Drugs
FDA Drug Safety Podcasts by Date
The FDA Drug Safety Podcasts are produced by FDA's Center for Drug Evaluation and Research (CDER). They provide emerging safety information about drugs in conjunction with the release of Public Health Advisories and other drug safety issues.
All Drug Safety Podcasts
| Ongoing safety review of Parkinson’s drug Mirapex (pramipexole) and possible risk of heart failure | September 21, 2012 |  Run Time: 00:3:06 | Transcript |
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| Rare cases of serious burns with the use of over-the-counter topical muscle and joint pain relievers | August 30, 2012 | Run Time: 00:3:46 | Transcript |
| FDA recommends against use of Revatio in children with pulmonary hypertension | August 30, 2012 | Run Time: 00:3:06 | Transcript |
| Codeine use in certain children after tonsillectomy and/or adenoidectomy may lead to rare, but life-threatening adverse events or death | August 15, 2012 | Run Time: 00:4:22 | Transcript |
| Seizure risk for multiple sclerosis patients who take Ampyra (dalfampridine) | July 23, 2012 | Run Time: 00:4:29 | Transcript |
| Cefepime and risk of seizure in patients not receiving dosage adjustments for kidney impairment | June 26, 2012 |
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| FDA advises healthcare providers to visually inspect Hospira Carpuject pre-filled cartridges for overfill | May 23, 2012 |
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| Revised recommendations for cardiovascular monitoring and use of multiple sclerosis drug Gilenya (fingolimod) | May 14, 2012 |
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| Safety review update of cancer drug Revlimid (lenalidomide) and risk of developing new types of malignancies | May 7, 2012 |
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| Updated information on drug interactions between Victrelis (boceprevir) and certain boosted HIV protease inhibitor drugs | April 26, 2012 |
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| New Warning and Contraindication for blood pressure medicines containing aliskiren (Tekturna) | April 20, 2012 |
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| Updated information about the risk of blood clots in women taking birth control pills containing drospirenone | April 11, 2012 |
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| Revised recommendations for Celexa (citalopram hydrobromide) related to a potential risk of abnormal heart rhythms with high doses | March 30, 2012 |
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| Interactions between certain HIV or hepatitis C drugs and cholesterol-lowering statin drugs can increase the risk of muscle injury | March 2, 2012 |
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| Important safety label changes to cholesterol-lowering statin drugs | March 2, 2012 |
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| Important drug interactions between Victrelis (boceprevir) and ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitor drugs | February 10, 2012 |
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Clostridium difficile-associated diarrhea can be associated with stomach acid drugs known as proton pump inhibitors (PPIs) | February 8, 2012 |
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| New risk factor for Progressive Multifocal Leukoencephalopathy (PML) associated with Tysabri (natalizumab) | January 20, 2012 |
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| New Boxed Warning and Contraindication for Adcetris (brentuximab vedotin) | January 13, 2012 |
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| Update - Preliminary findings from ongoing investigations of CardioGen-82 | January 13, 2012 |
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| FDA Drug Safety Podcast for Healthcare Professionals: Addition of another concentration of liquid acetaminophen marketed for infants | December 23, 2011 |
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| Safety review of a reported death after the first dose of Multiple Sclerosis drug Gilenya (fingolimod) | December 23, 2011 |
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| Addition of another concentration of acetaminophen marketed for infants | December 22, 2011 |
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| Review update of Multaq (dronedarone) and increased risk of death and serious cardiovascular adverse events | December 20, 2011 |
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| Revised dose limitation for Zocor (simvastatin) when taken with amiodarone | December 16, 2011 |
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| Selective serotonin reuptake inhibitor (SSRI) antidepressant use during pregnancy and reports of a rare heart and lung condition in newborn babies | December 15, 2011 | Run Time: 00:04:04 | Transcript |
| Safety Review Update of Medications used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in adults | December 14, 2011 |
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| Safety review of post-market reports of serious bleeding events with the anticoagulant Pradaxa (dabigatran etexilate mesylate) | December 8, 2011 |
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| Modified Risk Evaluation and Mitigation Strategies (REMS) for Nplate (romiplostim) and Promacta (eltrombopag) | December 7, 2011 |
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| FDA and FTC: HCG Diet Products Are Illegal | December 6, 2011 |
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| Review update of Trilipix (fenofibric acid) and the ACCORD Lipid trial | November 9, 2011 |
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| Reminder to healthcare providers and patients to enroll in the Avandia-Rosiglitazone Medicines Access Program | November 4, 2011 |
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| UPDATE on Tumor Necrosis Factor (TNF) blockers and risk for pediatric malignancy | November 4, 2011 |
