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U.S. Department of Health and Human Services

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FDA Drug Safety Podcasts

Drug Safety Podcast Banner Graphic

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.   

 

Latest Drug Safety Podcasts

FDA Drug Safety Podcast: FDA clarifies Warning about Pediatric Use of Revatio (sildenafil) for Pulmonary Arterial HypertensionMarch 31, 2014 Listen to This Podcast
Run Time:
00:1:58
 
Transcript 
FDA Drug Safety Podcast: FDA approves label changes for antibacterial Doribax (doripenem) describing increased risk of death for ventilator patients with pneumoniaMarch 6, 2014Listen to This Podcast
Run Time:
00:2:00
Transcript
FDA Drug Safety Podcast: FDA to review heart failure risk with diabetes drug saxagliptin (marketed as Onglyza and Kombiglyze XR)February 11, 2014Listen to This Podcast
Run Time:
00:1:59
Transcript
FDA Drug Safety Podcast: FDA evaluating risk of stroke, heart attack and death with FDA-approved testosterone productsJanuary 31, 2014Listen to This Podcast
Run Time:
00:3:00
Transcript
FDA Drug Safety Podcast: FDA warns of possible harm from exceeding recommended dose of over-the-counter sodium phosphate products to treat constipationJanuary 8, 2014Listen to This Podcast
Run Time:
00:3:00
Transcript
FDA Drug Safety Podcast: FDA requires multiple new safety measures for leukemia drug Iclusig; company expected to resume marketingDecember 20, 2013Listen to This Podcast
Run Time:
00:6:21
Transcript
FDA Drug Safety Podcast: FDA warns of rare risk of long-lasting erections in males taking methylphenidate ADHD medications and has approved label changesDecember 18, 2013Listen to This Podcast
Run Time:
00:6:08
Transcript
FDA Drug Safety Podcast: FDA warns of serious skin reactions with the anti-seizure drug Onfi (clobazam) and has approved label changesDecember 3, 2013Listen to This Podcast
Run Time:
00:4:24
Transcript
FDA Drug Safety Podcast: FDA requires removal of some prescribing and dispensing restrictions for rosiglitazone-containing diabetes medicinesNovember 25, 2013Listen to This Podcast
Run Time:
00:4:35
Transcript
FDA Drug Safety Podcast: FDA warns of rare but serious risk of heart attack and death with cardiac nuclear stress test drugs Lexiscan (regadenoson) and Adenoscan (adenosine)November 20, 2013Listen to This Podcast
Run Time:
00:4:57
Transcript
FDA Drug Safety Podcast: FDA requests label changes and single-use packaging for some over-the-counter topical antiseptic products to decrease risk of infectionNovember 13, 2013Listen to This Podcast
Run Time:
00:6:01
Transcript
FDA Drug Safety Podcast: Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparinsNovember 6, 2013Listen to This Podcast
Run Time:
00:7:24
Transcript
FDA Drug Safety Podcast: FDA approves label changes for anti-seizure drug Potiga (ezogabine) describing risk of retinal abnormalities, potential vision loss, and skin discolorationOctober 31, 2013Listen to This Podcast
Run Time:
00:3:14
Transcript
FDA Drug Safety Podcast: FDA asks manufacturer of the leukemia drug Iclusig (ponatinib) to suspend marketing and salesOctober 31, 2013Listen to This Podcast
Run Time:
00:5:16
Transcript
FDA Drug Safety Podcast: FDA investigating leukemia drug Iclusig (ponatinib) after increased reports of serious blood clots in arteries and veinsOctober 17, 2013Listen to This Podcast
Run Time:
00:4:06
Transcript
FDA Drug Safety Podcast: FDA warns of increased risk of death with IV antibacterial Tygacil (tigecycline) and approves new Boxed WarningSeptember 27, 2013Listen to This Podcast
Run Time:
00:3:47
Transcript
FDA Drug Safety Podcast: Boxed Warning and new recommendations to decrease risk of hepatitis B reactivation with the immune-suppressing and anti-cancer drugs Arzerra (ofatumumab) and Rituxan (rituximab)September 25, 2013Listen to This Podcast
Run Time:
00:7:29
Transcript
FDA Drug Safety Podcast: FDA requiring color changes to Duragesic (fentanyl) pain patches to aid safety―emphasizing that accidental exposure to used patches can cause deathSeptember 23, 2013Listen to This Podcast
Run Time:
00:4:41
Transcript
FDA Drug Safety Podcast: FDA investigating rare brain infection in patient taking Gilenya (fingolimod)August 29, 2013Listen to This Podcast
Run Time:
00:03:39
