Posts Tagged ‘Naples’
The Florida Yaz HotlineThe Florida Yaz Helpline is seeking all women with blood clot injuries from Yaz and encourages women who may have suffered Yaz blood clots or other serious side effects to consider filing a Yaz lawsuit.
Yaz Complications Alert
- Heart attack
- Deep vein thrombosis
- blood clots in the legs
- Pulmonary embolism
- blockages in the lungs
Have You Or a Loved One been Injured By Yaz?Yaz, Yasmin, Beyaz and Ocella side effects complication include:
- Blood clots
- Pulmonary Embolism (PE)
- Deep Vein Thrombosis (DVT)
- Heart attack
- Gall Bladder problems
- Gall Bladder Removal
Yaz Birth Control Pills Helpline Is reaching out to women who have been severely injured by Yaz. Yaz causes Blood Clots in young women a very vulnerable age. Yaz lawyers are filing more Yaz lawsuits for yaz injury. Bayer has begun settlements for Yaz Bloodclots. Now is the time for women injured by Yaz to step forward and claim what is due them.
Yaz Blood Clot Lawyers Fighting are fighring along side the Yaz Helpline to bring justice to women whose lives have been destroyed by these Yaz and yasmin birth control pills.
Millions of women need take birth control pills to avoid unwanted pregnancy. Two of these Yaz and Yasmin cause blood clots and related medical problens such as stroke, pulmonary embolism and deep vein thrombosis.
Reports of serious Yaz side effects and Yasmin side effects are out there on blogs and chat rooms, and the problems associated with these medications are not only dangerous, but in some cases fatal.
Yaz and Yasmin are both manufactured by Bayer Healthcare Pharmaceuticals, one of the largest drug companies in the world. As is the Mirena IUD currently in the news as well. Yasmin was originally approved for use in the United States by the FDA in 2001, and Yaz followed its predecessor in 2006 with a slightly different formula.
Yaz and Yasmin Side Effects
Deep Vein Thrombosis (DVT) – DVT is an otherwise rare condition where a blood clot forms deep inside the tissue of the body, usually in the leg. Eventually, this clot will break off and travel through the body before settling in the lungs or brain causing a potential stroke.
Pulmonary Embolisms – Pulmonary embolisms are extremely dangerous blood clots that appear in the lungs. Some of these blood clots form directly in or near the lungs and others are move there after forming somewhere else in the body.
The Yaz helpline wants to hear from all women injured by Yaz or their family, mothers or Husbands. We must seek justice.
Yaz Bith Control Pills Helpline announces, the Yaz Bith Control Pills lawsuits are being filed by yaz lawyers. Settlements have already started.
Yaz Birth Control Pills Helpline is reaching out to women who have blood clots, stroke or Pulmonary Embolism from yaz or Yasmin Birth Control Pills. Bayer has started settlements. We do not want you to be left out.
Yaz causes blood clots, Pulmonary Embolism, Strokes and deep vein thrombosis. Blood clots that end up in the lungs or brain can be fatal.
The U.S. Food and Drug Administration has issued many warnings regarding the progestin in Yaz called drospirenone. Drospirenone causes adverse side effects including blood clots, deep vein thrombosis or a pulmonary embolism. Yaz lawsuits by yaz lawyers focus on blood clots
Other lawsuits are for strokes, heart attacks. If you have experienced these issues, Many women are not aware of the right to sue for these life altering and sometimes deadly complications
Bayer did not properly warn about the adverse effects they had knowledge of. Yaz Lawsuits claim that Bayer was aware of the issues with Yaz and Yasmin, but continued to promote their drug without a proper warning on the label.
The evidence is already strong enough to support most Yaz Lawsuit claims. You must call the Yaz Birth Control Pills helpline today. If a daughter or wife or friend has blood clots from Yaz tell her about the Yaz lawsuits or contact us on her behalf.
Lawyers in Ft Lauderdale, Boca Raton, Miami, West Palm beach, Orlando, Tampa, are accepting Yaz related Blood clot and Pulmonary Embolism cases for the immediate filing of Yaz lawsuits
NuvaRing, Yaz, Yasmin Risk of Stroke and Heart Attack are causing lawsuits for be filed. If you have a Yaz blood clot, stroke or Pulmonary Embolism injury fro Yaz or yasmin call now.
New England Journal of Medicine June 2012 Study
The New England Journal of Medicine published a study on June 14, which suggests that these forms of birth control that contain a combination of estrogen and progestin can double a woman’s risk of having a heart attack or stroke.
The Danish study, analyzed more than 1.6 million women aged 15 to 49. These women were taking low-dose estrogen birth control pills combined with progestins. They suffered heart attacks and strokes between 1.5 and 2 times more often than women not using hormonal contraception. The risks were as much 2.5 to 3 times higher among users of combined hormonal device, including vaginal rings, compared to non-users. The highest risks were seen in women over 45, or those who had high blood pressure.
