Novartis isn’t the only drug company to delve into web advertising. Last year, FDA’s Division of Drug Marketing, Advertising and Communications sent notices to 14 major pharmaceutical manufacturers informing them that their sponsored link advertisements violated disclosure agreements and did not adequately warn consumers of the drugs’ risks. This prompted Google to produce “FDA Friendly” banner ads, which were used by Bayer to market its blockbuster birth control pill Yaz. The ads’ headlines link to the product’s site, but the text encourages viewers to read the product information including the boxed warning.

Bayer is required to be extra cautious with its advertising of Yaz. The company launched its birth control pill with an advertising campaign that the FDA later said was misleading. The agency accused the company of overstating the drug’s benefits and using busy images to clutter its message on drug risks. Bayer was fined and ordered to run new ads that clearly stated the drug’s risks, which include blood clots, heart attacks, strokes, and gallbladder problems.

SOURCE: Yaz Lawsuit › FDA cracks down on drug companies’ use of web marketing

“Defendants have been issued warnings by the FDA at least three times – in 2003, 2008 and 2009 – for misleading the public through the use of ads which overstate the efficacy of YAZ/Yasmin and minimize serious risks associated with the drug,” the lawsuit reads.

Heather was prescribed and took Yaz/Yasmin beginning in October 2008 through July 2009 and during that time suffered multiple pulmonary emboli. She believes her birth control pill put her at greater risk for developing the serious side effects and blames Bayer for ignoring the link between the use of the pills and the increased risk of serious and life threatening side effects. Heather’s is one of more than a thousand lawsuits filed against Bayer for inadequately warning women of the risks of blood clots, strokes, heart attacks, gallbladder problems and other serious health issues, including death.

Heather’s lawsuit was filed against Bayer Corporation as well as Bayer Healthcare, Bayer Pharmaceuticals, Berlex, Berlex Laboratories, Bayer Schering Pharma AG, and Bayer Healthcare AG under the Louisiana Products Liability Act. She is seeking damages for medical expenses, physical pain and suffering, mental anguish, physical disfigurement, physical impairment, loss of earnings, loss of earning capacity, interest, and court costs.

SOURCE: Yaz Lawsuit › Another woman files lawsuit against makers of Yaz

Now, Bayer has waged another fight against the rival drug company. Bayer filed suit against Teva claiming some information on Gianvi’s label was false. The drug’s safety label claimed the birth control pill contained the same technology as Yaz that extended its shelf life. According to Bayer, Teva will inform U.S. pharmacists on a weekly basis for three months about the corrected physician prescribing information on the label. Teva has already updated the information on its U.S. website and provided the Food and Drug Administration with the corrected information.

Yaz contains drospirenone and ethinyl estradiol that is enclosed within a beta-cyclodextrin (betadex) clathrate. A clathrate is a molecule that forms a “cage” around another molecule or molecules. The betadex clathrate in Yaz is a Bayer-patented technology that protects the enclosed ethinyl estradiol molecule and stabilizes the product against oxidation. This patented technology enhances the product’s shelf life.

Bayer also faces more than a thousand lawsuits from women who claim they have suffered serious injuries such as blood clots, strokes and gallbladder damage from Yaz but the drug’s safety label did not adequately warn them about the risks.

Yaz has earned Bayer more than $1.5 billion since 2009.

SOURCE: Yaz Lawsuit › Bayer, Teva rival birth control pills go head-to-head in court

Holly Grigg-Spall

“I’d been popping a drug every morning for years knowing only what my doctor had said: the Pill ‘regulated’ my periods. I had always backed it up with condoms. I had taken it through my teens when I wasn’t having sex. It was an unthinking habit. It took one last switch to another brand, an eye-opening two-month break, then six months back on the Pill to make me realize what it had been doing to my body and my mind throughout my adult life. I came to understand why I felt so very sick,” she writes in a recent column recognizing the Pill’s 50th anniversary.

Over the course of a decade, the writer took four different birth control pills, including Yasmin, a pill also marketed as Yaz in the United States and the UK. Made by Bayer HealthCare, the oral contraceptive has become one of the most widely used birth control pills in the world.

“I was taking the brand Yasmin, which I had requested from my doctor after reading in magazines about its amazing skin-clearing and weight-loss side effects. My sisters and many of my friends were also taking it. Yasmin was marketed aggressively in the US, and news of its supposed benefits spread quickly to young women in the UK. The New York Times recently described Yasmin as the ‘go-to drug brand for women,’ which has been sold as a ‘quality-of-life’ treatment,” Grigg-Spall wrote.

Last year, the Food and Drug Administration (FDA) penalized Bayer for overstating the benefits and covering up the risks of Yaz and Yasmin and ordered Bayer to produce commercials that clarified the uses and risks of the drugs. Bayer now faces more than 1,000 lawsuits from women who say they were harmed by the drugs but were not adequately warned of the risks involved. That information was enough to convince Grigg-Spall to look for other alternatives in contraception.

