FDA Drug Safety Podcasts: Recent Episodes
U.S. Food and Drug Administration, Center for Drug Evaluation and Research
FDA Drug Safety Podcasts, produced by FDA's Center for Drug Evaluation and Research, provide emerging safety information about drugs in conjunction with the release of Drug Safety Communications. For more information, please visit: www.fda.gov/drugsafetypodcasts
Serious liver injury being observed in patients without cirrhosis taking Ocaliva (obeticholic acid) to treat primary biliary cholangitis
Listen to an audio podcast of the September 12th, 2024 FDA Drug Safety Communication on rare occurrence of serious liver injury with use of Veozah (fezolinetant) for hot flashes due to menopause.
Listen to FDA Drug Safety Podcast titled, FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab).
Listen to FDA Drug Safety Podcast, FDA's preliminary evaluation has not found evidence that use of GLP-1 RAs causes suicidal thoughts/actions.
Listen to an audio podcast of the November 28, 2023, FDA Drug Safety Communication, FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan).
Listen to an audio podcast of the May 11, 2023, FDA Drug Safety Communication on warnings to improve safe use of prescription stimulants used to treat ADHD and other conditions
Listen to an audio podcast of the April 13, 2023, FDA Drug Safety Communication, FDA updates prescribing information for all opioid pain medicines to provide additional guidance for safe use.
FDA investigating risk of severe hypocalcemia in patients on dialysis receiving osteoporosis medicine Prolia (denosumab)
Listen to an audio podcast of the June 30, 2022, FDA Drug Safety Communication. Results from a clinical trial show a possible increased risk of death with Copiktra (active ingredient duvelisib) compared to another medicine to treat leukemia and lymphoma.
Listen to an audio podcast of the 6/1/22 for Ukoniq . FDA withdrew its approval for the cancer medicine Ukoniq (active ingredient umbralisib) due to safety concerns. Ukoniq was approved to treat two specific types of lymphoma: marginal zone lymphoma (MZL) and follicular lymphoma (FL)
Listen to an audio podcast of the March 30, 2022 FDA Drug Safety Communication Iodinated Contrast Media
Listen to an audio podcast of the February 3, 2022, FDA Drug Safety Communication, FDA is investigating a possible increased risk of death with the cancer medicine Ukoniq (umbralisib). We are re-evaluating this risk against the benefits of Ukoniq for its approved uses.
Listen to an audio podcast of the January 12, 2022, FDA Drug Safety Communication warning that dental problems have been reported with medicines containing buprenorphine that are dissolved in the mouth.
“Listen to FDA Drug Podcast, FDA warns that getting alcohol-based hand sanitizer in the eyes can cause serious injury
Listen to an audio podcast of the September 1, 2021 FDA Drug Safety Communication on requiring revisions to the Boxed Warning for Xeljanz/Xeljanz XR, Olumiant, and Rinvoq to include information about the risks of serious heart-related events, cancer, blood clots, and death.
Listen to an audio podcast of the July 20, 2021 FDA Drug Safety Communication, FDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancy; still advises most pregnant patients should stop taking statins
Listen to an audio podcast of the June 16, 2021 Drug Safety Communication "FDA warns that vapors from alcohol-based hand sanitizers can cause symptoms such as headache, nausea, and dizziness after applying to the skin"
Listen to FDA Drug Safety Podcast on due to risk of serious liver injury, FDA restricts use of Ocaliva in primary biliary cholangitis (PBC) patients with advanced cirrhosis
Listen to an audio podcast of the March 31, 2021 FDA Drug Safety Communication that FDA review of studies show a potential increased risk of heart rhythm problems, in patients with heart disease taking lamotrigine (Lamictal). FDA requiring studies to evaluate heart risk across the drug class.
Listen to an audio podcast of the March 25, 2021 FDA Drug Safety Communication warning that abuse and misuse of the over the counter (OTC) nasal decongestant propylhexedrine (brand name Benzedrex) can lead to serious harm such as heart and mental health problems.
Listen to FDA Drug Safety Podcast on Drug Safety Communication titled "Initial safety trial results find increased risk of serious heart-related problems and cancer with tofacitinib (Xeljanz, Xeljanz XR)
Listen to an audio podcast of the October 15, 2020 FDA Drug Safety Communication titled "FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid. This issue affects all NSAIDs availbale by prescription and over-the-counter (OTC)."
Listen to FDA Drug Safety Podcast on Drug Safety Communication titled "FDA warns about serious Problems with high doses of the allergy medicine diphenhydramine (Bendaryl).
