See: Yazdidbad.com
This post has turned into an entire website. For more information see YazDidBad.com
There are now over 1,100 lawsuits filed by women and their families who suffered strokes after taking the birth control pills Yaz, Yasmin and Ocella according to the December 31, 2009 10K filed by Bayer AG.
Yaz®, Yasmin®, Gianvi and Ocella® UA-10156234-1 Health Effects
- Blood clots
- Deep vein thrombosis
- Strokes
- Heart attacks
- Gall bladder damage
- Kidney problems
- Sudden cardiac death
Yaz, Yasmin, Gianvi and Ocella Birth Control Pills – What Makes them Different?
In short: Yaz, Yasmin, Gianvi and Ocella are associated with GREATER HEALTH RISKS and do NOT provide greater benefits.
The theory is that it is wise to take a birth control pill that is safer than Yaz, Yasmin, Gianvi or Ocella.
There is NO REASON to take a birth control pill that is more dangerous to your health.
Allegations regarding Yaz and Yasmin birth control pills focus on knowledge by Bayer of the serious health risks associated with the hormone drospirenone (or “drsp”) contained in both Yaz and Yasmin, and the failure to adequately warn the public about these risks.
Specifically, allegations are that women who take Yasmin or Yaz birth control (also known by the generic name Ocella and Gianvi) are at a greater risk of developing severe health problems, including blood clots, strokes, pulmonary embolism, gallbladder problems, and other severe health complications than with other oral contraceptives.
FDA and Yaz Birth Control Pills
Beginning in 2003, the FDA issued three warning letters to the drug manufacturers for false and misleading television advertisements about Yasmin and Yaz. The FDA found that several Yasmin and Yaz advertisements minimized the health risks associated with these medications, while promoting them for the treatment of conditions that the FDA had not approved.
WATCH OUT — GIANVI IS YAZ
AND NOW THIS:
Teva admits Gianvi label information was false: Bayer
17 June 2010
June 17 (Reuters) – Bayer said Teva’s U.S. unit admitted in a court proceeding on Wednesday that some of the information included on packages of its oral contraceptive Gianvi was false and agreed to correct its labeling.
Bayer said Gianvi, a generic version of Bayer’s YAZ birth control pill sold in the United States, falsely claimed that it contained Bayer’s technology that extended the shelf life of the drug.
Teva will inform U.S. pharmacists on a weekly basis for three months about the corrected physician prescribing information on the label, Bayer said in a statement.
Teva has already provided the U.S. Food and Drug Administration with the corrected information and has also corrected the labeling of the drug on its U.S. website, Bayer said.
Teva Admits to Making False Statements in US Gianvi™ Label and Agrees to Corrective Measures; – Bayer’s lawsuit under the Federal False Advertising Act (the Lanham Act) results in Teva agreement to make three months of weekly communications to pharmacists to correct false labels
Bayer HealthCare Pharmaceuticals; PR Newswire
Why are they more dangerous?
Yaz, Yasmin, Gianvi and Ocella (the generic version of Yasmin) are considered to be “combination” birth control pills.
Combination birth control pills contain two types of hormones: estrogen and progestin.
Yaz and Yasmin and the generic Gianvi and Ocella contain a relatively new type of progestin hormone known as drospirenone, or “DRSP” and a type of estrogen called ethinyl estradiol.
DRSP (Drospirenone) May Cause More Serious Health Risks
The problem is that medical studies have shown that birth controls containing DRSP may cause more serious health risks than other birth control pills AND they are no more effective than pills containing a natural hormone.
A Dutch medical study and a Danish medical study, concluded that birth control pills containing DRSP have a higher risk of causing thrombosis or a blot clots.
The FDA has warned that women with high levels of potassium levels shouldn’t take Yaz or Yasmin because DRSP may also cause an increase in potassium, which can be life-threatening.
Yaz® and Yasmin® Birth Control Pills
Yaz® and Yasmin® are manufactured and marketed by Bayer Healthcare Pharmaceuticals or Bayer AG which is a German Company and traded on the Frankfurt Exchange. Ocella and Gianvi the generic version of Yasmin is made by Barr Pharmaceutical which was purchased by the Israeli Company, Teva Pharmaceuticals and is traded on the Nasdaq under the ticker symbol: TEVA. (See About Teva below.)