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| Safety Review Update of Medications used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children and young adults | November 1, 2011 |
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| Updated information about the FDA-funded study on risk of blood clots in women taking birth control pills containing drospirenone | October 27, 2011 |
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| Voluntary market withdrawal of Xigris [drotrecogin alfa (activated)] due to failure to show a survival benefit | October 25, 2011 |
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| Safety review update of Chantix (varenicline) and risk of neuropsychiatric adverse events | October 24, 2011 |
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| Updated information about the drug interaction between linezolid (Zyvox) and serotonergic psychiatric medications | October 21, 2011 |
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| Updated information about the drug interaction between methylene blue and serotonergic psychiatric medications | October 21, 2011 |
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| Sprycel (dasatinib) and risk of pulmonary arterial hypertension | October 12, 2011 |
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| Safety review update on the possible increased risk of blood clots with birth control pills containing drospirenone | September 26, 2011 |
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| Abnormal heart rhythms may be associated with use of Zofran (ondansetron) | September 16, 2011 |
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Drug labels for the Tumor Necrosis Factor-alpha (TNFα) blockers now include warnings about infection with Legionella and Listeria bacteria | September 7, 2011 |
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Serious allergic reactions reported with the use of Saphris (asenapine maleate) | September 2, 2011 |
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| New contraindication and updated warning on kidney impairment for Reclast (zoledronic acid) | September 1, 2011 |
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| Abnormal heart rhythms associated with high doses of Celexa (citalopram hydrobromide) | August 24, 2011 |
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| Updated drug labels for pioglitazone-containing medicines | August 9, 2011 |
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| Long-term, high dosage use of Diflucan during pregnancy may lead to rare birth defects | August 8, 2011 |
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| Safety review update of Recombinant Human Growth Hormone (somatropin) and possible increased risk of death | August 5, 2011 |
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| Use of long-term, high-dose Diflucan (fluconazole) during pregnancy may be associated with birth defects in infants | August 5, 2011 |
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| FDA alerts healthcare professionals to stop performing heart scans with CardioGen-82 due to potential for increased radiation exposure in patients | August 2, 2011 |
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Chantix (varenicline) drug label now contains updated efficacy and safety information | August 2, 2011 |
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| Serious CNS reactions possible when linezolid (Zyvox®) is given to patients taking certain psychiatric medications | August 2, 2011 |
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| Serious CNS reactions possible when methylene blue is given to patients taking certain psychiatric medications | August 1, 2011 |
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| Ongoing safety review of oral osteoporosis drugs (bisphosphonates) and potential increased risk of esophageal cancer | July 21, 2011 |
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Increased radiation exposure due to undetected strontium breakthrough when using CardioGen-82 for cardiac positron emission tomography (PET) scans | July 18, 2011 |
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| Important safety changes to the influenza drug Tamiflu (oseltamivir phosphate) for oral suspension | July 11, 2011 |
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Children born to mothers who took Valproate products while pregnant may have impaired cognitive development | July 1, 2011 |
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| Modified dosing recommendations to improve the safe use of Erythropoiesis-Stimulating Agents (ESAs) in chronic kidney disease | June 27, 2011 |
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| Bad Ad Looks Good in Year One | June 23, 2011 |
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| Chantix may increase cardiovascular risk in certain patients | June 17, 2011 |
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| Chantix (varenicline) may increase the risk of certain cardiovascular adverse events in patients with cardiovascular disease | June 16, 2011 |
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| Update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer | June 16, 2011 |
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| Medication errors resulting from confusion between risperidone (Risperdal) and ropinirole (Requip) | June 13, 2011 |
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5-alpha reductase inhibitors (5-ARIs) may increase the risk of a more serious form of prostate cancer | June 10, 2011 |
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| New restrictions, contraindications, and dose limitations for Zocor (simvastatin) to reduce the risk of muscle injury
| June 9, 2011 |
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No increase in risk of cancer with certain blood pressure drugs--Angiotensin Receptor Blockers (ARBs) | June 2, 2011 |