Yaz, Yasmin have very serious Side Effects
Yaz and Yasmin users may suffer a serious side effect associated with the use of these drugs, including Venous Thromboembolism (Blood Clots), Deep Vein Thrombosis (blood clots in the leg), Pulmonary embolism (blood clots in the lung), Heart Attacks and Strokes. There are very serious side effects and possibly death for Yaz or yasmin birth control pills.
FDA October 2011 Study
In October 2011, a U.S. Food & Drug Administration (FDA) study the involving data on 800,000 American women using some form birth control between 2001 and 2008 revealed using NuvaRing increased the risk of blood clots, including deep vein thrombosis and pulmonary embolism, by 56% in comparison to older birth control pills.The Problem with Yaz and Yasmin
Why Does yaz Cause Blood Clots ?
Yaz and Yasmin both contain ethinyl estradiol, along with a synthetic progestin called drospirenone. Yaz and Yasmin are manufactured by the German pharmaceutical giant, Bayer.
The FDA’s study of hormonal contraceptives that was released last October suggested an approximately 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing pills compared to users of other hormonal contraceptives.
In a Drug Safety Communication issued on April 10, 2012, the FDA said it was requiring that the labels for drospirenone birth control be updated to warn that these contraceptives may be linked to a higher risk of blood clots.
There are currently over Ten Thousand Yaz and Yasmin Lawsuits
More than 10,000 personal injury lawsuits that allege Yaz and Yasmin caused heart attacks, strokes, blood clots and other serious injuries are currently pending in the Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation (MDL No. 2100) in the U.S. District Court for the Southern District of Illinois.
if you have been injured call the Yaz Birth Control Pills Helpline today
blood clots, pulmonary embolism, deep vein thrombosis, merck, stroke, wrongful death, Yaz, Yasmin
Yaz birth control pills have harmed many women by causing blood clots, Pulmonary Embolism, Stroke and heart Attacks. Yaz Birth Control pill helpline is happy to announce that Bayer Said to Pay $110 Million in Yaz Birth-Control Cases
By Jef Feeley and Margaret Cronin Fisk – Apr 13, 2012 5:48 PM ET
Bayer Germany’s largest drugmaker, will pay at least $110 million to settle about 500 lawsuits over claims that its Yasmin line of birth-control pills caused blood clots, in the first resolution of cases over the product, people familiar with the agreements said.
Officials of Bayer, based in Leverkusen, Germany, agreed to pay an average of about $220,000 a case to resolve the claims that its Yasmin and Yaz contraceptives caused sometimes fatal clots that can lead to heart attacks and strokes, two people familiar with the settlement said. The people sought anonymity because the accords haven’t been made public.
Bayer fell 2.5 percent in German trading today, and its American depositary receipts dropped 3.8 percent. The settlements came after a federal judge in Illinois postponed a Jan. 9 trial of a suit accusing Bayer and some of its units of misleading women about the health risks of its birth-control pills so a mediator could try to negotiate a settlement.
The case was the first set for trial of more than 11,000 lawsuits over injuries allegedly caused by the drugs.
“Sounds to me like mediation is paying off,” Carl Tobias, who teaches product-liability law at the University of Richmond in Virginia, said in a phone interview. “As a German company, Bayer probably would like to avoid the risks and costs of litigation in U.S. courts. Mediation tends to be a less- expensive way to deal with these kinds of cases.”
The settlements come as the U.S. Food and Drug Administration April 10 ordered Bayer and other contraceptive makers to strengthen the blood-clot warnings on their products.
Pills like Bayer’s Yasmin, which contain a synthetic hormone called drospirenone, will have warning labels saying researchers have found they may triple the risk for clots.
Bayer’s contraceptives generated $1.58 billion in sales in 2010, making them the drugmaker’s biggest-selling drugs after Betaseron, a multiple sclerosis medication. The Yasmin drugs have been the focus of regulators who question their safety.
“Bayer HealthCare confirms that some cases pending in the current YAZ/Yasmin litigation in the U.S. are being settled,” Rosemarie Yancosek, a U.S. spokeswoman for the drugmaker, said in an e-mailed statement. She declined to comment on the number of cases settled or the amount of the accords.
Bayer’s American depository receipts, each worth one ordinary share, fell $2.60, or 3.8 percent, to $65.83 in over- the counter trading today. Shares in Germany dropped 1.28 euros, or 2.5 percent, to 50.56 euros.
Bayer officials said in a Feb. 28 U.S. Securities and Exchange Commission filing that the drugmaker has settled 70 cases over the Yasmin line of contraceptives.
Those settlements included “terms and conditions which Bayer views to be reasonable,” officials said in the filing. “Bayer will continue to consider the option of settling individual lawsuits in the U.S. on a case-by-case basis.”
