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FDA Blood Clot Warning

FDA Warns of Increased Risk of Blood Clots associated with Yaz, Yasmin, and Ocella

The FDA is further reviewing the risk and expects to have results of its investigation later this summer.

On May 31, 2011, the Food and Drug Administration (FDA) issued a Safety Alert directed to women who use Yaz, Yasmin, Ocella, and other drospirenone-containing birth control pills. The warning announces that two recently published studies report a greater risk of suffering a blood clot associated with birth control pills that contain drospirenone than with other birth control pills. The two studies showed that women who use Yaz, Yasmin or Ocella have a 2-3 times greater risk of suffering a blood clot than women who use birth control pills that contain levonorgestrel (and not drospirenone), such as Alesse, Nordette, Triphasil, or Trivora. The studies are available for free on the British Medical Journal’s website, at the following links:

Risk of venous thromboembolism in users of oral contraceptives containing drospirenone or levonorgestrel: nested case-control study based on UK General Practice Research Database, by Lianne Parkin, Katrina Sharples, Rohini Hernandez, and Susan Jick: http://www.bmj.com/content/342/bmj.d2139.full

Risk of non-fatal venous thromboembolism in women using oral contraceptives containing drospirenone compared with women using oral contraceptives containing levonorgestrel: case-control study using United States claims data, by Susan Jick and Rohini Hernandez: http://www.bmj.com/content/342/bmj.d2151.full

Most birth control pills contain two types of hormones, an estrogen and a progestin. Drospirenone is the progestin hormone contained in the birth control pills Yaz, Yasmin, and Ocella. Other birth control pills use different progestin hormones, for example levonorgestrel or norgestimate.  A list of birth control pills that contain drospirenone is available here:http://www.fda.gov/Drugs/DrugSafety/ucm257164.htm#table1.

The FDA recommends that women using Yaz, Yasmin, or Ocella consult their healthcare provider before they stop using the pills. The FDA also recommends that women using Yaz, Yasmin or Ocella contact their healthcare provider immediately if they develop symptoms of a blood clot, such as persistent leg pain, severe chest pain, or sudden shortness of breath.

Blood clots are also known as venous thromboembolisms (VTE). A blood clot that forms in a vein deep in the body might also be called a deep vein thrombosis (DVT). A blood clot that forms in or travels to the lung is also called a pulmonary embolism (PE).

The FDA encourages anyone who has suffered an adverse event or side effect while using Yaz, Yasmin, or Ocella to report it to the FDA through their MedWatch Safety Information and Adverse Event Reporting Program. An Adverse Event report can be submitted to the FDA either online at www.fda.gov/MedWatch/report.htm, or by calling 1-800-332-1088.

The FDA’s warning is available here:http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm257337.htm.

Additional information from the FDA regarding the safety of Yaz, Yasmin and Ocella is available here: http://www.fda.gov/Drugs/DrugSafety/ucm257164.htm.

The FDA has also provided a list of questions and answers about birth control pills containing drospirenone and the risk of blood clots, available here:http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm257175.htm.

If you or someone you love has been injured by Yaz, Yasmin, or Ocella, contact the attorneys at Schlichter, Bogard, and Denton for a free consultation.

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