There is no doubt that with all oral contraceptives there is a slight risk for blood clots. Bayer, maker of Yaz and a family of other drospirenone-containing pills such as Yasmin, Beyaz and Safyral, has consistently claimed its pills were no more as dangerous than other birth control pills.

However, newer studies have indicated the risk of drospirenone-containing pills may be as much as 74 percent greater than older generation hormones, such as levonorgestrel.

Blood clots, also known as venous thromboembolism (VTE), can break away and move to the lungs and cause respiratory distress, to the heart and cause heart attacks, or to the brain and trigger strokes – all conditions that can be deadly. The pills have also been associated with a greater risk for gallbladder damage.

Nearly half of the advisory panel charged with reviewing the safety of Yaz voted that the risks associated with the pills were greater than the benefits. But the slight majority of the panel gave credit to the drug’s other so-called benefits, including treating certain menstrual-related problems and moderate acne.

Some voters also raised concerns that the studies did not adequately take into account factors that could contribute to the development of blood clots such as body mass index, smoking, socioeconomic status and family history. The studies were also observational, not controlled.

The committee ultimately voted 21 to 5 that the labels on dropsirenone-containing pills do not adequately reflect the risk-benefit profile and recommended that a stronger warning should be placed on the pills. The FDA is not required to follow the advice of its committee members, but it most often does.

Source: CNN

SOURCE: Yaz Lawsuit › Why would FDA panel not ban Yaz over blood clot risk?

All birth control pills carry a slight risk for blood clots, but critics have long argued that Yaz and Yasmin put women at even greater risk. Both Yaz and Yasmin are made by Bayer Healthcare and contain the hormone drospirenone.

Health Canada’s announcement comes just days after the U.S. Food and Drug Administration (FDA) said it was keeping a watchful eye on two recent studies published in the British Medical Journal that compared the blood clot risks with drospirenone-containing birth control pills to pills that contained another popular birth control hormone known as levonorgestrel.

Birth control pills that contain drospirenone include Bayer’s Yaz, Yasmin, Beyaz and Safyral, as well as generics Ocella, Gianvi, Loryna, Syeda, and Zarah. Bayer has maintained that its pills are no more dangerous than other birth control pills; however, the pharmaceutical company faces thousands of lawsuits from women or their families who say that their drospirenone-containing pills caused them serious injuries such as blood clots, strokes, heart attacks, gallbladder damage, and even death.

Both Health Canada and the FDA say they will review all available information to fully assess the risk of blood clots with drospirenone-containing pills and will take appropriate action as necessary once the review is complete.

Sources:
680 News
FDA

SOURCE: Yaz Lawsuit › Health Canada reviewing data linking Yaz to greater risk of blood clots

The studies referenced by the FDA looked at VTE rates in women using birth control pills containing drospirenone compared with women taking pills containing levonorgestrel. Data showed that the risk for venous thromboembolism, or pulmonary embolism, is as much as two to three times greater with drospirenone-containing pills than with levonorgestrel-containing pills.

Bayer launched its blockbuster birth control pill Yaz with a huge marketing campaign that claimed it could conquer symptoms of premenstrual syndrome and clear up acne. The FDA fined Bayer for overstating the benefits of the drug and downplaying the risks, including the risk for blood clots.

Women began asking their doctors for Yaz by name, making it the most prescribed birth control pill in the country. The success of Yaz was only slightly hampered by a series of ads Bayer was forced by the FDA to run that clearly stated the risks associated with the pill. It wasn’t until reports of deaths and serious injuries in women who used Yaz that the public began to take notice.

Bayer has defended its oral contraceptives, arguing they are no more dangerous than other birth control pills. The new studies suggest otherwise. Bayer now faces thousands of lawsuits from women and their families who say they were not adequately warned of the risks associated with the pills, including blood clots (including VTE), heart attacks, strokes and sudden death.

The FDA recommends women who have questions about their oral contraception contact their doctors. If they experience any of the following symptoms of VTE to seek medical help immediately – persistent leg pain, severe chest pain, sudden shortness of breath.