The company is expecting additional suits, officials said in the SEC filing. Last year, the U.S. Food and Drug Administration warned that women taking the pills were 74 percent more likely to suffer blood clots than women on other low-estrogen contraceptives.
The FDA examined data on more than 835,000 women who took pills containing drospirenone, including Bayer’s Yasmin line of birth-control pills, according to the FDA report.
Bayer’s Yasmin was the No. 4 oral contraceptive in the U.S. in 2011, with 4.6 percent of the market as of September, according to data from IMS Health.
Wave of Litigation
Since 2009, the German drugmaker has faced a wave of lawsuits in courts across the U.S. alleging the birth-control pills caused sometimes fatal blood clots. Lawyers suing the drugmaker cited FDA reports of at least 50 deaths tied to the pills from 2004 to 2008.
Lawyers for former Yaz users contend in court filings that Bayer officials sought to market the contraceptive fgor unapproved uses and misled women about the drug’s health risks
The cases filed in federal courts were consolidated before U.S. District Judge David Herndon in East St. Louis, Illinois, for pretrial proceedings.
Herndon scheduled a series of trials for early this year so juries could begin weighing claims that Bayer and its units marketed Yaz and other contraceptives as safer than rivals’ products while knowing they posed a higher clot risk.
At Bayer’s suggestion, Herndon called in Stephen Saltzburg, a George Washington University law professor, to serve as a mediator. Saltzburg’s job was to explore the possibility of “settlements in this litigation,” Herndon said in a December 2011 order. The judge put the trial schedule on hold while Saltzburg met with lawyers for the drugmakers and former Yaz users.
Among the lawyers settling Yaz cases as a result of Saltzburg’s efforts are mark Robinson, Chris Seeger and Michael Berg the people familiar with the accords said.
Those three lawyers are serving on the so-called plaintiffs steering committee in the cases before Herndon, according to court filings That group helps decide how the consolidated cases should progress through the litigation process.
Burg, a Denver-based plaintiffs’ lawyer who handles product-liability cases, also is listed in court filings as co- lead plaintiffs’ counsel in the Yaz cases. He declined to comment on the settlements in a interview today.
Seeger, based in New York, and Robinson, a Los Angeles- based attorney, didn’t immediately return calls seeking comment on the settlement.
The case is In re Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Product Liability Litigation, 09-md-02100, U.S. District Court, Southern District of Illinois (East St. Louis).
Margaret Cronin Fisk
editor responsible for this story: Michael Hytha
If you have been severly injured by Yaz or Yasmin or a loved one died contact us immediately to see if you are eligible to be a part of this lawsuit .
Call the yaz Birth control Pills Helpline today and speak to a female medical social worker. Yaz Birth control Pills lawyers are accepting Yaz cases for blood clot complications as well as stroke and pulmonary embolism.
If you or a loved one has been injured by yaz contact our Yaz Birth Control Pills Helpline for a Yaz case review. Some interesting new news on Yaz and Blood Clots problems follows:
Yaz pulmonary embolism among side effects
The oral contraceptive Yaz and the related drug Yasmin have been associated with a number of significant adverse side effects. Researchers believe that the drugs’ active ingredient, drospirenone, is to blame.
Drospirenone is a synthetic hormone that affects the body’s chemistry. One of its unintended consequences is to increase potassium levels, sometimes high enough to cause a dangerous condition known as “hyperkalemia.” Increased potassium levels are associated with the development of Yaz blood clots and gallbladder disease.
Yaz blood clots can have life-threatening consequences throughout an individual’s body. They can cause stroke, heart attack, and Yaz pulmonary embolism. Thousands of women who have been injured by Yaz pulmonary embolism and other significant side effects have hired a Yaz lawyer and filed claims against Bayer.
A Litttle Bit of yaz History
YAZ / Yasmin January 2012 Update: Minutes And Transcripts For FDA Advisory Committees 2011 Meeting Now Available Online (And More)
11 Of The 26 FDA Panel Members Voted There Were No Sufficient Unique Benefits For YAZ / Yasmin That Cannot Be Found In Other Hormonal Contraceptives
(Posted by tom Lamb at Drug Watch
On December 8, 2011 the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee held a joint meeting to discuss YAZ and Yasmin as well as several other relatively new birth control pills.
summary of FDA meeting
Issues: The committees discussed the benefits and risks of drospirenone-containing oral contraceptives in light of the emerging safety concern that the risk of venous thromboembolism (blood clots that can break loose and move within the circulatory system) associated with use of these products may be higher compared to oral contraceptives that contain the progestin, levonorgestrel. Drospirenone-containing oral contraceptives for the primary indication of pregnancy prevention include: YASMIN, YAZ (drospirenone/ethinyl estradiol tablets), BEYAZ, SAFYRAL (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets), Bayer HealthCare, and the generic equivalents for these products.
Bayer has settled Yaz Injury Claims. Our Yaz lawyers are still accepting Yaz Injury claims for Blood clots. New Warning added to yaz labels. Yaz lawyers are filing yaz lawsuits for victim of yaz.
