YAZ, Yasmin, And Ocella: News And Information

YAZ, Yasmin, and Ocella are oral contraceptives, or birth control pills, manufactured by Bayer HeathCare Pharmaceuticals, Inc. Yasmin was FDA approved for sale on the U.S. market in May 2001; YAZ was approved in 2006. Since that time there have been numerous reports of serious side effects associated with YAZ and Yasmin involving blood clots, some of which have resulted in death. Specifically, YAZ and Yasmin have been linked to several blood clot related conditions: pulmonary embolism (PE), deep vein thrombosis (DVT), strokes, and heart attacks. These conditions can, and sometimes do, lead to death.

YAZ, Yasmin, and Ocella are combined "fourth generation" oral contraceptives, with ethinyl estradiol (EE) as the estrogen component and a new progestin: drospirenone. Although these birth control pills carry a bolded warning for side effects having to do with hyperkalemia and increased serum potassium, they do not bold the other, more serious, cardiovascular side effects. These leads one to wonder: are the package inserts, or labels, for these oral contraceptive pills are strong enough?

In 2002, Public Citizen issued a Do Not Use! article advising against the use of Yasmin. It states that in spite of Bayer's claims, "there is no evidence that Yasmin is superior in any way to older contraceptive products... There is no medical reason that you should be using Yasmin rather than one of the older pills...."

YAZ, Yasmin, and Ocella have been associated with an increased risk of dangerous side effects such as:

---> Stroke
---> Heart Attack
---> Deep Vein Thrombosis (DVT)
---> Myocardial Infarction
---> Cerebrovascular Accidents
---> Pulmonary Embolism (PE)
---> Death

For more information on YAZ, Yasmin, and Ocella, you may also wish to visit my law firm's web site, www.DrugInjuryLaw.com. In the alternative, you may also submit a confidential free case evaluation.



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In spite of what you may think after simply browsing the web, YAZ and Yasmin (generic: Ocella) are not the same thing. Although they are both comprised of estrogen and the "fourth generation" progestin, drospirenone (drsp), they have some subtle, yet important, differences.

First, Yasmin contains 30 mcg of the estrogen component, ethinyl estrdiol. YAZ contains 20 mcg. That means you get a slightly lower dose of estrogen per pill.

However, the active YAZ pills are taken for 3 days longer than Yasmin, which has a normal 21 day active pill cycle. That means with YAZ, the hormones are in your system for longer. "3 additional days of drsp/EE thanks to shorter hormone-free intervals," the YAZ United States website boasts.

In addition to the estrogen remaining in your body for longer with YAZ, in both YAZ and Yasmin, the progestin "extends its activity" throughout the inactive pill period. Keep in mind, this is the ingredient with the bold-faced warning about its danger of hyperkalemia, which is considered a medical emergency.

The final difference between YAZ and Yasmin is their indications. YAZ can be taken for 3 indications as opposed to Yasmin, whose only indication is for birth control.

YAZ is indicated for the treatment of PMDD, or premenstrual dysphoric disorder. It is unknown how effective YAZ is at this treatment after it is used for more than 3 menstrual cycles. Keep in mind, PMDD is not PMS. YAZ has no claim to treat PMS.

YAZ is also indicated for the treatment of acne vulgaris.

Brief Summary:

YAZ and Yasmin (Ocella) both contain estrogen and the potentially very dangerous progestin, drsp.

YAZ contains slightly lower estrogen count, but has a longer active cycle, and has 3 indications.

Yasmin contains a higher estrogen count, has the standard 21day active cycle, and has 1 indication.

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In May 1960 the FDA approved the first ever hormonal contraceptive, the birth control pill. Engendered by Margaret Sanger, founder of Planned Parenthood, strongly believed that only in ideal circumstances should a man and woman conceive. The pill was her idea to help families wait and time conception for that perfect moment. Although Sanger's motives have been considered less than ethical, and often downright racist, her vision did lead to the sexual empowerment of women the world over.