Listen to an audio podcast of the September 23, 2020, FDA Drug Safety communication to address the serious risks of abuse, addiction, physical dependence, and withdrawal reactions as FDA required the Boxed Warning be updated for all benzodiazepine medicines.
FDA removes Boxed Warning about risk of leg and foot amputations for the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR)
Listen to an audio podcast of the 07.23.2020 FDA Drug Safety Communication: FDA recommends HCPs discuss naloxone with all patients when prescribing opioid pain relievers or medicines to treat opioid use disorder
Listen to an audio podcast of the April 24, 2020 FDA Drug Safety Communication: 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. Close supervision is recommended
Listen to an audio podcast of the February 13 2020 FDA Drug Safety Communicationrequesting the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market. Potential risk of cancer outweighs the benefits.
Listen to an audio podcast of the January 28, 2020 FDA Drug Safety Communication that FDA is strengthening an existing warning that constipation caused by the schizophrenia medicine clozapine (Clozaril, Fazaclo ODT, Versacloz, generics) can, uncommonly, progress to serious bowel complications.
Listen to an audio podcast of the January 14, 2020 FDA Drug Safety Communication titled "Safety clinical trial shows possible increased risk of cancer with weight-loss medicine Belviq, Belviq XR (lorcaserin).
Listen to an audio podcast of the December 19, 2019 FDA Drug Safety Communication warning that serious breathing difficulties may occur in patients using seizure and nerve pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR) who have respiratory risk factors.
Listen to an audio podcast of the August 28, 2019 FDA Drug Safety Communication: FDA warns about rare occurrence of serious liver injury with use of hepatitis C medicines Mavyret, Zepatier, and Vosevi with advanced liver disease.
Listen to an audio podcast of the July 26, 2019 FDA Drug Safety Communication on FDA approval of Boxed Warning about increased risk of blood clots and death with higher dose of arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR).
FDA adds Boxed Warning for risk of serious injuries caused by sleepwalking with certain prescription insomnia medicines
FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering
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
FDA warns that symptoms of a serious condition affecting the blood cells are not being recognized with the leukemia medicine Idhifa (enasidenib)
FDA warns about rare but serious risks of stroke and blood vessel wall tears with multiple sclerosis drug Lemtrada (alemtuzumab)
FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat)
FDA Drug Safety Podcast: FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes
FDA Drug Safety Podcast: FDA reinforces safety information about serious low blood sugar levels and mental health side effects with fluoroquinolone antibiotics; requires label changes
FDA Drug Safety Podcast: 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
FDA Drug Safety Communication: FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq)
FDA Drug Safety Podcast: FDA warns of serious immune system reaction with seizure and mental health medicine lamotrigine (Lamictal)
Listen to an audio podcast of the February 22, 2018 FDA Drug Safety Communication: FDA review finds additional data supports the potential for increased long-term risks with antibiotic clarithromycin (Biaxin) in patients with heart disease. As a result, we have added a new warning about this increased risk of death in patients with heart disease, and advised prescribers to consider using other antibiotics in such patients
Listen to an audio podcast of the February 1, 2018 FDA Drug Safety Communication warning that the liver disease medicine Ocaliva (obeticholic acid) has been incorrectly dosed daily instead of weekly in patients with moderate to severe primary biliary cholangitis, increasing the risk of serious liver injury.
Listen to an audio podcast of the January 30, 2018 FDA Drug Safety Communication detailing serious heart problems with high doses of the antidiarrheal medicine loperamide, including from abuse and misuse. FDA announced it is working with manufacturers to use blister packs or other single dose packaging and to limit the number of doses in a package.
Listen to an audio podcast of the January 11, 2018 FDA Drug Safety Communication requiring safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone to limit the use of these products to adults 18 years and older because the risks of these medicines outweigh their benefits in children younger than 18.
FDA Drug Safety Podcast: 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)
Listen to an audio podcast of the December 19, 2017 FDA Drug Safety Communication "FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings". This is an update to the FDA Drug Safety Communication: FDA identifies no harmful effects to date with brain retention of gadolinium-based contrast agents for MRIs; review to continue, issued May 22, 2017.
FDA Drug Safety Podcast: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric)
Listen to an audio podcast of the September 21, 2017 FDA Drug Safety Communication: FDA warns about serious liver injury with Ocaliva (obeticholic acid) for rare chronic liver disease. Ocaliva is being incorrectly dosed in some patients with moderate to severe decreases in liver function, resulting in an increased risk of serious liver injury and death. The recommended dosing and monitoring for patients on Ocaliva are described in the current drug label. We are working with the drug manufacturer, Intercept Pharmaceuticals, to address these safety concerns.