Subject: Yaz – State SOLs If you have an injury or a loved one has died ffrom Yaz and you are in the states listed below contact us for a yaz injury lawyer today.
Black box date was 8/14/2009 This is an Important date for your Yaz Injury Claim
Yaz Birth Control Pills Helpline Yaz lawyers are accepting clients with blood clots from yaz in the following states where the statute of limitation is :
3 year – SOL: 8/13/2012 for a Yaz Injury Claim. Yaz Lawyers are Accepting Cases for Yaz Blood Clot, Stroke and Pulmonary embolism, deep Vein thrombosis and wrongful death from yaz.
Arkansas yaz lawyers,
District of Columbia Yaz Lawyers,
Maryland Yaz Lawyers,
Massachusetts Yaz Lawyers,
Michigan Yaz Lawyers,
Mississippi Yasz Lawyers,
Montana Yaz Lawyers,
New Hampshire Yaz lawyers,
New Mexico yaz Lawyers,
New York yaz lawyers,
North Carolina yaz lawyers,
Rhode Island yaz lawyers,
South Carolina yaz lawyers,
South Dakota Yaz Lawyers,
Vermont yaz lawyers,
Washington yaz lawyers,
Wisconsin yaz lawyers,
are accepting cases for victims of blood clots from Yaz
4 year – SOL: 8/13/2013, Yaz lawyers are accepting cases for Yaz Blood Clots, Stroke, Pulmonary Embolism, deep vein Thrombosis and wrongful death from Yaz
Florida yaz Lawyers,
Nebraska yaz Lawyers,
Utah Yaz lawyers,
Wyoming yaz lawyers
5 year – SOL: 8/13/2014 Yaz lawyers are accepting clients with Pulmonary embolism, Stroke, Blood Clots, deep vein thrombosis and Wrongful death from Yaz
Missouri yaz Lawyers
6 year – SOL: 8/13/2015, yaz lawyers are accepting clients with complications from Yaz including: Blood clots, Stroke, heart Attack, Pulmonary embolism, deep vain thrombosis, and wrongful death from yaz birth control pills
Maine yaz Lawyers,
North Dakota yaz lawyers,
Yaz & Pulmonary Embolism, Deep Vein thrombosis, Blood Clots, Stroke
Pulmonary embolism is one of the serious side effects reported by women who have taken the birth control pills Yaz and Yasmin. A pulmonary embolism or "PE" occurs when there is a blockage of the main arteries of the lungs. In most cases, a PE is caused by blood clots that travel to the lungs from another part of the body – most commonly, the legs – and creates a blockage in the pulmonary artery. Recent medical studies have found that the hormone used in Yaz and Yasmin, known as drospirenone or drsp, is associated with a significantly higher risk of venous thrombosis, a medical term for blood clots in the veins.
Effects of Yaz Pulmonary Embolism and deep vein Thrombosis
When a pulmonary embolism occurs, the lung tissue served by each blocked artery is robbed of fuel and can die, which makes it difficult for the lungs to provide oxygen to the rest of the body. A pulmonary embolism can be life-threatening if not treated promptly.
Additional complications can also occur. In some cases a pulmonary embolism can lead to pulmonary hypertension, a condition in which the blood pressure in the lungs is too high. Obstructions, such as blood clots, in the arteries inside the lungs make the heart work harder to push blood through those vessels. When this occurs, it increases the blood pressure within those vessels and can wear out a section of the heart.
Additionally, if a blood clot travels to the brain, a stroke can occur. Blood clots from Yaz can be fatal. Contact a Yaz Birth Control Pills Helpline lawyer today.
Pulmonary Embolism from Yaz?, Blood Clot from Yaz?, Yaz lawyers filing lawsuits for injury and death from Yaz. Yaz Lawsuit lawyers are accepting cases to get you in before the statute of limitations runs out.
Medical Editor: William C. Shiel Jr., MD, FACP, FACR
Whenever a young and healthy athlete gets sick, it always gets the attention of the press. The news is even more dramatic when the condition can be life-threatening, as in the case of Serena Williams, who reportedly developed a pulmonary embolism in late February 2011. While it is possible to recover fully from a pulmonary embolism, it is indeed a serious condition and requires serious medications. In addition, Ms. Williams also reportedly required treatment for a hematoma, a collection of clotted blood that forms outside of a blood vessel.
A pulmonary embolism (PE) happens when a blood clot (thrombus) forms in the one of the body's large veins (known as deep vein thrombosis or DVT), breaks off, and travels (embolizes) in the circulatory system back to the heart and out into the arteries that carry blood to the lungs to load up oxygen. There the clot in the lungs (embolus) then clogs the artery that provides blood supply to part of the lung, preventing the normal exchange of oxygen and carbon dioxide. It also reduces the blood supply to the lung tissue itself. Lung tissue can die (infarct) if circulation is impaired.