Since that time there have been many "advancements". We now have the patch, the ring, IUDs, birth control pills which help with acne and premenstrual disorders, and pills which even allow a woman to skip her period for months or even years. What the pill can do, and allows women to do, has come a long way. But how far have advancements in safety come?

Only two years after Enovid, the first contraceptive pill to receive FDA approval, hit the markets, their were numerous reports of safety issues. Most were related to blood clotting:

"There were reports of blood clots, strokes --and possible links to cancer. As early as 1962, the manufacturer of the birth control pill Enovid, G.D. Searle and Company, received reports of 132 cases of blood clots in Pill users. Eleven of the cases resulted in death. Searle maintained that there was no conclusive proof that the Pill caused those deaths, and the FDA assured doctors the drug was safe." (PBS.org)

The incidents only grew. Now, with the advent of more "convenient" birth control choices such as Ortho Evra and NuvaRing, and birth control pills that "go beyond" such as antiandrogenic pills like YAZ, Yasmin, and Ocella, the safety issues associated with these new combination contracptives are reaching the mainstream media, and therefore, the public.

Interestingly enough, study after study has shown that the older hormonal contraceptives containing ethinyl estradiol and levonorgestrel, are the safest. The controversy now remains: why are these new progestins, such as drospirenone (in YAZ, Yasmin, and Ocella) and etonogestrel (found in NuvaRing), which appear to have more risk for thromboembolisms, allowed to remain on the market?

If there is a safe effective hormonal contraceptive available, why does the FDA continue to allow these new formulations? The ability to prevent pregnancy is not changing with these contraceptives, but the safety aspect is. Hormonal contraceptives appear to be increasingly dangerous. Where are the safety innovations? Rather than pouring money into research which might make hormonal contraceptives safer, pharmaceutical companies want products which are more convenient and have more uses, making them more money.

Earlier this year, I wrote a summary of a paper entitled "The Bitterest Pill" which examines these very issues. Perhaps it is worth taking another look in light of hormonal contraceptives' upcoming 50th birthday in 2010.

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Visit the Drug Injury Watch Focus Page on YAZ, Yasmin, and Ocella. There you will find a compilation featuring each of the posts from Drug Injury Watch written on these birth control pills. These posts are packed full of information ranging from safety issues to current litigation in YAZ, Yasmin, and Ocella lawsuits.

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Another Death Attributed To YAZ
September 29, 2009

After using the YAZ birth control pill for 10 months, a young Swiss women died suddenly this month due to a pulmonary embolism believed to be associated with the pill. Swissmedic as well as Bayer (manufacturers of YAZ) are conducting investigations into her death.

Regarding the woman's death Bloomberg.com, in their article "Bayer's Yaz Consumer's Death Probed By Swiss Agency", reported:

"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 Berlin-based spokesman for Bayer, said in an interview today. "Studies have shown that the risk isn't higher for Yaz than for other oral contraceptives."

However, contrary to what Bayer may claim here, there have been other studies not funded by Bayer, which have found just the opposite: YAZ presents an increased risk of blood clots such as pulmonary embolisms (PE) and deep vein thromboses DVT).

Jim Edwards writes an insightful blog, On Yaz, Bayer Believes "a Multiple of a Rare Event Is Still a Rare Event", about Bayer's inability, or unwillingness, to recognize the quality and safety issues with its best selling products, YAZ and Yasmin.

We will report the results of the Swissmedic investigation as soon as more information is available.

Bayer Gets Yet Another Warning About YAZ And Yasmin From The FDA
September 16, 2009

Just after the waves settled from their ad campaign fiasco, Bayer is in the FDA spotlight again, this time for quality issues.

In a warning letter dated August 5, 2009 which was only just released Tuesday (why the FDA waited so long for is anyone's guess), the FDA found testing problems in the Bayer plant in Bergahamen, Germany. The testing issues were related to the progestin component of YAZ and Yasmin birth control pills, drospirenone (DRSP).