Transcript
FDA Drug Safety Podcast: FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injectionAugust 16, 2013Listen to This Podcast
Run Time:
00:03:28
Transcript
FDA Drug Safety Podcast: FDA warns of rare but serious skin reactions with the pain reliever/fever reducer acetaminophenAugust 1, 2013Listen to This Podcast
Run Time:
00:05:43
Transcript
FDA Drug Safety Podcast: FDA approves label changes for antimalarial drug mefloquine hydrochloride due to risk of serious psychiatric and nerve side effectsJuly 29, 2013Listen to This Podcast
Run Time:
00:03:48
Transcript
FDA Drug Safety Podcast: FDA limits usage of Nizoral (ketoconazole) oral tablets due to potentially fatal liver injury and risk of drug interactions and adrenal gland problemsJuly 26, 2013Listen to This Podcast
Run Time:
00:07:35
Transcript
FDA Drug Safety Podcast: FDA approves label changes to include intestinal problems (sprue-like enteropathy) linked to blood pressure medicine olmesartan medoxomilJuly 3, 2013Listen to This Podcast
Run Time:
00:02:50
Transcript
FDA Drug Safety Podcast: FDA is investigating two deaths following injection of long-acting antipsychotic Zyprexa Relprevv (olanzapine pamoate)June 18, 2013Listen to This Podcast
Run Time:
00:03:08
Transcript
FDA Drug Safety Podcast: FDA Recommends Against Prolonged Use of Magnesium Sulfate to Stop Pre-term Labor Due to Bone Changes in Exposed BabiesMay 30, 2013Listen to This Podcast
Run Time:
00:4:37
Transcript
FDA Drug Safety Podcast: FDA approves label changes for zolpidem products, including new dosing and a recommendation to avoid driving the day after Ambien CR useMay 14, 2013Listen to This Podcast
Run Time:
00:3:49
Transcript
FDA Drug Podcast: Valproate Anti-seizure Products Contraindicated for Migraine Prevention in Pregnant Women due to Decreased IQ Scores in Exposed ChildrenMay 6, 2013Listen to This Podcast
Run Time:
00:08:43
Transcript
FDA warns about potential medication errors resulting from confusion regarding nonproprietary name for breast cancer drug Kadcyla (ado-trastuzumab emtansine)May 6, 2013Listen to This Podcast
Run Time:
00:06:28
Transcript
FDA limits duration and usage of Samsca (tolvaptan) due to possible liver injury leading to organ transplant or deathApril 30, 2013Listen to This Podcast
Run Time:
00:03:38
Transcript
Anti-seizure drug Potiga (ezogabine) linked to retinal abnormalities and blue skin discolorationApril 26, 2013Listen to This Podcast
Run Time:
00:04:39
Transcript
FDA investigating reports of possible increased risk of pancreatitis and pre-cancerous findings of the pancreas from incretin mimetic drugs for type 2 diabetesMarch 14, 2013Listen to This Podcast
Run Time:
00:04:29
Transcript
Azithromycin (Zithromax or Zmax) and the risk of potentially fatal heart rhythmsMarch 12, 2013Listen to This Podcast
Run Time:
00:05:21
Transcript
FDA suspends pediatric clinical trials of Sensipar (cinacalcet hydrochloride) after report of deathFebruary 27, 2013Listen to This Podcast
Run Time:
00:03:47
Transcript
Safety review update of codeine use in children; new Boxed Warning and Contraindication on use after tonsillectomy and/or adenoidectomyFebruary 21, 2013Listen to This Podcast
Run Time:
00:05:25
Transcript
Risk of next-morning impairment after use of insomnia drugs; FDA requires lower recommended doses for certain drugs containing zolpidemJanuary 11, 2013Listen to This Podcast
Run Time:
00:06:15
Transcript
Serious skin reactions after combination treatment with the Hepatitis C drugs Incivek (telaprevir), peginterferon alfa, and ribavirinDecember 26, 2012Listen to This Podcast
Run Time:
00:05:46
Transcript
Warning against use of Xyrem (sodium oxybate) with alcohol or drugs causing respiratory depressionDecember 21, 2012Listen to This Podcast
Run Time:
00:04:53
Transcript
Pradaxa (dabigatran etexilate mesylate) should not be used in patients with mechanical prosthetic heart valvesDecember 21, 2012Listen to This Podcast
Run Time:
00:03:58
Transcript
Safety review update of Chantix (varenicline) and risk of cardiovascular adverse eventsDecember 13, 2012Listen to This Podcast
Run Time:
00:04:19
Transcript
Important change to heparin container labels to clearly state the total drug strengthDecember 7, 2012Listen to This Podcast
Run Time:
00:03:56
Transcript
