Yaz & Yasmin Lawyers & Settlements

American Journal of Nursing Shows Oral Contraceptives Containing Drospirenone are More Dangerous than Others

The “Drug Watch” section of the September, 2012 edition of the American Journal of Nursing includes some startling information about hormonal contraceptive drugs containing the chemical drospirenone, such as YAZ,® Beyaz®, Safyral®, and Yasmin®.

Reviewing several studies comparing the relative risks of developing a blood clot for women using drospirenone-containing hormonal contraceptives versus women using other hormonal contraceptives, including one funded by the FDA itself, the American Journal of Nursing writes, “the FDA has concluded that there is an increased risk of blood clots if the contraceptive drospirenone; the increased risk may be as much as three times higher.”[1] (emphasis added)

Blood clots can be very dangerous, possibly resulting in stroke or heart attack. Thankfully, the article goes on to note that these drugs now contain such warnings on their packaging,[2] but I ask, why use any drug that has been found to be more dangerous than others with no increase in efficacy?  A Bayer executive begrudgingly admitted to the FDA that Yaz is no more effective at preventing pregnancy than competing pills. 

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[1] “Drug Watch” American Journal of Nursing September 2012. Vol. 112, No. 9; p. 24

[2] Ibid.

Yaz named as cause of blood clot in 2006 case report

A report published in 2006 in the medical journal Clinical and Applied Thombosis/Hemostasis reviews the case of a woman, aged 36 years, who came under the care of Dr. Y. Mira, presenting deep venous thromboses (blood clots) in the “left jugular and subclavian” veins.[1] Blood clots are a very serious occurrence, possibly leading to heart attack or stroke.

Because the patient had no family history of blood clotting,[2] and demonstrated no other risk factors, doctors concluded that the patient’s use of “Yazmin®,” a hormonal contraceptive containing drospirenone, known to place its users at a higher risk for the development of blood clots than other hormonal contraceptives, “was the only associated risk factor…,”[3] and likely caused the event.

Other oral contraceptives that contain drospirenone, and thus place women at a higher risk for blood clots, are YAZ®, Beyaz®, and Safyral®.

While this article did not describe in detail the biochemistry of how drospirenone causes blood clots, from it we learn that this chemical is known by the medical research community to be more dangerous than its “peer” chemicals, if you will, though it does not demonstrate increased efficacy in pregnancy prevention. As such, Dr. Mira’s piece may be used in a Yaz lawsuit to help provide evidence that the drugs Yaz®, Beyaz®, Safyal®, and Yazmin®, each place users at an unnecessarily high risk for serious adverse health effects.

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[1] “Ethinylestradiol/drospirenone Deep vein thrombosis: case report.” Case Report. Reactions Weekly 15 May 2010, No. 1301 © 2010 Adis Data Information BV; p. 23

[2] Ibid

[3] Mira, Y. (et al.) “Is Yasmin as safe as other contraceptive pills?” Clinical and Applied Thrombosis/Hemostasis 12:378-379, No. 3, Jul 2006.

Canadian Study Finds Contraceptives Like yaz to be more dangerous than others

The findings published in a 2011 edition of Canadian Medical Association Journal, Dr. Gronich (et al.) performed a wide-scope population-based study to determine whether or not oral contraceptives containing the chemical drospirenone (such as YAZ®) placed women at a higher risk of developing a blood clot than did oral contraceptives without drospirenone.

For this study, the Gronich team used the digital health records databases of an Israeli healthcare provider to review 329,995 women who had not previously been diagnosed with a blood clot[1] and found that overall, the rate of blood clot development was about 6 in every 10,000 women, replicating the findings of Lidegaard (et al.) 2009, whose work is also summarized on this blog.

Compared to so-called second-generation oral contraceptives (levonogestrel and norgestrel), drospirenone use was found to place women at a 43% higher risk of blood clot.[2] And, compared to third-generation oral contraceptives desogestrel, gestodene, and norgestimate, drospirenone use was found to place women at a 65% higher risk of blood clot.[3]

Accordingly, the study concludes that “Use of drospirenone-containing oral contraceptives was associated with a significantly increased risk of venous thrombotic events (deep vein thrombosis and pulmonary embolism) …”[4] The term “deep vein thrombosis” means blood clot in a large vein deep inside the body. “Pulmonary embolism” means a blood clot that has become mobile in the blood stream. Pulmonary embolism is indeed very dangerous, for if a traveling blood clot becomes lodged in the heart, one may have a heart attack, and if such a blood clot becomes lodged in the brain, one may have a stroke. Both these events are very serious and may be fatal.