“The Pill is handed out to women with acne, PMS, irregular periods, heavy periods. The Pill has developed into a medication for the disease of being female. In place of changing society, society decided to fix women. On the 50th anniversary of the Pill we should stop celebrating the fictionalized revolution of the Sixties and turn our attention to the rebellion underway today. Young women are ditching the Pill in droves. They have come to see that the Pill can be harmful, as is the sugar coating used to make us swallow.”

SOURCE: Yaz Lawsuit › Columnist: 50th anniversary of The Pill nothing to celebrate

“I hate the pill. Hormonal contraception, which covers birth control pills and nearly every other highly effective method on the market, murders my libido. I say that with as much certainty as I can, given the murky, multi-variate thing that is the human sex drive,” she writes in a post titled Why I hate the pill. “I’ve experimented with several pills, hoping that any slight variation in hormonal ingredients would yield a contraceptive that worked without neutering me. Each doused my interest in sex as completely as the other. Although a libido-destroying pill does wonders to lower your pregnancy risk, it’s also done a number on my relationships, self-esteem and emotional well-being.”

Sealey says she didn’t find relief from her problem when switching to other forms of birth control. Nothing seemed to be the right “fit.” But she makes a good point. “If you’re like me, you assume that someone, somewhere is figuring all of this out — that there will be a new kind birth control discovered or invented at some point because that’s just how human progress rolls on. I mean, they’re already working on another iPad. Surely, some lab rat is putting the finishing touches on the next breakthrough in contraception.”

Unfortunately, Sealey says, any prospect for the development of innovative birth control methods have stopped dead in their tracks. “According to a 2008 report by Harper and several colleagues, public and private funds for contraceptive research have dried up in recent years. Most pharmaceutical companies have withdrawn from investing in contraceptive R&D, perhaps due to fears of costly personal injury litigation. And those fears aren’t necessarily unfounded. A reported 1,100 lawsuits have been filed in the United States against Bayer HealthCare alone, mostly by women claiming health problems such as blood clots, strokes, heart attacks and gall bladder disease after taking the popular pills Yaz and Yasmin.”

Perhaps the key is not finding new methods, but making the ones currently marketed to women safer to use.

SOURCE: Yaz Lawsuit › Women deserve safer options in birth control

The first birth control pills approved for use in the 1960s contained high amounts of hormones, resulting in bothersome and sometimes dangerous side effects including mood swings, weight gain and blood clots. Since then, hormone levels in pills have dropped to as low as one-tenth of what they were 50 years ago. The side effects waned and benefits, such as regulated periods, less acne and bloating, and lighter flows, began to win over skeptics. Long term studies identified even greater benefits – a lower risk of ovarian and endometrial cancers.

But what also began to surface most recently were lawsuits aimed at the manufacturers of birth control products. For example, Johnson & Johnson recently settled thousands of lawsuits from women who suffered blood clots and strokes from the company’s Ortho Evra birth control patch. Similar lawsuits are mounting against Bayer Pharmaceuticals’ blockbuster oral contraceptive, Yaz. And most recently, lawsuits have been filed against the makers of the NuvaRing birth control device, all from women who say they were not adequately warned of their risk of serious and life-threatening injury.

“There are terrible misperceptions about these methods— and about all forms of contraception,” James Trussell, director of the Office of Population Research at Princeton University, told the Wall Street Journal. Given the women who have suffered needlessly, perhaps those misconceptions are with merit.

SOURCE: Yaz Lawsuit › Birth control pills celebrate 50th birthday, but safety still in question

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

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

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

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

Bayer has an obvious vested interest in the outcome of that survey. The drug company makes one of the nation’s most popular oral contraceptives, Yaz. It is also known by the brand name Yasmin and the generic brand Ocella. Bayer has hit snags over the years marketing its blockbuster birth control pill.

First, the Food and Drug Administration (FDA) fined the drug maker and ordered they spend millions on a revamped advertising campaign after the agency deemed its Yaz commercials were misleading and were not being forthright about the drug’s life-threatening side effects.

Next came the lawsuits – an estimated 1,100 to date – from women who say they were not adequately warned of the dangers in taking Yaz. These women suffered from serious health problems including blood clots, heart attacks, kidney failure, gallbladder disease and seizures. Some complications resulted in death or disability.

Bayer’s response to the mounting lawsuits has been unwavering. The company contends it will “defend itself vigorously against these lawsuits.”

Source: Daily Record

SOURCE: Yaz Lawsuit › Bayer has vested interest in survey results

Swissmedic

Birth control pills that contain drospirenone include the brand names Yaz and Yasmin as well as the generic Ocella. Drospirenone is a diuretic that can cause an increase in potassium in the blood that can lead to blood clots, strokes and sudden cardiac death. The drug has also been linked to significant problems with the gallbladder.

The most important updates of the product labeling for prescribers and patients concerns the frequency of venous thromboembolism, the presentation of the warning symptoms of venous thromboembolism, and the increased risk of venous thromboembolism after restarting oral contraception following a break of at least four weeks.

Yaz, manufactured by Bayer Healthcare Pharmaceuticals, Inc., is the only birth control pill sold in the U.S. that contains drospirenone. It is still prescribed by doctors despite numerous reports of serious injuries by women who took the oral contraceptives.

