Podcasts | PHAF

FDA Podcast

  • FDA warns about rare but serious allergic reactions with the skin antiseptic chlorhexidine gluconate;February 2, 2017;Transcript

  • FDA revises description of mental health side effects of stop-smoking medicines Chantix and Zyban to reflect clinical trial findings;December 16, 2016;Transcript

  • FDA review results in new warnings about using general anesthetics and sedation drugs in young children and pregnant women;December 14, 2016;Transcript

  • Updated FDA review concludes that use of pioglitazone may be linked to an increased risk of bladder cancer;December 12, 2016;Transcript

  • FDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C;October 4, 2016;Transcript

  • FDA warns about serious risks and death when combining opioid pain or cough medicines with benzodiazepines; requires its strongest warning;August 31, 2016;Transcript

  • FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects;July 26, 2016;Transcript

  • FDA strengthens kidney warnings for diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR);June 14, 2016;Transcript

  • Update: FDA evaluating the risk of burns and scars with Zecuity (sumatriptan) migraine patch;June 10, 2016 ; Transcript

  • FDA warns about serious heart problems with high doses of the antidiarrheal medicine loperamide (Imodium), including from abuse and misuse

  •  ;June 7, 2016;Transcript

  • FDA warns about serious bleeding risk with over-the-counter antacid products containing aspirin;June 6, 2016;Transcript

  • FDA evaluating the risk of burns and scars with Zecuity (sumatriptan) migraine patch;June 2, 2016;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;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;Transcript

  • FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together;May 12, 2016;Transcript

  • FDA warns about rare but serious skin reactions with mental health drug olanzapine (Zyprexa, Zyprexa Zydis, Zyprexa Relprevv, and Symbyax);May 10, 2016;Transcript

  • FDA warns about new impulse-control problems associated with mental health drug aripiprazole (Abilify, Abilify Maintena, Aristada);May 3, 2016;Transcript

  • FDA approves brand name change for antidepressant drug Brintellix (vortioxetine) to avoid confusion with antiplatelet drug Brilinta (ticagrelor);May 2, 2016;Transcript

  • FDA to review study examining use of oral fluconazole (Diflucan) in pregnancy;April 26, 2016;Transcript

  • FDA revises warnings regarding use of the diabetes medicine metformin in certain patients with reduced kidney function;April 8, 2016;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;Transcript

  • FDA warns about several safety issues with opioid pain medicines; requires label changes;March 29, 2016;Transcript

  • FDA cautions about dosing errors when switching between different oral formulations of antifungal Noxafil (posaconazole); label changes approved;January 4, 2016;Transcript

  • FDA eliminates the Risk Evaluation and Mitigation Strategy (REMS) for rosiglitazone-containing diabetes medicines;December 16, 2015;Transcript

  • FDA revises labels of SGLT2 inhibitors for diabetes to include warnings about too much acid in the blood and serious urinary tract infections;December 4, 2015;Transcript

  • FDA advises of rare cases of underactive thyroid in infants given iodine-containing contrast agents for medical imaging;November 17, 2015;Transcript

  • FDA review finds long-term treatment with blood-thinning medicine Plavix (clopidogrel) does not change risk of death;November 6, 2015;Transcript

  • FDA review found no increased cardiovascular risks with Parkinson’s disease drug entacapone;October 26, 2015;Transcript

  • FDA warns of serious liver injury risk with hepatitis C treatments Viekira Pak and Technivie;October 22, 2015;Transcript

  • FDA requires drug interaction studies with potassium-lowering drug Kayexalate (sodium polystyrene sulfonate);October 22, 2015;Transcript

  • FDA cautions about dose confusion and medication error with antibacterial drug Avycaz (ceftazidime and avibactam);September 22, 2015;Transcript

  • FDA evaluating the risks of using the pain medicine tramadol in children aged 17 and younger;September 21, 2015;Transcript

  • FDA modifies monitoring for neutropenia associated with schizophrenia medicine clozapine; approves new shared REMS program for all clozapine medicines;September 15, 2015;Transcript

  • FDA revises label of diabetes drug canagliflozin (Invokana, Invokamet) to include updates on bone fracture risk and new information on decreased bone mineral density;September 10, 2015;Transcript

  • FDA warns that DPP-4 inhibitors for type 2 diabetes may cause severe joint pain;August 28, 2015;Transcript

  • FDA warns of severe adverse events with application of Picato (ingenol mebutate) gel for skin condition; requires label changes;August 21, 2015;Transcript

  • FDA warns about cases of rare brain infection with MS drug Gilenya (fingolimod) in two patients with no prior exposure to immunosuppressant drugs;August 4, 2015;Transcript

  • FDA warns about prescribing and dispensing errors resulting from brand name confusion with antidepressant Brintellix (vortioxetine) and antiplatelet Brilinta (ticagrelor);July 30, 2015;Transcript

  • FDA evaluating the risk of brain deposits with repeated use of gadolinium-based contrast agents for magnetic resonance imaging (MRI);July 27, 2015;Transcript

  • FDA warns about a serious lung condition in infants and newborns treated with Proglycem (diazoxide);July 16, 2015;Transcript

