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FDA Drug Safety Communication: Medication errors resulting from confusion between risperidone (Risperdal) and ropinirole (Requip)
 Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary  Safety Announcement [06-13-2011] The U.S. Food and Drug Administration (FDA) is alerting the public to medication error reports in which patients were given risperidone (Risperdal) instead of ropinirole (Requip) and vice versa. In some cases, patients who took the wrong medication needed to…
Questions and Answers: 5-alpha reductase inhibitors (5-ARIs) may increase the risk of a more serious form of prostate cancer
On June 9, 2011, the U.S. Food and Drug Administration (FDA) informed the public of new safety information for drugs called 5-alpha reductase inhibitors (5-ARIs). Men who take these drugs may have an increased risk of being diagnosed with a more serious form of prostate cancer (high-grade prostate cancer). The Warnings and Precautions section of…
FDA Drug Safety Communication: 5-alpha reductase inhibitors (5-ARIs) may increase the risk of a more serious form of prostate cancer
Safety AnnouncementAdditional Information for Patients Additional Information for Healthcare Professionals Data Summary References   Safety Announcement [6-9-2011] The U.S. Food and Drug Administration (FDA) is informing healthcare professionals that the Warnings and Precautions section of the labels for the 5-alpha reductase inhibitor (5-ARI) class of drugs has been revised to include new safety information…
FDA Drug Safety Communication: New restrictions, contraindications, and dose limitations for Zocor (simvastatin) to reduce the risk of muscle injury
Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary Simvastatin Dose LimitationsRelative LDL-lowering Efficacy of Statin and Statin-based TherapiesReferences Safety Announcement [06-08-2011] The U.S. Food and Drug Administration (FDA) is recommending limiting the use of the highest approved dose of the cholesterol-lowering medication, simvastatin (80 mg) because of increased risk of muscle damage. Simvastatin…
FDA Drug Safety Communication: No increase in risk of cancer with certain blood pressure drugs–Angiotensin Receptor Blockers (ARBs)
 Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary  A list of medications containing an ARB is available here.  In July 2010, FDA communicated its intent to conduct a safety review of ARBs after a published meta-analysis of 5 randomized clinical trials reported a small but statistically significant increase in risk…
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…
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…
CDER Key Officials List
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