Thursday, August 15, 2013

Yaz and Yasmin: An Unacceptable Level of Risk?

Don’t feel bad if you missed last week’s headline news about the deaths of 23 young women from their birth control. It was a top story for CBC news and a few other Canadian sources, but it was barely a blip on the radar of most U.S. news outlets. Yaz and Yasmin, two similar new-generation birth control pills from Bayer, are suspected in the recent deaths of these young Canadian women.
These are among the best selling oral contraceptives in the world, but this is not the first time Yaz and Yasmin have been suspected of causing death or adverse effects. Earlier this year, Bayer agreed to pay up to $24 million to settle claims from plaintiffs with gall bladder injuries caused by the drugs, and the company set aside $1 billion to settle claims from approximately 4,800 women who have suffered blood clots due to Yaz or Yasmin. As of February, 2013, approximately 10,000 lawsuits against Bayer are still pending in the U.S., and an additional 1,200 unfiled claims are pending. The company anticipates additional lawsuits—and additional settlements—regarding blood clot injuries, such as pulmonary embolisms or deep-vein thrombosis.
The history of the birth control pill and its social impact is well documented. First approved by the U.S. Food and Drug Administration in 1960, it quickly became the world’s first “lifestyle drug,” and it has become the one of the most studied drugs in history. It is considered to be so safe that the American Congress of Obstetricians and Gynecologists (ACOG) recently recommended that oral contraceptives be sold without a prescription.
But all hormonal contraceptives–the pill, the patch, the shot and the vaginal ring–carry a risk of blood clots. For most users, this is a minor concern, affecting approximately six of every 10,000 pill users. For users of new-generation pills—that is, pills containing drospirenone, the fourth-generation synthetic progesterone found in Yaz, Yasmin, Ocella and several other brands—the risk jumps to ten of every 10,000 users, although Bayer maintains that their own clinical studies find the risk comparable to older pills. Note, however, that the risk in most of these studies is compared either to other hormonal contraceptives or to pregnancy, not to using effective non-hormonal contraception. As if women’s only choices were to be pregnant or be on the pill.
And it is this matter of women’s choices that brings me to my main point: Why we have we seen so little media attention to the safety profile of Yaz/Yasmin (and hormonal contraceptives more generally)? This isn’t about just a few unlucky Canadian women: Four women in Finland have died,more than 50 U.S. users of Yaz and Yasmin died in just a few years and France reports 20 deaths per year due to birth control pills between 2001 and 2011, with 14 attributed to the new-generation contraceptives. This is a major consumer safety concern, and a women’s health issue.
In an earlier time, this might have led to Congressional investigations, such as the Nelson Pill Hearings, which resulted in FDA-mandated Patient Package Inserts (PPIs)—the printed information about risks, ingredients and side effects included in pill packets, first required for oral contraceptives and then for all prescription drugs. It is hard to imagine today’s Congress calling for such an investigation. Among many other social changes since 1970, drug manufacturers in the U.S. hold more influence over both legislators and consumers, now spending nearly twice as much on promotion as they do on research and development.
A parallel can be found in the health crisis triggered by an outbreak of Toxic Shock Syndrome (TSS) linked to tampon use in 1980. TSS is a potentially fatal infection caused by bacterial toxin Staphylococcus Aureus. A new brand of superabsorbent tampon was linked with 813 cases of TSS, including 38 deaths, that year. By 1983, the number of menstrual-related cases reported to the CDC climbed past 2,200, and manufacturer Proctor & Gamble had “voluntarily” pulled the product from the market before the FDA forced them to do so. The intense media coverage, public concern and outcry from feminist activists pushed the FDA to reclassify tampons as a Class II medical device, an upgrade which meant tampons would require more specific regulation and possibly after-market surveillance. They were much slower to mandate absorbency standards, but eventually did so under court order. These actions resulted in a documented decrease in menstrual-related TSS, although it is important to note that it has not disappeared.
Today, more than 30 years later, young women are again dying from something purported to help them, something that affects mostly women. Thousands more are experiencing life-threatening, health-destroying side-effects, such as blindnessdepression and pulmonary embolism. Canada’s professional association of OB-GYNs defended the drug, suggesting that perhaps the recent deaths could be attributed to non-contraceptive reasons for which it was prescribed, such as PCOS or diabetes, both of which are associated with higher risks of blood clots. But there is little evidence of public concern, outside of Yaz/Yasmin user message boards. Even feminist outlets aren’t always covering these issues as vigorously as we might hope. 
Yet the birth control pill in general has never been more politicized in the U.S.: In the last year or so, we’ve seen headlines and public debates about insurance coverage of the pill, access to emergency contraception and so-called personhood bills which have been introduced in legislatures in at least eight states. Feminist activists and health care advocates have been working tirelessly to protect access to the pill along with other forms of birth control, as well as the right to end an unintended pregnancy—and feminist journalists have been writing about these activities.
In the urgency of responding defensively to these political attacks—and we must respond—feminists cannot ignore corporate threats. Just as preserving contraceptive and abortion access is critical to women’s health and well-being, so is protecting contraceptive safety.