Essentially anything that increases the potential for blood clots to form in the veins can increase your chances of developing a pulmonary embolus. While some medications and chronic medical problems can increase the tendency of blood to clot, even those who are healthy and fit can be at risk for pulmonary embolism due to prolonged immobilization (as with extended car or plane travel or hospitalization and bed rest) or circumstances that damage the blood vessel walls, making a clot more likely to form. Surgery and trauma to the leg are examples of conditions that can make a vein more likely to clot. Sudden chest pain and shortness of breath are the main symptoms of pulmonary embolism, but coughing may also occur. The pain is usually worse when taking a breath (known as pleurisy). The affected individual may have signs such as a blue-tinged discoloration of the skin and feel lightheaded or weak. In severe cases, the heart stops beating and sudden death results. Fortunately, treatment for pulmonary embolism is available, and most patients survive when appropriately diagnosed and treated with anti-clotting drugs. A higher incidence of death from pulmonary embolism occurs in patients who are older, have other underlying illnesses, or have a delay in diagnosis.
What is a pulmonary embolism?
The lungs are a pair of organs in the chest that are primarily responsible for the exchange of oxygen and carbon dioxide between the air we breathe and blood. The lung is composed of clusters of small air sacs (alveoli) divided by thin, elastic walls (membranes). Capillaries, the tiniest of blood vessels, run within these membranes between the alveoli and allow blood and air to come near each other. The distance between the air in the lungs and the blood in the capillaries is very small, and allows molecules of oxygen and carbon dioxide to transfer across the membranes.
The exchange of the air between the lungs and blood are through the arterial and venous system. Arteries and veins both carry and move blood throughout the body, but the process for each is very different.
Arteries carry blood from the heart to the body.
Veins return blood from the body to the heart.
The heart is a two-sided pump.
Oxygen-carrying blood travels from the left side of the heart to all the tissues of the body. The oxygen is extracted by the tissue, and carbon dioxide (a waste product) is delivered back into the blood.
The blood, now deoxygenated and with higher levels of carbon dioxide, is returned via the veins to the right side of the heart.
The blood is then pumped out of the right side of the heart to the lungs, where the carbon dioxide is removed and oxygen is returned to the blood from the air we breathe in, which fills the lungs.
Now the blood, high in oxygen and low in carbon dioxide, is returned to the left side of the heart where the process starts all over again.
The blood travels in a circle and is therefore referred to as circulation.
If a blood clot (thrombus) forms in the one of the body's veins (deep vein thrombosis or DVT), it has the potential to break off and enter the circulatory system and travel (or embolize) through the heart and become lodged in the one of the branches of the pulmonary artery of the lung. A clot that travels through the circulatory system to another location is known as an embolus (plural emboli).
A pulmonary embolus clogs the artery that provides blood supply to part of the lung. The embolus not only prevents the exchange of oxygen and carbon dioxide, but it also decreases blood supply to the lung tissue itself, potentially causing lung tissue to die (infarct).
A pulmonary embolus is one of the life-threatening causes of chest pain and should always be considered when a patient presents to a healthcare provider with complaints of chest pain and shortness of breath.
Non-thrombus causes of pulmonary embolus are rare but include:
- fat emboli from a broken femur,
- an amniotic fluid embolus in pregnancy, and
- in some cases, tumor tissue from cancer.
The presentation is the same as that of a blood clot, caused by blockage of part of the arterial tree of the lung. It is Obvious that any drug that causes a Pulmonary embolism must be uses with caution. Yaz birth control pills have shown to cause pulmonary embolism in young women. Call the yaz Birth Control Pills Helpline and Sperak to a female Medical social worker and a yaz lawyer.
Lawsuits mounting over alleged health risks of Bayer's Yaz contraceptive, lawyers filing lawsuits for Blood clots from yaz, Yasmin.
Published: Monday, July 11, 2011, 2:35 PM Updated: Monday, July 11, 2011, 2:55 PM
Susan Todd/The Star-Ledger By Susan Todd/The Star-Ledger
jcummins.jpgTim Farrell of The Star-LedgerJoan Cummins stands near a photo of her daughter, Michelle, who died last year of a pulmonary embolism. Cummins believes her daughter's death occurred as a result of her use of Yaz, a birth control pill made by Yaz.
Michelle Pfleger, a teenager from Hackettstown, was familiar enough with the birth control pill Yaz to ask for it when she visited her doctor before heading off to college.
She had seen the advertisements on television about how the drug could help clear up mild acne, relieve premenstrual irritability and, if she needed it, could prevent her from getting pregnant.
“Some of her friends were on it,” her mother, Joan Cummins, said recently, “and she thought it was a good one.”
But in May, Cummins filed a lawsuit against Bayer Healthcare, the drug company that sells Yaz, alleging that the birth control pill caused her 18-year-old daughter’s death nearly a year ago. Pfleger died after a blood clot lodged in her lung, causing her to go into cardiac arrest as she made her way to class at Elon University in North Carolina.
