Safety Alerts & Recalls

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FDA Adds Boxed Warning to Plavix (Clopidogrel)
The U.S. Food and Drug Administration (FDA) today added a boxed warning to the anti-blood clotting drug Plavix (clopidogrel), alerting patients and health care professionals that the drug can be less effective in people who are "poor metabolizers" and cannot metabolize the drug to convert it to its active form in the body. The warning also states that tests are available to identify patients who have the genetic differences in their liver enzymes which make them poor metabolizers of Plavix. Healthcare professionals may need to use other anti-blood clotting medications or different dosing strategies for Plavix in patients identified as poor metabolizers. Plavix is given to reduce the risk of heart attack, unstable angina, stroke, and heart disease related death in patients with heart disease. Plavix works by decreasing the activity of blood cells called platelets, making platelets less likely to form blood clots. Before it can work in the body, liver enzymes must metabolize Plavix to its active form. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203888.htm
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FDA Publishes Results of Ongoing Safety Review of Oral Bisphosphonates and Femur Fractures
Patients and healthcare professionals may have questions about oral bisphosphonate medications and fractures, specifically atypical subtrochanteric femur fractures which is a fracture in the bone just below the hip joint. Oral bisphosphonates are commonly prescribed to prevent or treat osteoporosis. Medications in this class include Alendronate (Fosamax, Fosamax Plus D), Ibandronate (Boniva), Risedronate (Actonel, Actonel W/Calcium), and Zoledronic acid (Reclast). Recent news reports have raised the question about whether there is an increased risk of this type of fracture in patients with osteoporosis using these medications. At this point, the data that the FDA has reviewed have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures. The FDA is working closely with outside experts, including members of the recently convened American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force, to gather additional information that may provide more insight into this issue. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203891.htm
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Date Published Title Drug Source
2010-03-12 FDA Adds Boxed Warning to Plavix (Clopidogrel) Clopidogrel FDA
2010-03-11 FDA Publishes Results of Ongoing Safety Review of Oral Bisphosphonates and Femur Fractures Alendronate FDA
2010-03-11 Black Box Warning for WinRho SDF Warns About Potentially Life Threatening Reaction WinRho SDF Manufacturer
2010-03-05 FDA Approves Name Change for Heartburn Drug Kapidex Dexlansoprazole FDA
2010-03-02 Wyeth Recalls Several Lots of Effexor XR 37.5 mg, 75 mg, and 150 mg Capsules Venlafaxine FDA
2010-03-01 Updated "Mifeprex Question and Answers" on FDA Website Mifepristone FDA
2010-03-01 LifeScan Recalls Eight Lots of OneTouch SureStep Test Strips Due To Falsely Low Readings Insulin Manufacturer
2010-02-23 The FDA Is Reviewing A Possible Safety Concern for HIV Drug Combination of INVIRASE with NORVIR Saquinavir FDA
2010-02-23 Ongoing Review of AVANDIA (ROSIGLITAZONE) and Cardiovascular Safety Rosiglitazone FDA
2010-02-19 Recall of Two Lots of PREMPRO 0.3 mg/1.5 mg EZ-DIAL Dispensers Estrogens Conjugated with Medroxyprogesterone FDA
2010-02-19 Recall of a Single Lot of Pilocarpine Hydrochloride 5 mg Tablets Pilocarpine FDA
2010-02-19 Recall of Four Lots of ANTIBACTERIAL WASHCLOTHS Containing Benzalkonium Chloride FDA
2010-02-18 Boxed Warning and Other Changes to the EXJADE Prescribing Information Deferasirox Manufacturer
2010-02-18 New Safety Requirements for Long-acting Inhaled Asthma Medications Called Long-Acting Beta-Agonists (LABAs) Formoterol with Budesonide FDA
2010-02-18 Product Confusion with Maalox Total Relief and Maalox Liquid Products Aluminium Hydroxide with Magnesium Hydroxide FDA
2010-02-17 Statin Benefits Still Outweigh New Safety Information Atorvastatin MediGuard CRT
2010-02-16 The FDA Requires a Risk Management Program for Erythropoiesis-Stimulating Agents (ESAs) Epoetin Alfa FDA
2010-02-05 Risk of Progressive Multifocal Leukoencephalopathy (PML) Increases with the Number of Tysabri (Natalizumab) Infusions Received Natalizumab FDA
2010-02-03 Voluntary Recall of Additional Lots of Sanofi Pasteur H1N1 Vaccine Manufacturer
2010-02-02 Lilly Changes Zyprexa Prescribing Information for Indication for Use in Adolescents (Ages 13 to 17) Fluoxetine with Olanzapine Manufacturer
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