main artical refer here
http://msmagazine.com/blog/2013/06/25/yaz-and-yasmin-an-unacceptable-level-of-risk/

Legal Help for Victims of the Side Effects of Yaz - Yaz Lawyers

If you or someone you love took Yaz and suffered from serious side effects, including deep vein thrombosis, pulmonary embolism, stroke, heart attack, or hyperkalemia, you have valuable legal rights.  Please fill out our online form, or call (1-877-774-9049) to discuss your case with a Yaz attorney.

Wednesday, February 6, 2013

Yaz Birth Control


Although many women started taking Yaz to improve their menstrual cycles, they learned that the everyday side effects of the drug created more problems than they thought.
Even though the mild to moderate side effects from Yaz can range from slight cramping to moderate nausea, this drug is also known for its severe and sometimes debilitating side effects that include migraine headaches, uncontrollable uterine bleeding and kidney disorders.
Yaz, Yasmin and Ocella are different from other birth control pills because they contain a new generation of synthetic progesterone called drospirenone, which is closely related to spironolactone, a diuretic. Drospirenone also has anti-androgenic properties, which means it works against testosterone and other hormones. It also contains synthetic estrogen, similar to most birth control pills.
Yaz is the only pill with 24 active pills that include the hormones and four inactive pills. This gives the patient an increased dose of hormones through the month. Most birth control pills include seven inactive pills.
Yaz is also known to put women at a higher risk of hypertension (high blood pressure), blood clots, liver function disturbances, liver tumors, anaphylactic reactions, changes in glucose levels that can lead to diabetes and to worsen lupus.

From Commonplace to Severe Yaz Side Effects

Yaz Birth Control
Yaz side effects are wide ranging, from upper respiratory infections, similar to that seen in the common cold, to high potassium levels. Researchers also warn that the drug can cause headaches, some as severe as migraines, vaginal yeast infections and unusual vaginal discharge.
Yaz has also been found to cause irregular non-menstrual bleeding, stomach cramps, hair loss and weight gain. Yaz is also known to cause acne, less sexual desire, darkening of the skin on the face, high blood sugar and problems tolerating contact lenses.
More severe side effects from Yaz include anaphylactic reactions, including itching, hives, difficulty breathing and face, lips, tongue swelling. The drug’s side effects also include breast lumps or discharge, a change in the amount of urine processed, fainting, arm and leg numbness, irregular heart beat and inflammatory bowel disease.
Patients with preexisting renal problems and hepatic disease should not take Yaz because Yaz interferes with potassium levels. Serum potassium levels should be checked in women starting Yaz because of the possibility of high potassium levels, called hyperkalemia. Because drospirenone is chemically similar to spironolactone, Yaz should not be used in patients with preexisting kidney problems.