FDA Approval
The U.S. Food and Drug Administration first approved :
- Yasmin® Birth Control Pillsin 2001
- Yaz® Birth Con trol Pills approved in 2006
- Ocella Birth Control Pills approved in 2008
- Teva marketed Ocella as Gianvi in 2010 (name change)
The Difference between Yaz and Yasmin Birth Control Pills
Yaz®, Yasmin®, Gianvi and Ocella® Birth Control Pills are the only birth control pills sold in the U.S. that contain drospirenone and estrogen.
Yaz® and Yasmin® contain nearly the same active ingredients:
- Ethinyl estradiol, an estrogen component and
- Drospirenone, a progestin.
Yaz® and Yasmin® are the only brand name birth control pills on the market with this combination of hormonal ingredients. Ocella, is the generic version of Yasmin.
Difference between Yasmin/Ocella- Gianvi and Yaz Birth Control Pills
The difference between Yasmin® and Yaz® are their progestin ingredient: drospirenone is a fourth generation progestin that is not found in other birth control pills sold in the U.S.
Drospirenone or DRSP Is a Diuretic
Drospirenone, the progestin component in Yaz®, Yasmin®, and Ocella® Birth Control Pills, is a diuretic– any drug or natural aid that promotes the formation of urine and excretion of water from the body. It can also contribute to heart rhythm disturbances, increased blood potassium levels called hyperkaelemia, and can cause sudden death.
Drospirenone can also contribute to severe gallbladder problems in very young women, necessitating gallbladder removal.
It is believed that drospirenone, when combined with estrogen, has adverse effects that are more dangerous than earlier generations of oral contraceptives.
Standard Birth Control Pill Risk
Doctors and researchers have found that women taking estrogen which is the basic ingredient in birth control pills, increased their risk of developing blood clots.
Blood clots in coronary arteries can cause heart attacks. Blood clots in the legs can cause pain, break off and travel to the lungs where they can cause potentially fatal blood clots in the lungs called pulmonary emboli. Blood clots traveling to the brain can cause strokes, and deaths. If the blood clots go undetected or untreated, they can be lethal.
FDA Adverse Event Database
Yaz®, Yasmin®, Gianvi and Ocella®
The FDA Adverse Event Database reveals a substantial number of serious adverse events associated with these drugs, including more than 59 deaths where the women were taking Yaz®, Yasmin®, or Ocella®.
Manufacturers of prescription drugs have a duty to patients to produce safe products, and to warn patients and their doctors of any adverse health effects.
In lawsuits filed against Bayer by patients represented by patients allege that Bayer sold Yaz®, Yasmin®, and Ocella® without adequate warnings about the increased risk of serious injuries and, specifically, failed to warn doctors and patients that Yaz® and Yasmin® are more dangerous than other oral birth control pills on the market.
It is believed Bayer improperly advertised and over-promoted Yaz® for uses such as treating acne and PMDD, while knowing that the risks of such use outweighed any benefits Yaz® may have for acne sufferers and those with symptoms of PMDD.
Teva Manufactures a Generic Yaz know as Ocella
Teva, the manufacturer of Ocella, filled nearly 630 million prescriptions in the United States in 2010. This means one out of every six prescriptions filled in the United States was filled by Teva. Teva is a a larger domestic supplier Pfizer, Novartis and Merck — combined.
Teva sells low-cost generics and is the generic industry leader,.
Teva produces 60 billion tablets a year in 38 different locations in the world.
Teva does not t advertise or brand its no-name products.
From 1999 to 2009, Teva’s revenue grew to about $14 billion from $1.3 billion and its profits went to $2 billion from about $135.5 million.
Teva anticipates revenue of $31 billion by 2015. Generic charge lower prices than pharmaceutical companies because they do not develop a medication from scratch. Instead, they use the active ingredients major pharmaceutical concerns have already created when the large pharma’s lose their medicine’s patent protections.
