Birth Control Pills Containing Drospirenone: Possible Increased Risk of Blood Clots

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FDA Drug Safety Communication: Safety Review of possible increased risk of blood clots with birth control pills containing drospirenone

  Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary   Safety Announcement [05-31-2011] The U.S. Food and Drug Administration (FDA) is informing the public about new information1,2 that is being assessed as part of FDA’s ongoing safety review of birth control pills that contain drospirenone. This review will further evaluate the risk of [...]

Questions and Answers – Ongoing safety review of birth control pills containing drospirenone and a possible increased risk of blood clots

On May 31, 2011, the U.S. Food and Drug Administration (FDA) informed the public about new information that is being assessed as part of FDA’s ongoing safety review of birth control pills containing the progestin hormone drospirenone. Two recently published studies report that there is an increased risk of deep vein thrombosis (DVT) and pulmonary [...]

Generic Drugs: Information for Industry

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CDER Key Officials List

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FDA Statement on the AIM-HIGH Trial

[05-26-2011] The U.S. Food and Drug Administration (FDA) will conduct a comprehensive review of the results from the clinical trial called the Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglyceride and Impact on Global Health Outcomes (AIM-HIGH) once they are available. The AIM-HIGH trial studied whether raising high-density lipoprotein (HDL) or “good” cholesterol levels [...]

Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes (P010030/S023 and P890003/S209)

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FDA Medical Device 2010 Quality System Data

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Class I Medical Device Recall: Beckman Coulter, Inc., Synchron LX Clinical Systems Ion Selective Electrolyte (ISE) Flow Cell

Recall Class: Class I Date Recall Initiated: April 5, 2011 Product: Synchron LX Clinical Systems Ion Selective Electrolyte (ISE) Flow Cell The following model numbers are affected by this recall. LX20 – 466200, LX20 PRO – 476100 LXi 725 – 476501 The products were distributed from March 1997 to April 2011. Use: These systems are [...]

Pentrexyl Forte Natural: Recall

<!– –> <!– Page Last Updated: 05/23/2011 –> Page Last Updated: 05/23/2011 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Article source: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm256407.htm