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Michael Monheit
Michael Monheit
Attorney • (215) 840-6573

Blood Clots: FDA says Yaz has a 75% Increased Risk

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An increased risk of blood clots has been seen in women taking the birth control pill Yaz, which contains drospirenone (a new type of synthetic progestin). While the U.S. Food and Drug Administration (FDA), is warning the public, it has yet to reach a decisive conclusion.

The agency reviewed two 2011 studies that looked at the risk of blood clots for women who use drospirenone-containing birth control pills, which was also mentioned in May 2011. FDA is continuing the review of a separate FDA-funded study that evaluated the risk of blood clots in users of several different hormonal birth control products. Preliminary results showed a 50 percent increased risk of VTEs in women taking drospirenone-containing pills versus other hormonal contraceptives.

A joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee has been scheduled for December 8, 2011 to discuss the risks vs. benefits due to the conflicting findings of six studies.

VTE Linked to Yaz Use

Venous thromboembolism (VTE) is a clinical condition also termed deep-vein thrombosis (DVT) or pulmonary embolism. In simple terms, they are clots that typically originate in the legs and can travel to the heart and/or lungs.

Risk factors for VTE include smoking, being overweight or a family history of blood clots.

Treatment of VTEs typically requires the use of blood thinners to wear down the thromboembolism.

Third Generation Birth Control Pills

Second and third generation oral contraceptives are birth control pills that contain two types of hormones: (1) estrogen and (2) progestin. The difference between second and third generation pills is the type of progestin contained in the pill.

Birth Control Risks – Mild

Weight loss or gain

Nausea

Emotional Sensitivity

Mood swings

Irregular bleeding

Breast tenderness

Birth Control Risk – Serious

Migraines

Increased risk of blood clots

Infertility

Higher blood pressure

And more

Profits over People

This is a clear case of profits over people. Third generation birth control pills were added at the risk of new dangers simply because the drug manufacturers no longer held a patent and thus they faced a loss of profit margins. This factor likely motivated the “need” for the new birth control pills while second generation birth control pills appear to be much safer based on recent study results.

We are not saying there is a risk free option; there isn’t. All birth control pills come with risk as outlined above. But our concern is an unnecessary increase in risk without a worthwhile benefit to the consumer (only a profit benefit to the manufacturer!!)

Warning

If you are taking a birth control pill that contains drospirenone, please talk to your medical doctor before making the decision to stop taking it.