Drug Insert and U.S. Food and Drug Administration Warnings

If Yaz is taken with certain drugs and foods, the effects of the pills could be altered. Always check with a doctor before taking the following drugs: ACE inhibitors, antibiotics, heparin, morphine, diuretics, salicylic acid, St. John’s wort and vitamin C.  Women who take long-term NSAIDs, such as ibuprofen and naproxen, should not take Yaz. Women who have ever had blood clots in the legs, lungs or eyes should not take Yaz. Yaz is known to increase the risk of severe and deadly blood clots.
Yaz Drug Insert WarningsPay close attention to the Yaz side effects and warnings in the drug insert.
Since the drug was released to the market in 2006, the drug’s maker, Bayer, has faced several warning from the FDA. Initially, the FDA fined the company for its slick advertising that proclaimed Yaz to be a cure-all for a multitude of known female menstrual conditions, including premenstrual dysphoric disorder (PMDD) and hormone-induced acne.
Bayer was repeated chastised by the FDA for its advertising practices. Then, in 2009, the FDA sent the company a warning letter regarding the quality of ingredients found during a routine inspection of the manufacturing plant in Germany.
The problems at the plant included dirty equipment and failure to adequately test the final products. At least eight batches of the low-quality birth control pills were sent to the U.S.
The FDA has also been grappling with the onslaught of complaints regarding the drug’s connection to blood clots. In September, the FDA said it “remains concerned” about the drug’s clot risks. Instead of recalling the drug or taking action against the drugmaker, the FDA tossed the decision to one of its advisory committees.
Even though the advisory committee voted to keep the drug on the market, some of the committee members have been criticized for their close ties to Bayer. This questionable relationship between the committee members and Bayer has brought the committee’s actions under suspicion.

Legal Help for Victims of the Side Effects of Yaz - Yaz Lawyers

If you or someone you love took Yaz and suffered from serious side effects, including deep vein thrombosis, pulmonary embolism, stroke, heart attack, or hyperkalemia, you have valuable legal rights.  Please fill out our online form, or call (1-888-925-3852) to discuss your case with a Yaz attorney.

Monday, February 4, 2013

Important Facts about Bayer’s Drospirenone-containing Birth Control Pills


Important Facts about Bayer’s Drospirenone-containing Birth Control Pills

Bayer HealthCare is committed to providing customers the latest information regarding the safety of its products.

In cooperation with the Food & Drug Administration (FDA), Bayer has updated the product information for Beyaz, SAFYRAL, YASMIN and YAZ. We would like to make you aware of new information regarding the risk of blood clots with the use of drospirenone (drsp) containing birth control pills (like Beyaz, SAFYRAL, YASMIN or YAZ).

Talk with your healthcare provider about your health, personal risk factors and your risk of getting a blood clot before deciding which birth control pill (also known as “the Pill”) is right for you. If you are currently using Beyaz, SAFYRAL, YASMIN or YAZ, do not stop taking it without first talking to your healthcare provider.

1. Do Beyaz, SAFYRAL, YASMIN and YAZ carry any greater risk for blood clots (venous thrombosis or VTE), than other birth control pills?

All users of birth control pills have an increased risk of developing a blood clot compared to non-users. Women who use birth control pills with drospirenone (like Beyaz, SAFYRAL, YASMIN, or YAZ) may have a higher risk of getting a blood clot. Some studies reported that the risk of blood clots was higher for women who use birth control pills that contain drospirenone than for women who use birth control pills that do not contain drospirenone. Blood clots can be life-threatening or lead to permanent disability. Talk with your healthcare provider about your health, personal risk factors and your risk of getting a blood clot before deciding which birth control pill is right for you.

If you are currently using Beyaz, SAFYRAL, YASMIN or YAZ, do not stop taking it without first talking to your healthcare provider. If you stop taking the Pill and a pregnancy occurs, there is an even higher risk of blood clots during pregnancy than in women who take birth control pills. (see question #2 below for more information regarding the risk of blood clots).

Do not use Beyaz, SAFYRAL, YASMIN or YAZ if you smoke and are over age 35. Smoking increases your risk of serious side effects from the Pill, which can be life-threatening, including blood clots, stroke, or heart attack. This risk increases with age and number of cigarettes smoked.

Do not use Beyaz, SAFYRAL, YASMIN, or YAZ if you have kidney, liver, or adrenal disease because this could cause serious heart and health problems, or if you have or have had blood clots, certain cancers, history of heart attack or stroke, or if you are or may be pregnant. These products do not protect against HIV infection (AIDS) or STDs.