The FDA reported that, rather than test each batch of drospirenone for proper quality, the Bayer plant was taking selective samples and assuming the quality based on an average. This testing method is not approved by the FDA for drug sale in the US.

The article, FDA warns Bayer over German manufacturing plant, from Associated Press reports, "After reviewing all drug batches shipped to the U.S. between 2007 and 2009, Bayer responded to the FDA in an April 7 letter that concluded 'the quality of these batches was not affected.'"

How convenient!

"But the FDA responded in its own letter last month, disagreeing with Bayer's 'rationale and conclusion.'"

As a result, the FDA has asked Bayer to fix these quality issues and schedule a new inspection. In the meantime, the FDA is considering stopping imports from the factory until the quality issue has been resolved.

Read the FDA's August 5, 2009 Warning Letter.

Bayer, Manufacturer Of YAZ And Yasmin, Looks To A New Type Of Birth Control Pill
July 31, 2009

The FDA-mandated corrective ad campaign has ended, as of July 26, for the YAZ advertisements which were deemed misleading for overstating benefits while downplaying risks. In the wake of this embarrassment, Bayer seeks approval for a new oral contraceptive pill: Qlaira.

Qlaira will be the first contraceptive pill to contain a type of oestrogen which is reportedly "identical" to the hormone produced by the female body. This new birth control pill will combine estradiol valerate (the new oestrogren) and the progestin dienogest.

Jim Edwards, in his July 10, 2009 article What Bayer's Qlaira Application May Reveal About Yaz Clot Risks, points out:

"Bayer doesn't say whether the new combination will be safer than older pills, some of which have a history of inducing fatal blood clots in women. It merely states that Qlaira will deliver 'the right levels at the right time.' ...That begs the uncomfortable question about Bayer's other pills, Yaz, Yasmin and Yasminelle. Are they delivering the "wrong" doses by comparison? And is there anything wrong with ethinylestradiol, which...is the estrogen ingredient in Yaz?"

YAZ, Yasmin, and Ocella (generic of Yasmin) have been associated with very dangerous side effects like those mentioned in the quote above, but also including heart attacks and strokes. Edwards wraps up his article with a pertinent question:

"...if one brand in Bayer's portfolio is demonstrably safer than the others, why should Bayer be allowed to market the less-safe ones in the same way as the safe ones? It's a question BNET has previously raised about Johnson & Johnson's contraceptive patch Ortho Evra. The product caused so many fatal clots in patients that J&J stopped promoting it, and yet it remains on the market as if there were nothing wrong with it."

What do you think? Please add to the discussion by leaving a Comment.

Switzerland 's Medicines Supervisor Concerned Over Yasmin's Serious Side Effects
June 15, 2009

Another young woman was seriously injured after taking oral contraceptives, this time in Switzerland. She was taking Yasmin, and was only 16 years old. She had a pulmonary embolism, which is a blood clot in the lungs. Luckily she survived, but she is now severly disabled.

Due to her injury and the injuries of many other women, the Swiss Agency for Therapeutics wants to get to the bottom of the contraceptive controversy: is Yasmin more dangerous than other contraceptive pills?

Thus far, studies have shown that third generation progestins, like desogestrel and gestodene carry double the risk of thromboembolism, or blood clotting, than the older second generation pills. Drospirenone is considered an even newer progestin, a "fourth generation".

The Swiss Agency for Therapeutics is hoping to complete this study by this fall. We will keep our eyes open for these results.

Full article from swissinfo.ch can be found, here.

For more detail visit Swissmedic.ch. It is written in German, thus I suggest Google Translate.