  • FDA strengthens warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) can cause heart attacks or strokes;July 9, 2015;Transcript

  • FDA evaluating the potential risks of using codeine cough-and-cold medicines in children;July 1, 2015;Transcript

  • FDA reporting permanent skin color changes associated with use of Daytrana patch (methylphenidate transdermal system) for treating ADHD;June 24, 2015;Transcript

  • FDA determines 2013 labeling adequate to manage risk of retinal abnormalities, potential vision loss, and skin discoloration with anti-seizure drug Potiga (ezogabine); requires additional study;June 16, 2015;Transcript

  • FDA cautions about dose confusion and medication errors for antibacterial drug Zerbaxa (ceftolozane and tazobactam);May 20, 2015;Transcript

  • FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid in the blood;May 15, 2015;Transcript

  • FDA strengthens warnings and changes prescribing instructions to decrease the risk of serious allergic reactions with anemia drug Feraheme (ferumoxytol);March 30, 2015;Transcript

  • FDA warns of serious slowing of the heart rate when antiarrhythmic drug amiodarone is used with hepatitis C treatments containing sofosbuvir Harvoni or Sovaldi in combination with another Direct Acting Antiviral drug;March 24, 2015;Transcript

  • FDA review of study sheds light on two deaths associated with the injectable schizophrenia drug Zyprexa Relprevv (olanzapine pamoate);March 23, 2015;Transcript

  • FDA updates label for stop smoking drug Chantix (varenicline) to include potential alcohol interaction, rare risk of seizures, and studies of side effects on mood, behavior, or thinking;March 9, 2015;Transcript

  • FDA cautions about using testosterone products for low testosterone due to aging; requires labeling change to inform of possible increased risk of heart attack and stroke with use;March 3, 2015;Transcript

  • FDA requires label warnings to prohibit sharing of multi-dose diabetes pen devices among patients;February 25, 2015;Transcript

  • FDA has reviewed possible risks of pain medicine use during pregnancy;January 9, 2015;Transcript

  • FDA reporting mental health drug ziprasidone (Geodon) associated with rare but potentially fatal skin reactions;December 11, 2014;Transcript

  • FDA warns about case of rare brain infection PML with MS drug Tecfidera (dimethyl fumarate);November 25, 2014;Transcript

  • FDA reviews long-term antiplatelet therapy as preliminary trial data shows benefits but a higher risk of non-cardiovascular death;November 16, 2014;Transcript

  • FDA approves label changes for asthma drug Xolair (omalizumab), including describing slightly higher risk of heart and brain adverse events;September 26, 2014;Transcript

  • FDA recommends not using lidocaine to treat teething pain and requires new Boxed Warning;June 26, 2014;Transcript

  • FDA warns of rare but serious hypersensitivity reactions with certain over-the-counter topical acne products;June 25, 2014;Transcript

  • FDA review of cardiovascular risks for diabetics taking hypertension drug olmesartan not conclusive; label updates required;June 24, 2014;Transcript

  • FDA warns that cancer drug docetaxel may cause symptoms of alcohol intoxication after treatment;June 20, 2014;Transcript

  • FDA adding general warning to testosterone products about potential for venous blood clots;June 19, 2014;Transcript

  • FDA warns of next-day impairment with sleep aid Lunesta (eszopiclone) and lowers recommended dose;May 15, 2014;Transcript

  • 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;Transcript

  • FDA requires label changes to warn of rare but serious neurologic problems after epidural corticosteroid injections for pain;April 23, 2014;Transcript

  • FDA clarifies Warning about Pediatric Use of Revatio (sildenafil) for Pulmonary Arterial Hypertension;March 31, 2014;Transcript

  • FDA approves label changes for antibacterial Doribax (doripenem) describing increased risk of death for ventilator patients with pneumonia;March 6, 2014;Transcript

  • FDA to review heart failure risk with diabetes drug saxagliptin (marketed as Onglyza and Kombiglyze XR);February 11, 2014;Transcript

  • FDA evaluating risk of stroke, heart attack and death with FDA-approved testosterone products;January 31, 2014;Transcript

  • FDA warns of possible harm from exceeding recommended dose of over-the-counter sodium phosphate products to treat constipation;January 8, 2014;Transcript

  • FDA requires multiple new safety measures for leukemia drug Iclusig; company expected to resume marketing;December 20, 2013;Transcript

  • FDA warns of rare risk of long-lasting erections in males taking methylphenidate ADHD medications and has approved label changes;December 18, 2013;Transcript

  • FDA warns of serious skin reactions with the anti-seizure drug Onfi (clobazam) and has approved label changes ;December 3, 2013;Transcript

  • FDA requires removal of some prescribing and dispensing restrictions for rosiglitazone-containing diabetes medicines  ;November 25, 2013;Transcript

  • 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 ;Transcript

  • FDA requests label changes and single-use packaging for some over-the-counter topical antiseptic products to decrease risk of infection;November 13, 2013 ;Transcript

  • Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins;November 6, 2013;Transcript

  • FDA approves label changes for anti-seizure drug Potiga (ezogabine) describing risk of retinal abnormalities, potential vision loss, and skin discoloration;October 31, 2013;Transcript