In one of the latest court battles pitting consumers against a giant drugmaker, Cummins and thousands of others are alleging Bayer did not provide adequate warnings about the health risks associated with Yaz, and they are blaming the drug for causing blood clots, heart attacks, strokes and, in some cases, sudden deaths.
“Her death was so unexpected,” Cummins said. “Once we researched it, we felt very strongly that this was the cause of my daughter’s death, that the embolism was caused by Yaz.”
In an e-mailed response to questions about the mounting litigation against Bayer, spokeswoman Rose Talarico said the company would “defend itself vigorously” against the lawsuits.
“Bayer stands behind the safety of its oral contraceptives, which are safe and effective when used as directed and according to product labeling and good clinical practice,” she said. “The lawsuits filed by plaintiffs focus on side effects that are warned about in the labeling for Yaz and Yasmin.”
Yaz and its predecessor, Yasmin, are part of a group of oral contraceptives, including widely used generics such as Ocella, that contain a combination of the estrogen ethinyl estradiol and drospirenone, a synthetic hormone.
Both drugs were made by Berlex Labs, which was acquired in 2006 by Bayer Healthcare, the U.S. division of Bayer AG, the German pharmaceutical company. The Food and Drug Administration approved Yasmin in 2001, and five years later they allowed Berlex to begin selling Yaz, another version of the drug.
The two pills, backed by marketing campaigns, quickly became top-sellers, generating hundreds of millions in annual sales for Bayer. Last year, annual sales of Yaz reached $361 million, according to Pennsylvania-based SDI Health, which tracks sales of prescription drugs. Annual sales of Yasmin have declined since 2008 when the drug generated $329 million.
When they were approved by regulators, the pills were considered an advance over older forms of oral contraceptives because they were taken for 24 days rather than the usual 21, which was believed to benefit women because it created less hormonal fluctuation.
But early on, there were concerns about the health risks associated with drospirenone. A year after Yasmin went on the market, the nonprofit consumer advocacy group Public Citizen placed the drug on its list of “Do not use pills.”
The group warned consumers that drospirenone caused elevated blood levels of potassium, which could trigger serious heart problems. It also said that Yasmin did not work better than older oral contraceptives that were less likely to cause blood clots and other dangerous side effects.
Sidney Wolfe, director of Public Citizen’s Health Research Group, said even as a prescription drug’s safety risks become better understood, it can take years for regulators to insist on stronger warnings or for a drug to be removed from the market. “When you have enough evidence to suggest that there is no unique benefit and there are unique risks, that should be it,” Wolfe said.
The mounting litigation, he said, also will have little impact on whether the drug is ever removed from the market. “If companies think they will make more money by continuing to sell a drug, they will,” Wolfe said. “That’s the calculus, if they make more money than they will lose in litigation.”
In the case of Yaz, the mounting product liability lawsuits generally argue that Bayer provided inadequate warnings about the health risks for women taking the drospirenone-containing birth control pills.
More than 900 lawsuits have been filed in Bergen County — one of four courts where the mass tort litigation will be heard. Hundreds of other cases are filed in courts in Philadelphia, California and Illinois.
“We feel physicians and patients should have been advised with a stronger warning. That’s one of the tenets of the case,” said Cherry Hill attorney Greg Spizer, whose firm is handling about 200 lawsuits related to Yaz.
“Warnings are vital so physicians and patients can make sound decisions,” he said. “That’s the heart of what these cases are about.”
Ongoing studies of the drugs continue to reveal more information about the potential dangers of drospirenone-containing contraceptives.
In June, FDA regulators acknowledged new evidence that raised more questions about the safety of Yaz and birth control pills like it, including the top-selling generic Ocella.
The agency posted a notice on its website saying it was aware of studies recently published in the British Medical Journal that showed oral contraceptives containing drospirenone were two to three times more likely to cause blood clots than other birth control pills.
According to Lisa Spitzer MSW at the yaz Birth Control Pills Helpline "We are receiving calls Daily from women, mothers, Daughters and wives who have complications from Yaz"."The Yaz Trials have begun and it is not to late to seek justice form injuries form Yaz"
“Bayer so effectively mass marketed this, it became the contraceptive du jour,” she said. “It was the pill most women were getting.”
Yaz lawsuits mounting up. Bayer began settlements for Yaz. Contact a yaz Blood Clot lawyer today. File your Yaz lawsuit. The Yaz Men: Members of FDA panel reviewing the risks of popular Bayer contraceptive had industry ties
By Jeanne Lenzer and Keith Epstein
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Last month, the U.S. Food and Drug Administration convened a committee of medical experts to weigh new evidence concerning the potential dangers of drospirenone, a synthetic hormone contained in popular birth control pills including Bayer AG’s Yaz and Yasmin. In a decision that helped ensure the continued presence of these drugs on American pharmacy shelves, the committee concluded by a four-vote margin that the benefits of drugs with drospirenone outweigh the risks. However, an investigation by the Washington Monthly and the British medical journal BMJ has found that at least four members of the committee have either done work for the drugs’ manufacturers or licensees or received research funding from them. The FDA made none of those financial ties public.
