FDA 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 Drug Safety Communications.
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| Title | Date | Podcast | Transcript |
|---|---|---|---|
| Serious liver injury being observed in patients without cirrhosis taking Ocaliva (obeticholic acid) to treat primary biliary cholangitis | December 12, 2024 | Listen Run Time: 00:5:05 | Transcript |
| FDA adds warning about rare occurrence of serious liver injury with use of Veozah (fezolinetant) for hot flashes due to menopause | September 20, 2024 | Listen Run Time: 00:3:30 | Transcript |
| FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab) | January 19, 2024 | Listen Run Time: 00:4:00 | Transcript |
| Update on FDA’s ongoing evaluation of reports of suicidal thoughts or actions in patients taking a certain type of medicines approved for type 2 diabetes and obesity | January 11, 2024 | Listen Run Time: 00:3:30 | Transcript |
| FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan) | November 28, 2023 | Listen Run Time: 00:5:05 | Transcript |
| FDA updating warnings to improve safe use of prescription stimulants used to treat ADHD and other conditions | May 11, 2023 | Listen Run Time: 00:5:30 | Transcript |
| FDA updates prescribing information for all opioid pain medicines to provide additional guidance for safe use | April 13, 2023 | Listen Run Time: 00:7:30 | Transcript |
| FDA investigating risk of severe hypocalcemia in patients on dialysis receiving osteoporosis medicine Prolia (denosumab) | November 22, 2022 | Listen Run Time: 00:4:00 | Transcript |
| FDA warns about possible increased risk of death and serious side effects with cancer drug Copiktra (duvelisib) | June 30, 2022 | Listen Run Time: 00:4:00 | Transcript |
| FDA withdrew its approval for the cancer medicine Ukoniq (umbralisib) due to safety concerns | June 1, 2022 | Listen Run Time: 00:2:00 | Transcript |
| FDA recommends thyroid monitoring in babies and young children who receive injections of iodine-containing contrast media for medical imaging | March 30, 2022 | Listen Run Time: 00:4:30 | Transcript |
| FDA investigating possible increased risk of death with lymphoma medicine Ukoniq (umbralisib) | February 3, 2022 | Listen Run Time: 00:3:30 | Transcript |
| FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain | January 12, 2022 | Listen Run Time: 00:5:59 | Transcript |
| FDA warns that getting alcohol-based hand sanitizer in the eyes can cause serious injury | November 2, 2021 | Listen Run Time: 00:4:00 | Transcript |
| FDA requires warnings about increased risk of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions | September 1, 2021 | Listen Run Time: 00:4:00 | Transcript |
| FDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancy; still advises most pregnant patients should stop taking statins | July 20, 2021 | Listen Run Time: 00:3:00 | Transcript |
| FDA warns that vapors from alcohol-based hand sanitizers can have side effects | June 16, 2021 | Listen Run Time: 00:4:29 | Transcript |
| Due to risk of serious liver injury, FDA restricts use of obeticholic acid (Ocaliva) in primary biliary cholangitis (PBC) patients with advanced cirrhosis | May 26, 2021 | Listen Run Time: 00:3:38 | Transcript |
| Studies show increased risk of heart rhythm problems with seizure and mental health medicine lamotrigine (Lamictal) in patients with heart disease | March 31, 2021 | Listen Run Time: 00:3:00 | Transcript |
| FDA warns that abuse and misuse of the OTC nasal decongestant propylhexedrine can lead to serious harm | March 25, 2021 | Listen Run Time: 00:3:00 | Transcript |
| Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib) | February 4, 2021 | Listen Run Time: 00:3:00 | Transcript |
| FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid | October 15, 2020 | Listen Run Time: 00:3:00 | Transcript |
| FDA warns about serious problems with high doses of the allergy medicine diphenhydramine (Benadryl) | September 24, 2020 | Listen Run Time: 00:3:00 | Transcript |
| FDA requiring Boxed Warning updated to improve safe use of benzodiazepine drug class | September 23, 2020 | Listen Run Time: 00:3:00 | Transcript |
| FDA removes Boxed Warning about risk of leg and foot amputations for the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) | August 26, 2020 | Listen Run Time: 00:2:59 | Transcript |
| FDA recommends health care professionals discuss naloxone with all patients when prescribing opioid pain relievers or medicines to treat opioid use disorder | July 23, 2020 | Listen Run Time: 00:3:31 | Transcript |
| FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems | April 24, 2020 | Listen Run Time: 00:3:32 | Transcript |
| FDA requires Boxed Warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitis | March 4, 2020 | Listen Run Time: 00:3:00 | Transcript |
| FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market | February 13, 2020 | Listen Run Time: 00:3:00 | Transcript |
| FDA strengthens warning that untreated constipation caused by schizophrenia medicine clozapine (Clozaril) can lead to serious bowel problems | January 28, 2020 | Listen Run Time: 00:3:00 | Transcript |
| Safety clinical trial shows possible increased risk of cancer with weight-loss medicine Belviq, Belviq XR (lorcaserin) | January 14, 2020 | Listen Run Time: 00:2:00 | Transcript |
| FDA warns about serious breathing problems with seizure and nerve pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR) | December 19, 2019 | Listen Run Time: 00:3:00 | Transcript |
| FDA warns about rare but severe lung inflammation with Ibrance, Kisqali, and Verzenio for breast cancer | September 13, 2019 | Listen Run Time: 00:3:00 | Transcript |
| FDA warns about rare occurrence of serious liver injury with use of hepatitis C medicines Mavyret, Zepatier, and Vosevi in some patients with advanced liver disease | August 28, 2019 | Listen Run Time: 00:3:00 | Transcript |
| FDA review finds no increased risk of prostate cancer with Parkinson's disease medicines containing entacapone (Comtan, Stalevo) | August 13, 2019 | Listen Run Time: 00:3:00 | 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 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 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 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 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 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 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 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 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 Run Time: 00:3:00 | Transcript |
| FDA limits packaging for anti-diarrhea medicine Loperamide (Imodium) to encourage safe use | January 30, 2018 | Listen 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 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 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 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 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 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 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 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 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 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 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 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 Run Time: 00:3:00 | Transcript |
| FDA warns about rare but serious allergic reactions with the skin antiseptic chlorhexidine gluconate | February 2, 2017 | Listen Run Time: 00:3:00 | Transcript |
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