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KEYCODE BAYER 421

PRWEB, August 12, 2009

Ohio Law Firm Warns of Birth Control Pill YAZ®/Yasmin® Side Effects

The widely-used oral contraceptive YAZ® (alternatively named Yasmin® ) has recently been targeted by the Food and Drug Administration (FDA) as a drug that is both dangerous and less effective than advertised. FDA reports reveal consumers of YAZ®/Yasmin® have been known to suffer debilitating injuries, such as deep vein thrombosis (DVT), stroke, heart attack, and pulmonary embolism - and have even died. The Ohio Law Firm of Spangenberg, Shibley & Liber LLP is alerting those who have experienced any YAZ®/Yasmin® side effects and resulting injuries to know their rights and encourages injured parties to reach out to them for a free legal consultation available nationwide.

In a 2009 FDA Warning Letter on YAZ®/Yasmin® the FDA has called for the manufacturer of YAZ®/Yasmin®, Bayer HealthCare Pharmaceuticals, to run advertisements explaining how it overstated the benefits of the birth control pill and to provide adequate warning of the drug's risks. As a result, physicians prescribing the YAZ®/Yasmin® pill may not be fully aware of the potential threat to patient health.

In a letter admonishing Bayer about its advertising, the FDA notes that the side effects of YAZ®/Yasmin® are more dangerous than those of other oral contraceptives in part because the drug contains drospirenone, a progestin that can elevate potassium levels in the blood. YAZ®/Yasmin® and its recently approved generic version is the only approved oral contraceptive to contain drospirenone. According to the FDA, drospirenone poses a problem to the body by increasing potassium levels, which in turn may create the metabolic condition known as hyperkalemia. One such consequence is cardiac arrhythmia, a disturbance of the flow of blood through the heart, which can lead to the formation of blood clots. "Because Bayer uses a warning typical of most oral contraceptives with respect to blood clot complications, the prescribing doctors may be lulled into a false sense of security when prescribing YAZ®/Yasmin®" says Spangenberg lawyer, Stuart E. Scott. "Our concern is that this very popular drug is being prescribed by doctors who believe it carries the same risk for blood clot complications as earlier generation oral contraceptives when the situation may be that YAZ®/Yasmin® has a much higher risk for serious blood clot complications while being no more effective in preventing pregnancy."

Anyone currently using YAZ®/Yasmin® should consult a physician if she notices abnormal heartbeats or pain with swelling in her legs - a sign of possible blood clot formation. Treatment for blood clots may require the use of anticoagulation medications (blood thinners) such as Coumadin® to prevent formation of further dangerous blood clots. Patients suspecting that their health has been damaged because of inadequate warnings about the side effects of YAZ®/Yasmin® may seek advice about their legal rights to obtain fair compensation for their injury.

Daily Telegraphy 14 Aug 2009

Tens of thousands of women “should consider switching pill”

Switching contraceptive pill reduces the risk of a potentially fatal blood clot, according to a pioneering study

