YAZ, Yasmin, Ocella, Gianvi, Zarah, Loryna, Syeda, Vestura, Beyaz, And Safyral: News And Information

The U.S. Food and Drug Administration (FDA) has approved a new oral contraceptive,(OC), Safyral (drospirenone 3 mg/ ethinyl estradiol 30 mcg/ levomefolate calcium 451 mcg tablets and levomefolate calcium 451 mcg tablets). In women who choose an OC for birth control, Safyral raises folate levels for the purpose of reducing the risk of rare neural tube defects (NTDs) in a pregnancy conceived while taking Safyral or shortly after discontinuing it. Safyral provides the birth control Yasmin (drospirenone 3 mg/ ethinyl estradiol 30 mcg) with 451 mcg levomefolate calcium, which is a B vitamin.

SAFYRAL is the second Bayer OC which contains folate. In September, the FDA approved Beyaz, the first OC approved by the FDA to raise folate levels in women who choose an OC for birth control.

Women of childbearing age are advised by the CDC and other groups to supplement their diet with at least 400 mcg of folic acid daily to prevent neural tube defects, which occur during the first weeks of gestation. Adding folate to the OC raises folate levels in women who conceive while on the new pill or shortly after discontinuing it.

The progestin drospirenone may increase potassium. You should not take Safyral if you have kidney, liver or adrenal disease because this could cause serious heart and health problems. Other drugs may also increase potassium. and during the first month that you take Safyral, you should have a blood test to check your potassium level.

The newest Bayer Healthcare oral contraceptive to hit the market is known as Beyaz. This new oral contraceptive is strikingly similar to YAZ in that it is a drospirenone estrogen / ethinylestradiol (EE) progestin combination, however differs in that Beyaz also contains a folate.

Beyaz claims to prevent pregnancy, treat symptoms of premenstrual dysphoric disorder (PMDD), and treat moderate acne vulgaris much like YAZ.

In addition, Beyaz also claims to increase folate levels in the body which in turn help produce and maintain cells. Having low folate levels is a known association with neural tube defects such as spina bifida. By increasing the folate levels in one's body the new pill, Beyaz, is thought to combat tube defects when a pregnancy is conceived while taking the product or shortly after discontinuing the product.

So now Beyaz is able to be marketed as the only oral contraceptive pill that can prevent pregnancy and at the same time prevent neural tube defects when it fails to work in preventing pregnancy.

As it is a form of YAZ, the serious side effects it can cause may outweigh the new benefits of Beyaz. These dangerous side effects include pulmonary embolism, blood clots, deep vein thrombosis, stroke, and heart attack.

For more information on YAZ, Yasmin, Ocella, Gianvi, Zarah, Loryna, Syeda, Vestura, Beyaz, and Safyral 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.

Sandoz has recently announced the US launch and Food and Drug Administration (FDA) approval for two generic contraceptives. First launched was Loryna, which is a generic equivalent of YAZ; then, Syeda, a generic version of Yasmin.

In release articles for both contraceptives, Sandoz says that both Loryna and Syeda were released primarily in order to prevent pregnancy. Sandoz then states in the releases that they are: "committed to serving the needs of women in the US, including through the launch of these products, which offer cost-saving options for fertility control."

Both Loryna and Syeda contain the female hormone drospirenone, which is commonly associated with fourth-generation forms of contraceptives. YAZ and Yasmin are the most popular brand-name birth control pills that contain this hormone.

The recent release of these two new fourth-generation birth control pills also trigger new concerns regarding the risks involved in taking them. Although both Sandoz contraceptives were approved by the FDA, dangers of taking these generic versions of YAZ and Yasmin are inevitably in existence. Any new findings or updates on recently released Loryna and/or Syeda will be promptly reported.

In spite of what you may think after simply browsing the web, YAZ and Yasmin (YAZ generics: Gianvi, Vestura, and Loryna; Yasmin generics: Ocella, and Zarah) 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 and Zarah) 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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Photo courtesy JenniPenni on Flickr.com

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Visit the Drug Injury Watch Focus Page on YAZ, Yasmin, Ocella, Gianvi, Zarah, Loryna, Syeda, Vestura, Beyaz, and Safyral. 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, Ocella, Gianvi, Zarah, Loryna, Syeda, Vestura, Beyaz, and Safyral lawsuits.