Because of the striking findings it reports, a lawyer may use this article in a pharmaceutical lawsuit to demonstrate that women using drospirenone-containing oral contraceptives such as YAZ® are unduly placed at a higher risk of adverse health effects, for drospirenone-containing oral contraceptives are no more effective than other such contraceptives.

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[1] Gronich, N., et al. (2011) “Higher risk of venous thrombosis associated with drospirenone-containing oral contraceptives: a population-based cohort study” Canadian Medical Association Journal 183(18); p. 3-4

[2] Gronich, N., et al. (2011) “Higher risk of venous thrombosis associated with drospirenone-containing oral contraceptives: a population-based cohort study” Canadian Medical Association Journal 183(18); p.4

[3] Ibid

[4] Gronich, N., et al. (2011) “Higher risk of venous thrombosis associated with drospirenone-containing oral contraceptives: a population-based cohort study” Canadian Medical Association Journal 183(18); p.5

eMPR Warns of Increased Risk of Yaz and Drospirenone Use

The online drug reference for healthcare professionals, Monthly Prescribing Reference, published a 2011 warning to users of oral contraceptives containing the chemical drospirenone, such as YAZ®. Here is what was said:

“Two studies did not report any difference in VTE risk” (VTE risk is the risk of developing a possibly-mobile deep-vein blood clot) “between drospirenone-containing products and products containing levonorgestrel or other progestins. Two publications from 2009, however, reported a 1.5- to 2-fold higher VTE risk with drospirenone-containing contraceptives as compared with levonorgestrel-containing contraceptives while two articles published in 2011 reported a 2- to 3-fold greater risk of VTE.”[1] (emphasis added)

VTE is a very serious condition. If a blood clot becomes lodged in the heart, one can have a heart attack. If a blood clot becomes lodged in the brain, one can have a stroke. Because of this report’s clear sentiment that drugs containing drospirenone, such as YAZ®, have been found to be more dangerous than other hormonal contraceptives, a Yaz lawyer can make use of this article in effort to provide convincing evidence to court that YAZ® unnecessarily places women at higher risk for adverse health effects, given YAZ® is no more effective than other similar drugs.

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[1] “SAFETY ALERT: FDA Provides Safety Update on Increased VTE Risk with Drospirenone-Containing Oral Contraceptives – MPR” Monthly Prescribing Reference. September 27, 2011. © 2012 Haymarket Media, Inc. Available at <http://www.empr.com/safety-alert-fda-provides-safety-update-on-increased-vte-risk-with-drospirenone-containing-oral-contraceptives/article/212912/> accessed 8 October 2012

how likely are you to suffer a side effect from yaz?

The Blog That Ate Manhattan has an excellent post with visual aids regarding the risk of developing a DVT while taking Yaz.  As the excerpt below shows, the overall risk of developing a DVT while taking Yaz, isn’t terribly high in the grand scheme of things.  But it is much higher than your risk of developing a DVT if you take another brand of pill, or don’t take a pill at all.

The basis of most Yaz lawsuits is that Bayer did not adequately explain to women that the risk of developing a DVT or having a pulmonary embolism is much higher while taking Yaz than competing birth control pills. 

The article is worth a read, but here’s the excerpt:

DVT Risk – Yaz

The risk from using Yaz and Yasmin comes in pretty close to that of the patch, at around 10 per 10,0000. The risk for clots with Yaz decreases the longer you use it. So if you’ve been on it for over a year with no clot, your risk drops significantly for getting a clot in the future, to about 5 per 10,000.

Source:  Birth Control & Blood Clots – Visualizing The Risks | The Blog That Ate Manhattan

Study Shows YAZ Places Users at Higher Risk of Hyperkalemia

A recent study published in the journal BioMedCentral Pharmacology aimed to evaluate potential health risks posed to users of hormonal contraceptives containing drospirenone, such as YAZ®.