In the first study claiming to conclusively rank the health risks associated with the different types of contraceptive pill, researchers found that some raised the chances of developing clots like deep vein thrombosis (DVT) by twice as much as others.
While all types of the oral contraceptive increase the risk of a clot, some combinations of hormones are worse than others.
Researchers warn that many women are not using the safest type to minimise their chance of clots like DVT, a blood clot in the leg or the lungs.
The study found that "second generation" pills first used in the 1970s, such as Microgynon, which contained low levels of the female sex hormone oestrogen combined with a second hormone levonorgestrel, were the safest.
Newer "third generation" pills, which have been available since the 1980s, which contained a hormone called desogestrel, carried twice the risk of DVT than the second generation medication.
The study also found that pills with higher or “standard” doses of oestrogen were also linked to an increased risk.
Prof Frits Rosendaal, of the Leiden University Medical Centre in the Netherlands, who led the study, said that although the over all risks were small, about one in 1,000 years spent using the pill, they should be considered when choosing a pill.
Around three million women in Britain are thought to take the pill to prevent pregnancy, and 100 million worldwide.
Prof Rosendaal said: “With such a large number of women using oral contraceptives, even the smallest increase of side effects will affect many.
“Knowledge of these risks and efforts to reduce them are of crucial importance.”
The study, published in the British Medical Journal, looked at 26 different oral contraceptives used by more than 3,000 women aged 18 to 50, 1,524 who suffered a blood clot and 1,760 healthy controls.
The research confirmed previous studies which have shown that the pill can increase the risk of suffering such a clot up to fivefold.
Compared to women on a pill containing levonorgestrel, those taking drugs containing other hormones including gestodene, desogestrel, cyproterone acetate and drospirenone were all at a higher risk of developing a clot.
The team found that women taking levonorgestrel had an almost fourfold increased risk of suffering a clot compared to women not on the Pill.
Those taking gestodene, such as Femodette, had an almost sixfold increased risk, while those on desogestrel had a risk that was more than sevenfold.
Women taking a pill with norgestimate, such as Cilest, had an almost sixfold extra risk as did those on drospirenone, such as Yasmin.
Those taking a drug containing cyproterone acetate, such as Dianette, often prescribed for acne, had an almost sevenfold additional risk.
A spokesman for Bayer, which makes Dianette, said: "This is a well known "class effect". However, this risk is lower than the risk of (such clots) in pregnancy."
Current NHS advice is that women should take pills containing levonorgestrel, but the Family Planning Association (FPA) warned that many women may not be, especially those who have taken the pill for a long time.
However, the FPA said that every women found the side effects of the pill different and that there were a number of good reasons why they might be on a different hormone combination.
Studies since the 60s have suggested that the pill can increase the risk of blood clots.
The drugs have also been linked to a slightly higher risk of breast cancer and cervical cancer in women if used long-term.
Lynn Hearton, helpline and information services manager at the (FPA), said: "It is important to realise that this study mirrors the current guidance for health professionals who prescribe the combined pill.
"The study reaffirms what we already know and that all brands of the pill are very safe.
"Although the combined pill does slightly increase the risk of thrombosis, the risk is still really low.
"If any women are worried about the pill they should not stop using it. They should continue taking it and seek advice from a health professional." By Kate Devlin, Medical Correspondent

The National Law Journal, July 14, 2009

Bayer Sued Over Safety of Popular Birth Control Pills

First came the warning letter from the U.S. Food and Drug Administration; now it's lawsuits.
Bayer HealthCare Pharmaceuticals has been hit with four individual federal lawsuits -- three in Ohio, one in Wisconsin -- involving the safety of its popular birth control pills Yaz and Yasmin. And plaintiffs lawyers vow that plenty more are in the pipeline.
The back-to-back lawsuits -- which were filed on July 7, 9 and 10 -- come after Bayer reached an agreement with the Food and Drug Administration in 2008 to run a $20 million corrective ad campaign for overstating the benefits of Yaz and downplaying its risks. The FDA had issued Bayer a warning letter about the ads, noting that Yaz actually has additional risks compared to other birth control pills because it contains the progestin drospirenone, which can increase potassium levels.
Plaintiffs lawyers say the FDA letter will serve as handy evidence in their lawsuits, which allege that Bayer failed to warn women and their doctors of the pills' increased risk of injury -- most notably blood clots -- while overpromoting the benefits of the drugs.
"That's going to be important evidence -- overpromotion and downplaying the risks," attorney Janet G. Abaray, who is representing the plaintiffs, said of the FDA warning letter, noting that more lawsuits are coming. "We expect to be filing consistently over the next several weeks and months. We have many cases. It's just a matter of getting all of the medical records."
Abaray, a shareholder in the Cincinnati office of Burg Simpson Eldredge Hersh & Jardine, said that her law firm has amassed evidence that shows that there are many more adverse events reported to the FDA for Yaz and Yasmin than for other birth control pills that have been around longer. Yaz received FDA approval in 2006, Yasmin in 2001.
"It's a very large discrepancy," she said, stating that doctors are unaware of these adverse events figures unless they figure it out for themselves, which, she claimed, they often don't. "The drug companies have known about the adverse effects for some time, and they have not warned the doctors or their patients."
Bayer, meanwhile, defended the safety of Yaz and Yasmin. Bayer spokesperson Rose Talarico said, "Bayer is committed to the ethical manufacture, marketing and distribution of our products. Patient safety is our top priority. We continually evaluate the safety of all our marketed products." She continued: "All oral contraceptives contain clear labeling indicating the benefits and risks. Bayer stands behind the safety and efficacy of Yaz and Yasmin when used as directed. A woman and her health care professional should always discuss the benefits and potential risks of adverse health effects associated with all oral contraceptives."
Talarico could not comment on the litigation, citing company policy. But she did say, "We remain confident in our defenses of these claims and will vigorously defend against them." Tresa Baldas

see also:
Bayer: Misleading Information About Oral Contraceptive Yaz
FDA cites Bayer for misleading birth control ads / Australian student killed