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| Safety Review of possible increased risk of blood clots with birth control pills containing drospirenone | May 31, 2011 |
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| Updated Risk Evaluation and Mitigation Strategy (REMS) to restrict access to rosiglitazone-containing medicines, including Avandia, Avandamet, and Avandaryl | May 19, 2011 |
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| Connection problems involving certain needleless pre-filled glass syringes containing adenosine and amiodarone
| May 6, 2011 |
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| Safety update on Progressive Multifocal Leukoencephalopathy (PML) associated with Tysabri (natalizumab)
| April 26, 2011 |
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| Safety Review update on reports of Hepatosplenic T-Cell Lymphoma in adolescents and young adults receiving tumor necrosis factor (TNF) blockers, azathioprine and/or mercaptopurine
| April 18, 2011 |
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Primatene Mist With Chlorofluorocarbons No Longer Available After Dec. 31, 2011 | April 18, 2011 |
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| Ongoing safety review of Revlimid (lenalidomide) and possible increased risk of developing new malignancies
| April 13, 2011 |
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| Special storage and handling requirements must be followed for Pradaxa (dabigatran etexilate mesylate) capsules
| March 29, 2011 |
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Risk of Low Magnesium Levels Associated with Long-Term Use of Proton Pump Inhibitors | March 11, 2011 |
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| Serious health problems seen in premature babies given Kaletra (lopinavir/ritonavir) oral solution
| March 9, 2011 |
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| Liver injury warning to be removed from Letairis (ambrisentan) tablets
| March 4, 2011 |
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| Risk of oral clefts in children born to mothers taking Topamax (topiramate)
| March 4, 2011 |
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Low magesium levels can be associated with long-term use of Proton Pump Inhibitor drugs (PPIs) | March 2, 2011 |
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| Safety Review update of Abacavir and possible increased risk of heart attack
| March 1, 2011 |
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| Antipsychotic drug labels updated on use during pregnancy and risk of abnormal muscle movements and withdrawal symptoms in newborns
| February 23, 2011 |
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| New warnings against use of terbutaline to treat preterm labor
| February 22, 2011 |
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| Avandia (rosiglitazone) labels now contain updated information about cardiovascular risks and use in certain patients
| February 3, 2011 |
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| Severe liver injury associated with the use of dronedarone (marketed as Multaq)
| January 20, 2011 |
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FDA Reduces Dose of Acetaminophen in Combination Prescription Products | January 13, 2011 |
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| Prescription Acetaminophen Products to be Limited to 325 mg Per Dosage Unit; Boxed Warning Will Highlight Potential for Severe Liver Failure
| January 13, 2011 |
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| Update to ongoing safety review of Lantus (insulin glargine) and possible risk of cancer
| January 12, 2011 |
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| Ongoing safety review of Recombinant Human Growth Hormone (somatropin) and possible increased risk of death
| December 29, 2010 |
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| Abnormal heart rhythms associated with use of Anzemet (dolasetron mesylate)
| December 21, 2010 |
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| Death resulting from overdose after accidental ingestion of Tessalon (benzonatate) by children under 10 years of age
| December 16, 2010 |
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FDA recommends against the continued use of propoxyphene | November 30, 2010 |
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Needleless Pre-filled Glass Syringes: Stakeholder Advisory - Compatibility Problems with Needleless Intravenous Access Systems | November 30, 2010 |
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FDA Drug Safety Podcast: | November 19, 2010 |
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Invirase (saquinavir) labels now contain updated risk information on abnormal heart rhythms | October 25, 2010 |
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Update to Ongoing Safety Review of GnRH Agonists and Notification to Manufacturers of GnRH Agonists to Add New Safety Information to Labeling Regarding Increased Risk of Diabetes and Certain Cardiovascular Diseases | October 21, 2010 |
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FDA issues warnings to marketers of unapproved ‘chelation’ products | October 19, 2010 |
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Safety update for osteoporosis drugs, bisphosphonates, and atypical fractures | October 18, 2010 |
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FDA Recommends Against the Continued Use of Meridia (sibutramine) | October 13, 2010 |
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HHS FDA: Briefing on Avandia | September 23, 2010 |
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FDA significantly restricts access to the diabetes drug Avandia | September 28, 2010 |
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Ongoing Safety Review of Actos (pioglitazone) and Potential Increased Risk of Bladder Cancer After Two Years Exposure | September 22, 2010 |