2. How does the risk of blood clots with the use of birth control pills compare to non-use, or to the risk of blood clots during pregnancy or the first few months after child-birth (postpartum period)?

Users of birth control pills have an increased risk of developing a blood clot compared to non-users. However, a woman’s risk of blood clots is higher during pregnancy and especially during the first few months after child-birth (see figure below) than that of a woman on The Pill. To put the risk of developing a blood clot into perspective: If 10,000 women who are not pregnant and do not use birth control pills are followed for one year, between 1 and 5 of these women will develop a blood clot. The figure
below shows the likelihood of developing a serious blood clot for women who are not pregnant and do not use birth control pills, for women who use birth control pills, for pregnant women, and for postpartum women in the first 12 weeks after delivering a baby.

3. Do all birth control pills carry the risk of blood clots (venous thrombosis or VTE), stroke and heart attack?
Yes, all birth control pills carry the risk of blood clots, stroke and heart attack, especially in women who have other risk factors
such as smoking, obesity, or those women who are over the age of 35. These serious side effects of the Pill are uncommon in healthy women, and occur infrequently. However, it is important that you be familiar with these serious risks because any of these conditions can be life-threatening or lead to permanent disability.
Please refer to question #1 regarding risks of blood clots that may be greater in users of Beyaz, SAFYRAL, YASMIN or YAZ. The Pill may increase a woman’s tendency to develop strokes (stoppage or rupture of blood vessels in the brain) and heart
attacks (blockage of blood vessels in the heart). Blood clots and blockage of blood vessels are the most serious side effects of
taking birth control pills. A clot in the legs (deep vein thrombosis), can cause pain and swelling, and a clot that travels to the lungs (pulmonary embolism) can cause sudden blocking of the vessel carrying blood to the lungs.

The increased risk of blood clots is highest when you first start taking birth control pills and when you restart the same or different birth control pills after not using them for a month or more.

Do not use these products if you smoke and are over the age of 35. Smoking increases your risk of serious side effects from the Pill, which can be life-threatening, including blood clots, stroke, or heart attack. This risk increases with age and the number of cigarettes smoked.

Some women should not use the Pill including women who have or have had blood clots, certain cancers, a history of heart attack or stroke, as well as those who are or may be pregnant.

Talk to your healthcare provider before taking any birth control pill to be sure that it is right for you.




Legal Help for Victims of the Side Effects of Yaz - Yaz Lawyers

If you or someone you love took Yaz and suffered from serious side effects, including deep vein thrombosis, pulmonary embolism, stroke, heart attack, or hyperkalemia, you have valuable legal rights.  Please fill out our online form, or call (1-888-925-3852) to discuss your case with a Yaz attorney.

Saturday, February 2, 2013

What are Beyaz® and YAZ® prescribed for?