In this report, Dr. Bird’s team studied 1,148,183 women, and found that users of drospirenone-containing contraceptives were about 10% more likely to develop hyperkalemia (a markedly-increased level of potassium in the blood) than were users of more traditional hormonal contraceptives, such as those containing levonorgestrel.[1]

For those of us less aware of hyperkalemia, Bird writes that “Hyperkalemia is a potentially serious condition … manifesting as weakness, flaccid paralysis, hypoventilation, and metabolic acidosis. Hyperkalemia can also result in cardiac toxicity with electrocardiographic changes, which in severe cases may lead to the terminal events of ventricular fibrillation or asystole.”[2] (emphasis added)

Allow me to explain. Here is how MedlinePlus, a service of the U.S. National Library of Medicine, and the National Institutes of Health, defines the ailments Dr. Bird writes can result from hyperkalemia:

Flaccid Paralysis: “paralysis in which muscle tone is lacking in the affected muscles and in which tendon reflexes are decreased or absent.”[3]

Hypoventilation: “deficient ventilation of the lungs that results in reduction in the oxygen content or an increase in carbon dioxide of the blood or both.”[4] This is bad – all of your organs need oxygen to function.

Metabolic Acidosis: “Acidosis resulting from excess acid due to abnormal metabolism, excessive acid intake, or renal retention or from excessive loss of bicarbonate (as in diarrhea).”[5]

Acidosis: “An abnormal condition of reduced alkalinity of the blood and tissues that is marked by sickly sweet breath, headache, nausea and vomiting, and visual disturbances and is usually a result of excessive acid production.”[6]

Ventricular Fibrillation: “Very rapid uncoordinated fluttering contractions of the ventricles of the heart resulting in loss of synchronization between heartbeat and pulse beat.”[7]

Asystole: “A condition of weakening or cessation of systole.”[8]

Systole: “The contraction of the heart by which the blood is forced onward and the circulation kept up.”[9]

The Bird (et al.) results, though deemed not clinically significant[10] due to the sample size, suggest danger of YAZ® use and ought to prompt further study on this subject.   Until further studies confirm the link, Yaz lawyers will most likely not be able to obtain any Yaz settlements for women who develop hyperkalemia.

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[1] Bird, S.T., et al. (2011) “The association between drospirenone and hyperkalemia: a comparative-safety study” BMC Clinical Pharmacology 2011, 11:23; p. 1

[2] Bird, S.T., et al. (2011) “The association between drospirenone and hyperkalemia: a comparative-safety study” BMC Clinical Pharmacology 2011, 11:23; p. 2

[3] “Flaccid Paralysis” MedlinePlus. U.S. National Library of Medicine. National Institutes of Health. Available at <http://www.merriam-webster.com/medlineplus/flaccid%20paralysis> Accessed 4 October 2012

[4] “Hypoventilation” MedlinePlus. U.S. National Library of Medicine. National Institutes of Health. Available at <http://www.merriam-webster.com/medlineplus/hypoventilation> Accessed 4 October 2012

[5] “Metabolic Acidosis” MedlinePlus. U.S. National Library of Medicine. National Institutes of Health. Available at <http://www.merriam-webster.com/medlineplus/Metabolic%20Acidosis> Accessed 4 October 2012

[6] “Acidosis” MedlinePlus. U.S. National Library of Medicine. National Institutes of Health. Available at <http://www.merriam-webster.com/medlineplus/acidosis> Accessed 4 October 2012

[7] “Ventricular Fibrillation” MedlinePlus. U.S. National Library of Medicine. National Institutes of Health. Available at <http://www.merriam-webster.com/medlineplus/ventricular%20fibrillation> Accessed 4 October 2012

[8] “Asystole” MedlinePlus. U.S. National Library of Medicine. National Institutes of Health. Available at <http://www.merriam-webster.com/medlineplus/asystole> Accessed 4 October 2012

[9] “Systole” MedlinePlus. U.S. National Library of Medicine. National Institutes of Health. Available at <http://www.merriam-webster.com/medlineplus/systole> Accessed 4 October 2012

[10] Bird, S.T., et al. (2011) “The association between drospirenone and hyperkalemia: a comparative-safety study” BMC Clinical Pharmacology 2011, 11:23; p. 5

The Nurse Practitioner Warns of Increased Risk of Blood Clot with Drospirenone Use

In the “Medication Update” section of a 2011 edition of the medical journal The Nurse Practitioner, a warning regarding the use of drospirenone-containing oral contraceptives is made. Oral contraceptives containing drospirenone are YAZ®, Beyaz®, Safyal®, and Yazmin®.

