs’ attorneys fired back with a motion to include the redaction rules and remove the protective order for Natazia. Herndon changed the redaction rule, finding that the information about other drugs could lead to discovery of admissible evidence.

“From the exhibits counsel demonstrated in open court, it was clear that the redaction complained of made the production virtually useless in too many instances,” Herndon wrote. A status conference is planned for Oct. 12.

SOURCE: Yaz Lawsuit › Ruling prevents Bayer from editing documents in Yaz lawsuits

Watson Pharmaceuticals

Like Yasmin, Zarah is a combination of the diuretic drospirenone and the hormone ethinyl estradiol. While all birth control pills carry risks of blood clots and other serious injuries, some studies suggest that Yasmin and its sister contraceptive, Bayer’s Yaz, carry a greater risk than other pills. To date, more than 2,000 lawsuits have been filed against Bayer from women who claim they were harmed but not adequately warned by the drug company that by taking the pills they would be at greater risk of life threatening blood clots, strokes, heart attacks and even gallbladder problems.

The lawsuits don’t seem to sway drug makers from moving forward with generic versions of Yaz and Yasmin. Watson, too, is facing a lawsuit from Bayer, which claims  Zarah infringes on Bayer’s patent for Yasmin. The case is currently pending in the U.S. District Court for the Southern District of New York. Despite the lawsuit, Watson has begun shipping Zarah for distribution.

SOURCE: Yaz Lawsuit › Watson receives FDA approval for Zarah, generic version of Yasmin

Bayer cleverly launched Yaz in 2006, promising that the new formulation birth control pill – a combination of ethinyl estradiol and drospirenone – not only prevented pregnancy but also helped treat premenstrual symptoms and acne. Women began to ask their doctors for the pill by name, skyrocketing sales. Soon after, a review by the Food and Drug Administration (FDA) found the ads for Yaz to be misleading. The agency accused Bayer of over-stating the drug’s benefits and covering up its risks, and ordered the company to run correction ads. But the new formulation of active ingredients offered by Yaz had already hit superstar status among women.

Gradually, however, reports of women suffering sometimes fatal blood clots and other serious health problems began to surface. Bayer is now facing more than 2,000 lawsuits from women who allege they were not adequately warned that Yaz could cause them serious harm.

Rising out of the flurry of lawsuits, Bayer seems determined not to lose ground in all the bad press from Yaz. It is launching Natazia. This pill contains a new type of estrogen that has never been used before in an oral contraceptive. It hits the market with a Black Box Warning on its safety label, informing that women with a high risk of arterial or venous thrombotic diseases, undiagnosed abnormal genital bleeding, breast cancer or other estrogen- or progestin-sensitive cancer, liver tumors (benign or malignant) or liver disease, or who are pregnant, not to take Natazia. For women who don’t fall under any of the risk categories, is Natazia worth trying?

National Public Radio this week responded to the news of Natazia this way: “It’s a good time to look at the Yaz saga and see if it has anything to teach women and their doctors when they choose a contraceptive.” Indeed. The moral of this story: Beware of the latest and greatest drugs unless there’s some reason that the ones that have been around for a while don’t work for you.

SOURCE: Yaz Lawsuit › Bayer launches new birth control pill amid a flurry of Yaz lawsuits

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

The biggest disappointment on Bayer’s books was a 10.2 percent decrease in profits from sales of its blockbuster oral contraceptive, Yaz, also known as Yasmin and Yasminelle. Sales of the birth control pill, which combines drospirenone and ethinyl estradiol, have suffered in the U.S., according to Bayer, because “the discussion surrounding the thrombosis risk of contraceptives containing drospirenone.” Bayer says that it continues to believe that the risk profile is comparable to that of other combinations and “Yaz and Yasmin remain good choices for contraception when used as directed.”

Bayer is facing hundreds of lawsuits in the U.S. and beyond, claiming the company didn’t adequately warn consumers of an increased risk of serious health problems including stroke, heart attack, gallbladder problems and blood clots associated with Yaz.

As a result of the company’s weak pharmaceutical line, Bayer has lowered its sales guidance for the health care unit for 2010 to 3 percent from 5 percent. According to Bayer chairman Werner Wenning, “we are optimistic about the future and intend to build on the positive developments prior to 2009.”

SOURCE: Yaz Lawsuit › Bayer’s drug sales suffer due to bad press on Yaz blood clot risk

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