Updated information on 32 mg intravenous ondansetron (Zofran) dose and pre-mixed ondansetron productsDecember 6, 2012Listen to This Podcast
Run Time:
00:03:43
Transcript
Investigation into New England Compounding CenterNovember 13, 2012Listen to This Podcast
Run Time:
00:03:00
Transcript
AmeridoseNovember 13, 2012Listen to This Podcast
Run Time:
00:02:00
Transcript
Update on the risk for serious bleeding events with the anticoagulant PradaxaNovember 2, 2012Listen to This Podcast
Run Time:
00:05:30
Transcript
Serious adverse events from accidental ingestion by children of over-the-counter eye drops and nasal spraysOctober 25, 2012Listen to This Podcast
Run Time:
00:04:01
Transcript
Ongoing safety review of Parkinson’s drug Mirapex (pramipexole) and possible risk of heart failureSeptember 21, 2012Listen to This Podcast
Run Time:
00:03:06
Transcript
Rare cases of serious burns with the use of over-the-counter topical muscle and joint pain relieversSeptember 13, 2012Listen to This Podcast
Run Time:
00:03:46
Transcript
FDA recommends against use of Revatio in children with pulmonary hypertensionAugust 30, 2012Listen to This Podcast
Run Time:
00:03:06
Transcript
Codeine use in certain children after tonsillectomy and/or adenoidectomy may lead to rare, but life-threatening adverse events or deathAugust 15, 2012Listen to This Podcast
Run Time:
00:04:22
Transcript
Seizure risk for multiple sclerosis patients who take Ampyra (dalfampridine)July 23, 2012Listen to This Podcast
Run Time:
00:04:29
Transcript
New information regarding QT prolongation with ondansertron (Zofran)July 5, 2012Listen to This Podcast
Run Time:
00:04:34
Transcript
Cefepime and risk of seizure in patients not receiving dosage adjustments for kidney impairmentJune 26, 2012Listen to This Podcast
Run Time:
00:03:17
Transcript
FDA advises healthcare providers to visually inspect Hospira Carpuject pre-filled cartridges for overfillMay 23, 2012Listen to This Podcast
Run Time:
00:03:14
Transcript
Revised recommendations for cardiovascular monitoring and use of multiple sclerosis drug Gilenya (fingolimod)May 14, 2012Listen to This Podcast
Run Time:
00:03:47
Transcript
Safety review update of cancer drug Revlimid (lenalidomide) and risk of developing new types of malignanciesMay 7, 2012Listen to This Podcast
Run Time:
00:03:02
Transcript
Updated information on drug interactions between Victrelis (boceprevir) and certain boosted HIV protease inhibitor drugsApril 26, 2012Listen to This Podcast
Run Time:
00:03:55
Transcript
New Warning and Contraindication for blood pressure medicines containing aliskiren (Tekturna)April 20, 2012Listen to This Podcast
Run Time:
00:03:45
Transcript
Updated information about the risk of blood clots in women taking birth control pills containing drospirenoneApril 11, 2012Listen to This Podcast
Run Time:
00:03:04
Transcript
Revised recommendations for Celexa (citalopram hydrobromide) related to a potential risk of abnormal heart rhythms with high dosesMarch 30, 2012Listen to This Podcast
Run Time:
00:05:29
Transcript
Interactions between certain HIV or hepatitis C drugs and cholesterol-lowering statin drugs can increase the risk of muscle injuryMarch 2, 2012Listen to This Podcast
Run Time:
00:02:22
Transcript
Important safety label changes to cholesterol-lowering statin drugsMarch 2, 2012Listen to This Podcast
Run Time:
00:03:37
Transcript
Important drug interactions between Victrelis (boceprevir) and ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitor drugsFebruary 10, 2012Listen to This PodcastTranscript
Clostridium difficile-associated diarrhea can be associated with stomach acid drugs known as proton pump inhibitors (PPIs)February 8, 2012Listen to This PodcastTranscript
New risk factor for Progressive Multifocal Leukoencephalopathy (PML) associated with Tysabri (natalizumab)January 20, 2012

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Run Time:
00:04:54

Transcript
New Boxed Warning and Contraindication for Adcetris (brentuximab vedotin)January 13, 2012

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Run Time:
00:04:21

Transcript
Update - Preliminary findings from ongoing investigations of CardioGen-82January 13, 2012

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Run Time: 00:04:38

Transcript

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