Source: World Radio Switzerland

SOURCE: Yaz Lawsuit › Yaz, Yasmin to stay on Swiss market despite risk of serious injury

The gallbladder’s sole function is to store bile, a dark green to yellowish brown fluid produced by the liver to aid in the digestion of fats in the small intestine. When the gallbladder becomes diseased, it can become inflamed and produce gallstones. A gallbladder attack occurs when the stones block the flow of bile. These attacks can cause excruciating pain and oftentimes the only remedy is to have the gallbladder removed.

Common contributing factors include weight gain or loss, hypothyroidism or thyroid disease, high cholesterol, alcohol intake, family history of gallbladder disease, and diabetes. However, use of estrogen and birth control pills are also considered risk factors as estrogen increases the concentration of cholesterol in the bile.

Gallbladder disease is one of the many serious adverse events reported with use of one particular brand of birth control pill, Yaz, also known as Yasmin and Ocela. An estimated 1,100 lawsuits have been filed against Bayer, the makers of Yaz, by women who say the birth control pill caused them to develop gallbladder disease, blood clots, seizures, cardiac arrhythmias, heart attacks, or strokes. As many as 59 deaths to date have been linked to Yaz.

SOURCE: Yaz Lawsuit › Birth control pill Yaz linked to gallbladder disease

Yaz, also known by the brand name Yasmin and the generic brand Ocella, is Bayer’s top-selling oral contraceptive and one of the most popular choices among women and doctors for birth control. Last year, the company raked in more than a billion dollars from the sale of Yaz. The pill is different from other birth control pills because it contains a diuretic, drospirenone, that can raise the potassium in blood to dangerous levels and cause to blood clots that can lead to sudden cardiac death, pulmonary embolism or strokes.

The lawsuits allege that Bayer didn’t do enough to warn women about the serious health risks to women who take Yaz. Even the Food and Drug Administration (FDA) cracked down on the drug company, saying advertisements for the birth control pill were overstating its benefits and understating the risks involved. Yaz commercials touted added benefits such as treatment for symptoms of premenstrual syndrome and acne. Since the FDA crackdown, Yaz was forced to run a series of ads clarifying the use of Yaz and clearly stating the dangers of taking the drug.

Victims say it’s too little, too late.

Bayer’s 2009 annual report does not specify how many women have died from the drug, but the FDA puts the count as high as 59.

SOURCE: Yaz Lawsuit › Bayer facing more than 1,100 lawsuits from women injured by Yaz

Bayer HealthCare

Yaz, also known by the brand name Yasmin and the generic brand Ocella, is a different type of oral contraceptive that combines ethinyl estradiol with the diuretic drospirenone. Some health professionals say that the addition of drospirenone in birth control raised the potassium level in users’ blood. This increase in potassium can lead to hyperkalemia and cause heart rhythm disturbances that can cause blood clots that can cause sudden cardiac death or pulmonary embolism or strokes. At least 50 women and their family members have filed suit against the Bayer claiming the drug manufacturer knew of the potential risks but did not properly warn women.

Bayer has argued that it sufficiently warned women that Yaz, like all birth control pills, carries a risk of life-threatening side effects.

Last year, Bayer, after getting its hand slapped by the Food and Drug Administration (FDA), shelled out $20 million to air advertisements to clarify the drug’s use. The FDA argued the company’s previous ads misled consumers by broadening the drug’s indication. The commercials promoted Yaz as a treatment for PMS, a condition for which it was not indicated, and acne, a condition in which Yaz has a limited indication. The FDA also said that the drug’s risk information was not stated clearly and was clouded with distracting visuals, background music and other “competing modalities.”

Meanwhile, Yaz remains on the market and continues to rake in money for Bayer. Yaz scored $9 billion in the first nine months of 2009, a sizable increase over the $600 million it made in 2008.

SOURCE: Yaz Lawsuit › Bayer pockets billions from dangerous birth control pill Yaz

What Adrienne didn’t know was that while the combination birth control pill had benefits, it also increased users’ risk of serious side effects such as heart attack, cardiac arrhythmias, stroke, pulmonary embolism, blood clots, kidney failure, seizures, deep vein thrombosis, gallbladder disease, hepaic adenomas and sudden death. Adrienne believes Ocella caused her to suffer from a stroke and other serious side effects. She claims it also left her at an increased risk of developing additional side effects such as blood clots in the deep veins and lungs.

On December 28, 2009, Adrienne and her husband Kenneth, filed a lawsuit against Bayer HealthCare, the manufacturer of Yaz, and other manufacturers and distributors, seeking $75,000 from each defendant, as well as punitive damages and compensation for medical care, pain, suffering, and mental anguish.

Adrienne’s lawsuit is one of hundreds from women who say they have suffered serious side effects from Yaz, Yasmin and Ocella. The Food and Drug Administration (FDA) reports that between 2004 and 2008, more than 50 deaths have been attributed to the drugs.

SOURCE: Yaz Lawsuit › Woman claims Yaz/Yasmin/Ocella caused her stroke