Personal Injury Law

Birth Control Pill YAZ Is Subject Of Ongoing Safety Study Regarding Cardiovascular Side Effects

By Tom Lamb

Comparison Of This DRSP/EE Pill To Other Established Oral Contraceptives For Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Heart Attack, And Stroke

(Posted by Tom Lamb at DrugInjuryWatch.com)

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 with do 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.

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 ?g 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 effectsfrom 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 whileusing YAZ pills.

All of this leaves us wondering whether YAZ is an 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.

Full post as published by Drug Injury Watch on May 18, 2009 (boomark / email).