What are Beyaz® and YAZ® prescribed for? 
For women who choose the Pill for birth control, Beyaz and YAZ are approved to:
  • Prevent pregnancy - 99% effective when taken as directed
  • Treat premenstrual dysphoric disorder (PMDD)
    • Beyaz and YAZ are not approved to treat Premenstrual Syndrome (PMS), a less serious set of symptoms occurring before your period
  • Treat moderate acne in women at least 14 years of age
Beyaz is also approved for women who choose the Pill for birth control to:
  • Provide a daily dose of folate supplementation, which is recommended for women in their reproductive years. Folate lowers the risk of having rare neural tube birth defects in a pregnancy occurring during Beyaz use or shortly after stopping
Who should not take Beyaz or YAZ?
Do not use Beyaz or YAZ if you smoke and are over age 35. Smoking increases your risk of serious side effects from the Pill, which can be life-threatening, including blood clots, stroke or heart attack. This risk increases with age and number of cigarettes smoked.
Do not use Beyaz or YAZ if you have kidney, liver, or adrenal disease because this could cause serious heart and health problems, or if you have or have had blood clots, certain cancers, history of heart attack or stroke, or if you are or may be pregnant.
What are the most serious risks of taking Beyaz or YAZ?
Beyaz and YAZ increase the risk of serious conditions including blood clots, stroke, and heart attack. These can be life-threatening or lead to permanent disability. The risk of blood clots is highest during the first year of use. This increased risk is highest when you first start taking birth control pills and when you restart the same or different birth control pills after not using them for a month or more. Users of drospirenone-containing pills (like Beyaz and YAZ) may have a higher risk of blood clots than users of birth control pills that do not contain drospirenone. Talk to your healthcare provider about your risk of blood clots before deciding which Pill is right for you.
In addition, drospirenone is a different kind of hormone that for some may increase potassium too much. Consult your healthcare provider if you are on daily long-term treatment for a chronic condition with medications that may also increase potassium (see below), as you should have a blood test to check your potassium level during the first month of taking Beyaz or YAZ.
Call your healthcare provider right away if you have:
  • Persistent leg pain; sudden shortness of breath; sudden blindness, partial or complete; severe pain in your chest; sudden, severe headache unlike your usual headaches; weakness or numbness in an arm or leg, or trouble speaking; yellowing of the skin or eyes
What medications may increase potassium?
NSAIDs—ibuprofen (Motrin®, Advil®), naproxen (Aleve® and others) when taken long-term and daily for arthritis or other problems, potassium-sparing diuretics (spironolactone and others), potassium supplementation, ACE inhibitors (Capoten®, Vasotec®, Zestril®, and others), angiotensin-II receptor antagonists (Cozaar®, Diovan®, Avapro®, and others), aldosterone antagonists, and heparin.
What are the most common side effects in Beyaz and YAZ clinical trials?
The most common side effects were headache/migraine, menstrual irregularities, nausea/vomiting, breast pain/tenderness, fatigue, irritability, decreased libido, weight gain, and mood changes.

Legal Help for Victims of the Side Effects of Yaz - Yaz Lawyers

If you or someone you love took Yaz and suffered from serious side effects, including deep vein thrombosis, pulmonary embolism, stroke, heart attack, or hyperkalemia, you have valuable legal rights.  Please fill out our online form, or call (1-888-925-3852) to discuss your case with a Yaz attorney.