Yaz and Yasmin are among Bayer’s top selling pharmaceutical products. According to the German drug manufacturer, over 4 million women worldwide use Yasmin alone. But the drug has also sparked growing controversy in recent months. A series of studies published in BMJ have shown that users of pills containing drospirenone have an increased risk of blood clots, which can cause deep vein thrombosis, pulmonary embolism, stroke, heart attack and death. And thousands of women have filed a lawsuit against Bayer, saying they were injured by Yaz or Yasmin.
Other Bayer products containing the hormone drospirenone are Beyaz and Safyral. In addition, four companies—Bayer, Teva, Watson and Sandoz—sell five generic versions of the drugs evaluated by the committee last month.
The FDA’s decision not to reveal its advisors’ relationships with the drugs’ manufacturers and Bayer raises serious questions about the agency’s treatment of potential conflicts of interest, a historically problematic area for the department. In 2004, controversy erupted over another FDA advisory hearing—involving the painkiller Vioxx—when it became clear that advisors with financial conflicts of interest were more likely than those without conflicts to vote that Vioxx was safe and should be allowed to stay on the market. The drug was ultimately withdrawn after a study showed it was associated with approximately 60,000 deaths. In 2008, partly in response to this uproar, the agency issued a new guidance on how to handle conflicts of interest among its advisors, stating that it wanted to reduce “bias” and to be more “transparent.”
The agency’s handling of the drospirenone hearings casts major doubt on how far it has gone to attain those goals.
What’s more, interviews and records also show that the drospirenone advisory committee, when it voted last month, lacked significant information about increased risks to the health of women using contraceptives containing drospirenone.
The FDA ordered the safety review of drugs containing the hormone after three articles published in the BMJ found an increased incidence of blood clots among users of the pills. The advisors were given these studies prior to the December 8 meeting. However, the panel was not shown documents from a report by David Kessler, a former FDA commissioner and an expert witness in the lawsuit filed against Bayer on behalf the women who say they were injured by Yaz and Yasmin. Kessler’s report cites internal Bayer corporate documents that suggest the company had withheld safety data from the FDA.
The documents show that in 2004, Bayer scientists reported in a draft analysis that Yasmin incurs a “several-fold increase” in reporting rates for blood clots compared to three other oral contraceptives, and that Yasmin’s rate of all serious adverse events was “10 fold higher” than that of other products.
In his report, Kessler writes that Bayer failed to report safety data to the FDA, engaged in off-label promotion of the pills, and paid $450,000 to a high profile gynecologist to sponsor her book tour in which she promoted such off-label uses.
Kessler’s report, originally under seal, was not released until December 6, two days prior to the advisory meeting. The FDA said it could not give the advisors the information because the date to submit documents had passed.
The FDA relies on some 50 advisory committees to obtain “independent” expert advice and “maintain the public trust.” Recommendations on evidence for safety and efficacy can lead to drug approvals and withdrawals; while nonbinding, recommendations by such committees can move stock prices and are generally regarded as indicators of official FDA action.
Under FDA guidelines, when advisory committee members have a financial relationship with a drug company whose product is under review, the agency can issue waivers that acknowledge the advisors’ links to industry but allow them to vote if their expertise is needed and no other specialists are available. Such waivers often serve as the only public signal that advisors have financial conflicts of interest. In the hearings on drospirenone, the FDA issued none.
And yet, according to public records, recently unsealed court documents, and interviews with some of the FDA advisors, at least four of the advisory committee members in this case have served as paid researchers, consultants, “key opinion leaders,” or speakers for Bayer or other manufacturers or licensees of drospirenone. A fifth advisor agreed to serve as a consultant but never executed the agreement. A sixth received consulting fees from a law firm representing Bayer.
In a 15-to-11 vote, the committee decided that the benefits of drospirenone outweighed its risks.Had those members with undisclosed conflicts of interest voted the other way, the committee would have come to the opposite conclusion. The committee also voted 21 to 5 to change the drug labels to warn that the hormone can cause blood clots. But the panel stopped short of recommending that the labels should warn that they are more likely than other contraceptive pills to cause blood clots. Instead the experts suggested that the labels say that the evidence about blood clots is “conflicting.”
Ironically, while the FDA allowed voting by advisors with business connections to drospirenone, the agency did bar another advisor—Sidney M. Wolfe, the panel’s lone consumer advocate—on the grounds that he has an “intellectual conflict of interest.” Wolfe, a former researcher, is a frequent critic of FDA practices on behalf of the advocacy group Public Citizen. Wolfe, the author of the consumer guide Good Pills, Bad Pills, had marked Yaz with a “do not take” advisory to readers. Jerome Hoffman, professor emeritus of medicine at UCLA, questioned Wolfe’s exclusion from the panel: “The idea that because he has an opinion on data that already exist he should be prevented from voting is nutty.”
