Drugs

FDA Drug Safety Podcasts by Date

CDER Drug Safety Podcasts

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 Podcast:

FDA Drug Safety Podcast: FDA approves label changes for asthma drug Xolair (omalizumab), including describing slightly higher risk of heart and brain adverse events September 26, 2014 Listen to This Podcast
Run Time:
00:3:00
Transcript
FDA Drug Safety Podcast: FDA recommends not using lidocaine to treat teething pain and requires new Boxed Warning June 26, 2014 Listen to This Podcast
Run Time:
00:3:00
Transcript
FDA Drug Safety Podcast: FDA warns of rare but serious hypersensitivity reactions with certain over-the-counter topical acne products June 25, 2014 Listen to This Podcast
Run Time:
00:3:00
Transcript
FDA Drug Safety Podcast: FDA review of cardiovascular risks for diabetics taking hypertension drug olmesartan not conclusive; label updates required June 24, 2014 Listen to This Podcast
Run Time:
00:3:00
Transcript
FDA Drug Safety Podcast: FDA warns that cancer drug docetaxel may cause symptoms of alcohol intoxication after treatment June 20, 2014 Listen to This Podcast
Run Time:
00:3:00
Transcript
FDA Drug Safety Podcast: FDA adding general warning to testosterone products about potential for venous blood clots June 19, 2014 Listen to This Podcast
Run Time:
00:2:00
Transcript
FDA Drug Safety Podcast: FDA warns of next-day impairment with sleep aid Lunesta (eszopiclone) and lowers recommended dose May 15, 2014 Listen to This Podcast
Run Time:
00:3:00
Transcript
FDA Drug Safety Podcast: FDA study of Medicare patients finds risks lower for stroke and death but higher for gastrointestinal bleeding with Pradaxa (dabigatran) compared to warfarin May 13, 2014 Listen to This Podcast
Run Time:
00:3:00

 
Transcript
FDA Drug Safety Podcast: FDA requires label changes to warn of rare but serious neurologic problems after epidural corticosteroid injections for pain April 23, 2014 Listen to This Podcast
Run Time:
00:3:00

 
Transcript
FDA Drug Safety Podcast: FDA clarifies Warning about Pediatric Use of Revatio (sildenafil) for Pulmonary Arterial Hypertension March 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 pneumonia March 6, 2014 Listen 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, 2014 Listen 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 products January 31, 2014 Listen 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 constipation January 8, 2014 Listen 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 marketing December 20, 2013 Listen 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 changes December 18, 2013 Listen 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 changes  December 3, 2013 Listen 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 medicines   November 25, 2013 Listen 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, 2013  Listen 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 infection November 13, 2013  Listen 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 heparins November 6, 2013 Listen 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 discoloration October 31, 2013 Listen 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 sales October 31, 2013 Listen 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 veins October 17, 2013 Listen 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 Warning September 27, 2013 Listen 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, 2013 Listen 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 death September 23, 2013 Listen 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, 2013 Listen to This Podcast
Run Time: 00:3:39
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 injection
 