Women who smoke and are older than 35 years of age should not take combination birth control pills because they increase the risk of serious cardiovascular events, including blood clots.

Source: FDA

SOURCE: Yaz Lawsuit › FDA warns of elevated blood clot risk in Yaz birth control pills

Bayer

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

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

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

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

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

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

Bayer

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

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

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

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

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

When customers go to Google’s search engine and perform a search for information on Yaz or “the pill,” they will see this simple new ad format appear in the search results. Some sponsored links will appear at the top of the results in a yellowish box. One of the links will lead to Bayer’s website for Yaz and will contain a gray-text notice: “Click to see full safety and prescribing information, including boxed warning.”

Why is Bayer using this new format for Yaz? Because the U.S. Food and Drug Administration has warned pharmaceutical companies about using the text promos for drug advertising since they do not contain any warnings or disclaimers to customers about possible side effects, health risks, and other drawbacks.

Bayer clashed with the FDA last year over its Yaz advertisements. The company aired a couple of television commercials titled “Not Gonna Take It” and “Balloons” that promoted the drug for unapproved uses, downplayed its risks and side effects, and used competing music and visual to draw the viewer’s attention away from the safety information. The FDA ordered the ads off the air and requested that Bayer spend a minimum of $20 million on a “corrective” ad campaign.

Other drug companies, anxious to promote their drugs through Google’s sponsored links without being called out by the FDA, will no doubt keep a watchful eye on the agency’s reaction to the new Yaz links.

SOURCE: Yaz Lawsuit › Bayer tests Google’s new ad format for Yaz promotion

“Even though I’m old, I don’t want the horrifying side effects of aging to prevent me from doing what I love,” Haskins, who just turned 30, jokes. “I want to walk with canoes, peel oranges, play fetch with my pup, and do stuff with horses,” she says while a montage of images pulled from actual television drug ads plays. In one of the ads Haskins shows, anatomy takes the form of bouncing water balloons; in another, people are made of pipes. After all, cute, cartoon-like illustrations help lighten ads for drugs that pose very serious side effects for some people.

Amusing as Haskins’ Target episode is, it effectively illustrates just how outlandish and just plain silly some pharmaceutical advertising can be.

It’s also not the first time that Haskins has featured drug commercials on Target: Women. Last year, she spoofed big pharma television ads for birth control drugs, noting how they are touted as a way to have fewer periods more than anything else.

“Fewer periods! Yay! Now we don’t have to leave the tribe and go sit in that hut for a week. That was a bummer,” Haskins says.

Drugs developed for one thing but marketed as a treatment for something else is a common ruse employed by some pharmaceutical companies to make their products more enticing. Negative disclosures about the drugs, such as the legally required information about side effects, may be washed out with distracting music and visuals. That was how Bayer advertised Yaz last year, before the Food and Drug Administration cited the company for false and misleading advertising and ordered a redo.

“You may have seen some Yaz commercials recently that were not clear. The FDA wants us to correct a few points in those ads,” the presenter in the revised commercial says.

The Yaz advertisements spawned a number of video skits lampooning the drugmaker’s claims and the style in which they are presented: a group of girlfriends in a lively bar discussing side effects in a way that would never happen in real life. One woman, who says she “didn’t go to med school for nothing,” gives her friends an off the cuff and very clinical rundown of the drug’s risks while her friends listen intently.

Inserting herself into this scenario, Haskins asks “Does anyone think Stephanie is acting super weird right now?”

For all the risks attached to some blockbuster drugs, it’s good to see that the absurdity of drug advertising isn’t sliding by unnoticed.

SOURCE: Yaz Lawsuit › Comedian lampoons the absurdity of drug ads

The plaintiff claims that at the time, she was not aware the FDA had not approved Yaz for the treatment of skin conditions. In an extensive and aggressive marketing campaign, Bayer touted its birth control drug as an effective treatment for acne and symptoms associated with Premenstrual Syndrome (PMS) – conditions for which the FDA never tested or approved Yaz.