FDA "Table Of Potential Signals Of Serious Risks" Includes Yasmin
June 5, 2009

Through the Adverse Event Reporting System the FDA keeps tabs on emerging safety issues regarding the pharmaceutical drugs it has approved. In a table outlining the current drugs and conditions which entail a potential safety risk, Yasmin was among those being considered for a stronger warning label.

According to the table there have been Adverse Event Reports of pancreatitis. The FDA points out that the warning label does already contain a warning for this condition, but presumably due to the number and severity of the reports, they are considering stiffening that warning.

Considering that Yasmin, YAZ, and Ocella all contain the same ingredients (albeit YAZ has slightly different quantities), shouldn't YAZ and Ocella be included?

Take a look at the table, here.

Two Ohio Women Come Forward Against YAZ
June 2, 2009

The Toledo Blade, a Pulitzer Prize winning publication out of Toledo, Ohio, highlights two local women -- one seriously injured and the other whose daughter was killed - who are seeking justice from Bayer HealthCare Pharmaceuticals for its product YAZ.

The first woman, Angela Beck, suffered from multiple blood clots in her lungs, also called pulmonary embolisms. Stephanie Hoover was killed by a blood clot in her brain, a stroke. Mrs. Beck and Ms. Hoover's mother are convinced that these events were due to the hormonal birth control YAZ.

YAZ is different from other hormonal birth controls in that it contains a new progestin as an active ingredient. This progestin, drospirenone, keeps the body from retaining water. It is marketed as a means to reduce bloating. However, it can also cause dehydration. Dehydration increases the body's risk for clotting. Estrogen, as many women already well know, also increases the risk for clotting. The math is clear: estrogen + a dehydrating progestin = higher risk for blood clots.

But what doesn't add up, the Ohio women say, are the claims made by Bayer regarding its product YAZ. From their misleading advertisements to their questionable warning label, even the FDA has its eye on Bayer (see article below).

From the Toledo Blade:

"'...it's promising all these other [benefits] but you're also taking a greater risk for a health issue. You've got to be told so you can weigh the options,' [Beck] said."

"'It doesn't contain the warnings it ought to nor does it share with women the potential risks that exist with this potential dehydration,' Mr. Zoll said of the drug. 'There's been death, stroke, embolism. Women of all ages, but sometimes very young women.'"

Young indeed. Ms. Hoover was only 25 years old when she succumbed to a stroke. Mrs. Beck was lucky to survive, "I think about it all the time and I worry about getting [pulmonary embolisms] again all the time. I take an aspirin every other day just to prevent it and any time I get pain, I worry."

Read the full article at the Toledo Blade website, here.

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May 20, 2009

Bayer HealthCare markets YAZ as "Beyond Birth Control," but recently they have been forced to correct advertisements which mislead the public on exactly for which indications the drug is approved. Although the FDA did approve the YAZ birth control pill as an effective contraceptive with a potential side benefit of treating PMDD, or premenstrual dysphoric disorder, the ads went too far. The New York Times reported,

"The FDA first moved against the Yaz campaign last October, with a warning letter to Bayer saying that two television ads overstated the drug's benefits while understating its risks. By giving consumers the impression that Yaz was generally a drug for acne and general mood problems, the company's ads ran afoul of federal laws against promoting the unapproved uses of a drug, the FDA. said."

"Regulators say the ads overstated the drug's ability to improve women's moods and clear up acne, while playing down its potential health risks."

As a result, the FDA forced Bayer to run an ad campaign correcting the misleading information. "Under a settlement with the states, Bayer agreed last Friday to spend at least $20 million on the campaign and for the next six years to submit all Yaz ads for federal screening before they appear." These ads must also reach the intended market of the original ads.

Interestingly enough, back in 2003, Yasmin encountered a similar advertising issue. The FDA sent a warning letter to Berlex Laboratories (the then manufacturers of Yasmin) complaining that the Yasmin ads were misleading the public in regards to the effectiveness of Yasmin over other oral contraceptives. The warning letter stated, "FDA is not aware of substantial evidence or substantial clinical experience demonstrating that Yasmin is superior to other COCs or that the drospirenone in Yasmin is clinically beneficial." It also reprimanded Berlex for downplaying the risks associated with the pill. To be fair, Bayer did not own Yasmin during that misleading ad campaign.

