FDA Drug Safety Podcasts http://www.fda.gov/cder/drug/podcast/default.htm en-us U.S. Food and Drug Administration, Center for Drug Evaluation and Research The FDA Drug Safety Podcasts provide emerging safety information about drugs in conjunction with the release of Public Health Advisories. Center for Drug Evaluation and Research druginfo@fda.hhs.gov (CDER Division of Drug Information) no Tue, 23 Dec 2008 13:55 EDT cderwebmaster@fda.hhs.gov (CDER Webmaster) Suicidal Thoughts and Behavior: Antiepileptic Drugs: Overview Version Fri, 19 Dec 2008 14:55 EDT http://www.fda.gov/cder/drug/podcast/antiepileptics_overview.htm http://www.fda.gov/cder/drug/podcast/antiepileptics_overview.htm epileptic drugs, suicidal thought and behaviors Suicidal Thoughts and Behavior: Antiepileptic Drugs: full version Fri, 19 Dec 2008 14:55 EDT http://www.fda.gov/cder/drug/podcast/antiepileptics_full.htm http://www.fda.gov/cder/drug/podcast/antiepileptics_full.htm epileptic drugs, suicidal thought and behaviors Measures undertaken to Address Concerns about Marketing of Unapproved Drugs Fri, 10 Oct 2008 09:16:00 EDT http://www.fda.gov/cder/drug/podcast/Unapproved_Drugs_ReachMD_DrWoo.htm http://www.fda.gov/cder/drug/podcast/Unapproved_Drugs_ReachMD_DrWoo.htm unapproved drugs, marketing As part of a multi-year phase out, chlorofluorocarbon (CFC) propelled albuterol inhalers will not be available after December 31, 2008. Healthcare professionals should transition patients to the hydrofluoralkane (HFA) propelled albuterol inhalers now. Full Version. Fri, 26 Sep 2008 14:20:00 EDT http://www.fda.gov/cder/drug/podcast/albuterol_inhalers_20080926.htm http://www.fda.gov/cder/drug/podcast/albuterol_inhalers_20080926.htm cfc, albuterol, hfa, inhalers As part of a multi-year phase out, chlorofluorocarbon (CFC) propelled albuterol inhalers will not be available after December 31, 2008. Healthcare professionals should transition patients to the hydrofluoralkane (HFA) propelled albuterol inhalers now. Full Version. Fri, 30 May 2008 12:00:00 EST http://www.fda.gov/cder/drug/podcast/albuterol_inhalers_full.htm http://www.fda.gov/cder/drug/podcast/albuterol_inhalers_full.htm cfc, albuterol, hfa, inhalers As part of a multi-year phase out, chlorofluorocarbon (CFC) propelled albuterol inhalers will not be available after December 31, 2008. Healthcare professionals should transition patients to the hydrofluoralkane (HFA) propelled albuterol inhalers now. Overview Version. Fri, 30 May 2008 12:00:00 EST http://www.fda.gov/cder/drug/podcast/albuterol_inhalers_overview.htm http://www.fda.gov/cder/drug/podcast/albuterol_inhalers_overview.htm cfc, albuterol, hfa, inhalers Hydrocodone, the narcotic ingredient in this medicine that controls cough, can cause life-threatening breathing problems and death when given above or more frequently than the recommended dose. Tussionex should not be used in children less than 6 years old. Full Version. Thu, 13 Mar 2008 16:00:00 EST http://www.fda.gov/cder/drug/podcast/tussionex_full.htm http://www.fda.gov/cder/drug/podcast/tussionex_full.htm tussionex, pennkinetic, hydrocodone, cough Hydrocodone, the narcotic ingredient in this medicine that controls cough, can cause life-threatening breathing problems and death when given above or more frequently than the recommended dose. Tussionex should not be used in children less than 6 years old. Overview Version. Thu, 13 Mar 2008 16:00:00 EST http://www.fda.gov/cder/drug/podcast/tussionex_overview.htm http://www.fda.gov/cder/drug/podcast/tussionex_overview.htm tussionex, pennkinetic, hydrocodone, cough The medication in the Spiriva or Foradil capsules is specifically designed to be inhaled through inhalation devices. Both Spiriva and Foradil will not treat a patient's breathing condition if the contents of a capsule are swallowed rather than inhaled. Full Version. Mon, 03 Mar 2008 12:15:00 EST http://www.fda.gov/cder/drug/podcast/spiriva_foradil_full.htm