The warning reads as follows:

“The FDA notified healthcare providers and patients that two newly published studies evaluating the risk of [blood clot development] in women who use oral contraceptives (OCs) containing the progestin drospirenone found a greater risk of [blood clot] associated with drospirenone-containing OCs compared with OCs that contain levonorgestrel.”[1]

That increased risk of developing a blood clot was stated to be “two or three times greater … in women taking drospirenone-containing OCs than was seen among women taking levonorgestrel-containing OCs.”[2]

The development of a blood clot can be a very serious medical event. If a blood clot becomes lodged in the brain, one can have a stroke, and if a blood clot becomes lodged in the heart, one may have a heart attack.

A lawyer may cite this article in a Yaz lawsuit to demonstrate that the medical community has been aware of the increased risk of adverse health effects posed to users of oral contraceptives such as YAZ®, and that users of this and other such drugs are placed at higher risk without any potential higher reward: drospirenone-containing oral contraceptives are no more effective than those that do not contain drospirenone.

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[1] “Medication Update” The Nurse Practitioner Vol. 36, No. 8. © 2011 Lippincott Williams & Wilkins; p. 56

[2] Ibid

Yaz may have caused woman’s heart attack in 2009

A woman, aged 45 years, who had been taking a drospirenone-containing hormonal contraceptive for “5 years”[1] was admitted to a hospital “with angina,”[2] which is “chest pain or discomfort you get when your heart muscle does not get enough blood.”[3] Doctors quickly realized that the woman was having a heart attack, and after a great many procedures and drug administrations, the woman was released “after 8 days,”[4] and “in a stable condition.”[5]

This woman’s doctors believed that “her use of ethinylestradiol/drospirenone was … related to the [heart attack],”[6] and eventually published an article on this in the medical journal Clinical and Applied Thrombosis/Hemostasis titled “Acute myocardial infarction due to oral contraceptive,” (May-June 2009).

Examples of oral contraceptives containing drospirenone are YAZ®, Yazmin®, Beyaz®, and Safyal®. Demonstrating the possible dangers to which these hormonal contraceptive can lead, this article may be used in a pharmaceutical lawsuit to illustrate the undue harm posed to users of these drugs, for these oral contraceptives are no more effective than oral contraceptives without drospirenone.

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[1] “Acute Myocardial Infarction: Case Report.” Case Reports. Reactions Weekly 8 Aug 2009, No. 1264 © 2009 Adis Data Information BV; p. 17

[2] Ibid

[3] “Angina” MedlinePlus. National Library of Medicine. National Institutes of Health. Available at <http://www.nlm.nih.gov/medlineplus/angina.html> Page Updated 5 October 2012, Accessed 10 October 2012

[4] “Acute Myocardial Infarction: Case Report.” Case Reports. Reactions Weekly 8 Aug 2009, No. 1264 © 2009 Adis Data Information BV; p. 17

[5] Ibid

[6] Ibid

Medical Journal Reports on heart attack that may have been caused by yaz

A 2010 report by the medical journal Reactions describes the case of a 20-year-old woman, otherwise in good health, who suffered a heart attack while taking an oral contraceptive containing the chemical drospirenone, found in contraceptives such as YAZ®.

The case of this woman, holding no risk factors for blood clot or heart attack other than the consumption of drospirenone-containing oral contraceptives, warranted the following comment from the author: “We consider that the use of the contraceptive pill contributed significantly to the thromboembolic event described here.”[1] (Thromboembolic event means blood clot.) Thankfully, the woman recovered.[2]

Though this article does not provide explicit biological evidence of how drospirenone-containing contraceptives produce increased risk to users of blood clot, this publication may be used by a pharmaceutical lawyer to illustrate one simple case of the undue dangers drospirenone use may pose.

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[1] “Ethinylestradiol/drospirenone – Pulmonary Embolism: Case Report” Reactions April 24 2010 No. 1298 © 2012 Adis Data Information BV; p. 17

[2] Ibid