In October 2008, FDA officials warned Bayer that its Yaz ads intentionally mislead and confused viewers by overstating the drug’s effectiveness, overselling its benefits, and not adequately communicating the drug’s potential for serious side effects, including blood clots, cardiac arrest, and gallbladder disease. According to the FDA, the commercials used distracting visuals, multiple scene changes, and background music that effectively interfered with the audio presentation about the serious risks associated with the drug.

“Bayer promoted Yaz with the slogan ‘the difference a little chemistry can make,’” the plaintiff said. “What Bayer did not disclose was how negative that difference can be. Yaz gave me life-threatening injuries that have forever altered my life.”

After several months of Yaz therapy, the plaintiff developed an acute pain in her left shoulder and had difficulty breathing. A visit to the doctor revealed the plaintiff had developed blood clots in both her lungs. She was hospitalized immediately and treated successfully, but just one month later she developed gallstones and had to undergo surgery for their removal.

The plaintiff alleges that she “suffered months of anxiety and nausea related to (the) medical procedures and drugs given to treat the adverse side effects (she) developed from taking Yaz.”

The complaint charges that had Bayer properly warned patients about the dangers of using Yaz strictly as an acne treatment, the plaintiff could have avoided serious injury.

The lawsuit was filed in the Superior Court of New Jersey, where Bayer’s American operations are based. The plaintiff seeks an unspecified amount of compensatory damages.

SOURCE: Yaz Lawsuit › Injured by Yaz, SC nurse files lawsuit against Bayer

Pulmonary embolisms are blockages in one of the arteries leading to the lungs formed by a substance that has migrated through the bloodstream from another part of the body, commonly the legs. Clinical studies of Yaz conducted in Denmark and the Netherlands suggest a link between the Yaz ingredient drosperinone and a higher occurrence of blood clots than in women who took traditional contraceptives containing levonorgestrel.

A spokesperson for Bayer said that the company is cooperating with the investigation, but that it stood by the safety of its drug.

“A singular case, as tragic and sad as it is, does not indicate an increased risk for the whole group of women who take the pill,” Oliver Renner, a Bayer spokesman, told Bloomberg. “Studies have shown that the risk isn’t higher for Yaz than for other oral contraceptives.”

Of course, Bayer’s spokesperson dismisses the results of the two independent clinical trials and focuses on the more favorable outcome the Bayer-funded clinical test, which suggested the risks of Yaz were similar to those of traditional birth control therapies.

As the top selling oral contraceptive in the world, Yaz is big business for Bayer. The drug brought in $1.86 billion just in the first quarter of 2009.

SOURCE: Yaz Lawsuit › Switzerland investigates the death of young Yaz user

The New York Times recently published a report about the dangers frequently associated with Yaz and other oral contraceptives. The article observes that one Bayer-sponsored European study involving tens of thousands of women found no difference in the level of cardiovascular problems or death between women taking Yaz and women who took levonorgestrel, a much older progestin-based drug.

However, the results of two other studies conducted in Denmark and the Netherlands and published in the British Medical Journal last month, showed that women who took Yaz and other newer progestins had a higher risk of blood clots, which can adversely affect the heart.

One doctor quoted in the New York Times report theorized that Yaz and other newer forms of birth control may have a different affect in European populations versus the more racially diverse and genetically mixed American population.

However, Dr. Frits Rosendaal, a clinical epidemiologist at Leiden University Medical Center in the Netherlands, told the New York Times that patients taking Yaz should switch to birth control drugs containing levonorgestrel. “Even if the risk of thrombosis is low, why not choose the lowest risk, just in case?” he told the New York Times.

Both Bayer and the FDA are conducting ongoing studies designed to measure the safety risks of Yaz and Yasmin against drugs that do not contain drospirenone.

SOURCE: Yaz Lawsuit › Yaz health risks: better safe than sorry?