http://www.fda.gov/cder/drug/podcast/spiriva_foradil_full.htm The medication in the Spiriva or Foradil capsules is specifically designed to be inhaled through inhalation devices. Both Spiriva and Foradil will not treat a patient's breathing condition if the contents of a capsule are swallowed rather than inhaled. Overview Version. Mon, 03 Mar 2008 12:15:00 EST http://www.fda.gov/cder/drug/podcast/spiriva_foradil_overview.htm http://www.fda.gov/cder/drug/podcast/spiriva_foradil_overview.htm Serious adverse events have recently been reported in patients who received high bolus doses (over a short period of time, usually a few minutes) of heparin sodium, including allergic or hypersensitivity-type reactions, with symptoms of oral swelling, nausea, vomiting, sweating, shortness of breath, and cases of severe hypotension requiring treatment. Full Version. Wed, 13 Feb 2008 15:15:00 EST http://www.fda.gov/cder/drug/podcast/heparin_full.htm http://www.fda.gov/cder/drug/podcast/heparin_full.htm Serious adverse events have recently been reported in patients who received high bolus doses (over a short period of time, usually a few minutes) of heparin sodium, including allergic or hypersensitivity-type reactions, with symptoms of oral swelling, nausea, vomiting, sweating, shortness of breath, and cases of severe hypotension requiring treatment. Overview Version. Wed, 13 Feb 2008 15:15:00 EST http://www.fda.gov/cder/drug/podcast/heparin_overview.htm http://www.fda.gov/cder/drug/podcast/heparin_overview.htm New information about the possibility of serious neuropsychiatric symptoms (changes in behavior, agitation, depressed mood, and suicidal ideation and behavior) in patients taking Chantix. Full Version. Fri, 01 Feb 2008 14:45:00 EST http://www.fda.gov/cder/drug/podcast/varenicline_full.htm http://www.fda.gov/cder/drug/podcast/varenicline_full.htm New information about the possibility of serious neuropsychiatric symptoms (changes in behavior, agitation, depressed mood, and suicidal ideation and behavior) in patients taking Chantix. Overview Version. Fri, 01 Feb 2008 14:45:00 EST http://www.fda.gov/cder/drug/podcast/varenicline_overview.htm http://www.fda.gov/cder/drug/podcast/varenicline_overview.htm FDA is recommending that over-the-counter (OTC) cough and cold medicines not be used to treat infants and children under 2 years of age because serious and potentially life-threatening side effects can occur. Full Version. Fri, 18 Jan 2008 15:30:00 EST http://www.fda.gov/cder/drug/podcast/otc_cough_cold_full.htm http://www.fda.gov/cder/drug/podcast/otc_cough_cold_full.htm FDA is recommending that over-the-counter (OTC) cough and cold medicines not be used to treat infants and children under 2 years of age because serious and potentially life-threatening side effects can occur. Overview Version. Fri, 18 Jan 2008 15:30:00 EST http://www.fda.gov/cder/drug/podcast/otc_cough_cold_overview.htm http://www.fda.gov/cder/drug/podcast/otc_cough_cold_overview.htm There have been cases where children and adults have died when they were mistakenly given Edetate Disodium instead of Edetate Calcium Disodium (Calcium Disodium Versenate) or when Edetate Disodium was used for "chelation therapies" and other uses that are not approved by the FDA. Full Version. Fri, 18 Jan 2008 15:30:00 EST http://www.fda.gov/cder/drug/podcast/edetate_disodium_full.htm http://www.fda.gov/cder/drug/podcast/edetate_disodium_full.htm There have been cases where children and adults have died when they were mistakenly given Edetate Disodium instead of Edetate Calcium Disodium (Calcium Disodium Versenate) or when Edetate Disodium was used for "chelation therapies" and other uses that are not approved by the FDA. Overview Version. Fri, 18 Jan 2008 15:30:00 EST http://www.fda.gov/cder/drug/podcast/edetate_disodium_overview.htm http://www.fda.gov/cder/drug/podcast/edetate_disodium_overview.htm