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FDA Says Yaz, Yasmin May Up Blood Clot Risks, Orders Label Changes for Drospirenone Birth Control Pills

Apr 11, 2012 | Parker Waichman LLP

The U.S. Food & Drug Administration (FDA) announced yesterday that it has finished reviewing a number of studies examining the link between Yaz, Yasmin and similar birth control pills and blood clots.   According to the agency, its review indicated that drospirenone-containing birth control pills like Yaz and Yasmin may pose a higher risk of blood clots compared to oral contraceptives made with other birth control pills.   In a Drug Safety Communication issued late yesterday, the FDA said the label of Yaz, Yasmin and similar birth control pills would be updated to include information about the studies it reviewed.

Background

Yaz, Yasmin and similar birth control pills are made with drospirenone, a fourth generation synthetic form of the female hormone, progestin.   This form of progestin can elevate the body’s potassium levels and lead to a condition called hyperkalemia in certain patients.  Hyperkalemia can cause a number of complications, including heart arrhythmias and cardiac arrest.
A number of studies have found that birth control pills that contain drospirenone may be more likely to cause blood clots compared to oral contraceptives made with other progestins.  Side effects possibly associated with Yaz, Yasmin and similar contraceptives include:

  •  Blood clots
  • Deep vein thrombosis
  • Pulmonary Embolism
  • Heart attack
  • Stroke
  • Sudden death


The FDA issued previous Drug Safety Communications related to the risk of blood clots with birth control pills that contain drospirenone on May 31, 20118, September 26, 20119, and October 27, 201110.  In December 2011, a panel of FDA advisors voted 21-5 to recommend that labels for Yaz, Yasmin and similar pills be updated with stronger warnings about their possible potential to cause serious, life threatening blood clots. 

What did the FDA's Yaz and Yasmin Safety Review Entail?

The FDA reviewed a number of observational (epidemiologic) studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills.  Some of the studies indicated an increased risk of blood clots with Yaz, Yasmin and similar birth control pills, while others did not.  According to the FDA, the studies reviewed did not provide consistent estimates of the comparative risk of blood clots between birth control pills that contain drospirenone and those that do not.  The studies also did not account for important patient characteristics (known and unknown) that may influence prescribing and that likely affect the risk of blood clots.  For these reasons, it is unclear whether the increased risk seen for blood clots in some of the epidemiologic studies is actually due to drospirenone-containing birth control pills, the FDA said.

The research reviewed by the FDA included an agency-study released in October 2011 that found drospirenone-containing oral contraceptives increased the risk of blood clots by almost 74%, compared to other oral contraceptives that are made with an older form of progestin.

What Action is the FDA Taking?

According to the FDA, the new labels for Yaz and Yasmin will now included the following information:

  • That some epidemiological (observational) studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins, whereas other epidemiological studies found no additional risk of blood clots with drospirenone-containing products
  • A summary of the previously released results of an FDA-funded study of the blood clot risk. That study, released last fall, found that drospirenone-containing birth control pills were associated with a 1.5-fold increase in the risk of blood clots, compared to those made with other progestins


Yaz and Yasmin will be subject to the modified labels, as will:

•    Beyaz (drospirenone 3 mg, ethinyl estradiol 0.02 mg and levomefolate calcium 0.451 mg)
•    Drospirenone and Ethinyl Estradiol (drospirenone 3 mg and ethinyl estradiol 0.03 mg)
•    Drospirenone and Ethinyl Estradiol (drospirenone 3 mg and ethinyl estradiol 0.02 mg)
•    Gianvi (drospirenone 3 mg and ethinyl estradiol 0.02 mg)
•    Loryna (drospirenone 3 mg and ethinyl estradiol 0.02 mg)
•    Ocella (drospirenone 3 mg and ethinyl estradiol 0.02 mg)
•    Safyral (drospirenone 3 mg, ethinyl estradiol 0.03 mg, and levomefolate calcium 0.451 mg)
•    Syeda (drospirenone 3 mg and ethinyl estradiol 0.03 mg)
•    Zarah (drospirenone 3 mg and ethinyl estradiol 0.03 mg)

Yaz and Yasmin Lawsuits
Yaz, Yasmin and similar birth control pills have been named in thousands of lawsuits alleging they caused users to suffer serious, life-threatening side effects including blood clots, strokes and gallbladder problems. Most of the cases have been consolidated in the Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation (MDL No. 2100) currently pending before Judge David Herndon in the U.S. District Court for the Southern District of Illinois


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