Listen to an audio podcast of the September 20, 2017 FDA Drug Safety Communication in which FDA urges caution about withholding opioid addiction medications from patients taking benzodiazepines or CNS depressants. The combined use of these drugs increases the risk of serious side effects; however, the harm caused by untreated opioid addiction can outweigh these risks.
Listen to an audio podcast of the September 6, 2017 FDA Drug Safety Communication titled "FDA recommends separating dosing of potassium-lowering drug sodium polystyrene sulfonate (Kayexalate) from all other oral drugs". A study found that sodium polystyrene sulfonate binds to many commonly prescribed oral medicines, decreasing the absorption and therefore effectiveness of those oral medicines.
Listen to an audio podcast of the May 22, 2017 FDA Drug Safety Communication. FDA announced that to date a review has not identified adverse health effects from gadolinium retained in the brain after the use of gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI); review to continue.
Listen to an audio podcast of the May 16, 2017, FDA Drug Safety Communication: FDA confirms increased risk of leg and foot amputations with the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR).
Listen to an audio podcast of the April 27, 2017 Drug Safety Communication: FDA approves label changes for use of general anesthetic and sedation drugs in young children. FDA is notifying the public that we have approved label changes previously announced in December 2016 regarding the use of general anesthetic and sedation medicines in pregnant women and children younger than 3 years.
An audio podcast of the April 20, 2017 FDA Drug Safety Communication. The FDA is restricting the use of codeine and tramadol medicines in children. The FDA is also recommending against the use of codeine and tramadol medicines in breastfeeding mothers due to possible harm to their infants.
FDA Drug Safety Podcast: FDA warns that Viberzi (eluxadoline), a medicine used to treat irritable bowel syndrome with diarrhea (IBS-D), should not be used in patients who do not have a gallbladder.
Listen to an audio podcast of the February 2, 2017 Drug Safety Communication: FDA is warning that rare but serious allergic reactions have been reported with the widely used skin antiseptic products containing chlorhexidine gluconate. As a result, we are requesting the manufacturers of over-the-counter (OTC) antiseptic products containing chlorhexidine gluconate to add a warning about this risk to the Drug Facts labels. Prescription chlorhexidine gluconate products already contain a warning about the possibility of serious allergic reactions in their labels.
FDA Drug Safety Podcast: FDA revises description of mental health side effects of stop-smoking medicines Chantix and Zyban to reflect clinical trial findings
FDA Drug Safety Podcast: FDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C
Drug Safety Podcast: FDA warns about serious risks and death when combining opioid pain or cough medicines with benzodiazepines; requires its strongest warning
FDA Drug Safety Podcast: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects
FDA strengthens kidney warnings for diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR)
FDA Drug Safety Podcast: FDA warns about serious heart problems with high doses of the antidiarrheal medicine loperamide (Imodium), including from abuse and misuse
FDA Drug Safety Podcast: FDA warns about serious bleeding risk with over-the-counter antacid products containing aspirin
FDA Drug Safety Podcast: FDA warns that prescribing of Nizoral (ketoconazole) oral tablets for unapproved uses including skin and nail infections continues; linked to patient death
FDA Drug Safety Podcast: 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
On May 12, 2016 FDA is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with acute sinusitis, acute bronchitis, and uncomplicated urinary tract infections who have other treatment options.
FDA Drug Safety Podcast: FDA warns about rare but serious skin reactions with mental health drug olanzapine (Zyprexa, Zyprexa Zydis, Zyprexa Relprevv, and Symbyax)
FDA Drug Safety Podcast: FDA warns about new impulse-control problems associated with mental health drug aripiprazole (Abilify, Abilify Maintena, Aristada)
FDA Drug Safety Podcast: FDA approves brand name change for antidepressant drug Brintellix (vortioxetine) to avoid confusion with antiplatelet drug Brilinta (ticagrelor)
FDA Drug Safety Podcast: FDA to review study examining use of oral fluconazole (Diflucan) in pregnancy
FDA announced that a safety review has found type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure
FDA Drug Safety Podcast: FDA revises warnings regarding use of the diabetes medicine metformin in certain patients with reduced kidney function
On March 22, 2016, FDA announced warnings about several safety issues with the entire class of opioid pain medicines. These safety risks are potentially harmful interactions with numerous other medications, problems with the adrenal glands, and decreased sex hormone levels.
FDA Drug Safety Podcast: FDA cautions about dosing errors when switching between different oral formulations of antifungal Noxafil (posaconazole); label changes approved