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Bayer Gets FDA Approval For New Birth Control
May 14, 2010

As hormonal birth control reaches its 50th birthday, Bayer is putting a new one out there. This one is called Natazia. The original name was Qlaira, which we covered previously (see "In The News... July 31, 2009).

Just as YAZ and Yasmin contain a new progesterone, Natazia has an even newer estrogen/progestin combination: estradiol valerate and dienogest. Of course, our concern is the safety of this new combination, and Bayer conveniently neglects to tell us anything about that.

In a May 7, 2010 article from Jim Edwards, More Questions Than Answers About Safety of Natazia, Bayer's New Contraceptive, he says:

It is the safety issue that is most curious about the new drug. Bayer said two of its trials for Natazia were "non-comparative, open labeled, singled arm studies." That's low quality science: It means the doctors conducting these tests knew which patients got which drugs. When doctors know who's getting what, their own biases tend to creep into the results. And the study did not compare Natazia to other contraceptives, which is why Bayer can only claim Natazia is "as effective" as other pills.... You'll note that Bayer's own site doesn't say anything about Natazia's risks.... Note that the trials studied its safety, but Bayer only tells the results for efficacy....

Hmmm...doesn't sound too good. As Jim later points out, if Natazia were safer than existing birth control, they would want to highlight this fact. If it is, in fact, less safe, what is the advantage of another new birth control pill on the market? It is as effective as others, but offers no additional safety? Why, exactly, did the FDA approve this drug, again?

Yet, Bayer is becoming known for its shady dealings with the safety issues surrounding its top-selling birth control pills. Twice the FDA has warned and taken action again Bayer for its Yasmin and, on a separate more recent occasion, YAZ commercial ads. In August 2009, the FDA warned Bayer about its manufacturing quality (see "In The News..." September 16, 2009). The testing procedures they were using only provided an average of quality. They were neglecting to test on each individual batch going out for consumer purchase.

Following this warning, the FDA actually issued a recall for YAZ because of these sketchy quality practices. Somehow Bayer was able to keep this recall very quiet such that hardly anyone even knew about it. Jim Edwards covers this as well in his article, Did You Know the FDA Recalled Bayer's Yaz Contraceptive? Neither Did Anyone Else.

The question is, will Bayer continue these questionable tactics as their new oral contraceptive Natazia hits the market? If the press release neglecting any information on safety is any indication, they already have.

Ocella Case To Join YAZ, Yasmin MDL
February 2, 2010

In late December 2009 another case was transferred into the Southern District of Illinois multi-district litigation (MDL). Yet, this case is different. The product in question is Ocella, the generic version of Yasmin.

Ocella is distributed by Barr Laboratories, but it is manufactured by Bayer. This means that Bayer is still responsible for the production and safety of this oral contraceptive. It also means that, as Bayer is the defendant, cases involving injuries resulting from the use of Ocella can be included in the MDL.

In this particular case, a woman suffered a stroke after using Ocella for only four months.

Our firm is also investigating injuries which may be associated with the use of Ocella. These injuries include stroke, heart attack, pulmonary embolism (PE), deep vein thrombosis (DVT), kidney failure, pancreatitis, gallbladder disease, and gallbladder removal. Visit our website if you would to find more information on YAZ, Yasmin, Ocella, as well as Gianvi, Zarah, Beyaz, and Safyral, or to fill out a free case evaluation.

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.

For more information on YAZ, Yasmin, Ocella, Gianvi, Zarah, Loryna, Syeda, Vestura, Beyaz, and Safyral 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.

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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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, Ocella, Gianvi, Zarah, Loryna, Syeda, Vestura, Beyaz, and Safyral 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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Illustration copyright 2000 by Nucleus Communications, Inc. All rights reserved. http://www.nucleusinc.com

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.

Below this, you can watch the ad that was presented by Bayer HealthCare after the warning letter was issued.

For more information on YAZ, Yasmin, Ocella, Gianvi, Zarah, Loryna, Syeda, Vestura, Beyaz, and Safyral 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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