Thursday, January 31, 2013

Study: Yaz Has Higher Risks of Blood Clots

A new study of 1.3 million Danish women over nine years adds to the evidence that some newer birth-control pills, including the best-seller Yaz, have a higher risk of causing potentially dangerous blood clots.
Newer pills containing drospirenone, a synthetic hormone, were linked to a six-fold increase in the risk of venous thromboembolism, which is the formation of clots in the lower leg or thigh that can break loose and travel to the lungs.
That risk was compared with a three-fold increase in women using older contraceptives containing the synthetic hormone levonorgestrel. The studywas published Tuesday on the Web site of BMJ, formerly known as the British Medical Journal.
A BMJ editorial added, “It is crucial, however, not to exaggerate the risk — oral contraceptives are remarkably safe and may confer important long-term benefits in relation to cancer and mortality.”
The Food and Drug Administration is already studying the possible increased risk of blood clots with pills containing the drospirenone. The F.D.A. says its preliminary results suggest a 1.5-fold increased risk compared with other hormonal contraceptives, to about 10 women in 10,000 from 6 women in 10,000.
Studies have differed, though. Some found no increased risk among women taking the newer pills. The F.D.A. has scheduled a joint meeting of two advisory committees on Dec. 8 to review the risks and benefits.
Bayer, the German drug company that makes Yaz and the related product Yasmin, has said the two have similar clot risks to other combination birth control pills, including levonorgestrel. The company updated its labels last year with that indication.
The new study, sought by the European Medicines Agency, challenges that finding.
Bayer, in a brief statement Wednesday, said it is “currently evaluating this publication and cannot comment at this time.”
Bayer also said its clinical data from more than 15 years supports the company’s assessment that its hormonal birth control products are safe and effective when used as indicated and that the risk of venous thromboembolism is similar to that from taking any other low-dose estrogen product studied.
Thousands of women have sued Bayer, contending that they have suffered injuries from taking Yaz or Yasmin. Bayer introduced Yasmin in 2001 and Yaz in 2006. Yaz contains the same amount of drospirenone but a smaller amount of ethinylestradiol, a synthetic estrogen commonly paired with progestins in birth control pills.
The Danish study found essentially no difference in the risk of venous thromboembolism between Yaz and Yasmin, and in both cases, about double that of some other hormonal birth control pills.
Some of the numbers were small, though. The study found 23 reported events of venous thromboembolism in the Yaz group, confirming 16 of them with medical records, compared with 78 reported events, confirming 57 of them, for users of older levonorgestrel. The latter group was more than four times larger than the Yaz group. That left levonorgestrel with more certainty about a relative risk of the clot of two to four times that of nonusers, while Yaz had a wider range of risk, four to 11 times that of nonusers, within statistical significance, the study said.
The researchers estimated 2,000 women would need to change birth control pills to prevent one incident of venous thromboembolism in a year.
Yaz has been marketed and F.D.A. approved for quality of life treatment for acne and severe premenstrual symptoms, in addition to birth control benefits. The drugs have had worldwide sales of $1.47 billion last year.
Yaz sales in the United States declined earlier this year, the company said, blaming generic competition.