August 16, 2013 Listen to This Podcast
Run Time: 00:3:28
Transcript
FDA Drug Safety Podcast: FDA warns of rare but serious skin reactions with the pain reliever/fever reducer acetaminophen August 1, 2013 Listen to This Podcast
Run Time: 00:5:43
Transcript
FDA Drug Safety Podcast: FDA approves label changes for antimalarial drug mefloquine hydrochloride due to risk of serious psychiatric and nerve side effects July 29, 2013 Listen to This Podcast
Run Time: 00:3:48
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 problems July 26, 2013 Listen to This Podcast
Run Time: 00:7:35
Transcript
FDA Drug Safety Podcast: FDA approves label changes to include intestinal problems (sprue-like enteropathy) linked to blood pressure medicine olmesartan medoxomil July 3, 2013 Listen to This Podcast
Run Time: 00:2:50
Transcript
FDA Drug Safety Podcast: FDA is investigating two deaths following injection of long-acting antipsychotic Zyprexa Relprevv (olanzapine pamoate) June 18, 2013 Listen to This Podcast
Run Time: 00:3:08
Transcript
FDA Drug Safety Podcast: FDA Recommends Against Prolonged Use of Magnesium Sulfate to Stop Pre-term Labor Due to Bone Changes in Exposed Babies May 30, 2013 Listen 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 use May 14, 2013 Listen 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 Children May 6, 2013 Listen to This Podcast
Run Time: 00:8:43
Transcript
FDA Drug Safety Podcast: FDA warns about potential medication errors resulting from confusion regarding nonproprietary name for breast cancer drug Kadcyla (ado-trastuzumab emtansine) May 6, 2013 Listen to This Podcast
Run Time: 00:6:28
Transcript
FDA Drug Safety Podcast: FDA limits duration and usage of Samsca (tolvaptan) due to possible liver injury leading to organ transplant or death April 30, 2013 Listen to This Podcast
Run Time: 00:3:38
Transcript
FDA Drug Safety Podcast: Anti-seizure drug Potiga (ezogabine) linked to retinal abnormalities and blue skin discoloration April 26, 2013 Listen to This Podcast
Run Time: 00:4:39
Transcript
FDA Drug Safety Podcast: FDA investigating reports of possible increased risk of pancreatitis and pre-cancerous findings of the pancreas from incretin mimetic drugs for type 2 diabetes March 14, 2013 Listen to This Podcast
Run Time: 00:4:29
Transcript
FDA Drug Safety Podcast: Azithromycin (Zithromax or Zmax) and the risk of potentially fatal heart rhythms March 12, 2013 Listen to This Podcast
Run Time: 00:5:21
Transcript
FDA suspends pediatric clinical trials of Sensipar (cinacalcet hydrochloride) after report of death February 27, 2013 Listen to This Podcast
Run Time: 00:3:47
Transcript
Safety review update of codeine use in children; new Boxed Warning and Contraindication on use after tonsillectomy and/or adenoidectomy February 21, 2013 Listen to This Podcast
Run Time: 00:5:25
Transcript
Risk of next-morning impairment after use of insomnia drugs; FDA requires lower recommended doses for certain drugs containing zolpidem January 11, 2013 Listen to This Podcast
Run Time: 00:6:15
Transcript
Serious skin reactions after combination treatment with the Hepatitis C drugs Incivek (telaprevir), peginterferon alfa, and ribavirin December 26, 2012 Listen to This Podcast
Run Time: 00:5:46
Transcript
Warning against use of Xyrem (sodium oxybate) with alcohol or drugs causing respiratory depression December 21, 2012 Listen to This Podcast
Run Time: 00:4:53
Transcript
Pradaxa (dabigatran etexilate mesylate) should not be used in patients with mechanical prosthetic heart valves December 21, 2012 Listen to This Podcast
Run Time: 00:3:58
Transcript
Safety review update of Chantix (varenicline) and risk of cardiovascular adverse events December 13, 2012 Listen to This Podcast
Run Time: 00:4:19
Transcript
Important change to heparin container labels to clearly state the total drug strength December 7, 2012 Listen to This Podcast
Run Time: 00:3:56
Transcript
Updated information on 32 mg intravenous ondansetron (Zofran) dose and pre-mixed ondansetron products December 6, 2012 Listen to This Podcast
Run Time: 00:3:43
Transcript
Investigation into New England Compounding Center November 13, 2012 Listen to This Podcast
Run Time: 00:3:00
Transcript
Ameridose November 13, 2012 Listen to This Podcast
Run Time: 00:2:00
Transcript
Update on the risk for serious bleeding events with the anticoagulant Pradaxa November 2, 2012 Listen to This Podcast
Run Time: 00:5:30
Transcript
Serious adverse events from accidental ingestion by children of over-the-counter eye drops and nasal sprays October 25, 2012 Listen to This Podcast
Run Time: 00:4:01
Transcript
Ongoing safety review of Parkinson’s drug Mirapex (pramipexole) and possible risk of heart failure September 21, 2012 Listen to This Podcast
Run Time: 00:3:06
Transcript
Rare cases of serious burns with the use of over-the-counter topical muscle and joint pain relievers August 30, 2012 Listen to This Podcast
Run Time: 00:3:46
Transcript
FDA recommends against use of Revatio in children with pulmonary hypertension August 30, 2012 Listen to This Podcast
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 Listen to This Podcast
Run Time: 00:4:22
Transcript
Seizure risk for multiple sclerosis patients who take Ampyra (dalfampridine) July 23, 2012 Listen to This Podcast
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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Run Time: 00:3:17

Transcript
FDA advises healthcare providers to visually inspect Hospira Carpuject pre-filled cartridges for overfill May 23, 2012

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Run Time: 00:3:14

Transcript
Revised recommendations for cardiovascular monitoring and use of multiple sclerosis drug Gilenya (fingolimod) May 14, 2012

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Run Time: 00:3:47

Transcript
Safety review update of cancer drug Revlimid (lenalidomide) and risk of developing new types of malignancies May 7, 2012

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Run Time: 00:3:02

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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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Run Time: 00:3:55

Transcript
New Warning and Contraindication for blood pressure medicines containing aliskiren (Tekturna) April 20, 2012

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Run Time: 00:3:45

Transcript
Updated information about the risk of blood clots in women taking birth control pills containing drospirenone April 11, 2012

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Run Time: 00:05:29

Transcript
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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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 injury March 2, 2012

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Run Time: 00:03:37

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Important safety label changes to cholesterol-lowering statin drugs March 2, 2012

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Run Time: 00:03:37

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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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Run Time: 00:03:38

Transcript

Clostridium difficile-associated diarrhea can be associated with stomach acid drugs known as proton pump inhibitors (PPIs)

February 8, 2012

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Run Time: 00:03:24

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New risk factor for Progressive Multifocal Leukoencephalopathy (PML) associated with Tysabri (natalizumab) January 20, 2012

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Run Time: 00:04:54

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

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Run Time: 00:04:21

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

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Run Time: 00:04:38

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Main Drug Safety Podcasts Page

Page Last Updated: 10/01/2014
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