A Comparison Of This "Fourth Generation" DRSP / EE Pill To Other Established Oral Contraceptives For Incidence Of Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Heart Attack (MI), And Stroke (CVA)
(Posted by Tom Lamb at DrugInjuryWatch.com)
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UPDATE: FDA Drug Safety Communication: Safety Review of possible increased risk of blood clots with birth control pills containing drospirenone [May 31, 2011]
… The European Medicines Agency (EMA) announced on May 27, 2011, that it is updating the product information on oral contraceptives containing drospirenone and ethinyl estradiol regarding the risk of venous thromboembolism after review of all available data, including the same newly published data FDA is reviewing.
The FDA is currently evaluating the conflicting results from these studies and will look at all currently available information to fully assess the risks and benefits of drospirenone-containing birth control pills. FDA will continue to communicate any new safety information to the public as it becomes available.
(6/2/11)
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UPDATE: November 2009 status "snapshot" of ongoing YAZ safety study called "International Active Surveillance Study of Women Taking Oral Contraceptives (INAS-OC Study)".
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YAZ (3 mg drospirenone/20 mcg ethinyl estradiol) is an oral contraceptive (OC) which is the first pill to combine 20 mcg of ethinyl estradiol (EE) with the so-called "fourth generation" progestin drospirenone (DRSP). YAZ was approved by the FDA in March 2006.
A company press release, "FDA Approves YAZ(R), The First Oral Contraceptive To Offer Drospirenone In A 24-Day, Active-Pill Regimen", issued at the time of FDA approval, can be read so as to suggest that the list of possible serious side effects of YAZ about which women should be most concerned does not include any cardiovascular side effects:
YAZ contains 3 mg of the progestin drospirenone that has antimineralocorticoid activity, including the potential for hyperkalemia in high-risk patients, comparable to a 25-mg dose of spironolactone. YAZ should not be used in patients with conditions that predispose to hyperkalemia (i.e., renal insufficiency, hepatic dysfunction, or adrenal insufficiency). Women receiving daily, long-term treatment for chronic conditions or diseases with medications that may increase serum potassium should have their serum potassium levels checked during the first treatment cycle. Medications that may increase serum potassium include ACE inhibitors, angiotensin-ll receptor antagonists, potassium-sparing diuretics, potassium supplementation medications, aldosterone antagonists and NSAIDs.
In fact, the current YAZ package insert, or label (accessed 5/18/09), includes this same text in bolded font, while the warning about cardiovascular side effects like deep vein thrombosis (DVT), pulmonary embolism (PE), heart attack, and stroke is not bolded for emphasis.
Seemingly, however, the FDA has had some concerns about an association between YAZ and DVT, PE, heart attack, and stroke, as seen below.
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A study called the International Active Surveillance Study of Women Taking Oral Contraceptives (INAS-OC), which was started in August 2005 and continues to date, is intended to evaluate the risk of those cardiovascular side effects for women who use DRSP/EE birth control pills like YAZ.
According to a May 11, 2009 article, "ACOG 2009: Preliminary Findings Favor 24-Day Regimen of Drospirenone and Ethinyl Estradiol for Contraception", published online by Medscape:
[P]reliminary findings from the International Active Surveillance Study of Women Taking Oral Contraceptives (INAS-OC) study were presented here at the American College of Obstetricians and Gynecologists (ACOG) 57th Annual Clinical Meeting by Jürgen Dinger, MD, PhD, from the Berlin Center for Epidemiology and Health Research in Germany….
"The INAS study is a transatlantic prospective cohort study that was requested by the [US Food and Drug Administration] to investigate the safety of a 24-day regimen of 3 mg DRSP and 20 μg ethinyl estradiol (24/4 regimen)," Dr. Dinger told the audience. To date, the INAS study has enrolled 52,219 women….
The study's objectives are to compare the cardiovascular safety of the 24/4 regimen of DRSP/EE to established oral contraceptives (OCs) during standard clinical practice (eg, deep venous thrombosis, pulmonary embolism, acute myocardial infarction, stroke); to investigate the incidence of rare serious adverse events associated with the use of 24/4 and established OCs; and to investigate contraceptive failure rates associated with the use of the 24-day and 21-day regimens of DRSP/EE and all other OCs.
For women using YAZ, here is some important information about the symptoms of these serious cardiovascular side effects from the WebMD.com web site:
This medication may rarely cause serious (sometimes fatal) problems from blood clots (e.g., pulmonary embolism, stroke, heart attack). Seek immediate medical attention if you experience: sudden shortness of breath, chest/jaw/left arm pain, confusion, coughing up blood, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, tingling/weakness/numbness in the arms/legs, headaches that are different from those you may have experienced in the past (e.g., headaches with other symptoms such as vision changes/lack of coordination, existing migraines becoming worse, sudden/very severe headaches), slurred speech, weakness on one side of the body, vision problems/changes.
A quick Internet search for the word "YAZ" will show among the results that there are discussion forums with "threads" like "WARNING ABOUT YAZ BIRTH CONTROL PILLS", at the SteadyHealth.com web site, where numerous women have reported having a DVT or PE while using YAZ pills.
All of this leaves us wondering whether YAZ is a possible unsafe birth control method, like Ortho Evra and NuvaRing….
If you or someone you know has developed a deep vein thrombosis (DVT), pulmonary embolism (PE), heart attack, or stroke while using YAZ — and you want to share your experience with others – you can do so by submitting a Comment, below.
Visit the YAZ, Yasmin, and Ocella Information page at our Drug Injury Law web site for more recent developments regarding personal injury and wrongful death lawsuits that involve YAZ, Yasmin, and Ocella.
Our Focus Page on YAZ / Yasmin / Ocella has a complete collection of our articles about these birth control pills as well as selected news reports about YAZ, Yasmin, and Ocella.
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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects
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