U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Drug Safety and Availability
  4. FDA Drug Safety Podcasts
  1. Drugs

FDA Drug Safety Podcasts

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 Drug Safety Communications.    

Download on iTunes

Latest Drug Safety Podcasts

Title Date Link to Podcast Link to Transcript
FDA approves Boxed Warning about increased risk of blood clots and death with higher dose of arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR) July 26, 2019 Listen
Run Time:
00:3:00
Transcript
FDA adds Boxed Warning for risk of serious injuries caused by sleepwalking with certain prescription insomnia medicines April 30, 2019 Listen
Run Time:
00:3:00
Transcript
FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering April 9, 2019 Listen
Run Time:
00:3:00
Transcript
Safety trial finds risk of blood clots in the lungs and death with higher dose of tofacitinib (Xeljanz, Xeljanz XR) in rheumatoid arthritis patients; FDA to investigate February 25, 2019 Listen
Run Time:
00:3:00
Transcript
FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat) February 21, 2019 Listen
Run Time:
00:3:00
Transcript
FDA warns that symptoms of a serious condition affecting the blood cells are not being recognized with the leukemia medicine Idhifa (enasidenib) November 29, 2018 Listen
Run Time:
00:3:00
Transcript
FDA warns about rare but serious risks of stroke and blood vessel wall tears with multiple sclerosis drug Lemtrada (alemtuzumab) November 29, 2018 Listen
Run Time:
00:3:00
Transcript
FDA warns about severe worsening of multiple sclerosis after stopping the medicine Gilenya (fingolimod) November 20, 2018 Listen to This Podcast
Run Time:
00:3:00
Transcript

FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes
August 29, 2018 Listen to This Podcast
Run Time:
00:3:00
Transcript
FDA warns about increased risk of cancer relapse with long-term use of azithromycin (Zithromax, Zmax) antibiotic after donor stem cell transplant August 3, 2018 Listen to This Podcast
Run Time:
00:3:00
Transcript
FDA reinforces safety information about serious low blood sugar levels and mental health side effects with fluoroquinolone antibiotics; requires label changes July 10, 2018 Listen to This Podcast
Run Time:
00:3:00
Transcript
Risk of serious and potentially fatal blood disorder prompts FDA action on oral over-the-counter benzocaine products used for teething and mouth pain and prescription local anesthetics May 23, 2018 Listen to This Podcast
Run Time:
00:3:00
Transcript
FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq) May 18, 2018 Listen to This Podcast
Run Time:
00:3:30
Transcript
FDA warns of serious immune system reaction with seizure and mental health medicine lamotrigine (Lamictal) April 25, 2018 Listen to This Podcast
Run Time:
00:3:00
Transcript
FDA review finds additional data supports the potential for increased long-term risks with antibiotic clarithromycin (Biaxin) in patients with heart disease February 22, 2018 Listen to This Podcast
Run Time:
00:2:00
Transcript
FDA adds Boxed Warning to highlight correct dosing of Ocaliva (obeticholic acid) for patients with a rare chronic liver disease February 1, 2018 Listen to This Podcast
Run Time:
00:3:00
Transcript
FDA limits packaging for anti-diarrhea medicine Loperamide (Imodium) to encourage safe use January 30, 2018 Listen to This Podcast
Run Time:
00:3:00
Transcript
FDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and older January 11, 2018 Listen to This Podcast
Run Time:
00:3:09
Transcript
FDA review finds no significant increase in risk of serious asthma outcomes with long-acting beta agonists (LABAs) used in combination with inhaled corticosteroids (ICS)  December 20, 2017  Listen to This Podcast
Run Time:
00:3:00
Transcript 
FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings December 19, 2017 Listen to This Podcast
Run Time:
00:3:00
Transcript
FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric) November 15, 2017 Listen to This Podcast
Run Time:
00:3:00
Transcript
FDA warns about serious liver injury with Ocaliva (obeticholic acid) for rare chronic liver disease September 21, 2017 Listen to This Podcast
Run Time:
00:3:00
Transcript
FDA urges caution about withholding opioid addiction medications from patients taking benzodiazepines or CNS depressants: careful medication management can reduce risks September 20, 2017 Listen to This Podcast
Run Time:
00:3:30
Transcript
FDA recommends separating dosing of potassium-lowering drug sodium polystyrene sulfonate (Kayexalate) from all other oral drugs September 6, 2017   Listen to This Podcast
Run Time:
00:3:00
Transcript 
FDA identifies no harmful effects to date with brain retention of gadolinium-based contrast agents for MRIs; review to continue  May 22, 2017  Listen to This Podcast
Run Time:
00:3:00
Transcript 
FDA confirms increased risk of leg and foot amputations with the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR)  May 16, 2017  Listen to This Podcast
Run Time:
00:3:00
 Transcript
FDA approves label changes for use of general anesthetic and sedation drugs in young children April 27, 2017 Listen to This Podcast
Run Time:
00:3:00
Transcript
FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women April 20, 2017 Listen to This Podcast
Run Time:
00:3:00
Transcript
FDA warns about increased risk of serious pancreatitis with irritable bowel drug Viberzi (eluxadoline) in patients without a gallbladder March 15, 2017 Listen to This Podcast
Run Time:
00:3:00
Transcript
FDA warns about rare but serious allergic reactions with the skin antiseptic chlorhexidine gluconate February 2, 2017   Listen to This Podcast
Run Time:
00:3:00
Transcript 
FDA revises description of mental health side effects of stop-smoking medicines Chantix and Zyban to reflect clinical trial findings December 16, 2016 Listen to This Podcast
Run Time:
00:3:00
Transcript
FDA review results in new warnings about using general anesthetics and sedation drugs in young children and pregnant women December 14, 2016 Listen to This Podcast
Run Time:
00:3:00
Transcript 
Updated FDA review concludes that use of pioglitazone may be linked to an increased risk of bladder cancer December 12, 2016 Listen to This Podcast
Run Time:
00:3:00
Transcript 
FDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C October 4, 2016 Listen to This Podcast
Run Time:
00:3:00
Transcript
FDA warns about serious risks and death when combining opioid pain or cough medicines with benzodiazepines; requires its strongest warning August 31, 2016 Listen to This Podcast
Run Time:
00:3:00
Transcript
FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects July 26, 2016 Listen to This Podcast
Run Time:
00:3:00
Transcript
FDA strengthens kidney warnings for diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR) June 14, 2016 Listen to This Podcast
Run Time:
00:3:04
Transcript
Update: FDA evaluating the risk of burns and scars with Zecuity (sumatriptan) migraine patch June 10, 2016 Listen to This Podcast
Run Time:
00:1:12
Transcript
FDA warns about serious heart problems with high doses of the antidiarrheal medicine loperamide (Imodium), including from abuse and misuse June 7, 2016 Listen to This Podcast
Run Time:
00:3:00
Transcript
FDA warns about serious bleeding risk with over-the-counter antacid products containing aspirin June 6, 2016 Listen to This Podcast
Run Time:
00:3:00
Transcript
FDA evaluating the risk of burns and scars with Zecuity (sumatriptan) migraine patch June 2, 2016 Listen to This Podcast
Run Time:
00:1:58
Transcript
FDA warns that prescribing of Nizoral (ketoconazole) oral tablets for unapproved uses including skin and nail infections continues; linked to patient death May 19, 2016 Listen to This Podcast
Run Time:
00:3:00
Transcript
Interim clinical trial results find increased risk of leg and foot amputations, mostly affecting the toes, with the diabetes medicine canagliflozin (Invokana, Invokamet); FDA to investigate May 18, 2016 Listen to This Podcast
Run Time:
00:3:00
Transcript
FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together May 12, 2016 Listen to This Podcast
Run Time:
00:3:00
Transcript
FDA warns about rare but serious skin reactions with mental health drug olanzapine (Zyprexa, Zyprexa Zydis, Zyprexa Relprevv, and Symbyax) May 10, 2016 Listen to This Podcast
Run Time:
00:3:00
Transcript
FDA warns about new impulse-control problems associated with mental health drug aripiprazole (Abilify, Abilify Maintena, Aristada) May 3, 2016 Listen to This Podcast
Run Time:
00:3:00
Transcript
FDA approves brand name change for antidepressant drug Brintellix (vortioxetine) to avoid confusion with antiplatelet drug Brilinta (ticagrelor) May 2, 2016 Listen to This Podcast
Run Time:
00:3:00
Transcript
FDA to review study examining use of oral fluconazole (Diflucan) in pregnancy April 26, 2016 Listen to This Podcast
Run Time:
00:2:00
Transcript
FDA revises warnings regarding use of the diabetes medicine metformin in certain patients with reduced kidney function April 8, 2016 Listen to This Podcast
Run Time:
00:3:00
Transcript
FDA announced that a safety review has found type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure April 5, 2016 Listen to This Podcast
Run Time:
00:3:00
Transcript
FDA warns about several safety issues with opioid pain medicines; requires label changes March 29, 2016 Listen to This Podcast
Run Time:
00:3:00
Transcript
FDA cautions about dosing errors when switching between different oral formulations of antifungal Noxafil (posaconazole); label changes approved January 4, 2016 Listen to This Podcast
Run Time:
00:3:00
Transcript

View All Past Podcasts in the FDA Archive

Additional Information

ResourcesForYou