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New dosing recommendations to prevent potential Valcyte (valganciclovir) overdose in pediatric transplant patients | September 16, 2010 |
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New warnings for using gadolinium-based contrast agents in patients with kidney dysfunction | September 13, 2010 |
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FDA Warns Consumers to Avoid TimeOut Capsules | September 8, 2010 |
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Increased risk of death with Tygacil (tigecycline) compared to other antibiotics used to treat similar infections | September 3, 2010 |
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Ongoing Safety Review of Stalevo and possible increased cardiovascular risk | August 23, 2010 |
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Serious medication errors from intravenous administration of nimodipine oral capsules | August 19, 2010 |
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Aseptic meningitis associated with use of Lamictal | August 19, 2010 |
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Aseptic meningitis associated with use of Lamictal | August 16, 2010 |
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Avoid Unintentional Exposure of Children and Pets to Evamist | August 11, 2010 |
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Ongoing safety review of Evamist (estradiol transdermal spray) and unintended exposure of children and pets to topical estrogen | August 03, 2010 |
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Eosinophilic pneumonia associated with the use of Cubicin (daptomycin) | August 03, 2010 |
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New boxed warning for severe liver injury with arthritis drug Arava (leflunomide) | July 13, 2010 |
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New risk management plan and patient Medication Guide for Qualaquin | July 15, 2010 |
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Ongoing safety review of Benicar and cardiovascular events | June 15, 2010 |
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Possible increased risk of fractures of the hip, wrist, and spine with the use of proton pump inhibitors | May 28, 2010 |
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Completed safety review of Xenical/Alli (orlistat) and severe liver injury | May 26, 2010 |
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Medication errors from swallowing topical Benadryl Extra Strength Itch Stopping Gel | May 17, 2010 |
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Ongoing Safety Review of GnRH Agonists and possible increased risk of diabetes and certain cardiovascular diseases | May 6, 2010 |
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New Boxed Warning on severe liver injury with propylthiouracil | April 26, 2010 |
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Questions and Answers: Phase-Out of CFC Metered-Dose Inhalers Containing flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil | April 20, 2010 |
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Follow up to the Public Health Alert about Changes to the Heparin Sodium USP Monograph | April 15, 2010 |
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Ongoing Safety Review of Stalevo (entacapone/carbidopa/levodopa) and possible development of Prostate Cancer | April 7, 2010 |
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Ongoing safety review of oral bisphosphonates and atypical subtrochanteric femur fractures | March 17, 2010 |
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Reduced effectiveness of Plavix in patients who are poor metabolizers of the drug | March 17, 2010 |
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Ongoing review of Avandia and Cardiovascular Safety | March 12, 2010 |
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Ongoing Safety Review of Invirase and Possible Association with Abnormal Heart Rhythms | February 25, 2010 |
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Serious Liver Disorder Associated with the Use of Videx/Videx EC | February 25, 2010 |
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Questions and Answers: New Safety Requirements for Long-Acting Asthma Medications called Long-Acting Beta Agonists (LABAs) | February 18, 2010 |
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Product Confusion with Maalox Total Relief and Maalox Liquid Products | February 17, 2010 |
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Availability of Tamiflu for Oral Suspension | December 11, 2009 |
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Availability of Tamiflu for Oral Suspension | December 11, 2009 |
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Epinephrine CFC Metered-dose Inhalers - Questions and Answers | September 25, 2009 |
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Questions and Answers About Acetaminophen and Liver Injury for Consumers | July 29, 2009 |
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The FDA recommends that consumers should not use body building products marketed as containing steroids or steroid-like substances | July 28, 2009 |
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FDA Requires New Boxed Warnings for the Smoking Cessation Drugs Chantix and Zyban | July 7, 2009 |
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Loss of Sense of Smell with Intranasal Cold Remedies Containing Zinc | June 16, 2009 |
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Potential Hazards of Skin Products Containing Numbing Ingredients for Relieving Pain from Mammography and Other Medical Tests and Conditions | January 16, 2009 |
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Potential Hazards of Skin Products Containing Numbing Ingredients for Relieving Pain from Mammography and Other Medical Tests and Conditions | January 16, 2009 |