  • FDA asks manufacturer of the leukemia drug Iclusig (ponatinib) to suspend marketing and sales;October 31, 2013;Transcript

  • FDA investigating leukemia drug Iclusig (ponatinib) after increased reports of serious blood clots in arteries and veins;October 17, 2013;Transcript

  • FDA warns of increased risk of death with IV antibacterial Tygacil (tigecycline) and approves new Boxed Warning;September 27, 2013;Transcript

  • 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;Transcript

  • 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;Transcript

  • FDA investigating rare brain infection in patient taking Gilenya (fingolimod);August 29, 2013;Transcript

  • 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;Transcript

  • FDA warns of rare but serious skin reactions with the pain reliever/fever reducer acetaminophen;August 1, 2013;Transcript

  • FDA approves label changes for antimalarial drug mefloquine hydrochloride due to risk of serious psychiatric and nerve side effects;July 29, 2013;Transcript

  • 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;Transcript

  • FDA approves label changes to include intestinal problems (sprue-like enteropathy) linked to blood pressure medicine olmesartan medoxomil;July 3, 2013;Transcript

  • FDA is investigating two deaths following injection of long-acting antipsychotic Zyprexa Relprevv (olanzapine pamoate);June 18, 2013;Transcript

  • FDA Recommends Against Prolonged Use of Magnesium Sulfate to Stop Pre-term Labor Due to Bone Changes in Exposed Babies;May 30, 2013;Transcript

  • 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;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;Transcript

  • FDA warns about potential medication errors resulting from confusion regarding nonproprietary name for breast cancer drug Kadcyla (ado-trastuzumab emtansine);May 6, 2013;Transcript

  • FDA limits duration and usage of Samsca (tolvaptan) due to possible liver injury leading to organ transplant or death;April 30, 2013;Transcript

  • Anti-seizure drug Potiga (ezogabine) linked to retinal abnormalities and blue skin discoloration;April 26, 2013;Transcript

  • 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;Transcript

  • Azithromycin (Zithromax or Zmax) and the risk of potentially fatal heart rhythms;March 12, 2013;Transcript

  • FDA suspends pediatric clinical trials of Sensipar (cinacalcet hydrochloride) after report of death;February 27, 2013;Transcript

  • Safety review update of codeine use in children; new Boxed Warning and Contraindication on use after tonsillectomy and/or adenoidectomy;February 21, 2013;Transcript

  • Risk of next-morning impairment after use of insomnia drugs; FDA requires lower recommended doses for certain drugs containing zolpidem;January 11, 2013;Transcript

  • Serious skin reactions after combination treatment with the Hepatitis C drugs Incivek (telaprevir), peginterferon alfa, and ribavirin;December 26, 2012;Transcript

  • Warning against use of Xyrem (sodium oxybate) with alcohol or drugs causing respiratory depression;December 21, 2012;Transcript

  • Pradaxa (dabigatran etexilate mesylate) should not be used in patients with mechanical prosthetic heart valves;December 21, 2012;Transcript

  • Safety review update of Chantix (varenicline) and risk of cardiovascular adverse events;December 13, 2012;Transcript

  • Important change to heparin container labels to clearly state the total drug strength;December 7, 2012;Transcript

  • Updated information on 32 mg intravenous ondansetron (Zofran) dose and pre-mixed ondansetron products;December 6, 2012;Transcript

  • Investigation into New England Compounding Center;November 13, 2012;Transcript

  • Ameridose;November 13, 2012;Transcript

  • Update on the risk for serious bleeding events with the anticoagulant Pradaxa;November 2, 2012;Transcript

  • Serious adverse events from accidental ingestion by children of over-the-counter eye drops and nasal sprays;October 25, 2012;Transcript

  • Ongoing safety review of Parkinson’s drug Mirapex (pramipexole) and possible risk of heart failure;September 21, 2012;Transcript

  • Rare cases of serious burns with the use of over-the-counter topical muscle and joint pain relievers;August 30, 2012;Transcript

  • FDA recommends against use of Revatio in children with pulmonary hypertension;August 30, 2012;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;Transcript

  • Seizure risk for multiple sclerosis patients who take Ampyra (dalfampridine);July 23, 2012;Transcript

  • Cefepime and risk of seizure in patients not receiving dosage adjustments for kidney impairment;June 26, 2012;Transcript

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

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

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

  • Updated information on drug interactions between Victrelis (boceprevir) and certain boosted HIV protease inhibitor drugs;April 26, 2012;Transcript

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

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

  • Revised recommendations for Celexa (citalopram hydrobromide) related to a potential risk of abnormal heart rhythms with high doses;March 30, 2012;Transcript

  • Interactions  between certain HIV or hepatitis C drugs and cholesterol-lowering statin drugs  can increase the risk of muscle injury;March 2, 2012;Transcript

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

  • Important drug interactions between Victrelis (boceprevir) and ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitor drugs;February 10, 2012;Transcript

  • Clostridium difficile-associated diarrhea can be associated with stomach acid drugs known as proton pump inhibitors (PPIs);February 8, 2012;Transcript

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

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

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

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