Legal Help for Victims of the Side Effects of Yaz - Yaz Lawyers

If you or someone you love took Yaz and suffered from serious side effects, including deep vein thrombosis, pulmonary embolism, stroke, heart attack, or hyperkalemia, you have valuable legal rights.  Please fill out our online form, or call (1-888-925-3852) to discuss your case with a Yaz attorney.

Monday, January 28, 2013

Just How Safe is Yaz? Women Need to Know!


The oral contraceptive Yasmin was released in 2001 by the pharmaceutical company Bayer, followed byYaz in 2006. They differ from other birth control pills in the synthetic progesterone they utilize, drospirenone, which is marketed as less likely to cause weight gain and bloating than other birth control pills. Yaz soon became the most popular birth control pill in the U.S., due in part to a widespread advertising campaign promoting the drug as what theNew York Times dubbed “a quality of life treatment,” claiming it could also clear up acne, prevent bloating and ease the depression and anxiety associated with both PMS and the controversial condition of PMDD. It prevents pregnancy at the same rate of effectiveness as all other oral contraceptives.
In 2009, the FDA requested that Bayer distribute a corrective advertisement to counter its aggressively screened commercials that were said to be making misleading assertions about the capabilities of the drug, promoting it for unapproved uses and making light of the more serious health risks (such as blood clots). However, in 2010 the drug remained the second-best-selling Bayer product, bringing in $1.5 billion in sales.
As of January 2012, there are approximately 10,000 lawsuits against Bayer by women who have suffered blood clots and by the families of those women who have died whilst taking Yaz or Yasmin. It is considered the most complained-about drug on the Internet, with thousands of women voicing concerns in online forums and support groups over health issues both physical and emotional. Jane Bennett and Alexandra Pope, authors of The Pill: Are You Sure It’s for You?, characterize many of these problems as “quality-of-life-threatening.” I have written extensively on my own experience with Yasmin in my blog, Sweetening the Pill, and for the UK Independent and have been quoted in Fabulous magazine the Washington Post
Two studies conducted with funding from Bayer revealed that Yaz and Yasmin held no higher risk of blood clots than other birth control pills. However, last month it was revealed that five other studies undertaken independent of Bayer suggested a 50-to-75 percent increased risk of clots for those taking these birth control pills in comparison to others. A former FDA commissioner, David Kessler, charged that Bayer deliberately withheld data about this early on in order to push through the drugs’ approvals. In response, the FDA called an advisory committee to evaluate the safety of birth control pills containing drospirenone. The decision had the potential to cause the drugs to be pulled off the market, but the panel voted by a four-person margin that the drugs’ benefit outweighed the risks.
Yet a government watchdog group, the Project on Government Oversight (POGO), conducted an independent investigation that revealed three of the advisors on the FDA panel had research or other financial ties to Bayer. A fourth advisor was connected to manufacturing the generic version of these pills. All four voted for Yaz and Yasmin to continue to be prescribed by doctors. POGO asked the FDA that a new advisory committee be brought together to make another assessment.
Should these developments impact women’s perspective on the birth control pill? Should we consider that use of the Pill for pregnancy prevention, let alone acne or PMS, is still today, as women’s health activist Barbara Seaman wrote in her 1969 book The Doctors’ Case Against the Pill, “like tinkering with nuclear bombs to fight off the common cold”?
Says Ms. blogger Elizabeth Kissling, professor of communication and women’s and gender studies at Eastern Washington University and past president of the Society for Menstrual Cycle Research:
I’m surprised there has not been a broader call for more research, or wider public discussions of the risks of this pill. When a drug company is withholding data and 10,000 lawsuits are pending, more than research is needed. I can’t help but wonder why we’re not seeing Congressional hearings–akin to the 1970 Nelson Pill Hearings–again, and more of an outcry from both physicians and patients.
Much of the media coverage of these recent developments and research was quick to assert the unimportance of women’s concerns. It was repeatedly reported that, when compared to the risk of blood clot development associated with pregnancy, the risk produced by taking any oral contraceptive–including Yasmin or Yaz–is of little concern. This is misleading in that it suggests there are only two states in which young women can choose to live: on birth control pills or pregnant. The fear has been voiced that any discussion of the negative impact of the Pill will prompt women to come off of it and fall unintentionally pregnant. No coverage that this writer has read discussed a comparison with non-hormonal contraceptive alternatives–which, of course, hold no increased risk of blood clots. Some of these alternatives are just as effective in preventing pregnancy as oral contraceptives, and others are more so.
According to Laura Wershler, veteran pro-choice sexual and reproductive health advocate and board director of the Canadian Federation for Sexual Health,
We need to reframe the idea that hormonal birth control is the gold standard of contraception. If women are quitting the Pill, and they have every right to do so, and they are not using alternative methods of birth control effectively, that’s proof positive that what we are teaching about contraception is incomplete and ineffective. If we make the Pill the ‘right’ choice, then why should we be upset when women stop taking it and get pregnant?
It is often claimed within news stories that the Pill “regulates” a woman’s menstrual cycle, when it, in fact, stops and replaces the cycle. All of this propaganda for the Pill is extremely misleading, and it further breeds a lack of confidence to know that Bayer paid women’s magazines to advocate for Yaz. Such actions blind women to their choices and to understanding how their bodies work. There is much research that supports the health benefits of consistent (typically monthly) ovulation, which can be found through the Centre for Menstrual Cycle and Ovulation Research.
The absence of education in body literacy is a major factor in unwanted pregnancies. However, this lack of education is beneficial to some: It helps sustain the billion-dollar profits of pharmaceutical companies.
Photo is the cover of The Pill: Are You Sure It’s for You?

Legal Help for Victims of the Side Effects of Yaz - Yaz Lawyers

If you or someone you love took Yaz and suffered from serious side effects, including deep vein thrombosis, pulmonary embolism, stroke, heart attack, or hyperkalemia, you have valuable legal rights.  Please fill out our online form, or call (1-888-925-3852) to discuss your case with a Yaz attorney.