Generics now account for 75 percent of the prescriptions filled in the United States, up from about 47 percent a decade ago, according to IMS Health, an industry research firm.
Teva has a market capitalization of about $53 billion.
Teva is now developing its own drugs: Copaxone is a treatment for multiple sclerosis.
The Food and Drug Administration recently cited Teva for “serious manufacturing violations” at a plant in Irvine, Calif., where the company makes intravenous drugs.
“Can they keep their finger on the pulse of every single smaller company they acquire, every generic maker and ingredient supplier?” says Joe Graedon, a consumer advocate, pharmacologist and co-founder of a drug information Web site called the People’s Pharmacy. “I don’t have an answer on that, but we have clearly seen some missteps over the last few months.”
Who is Bayer — This is a Huge Company Based in Germany
Bayer – Full-year 2009 Sales of $42.47B USD
Sales Bayer’s best-selling product – the oral contraceptives of the Yaz (drospirenone + ethinyl estradiol) family increased by 4.7% US to reach $1.74B.
Growth in the healthcare division was driven by positive business trends in both the pharmaceuticals and the consumer health segments, particularly in the emerging markets – further reinforcing BMI’s core view that emerging markets will drive industry growth. (See targeting Asia with Yaz.)
Sales in the pharmaceuticals segment increased by 4.4% in 2009, to reach US$14.27bn.
- Pharmaceuticals revenue earned in Europe declined by 1.8%,
- Pharmaceuticals revenue earned in North America increased by 2.5%,
- Asia-Pacific and Latin America 18.3%
- Africa and Middle East 8.2%
The highest growth rates among Bayer’s most significant gains were made by Aspirin Cardio (enteric coated acetylsalicylic acid; +14.9% to US$429mn), especially as a result of strong gains in China, where the drug is used to protect against myocardial infarction.
Another high achiever was the antihypertensive Kinzal/Pritor (telmisartan) (+14.5% to US$223mn).
Sales of cancer drug Nexavar (sorafenib) rose significantly (+27.9% to US$822mn), chiefly as a result of further market launches and the expansion of its registration in Japan to include being indication for treating liver cancer.
Sales of the subgroup’s best-selling products – the oral contraceptives of the Yaz (drospirenone + ethinyl estradiol) family increased by 4.7% to reach US$1.74bn
Sales of the subgroup’s best-selling products – the oral contraceptives of the Yaz (drospirenone + ethinyl estradiol) family and the multiple sclerosis drug Betaferon/Betaseron (interferon beta) – also increased by 4.7% and 5.7% respectively, to reach US$1.74bn and US$1.65bn.
Sales in the consumer health segment increased by 2.7% in 2009, to US$7.52bn. Consumer health revenue earned in Europe increased by 1.8%, while in North America, the Asia-Pacific and Latin America/Africa/Middle East it increased 3.0% and 14.4% and declined 2.3% respectively. The increase was largely attributable to significant sales gains in Russia and China, which offset a weaker business trend in the US.
In 2010, the Bayer is targeting currency- and portfolio-adjusted sales growth of more than 5% by continuing to invest in the research and development pipeline, in bioscience and in the emerging markets. The company aims to file a marketing application for its new antithrombotic drug Xarelto (rivaroxaban), which Bayer is developing together with its partner Johnson & Johnson, in H210.
Commenting on performance Bayer noted as follows:
Bayer says recovery brings spike in sales
Bayer Group said a recovery in its material sciences business helped boost first-quarter sales by 5.3 percent and net income by 63 percent. The chemicals and pharmaceuticals maker, which has its U.S. headquarters in Robinson, said global sales grew to $11 billion for the quarter while net income was $916.8 million, or $1.59 per share. In North America, sales rose by 2 percent to $2.9 billion. The company expects 2010 annual sales to increase by more than 5 percent. After a weak performance a year ago due to the economic recession, sales in Bayer’s materials business including raw materials used in polyurethanes, coatings and adhesives jumped by 36 percent. But sales of health-care and crop science products were sluggish.
Lee Ann Torrans
ltorrans@gmail.com