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Suicidal Thoughts and Behavior: Antiepileptic Drugs: Overview | December 19, 2008 |
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Suicidal Thoughts and Behavior: Antiepileptic Drugs Full Version | December 19, 2008 |
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FDA's Action Against Marketing Unapproved Drugs | October 17, 2008 |
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Measures undertaken to Address Concerns about Marketing of Unapproved Drugs | October 10, 2008 |
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Updated: Transition from Chlorofluorocarbon (CFC) Propelled Albuterol Inhalers to Hydrofluroalkane (HFA) Propelled Albuterol Inhalers | September 26, 2008 |
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Transition from Chlorofluorocarbon (CFC) Propelled Albuterol Inhalers to Hydrofluroalkane (HFA) Propelled Albuterol Inhalers Overview | May 30, 2008 |
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Transition from Chlorofluorocarbon (CFC) Propelled Albuterol Inhalers to Hydrofluroalkane (HFA) Propelled Albuterol Inhalers Full Version | May 30, 2008 |
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Important Information for the Safe Use of Tussionex Pennkinetic Extended-Release Suspension Overview | March 13, 2008 |
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Important Information for the Safe Use of Tussionex Pennkinetic Extended-Release Suspension Full Version | March 13, 2008 |
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Important Information on the Correct Use of Spiriva and Foradil Capsules Overview | March 3, 2008 |
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Important Information on the Correct Use of Spiriva and Foradil Capsules Full Version | March 3, 2008 |
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Important Warnings and Instructions for Heparin Sodium Injection (Baxter) Overview | February 13, 2008 |
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Important Warnings and Instructions for Heparin Sodium Injection (Baxter) Full Version | February 13, 2008 |
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Varenicline (marketed as Chantix) Overview | February 1, 2008 |
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Varenicline (marketed as Chantix) Full Version | February 1, 2008 |
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Use of Over-the-Counter (OTC) Cough and Cold Products in Infants and Children Overview | January 18, 2008 |
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Use of Over-the-Counter (OTC) Cough and Cold Products in Infants and Children Full Version | January 18, 2008 |
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Edetate Disodium (marketed as Endrate and generic products) Overview | January 18, 2008 |
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Edetate Disodium (marketed as Endrate and generic products) Full Version | January 18, 2008 |
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Fentanyl Transdermal System (Patch) (marketed as Duragesic and generics) Overview | December 21, 2007 |
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Fentanyl Transdermal System (Patch) (marketed as Duragesic and generics) Full Version | December 21, 2007 |
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Erythropoiesis-Stimulating Agents (ESAs) Overview | November 8, 2007 |
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Erythropoiesis-Stimulating Agents (ESAs) Full Version | November 8, 2007 |
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Safe Use of Fentora (fentanyl buccal tablets) Overview | September 27, 2007 |
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Safe Use of Fentora (fentanyl buccal tablets) Full Version | September 27, 2007 |
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Codeine Side-Effects in Nursing Infants Overview | August 17, 2007 |
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Codeine Side-Effects in Nursing Infants Full Version | August 17, 2007 |
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Nonprescription Cough and Cold Medicine Use in Children Overview | August 16, 2007 |
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Nonprescription Cough and Cold Medicine Use in Children Full Version | August 16, 2007 |
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Colistimethate (marketed as Coly-Mycin M and generic products) Overview | June 29, 2007 |
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Colistimethate (marketed as Coly-Mycin M and generic products) Full Version | June 29, 2007 |
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Tegaserod maleate (marketed as Zelnorm) Overview | March 30, 2007 |
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Tegaserod maleate (marketed as Zelnorm) Full Version | March 30, 2007 |
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Pergolide (marketed as Permax) Overview | March 29, 2007 |
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Pergolide (marketed as Permax) Full Version | March 29, 2007 |
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Erythropoiesis Stimulating Agents (ESAs) Overview | March 13, 2007 |
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Erythropoiesis Stimulating Agents (ESAs) Full Version | March 13, 2007 |
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Interferon gamma-1b (marketed as Actimmune) Overview | March 13, 2007 |
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Interferon gamma-1b (marketed as Actimmune) Full Version | March 13, 2007 |
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Topical Anesthetics Overview | February 6, 2007 |
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Topical Anesthetics Full Version | February 6, 2007 |
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Welcome from Dr. von Eschenbach | February 6, 2007 |
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