Each of the advisors with ties to manufacturers told the Washington Monthly and BMJ that they fully disclosed their ties to the FDA, and there are no indications that the advisors failed to make required disclosures to the agency. The FDA, however, has declined to make public advisors’ financial conflict of interest forms, explaining that the forms are “confidential” and no information from them can be shared under a section of the Ethics in Government Act.
When asked whether the agency was aware of any financial ties between its advisors and manufacturers or distributors of drospirenone, FDA spokeswoman Morgan Liscinsky said, “No waivers were issued.”
But the committee’s financial ties to Bayer begin with no less than its acting chair. Julia Johnson, a professor of obstetrics and gynecology at the University of Massachusetts Medical School, conducted four clinical trials—including one of drospirenone as hormone replacement—for Bayer or its subsidiary Berlex, a manufacturer of drospirenone. She said in an e-mail, “The FDA is very vigilant on examining potential conflicts of interest and was aware of all my research.” When asked for an interview, she said, “The U.S. FDA states that I cannot speak about the meeting.”
Another advisor with ties to industry is Paula Hillard, a professor of obstetrics and gynecology at Stanford School of Medicine who has served as a paid consultant to Bayer Schering. Dr Hillard said she had fully complied with all FDA disclosures and referred the Washington Monthly and BMJ to the FDA for further questions. The FDA declined to respond to any questions, again citing the confidentiality clause of the Ethics in Government Act.
Elizabeth Raymond, a senior medical associate at Gynuity Health Projects in New York and another member of the committee, conducted studies funded by Barr, which has a licensing agreement with Bayer for generic versions of Yaz. Dr Raymond said that the FDA was “fully aware of all of my relevant current and past activities.”
Anne E. Burke, an assistant professor of gynecology and obstetrics at Johns Hopkins University in Baltimore, has received research funding from Bayer-Berlex and Duramed, which has a licensing agreement with Bayer for generic Yaz and Yasmin. Dr Burke said that she fully disclosed this to the agency.
According to Dr Kessler’s report, an internal Bayer document indicated that a fifth advisor received payment from Bayer, but that advisor told the Washington Monthly and BMJ that although she initially agreed to serve as a consultant for Bayer, the company never pursued the agreement. She said FDA records indicated that she had ties to Bayer due to her disclosure about her agreement, but after she was nominated to be on the drospirenone advisory committee, she corrected the error.
A sixth advisor, meanwhile, confirmed that he received consulting fees from a law firm representing Bayer in 2006. He told BMJ and the Washington Monthly that he did not disclose the information to the FDA because the FDA “did not require information for that time frame for consulting unrelated to the meeting topic.”
Bayer spokesperson, Rosemarie Yancosek, said in an e-mailed statement: “Bayer had no input on who serves on the U.S. FDA Advisory Committee panel as the FDA has its own process for selecting panel members. Furthermore, it is Bayer’s understanding that the FDA has a procedure for determining conflicts of interest for potential panel members.”
The FDA does indeed have such a procedure, but critics argue that its guidelines define conflicts of interest too narrowly and provide too much flexibility in how they are applied. The guidelines are technically “suggested or recommended, but not required” provisions (http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM125646.pdf). Whether an advisor can participate depends on “whether the discussion at the meeting or outcomes of the meeting will have a direct and predictable effect on the individual’s interest.” For instance, someone who was previously involved in another role for a manufacturer, or whose university received money from a manufacturer, may be allowed to participate. Even having a contract for $100,000 over a five-year period would not necessarily exclude an advisor, according to the guidelines.
Despite the FDA’s frequent claims that there aren’t enough experts independent of industry, a list of over 100 industry-independent experts has been presented to the agency – yet none of those experts has been tapped as an advisor.
The Project on Government Oversight, a Washington-based nonpartisan watchdog group, plans to raise concerns about the FDA’s conflict of interest policies in a letter to the agency’s top official, Margaret Hamburg.
“It shouldn’t require a lawsuit and investigative journalism to learn about these kinds of conflicts,” said the group’s executive director, Danielle Brian. “The Yaz case puts FDA’s feckless ethics policy into stark relief. It also reveals the human impact of conflicts of interest and why we need an FDA that shuns even the appearance of such conflicts.”
The organization intends to urge the FDA to routinely disclose industry ties and more aggressively determine whether an advisor has a conflict. “Right now,” said Brian, “the bar for considering whether an advisor has a conflict is too high.”
Jeanne Lenzer and Keith Epstein collaborated on this article. Lenzer is a medical investigative journalist based in New York. Epstein is a Washington-based investigative editor and writer.