Read the full New York Times article here.

You can find the YAZ FDA warning letter here, and the Yasmin FDA warning letter here.

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What Are They?

Pulmonary embolism, commonly referred to in the medical community as PE, is a highly dangerous, life threatening condition.

From WebMD:
"Pulmonary embolism is the sudden blockage of a major blood vessel (artery) in the lung, usually by a blood clot. In most cases, the clots are small and are not deadly, but they can damage the lung. But if the clot is large and stops blood flow to the lung, it can be deadly. Quick treatment could save your life or reduce the risk of future problems."

Many times a PE is associated with a deep vein thrombosis (DVT), a blood clot which forms in a vein of the deep venous system. This type of blood clot can occur anywhere in the body, but they usually happen in extremities, like the leg. According to WebMD, "Among patients with DVT, pulmonary embolism will occur in 30%." This occurs because the blood clot makes its way to the lung, where very serious damage can occur.

What Are The Symptoms?

Often there are no symptoms of DVT. In fact, WebMD reports that over half of DVT cases showed no signs. However, if you do experience any of the symptoms listed below, seek medical care immediately. A DVT can quickly become a life threatening pulmonary embolism.

• Deep Vein Thrombosis
  
  
  
  • Swelling in one or both legs
    
  • Pain or tenderness in one or both legs, which may occur only while standing or walking
    
  • Warmth in the skin of the affected leg
    
  • Red or discolored skin in the affected leg
    
  • Visible surface veins
    
  • Leg fatigue
    

Although DVTs are most often the precursor to PE, don't expect a gradual onset beginning with the symptoms listed above. A pulmonary embolism can come on quickly and without warning. For that reason WebMD says that if you think you may have pulmonary embolism, call your doctor or go to the emergency room at the nearest hospital. Watchful waiting is not appropriate for pulmonary embolism.

• Pulmonary Embolism
  
  
  
  • Shortness of breath that may occur suddenly.
    
  • Sudden, sharp chest pain that may become worse with deep breathing or coughing.
    
  • Rapid heart rate.
    
  • Rapid breathing.
    
  • Sweating.
    
  • Anxiety.
    
  • Coughing up blood or pink, foamy mucus.
    
  • Fainting.
    
  • Heart palpitations.
    
  • Signs of shock.
    

Treatment and Recovery

Normally once the PE or DVT (or both) has been diagnosed, the first step is to dissolve the blood clot. From WebMD:

"If symptoms are severe and life-threatening, immediate and sometimes aggressive treatment is needed. Aggressive treatment may include thrombolytic medicines, which can dissolve a blood clot quickly but also increase the risk of severe bleeding. Another option for life-threatening, large pulmonary embolism is surgical removal of the clot, called an embolectomy. This surgery is only available at a few large hospitals."

The next step is to prevent future clotting. This involves anticoagulation medication which must be taken for several months. For an unfortunate few, it must be taken forever. All hormone therapy must be stopped (this includes any hormonal birth control methods) and if pregnancy occurs, a series a regular shots must be given to prevent clot formation.

Recovery

Recovering from pulmonary embolism can be a long and painful process. An excellent and informative source for recovery information from someone who has experienced, and recovered from, a PE has a great website over on HubPages.com. It is called Recovering From A Pulmonary Embolism.

Another avenue to connect with others and learn about the recovery process is through support groups. DailyStrength.org has a pulmonary embolism support group geared to open the lines of communication for PE sufferers everywhere.

For more information on YAZ, Yasmin, and Ocella, you may also wish to visit my law firm's web site, www.DrugInjuryLaw.com. In the alternative, you may also submit a confidential free case evaluation.



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