Thursday, January 24, 2013

Yaz® Drug Injury Lawyer

The Yaz® birth control pill has been on the market since 2006. Yaz is taken orally once daily to prevent pregnancy.
Yaz differs from other birth control methods because it contains a progestin hormone called drospirenone, which can increase potassium levels in the bloodstream.
Yasmin®, a birth control drug very similar to Yaz, has been on the market since 2001. It contains the same hormone as Yaz and is associated with the same health issues. Ocella® is sometimes supplied by pharmacies instead of Yaz or Yasmin, and carries the same risks.
Dangerous Side Effects
Yaz has been linked with serious adverse heart problems in women taking the drug. In a reprimanding letter sent to the manufacturer of Yaz, the Food and Drug Administration (FDA) warns of blood clots, heart attack, stroke, and gallbladder disease in Yaz users (1).
The FDA goes on to say, "Yaz has additional risks because it contains the progestin, drospirenone [...] can lead to hyperkalemia in high risk patients, which may result in potentially serious heart and health problems. Women taking Yaz must be concerned about the drug interactions that could increase potassium, in addition to the drug interactions common to all combination oral contraceptives (1)."
What Have Yaz Studies Revealed?
The British Medical Journal (BMJ) released a report revealing that blood clots in Yaz and Yasmin are as frequent as with third generation birth control pills. Third generation pills had an established warning for blood clots, but Yaz and Yasmin did not yet have such a warning.
The FDA then released results from a study that included over 800,000 American women who were taking various forms of birth control between 2001 and 2007. The research revealed that women taking Yaz had a 75 percent higher chance of getting a blood clot than women taking older forms of birth control pills.
Elevated Potassium Levels
Yaz also has been linked to a condition known as hyperkalemia. Hyperkalemia is a condition that describes abnormal levels of potassium in the bloodstream, which can lead to fatal arrhythmias. Arrhythmias are disorders of the speed at which the heart beats.
Heart Attack, Stroke, and Blood Clots
Yaz and other oral contraceptives present an increased risk of heart attack in users (2), especially in smokers. In addition to heart attack, there is an established link between oral contraceptives and blood clots and stroke.
Quality Control Issues
U.S. health regulators warned the manufacturer of Yaz about its quality control issues at a plant that makes several of the ingredients in Yaz. The FDA said inspectors found testing problems at the company's plant in Berghamen, Germany. One of the drugs on the list that may not be up to standards is Yaz's main ingredient, drospirenone (4).
Bloomberg reports that lawsuits have been filed against the manufacturer of Yaz, claiming that Bayer unlawfully promoted the drug by concealing side effects, including blood clots, heart attacks, and pulmonary embolisms in Yaz users.
Furthermore, a Swiss health regulation investigation into the death of a woman who took Yaz and died of a blood clot in her lung is currently underway.
Yaz Marketed for Unapproved Uses
In January 2009, the FDA required the maker of Yaz, which ran commercials claiming Yaz could be used to cure headaches and severe acne (uses that are not approved by the FDA), to launch a campaign correcting those false claims.
The FDA said, "These violations are concerning from a public health perspective because they encourage use of Yaz in circumstances other than those in which the drug has been approved, over-promise the benefits and minimize the risks associated with Yaz (1)."
Yaz is approved for use as an oral contraceptive, to treat moderate acne in women ages 14 and older, and to help reduce some emotional and physical symptoms of PMDD (a condition in which a woman has severe depression symptoms, irritability, and tension before menstruation). Yaz is not approved to cure PMS, severe acne, or all of PMDD's symptoms.
Despite the dangers, marketing violations, and manufacturing issues Yaz has been associated with, it is still on the market today.
We Want to Help
If  you or someone you care about took Yaz and suffered a blood clot, stroke, or heart attack, someone at our law firm would like to speak with you. We may be able to help.
Sources:
  1. "Yaz (drospirenone and ethinyl estradiol) Tablets Warning Letter to Bayer HealthCare," from the Food and Drug Administration (www.fda.gov).
  2. "Yaz  Prescribing Information," from the Yaz warning label. Accessed 4/3/09 via www.yaz-us.com.
  3. "Hormonal contraception and risk of venous thromboembolism: national follow-up study" from the British Medicine Journal. Accessed 8/20/09 via www.bmj.com.
  4. "FDA warns Bayer over German manufacturing plant," from The Associated Press via www.yahoo.com.
Yaz® and Yasmin® are registered trademarks of Bayer Pharmaceuticals. Ocella® is a registered Barr Laboratories, Inc. Trademarked names are used only to identify the productions in question.
This law firm is not associated with, sponsored by, or affiliated with The Associated Press, Barr Laboratories, Inc., Bayer Pharmaceuticals, the British Medicine Journal, the Food and Drug Administration, or Yahoo!

Legal Help for Victims of the Side Effects of Yaz - Yaz Lawyers

If you or someone you love took Yaz and suffered from serious side effects, including deep vein thrombosis, pulmonary embolism, stroke, heart attack, or hyperkalemia, you have valuable legal rights.  Please fill out our online form, or call (1-888-925-3852) to discuss your case with a Yaz attorney.

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