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FDA Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.)

FDA Drug Infomation

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FDA Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.) is an FDA podcast series that provides information about new product approvals, emerging safety information for cancer treatments, and other current topics in cancer drug development.

FDA investigating risk of severe hypocalcemia in patients on dialysis receiving osteoporosis medicine Prolia (denosumab)

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA warns about possible increased risk of death and serious side effects with cancer drug Copiktra (duvelisib)

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA withdrew its approval for the cancer medicine Ukoniq (umbralisib) due to safety concerns

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA recommends thyroid monitoring in babies and young children who receive injections of iodine-containing contrast media for medical imaging

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA investigating possible increased risk of death with lymphoma medicine Ukoniq (umbralisib)

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA warns that getting alcohol-based hand sanitizer in the eyes can cause serious injury

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

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

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancy; still advises most pregnant patients should stop taking statins

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA warns that vapors from alcohol-based hand sanitizers can have side effects

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

Due to risk of serious liver injury, FDA restricts use of obeticholic acid (Ocaliva) in primary biliary cholangitis (PBC) patients with advanced cirrhosis

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

Studies show increased risk of heart rhythm problems with seizure and mental health medicine lamotrigine (Lamictal) in patients with heart disease

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA warns that abuse and misuse of the OTC nasal decongestant propylhexedrine can lead to serious harm

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib)

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA warns about serious problems with high doses of the allergy medicine diphenhydramine (Benadryl)

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA requiring Boxed Warning updated to improve safe use of benzodiazepine drug class

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA removes Boxed Warning about risk of leg and foot amputations for the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR)

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA recommends health care professionals discuss naloxone with all patients when prescribing opioid pain relievers or medicines to treat opioid use disorder

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

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

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA strengthens warning that untreated constipation caused by schizophrenia medicine clozapine (Clozaril) can lead to serious bowel problems

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

Safety clinical trial shows possible increased risk of cancer with weight-loss medicine Belviq, Belviq XR (lorcaserin)

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA warns about serious breathing problems with seizure and nerve pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR)

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

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

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

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)

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA adds Boxed Warning for risk of serious injuries caused by sleepwalking with certain prescription insomnia medicines

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

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

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA warns that symptoms of a serious condition affecting the blood cells are not being recognized with the leukemia medicine Idhifa (enasidenib)

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA warns about rare but serious risks of stroke and blood vessel wall tears with multiple sclerosis drug Lemtrada (alemtuzumab)

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat)

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA Drug Safety Podcast: FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA Drug Safety Podcast: FDA warns about increased risk of cancer relapse with long-term use of azithromycin (Zithromax, Zmax) antibiotic after donor stem cell transplant

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

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

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

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

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA Drug Safety Podcast: FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq)

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA Drug Safety Podcast: FDA warns of serious immune system reaction with seizure and mental health medicine lamotrigine (Lamictal)

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA Drug Safety Podcast: FDA review finds additional data supports the potential for increased long-term risks with antibiotic clarithromycin (Biaxin) in patients with heart disease

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA Drug Safety Podcast: FDA adds Boxed Warning to highlight correct dosing of Ocaliva (obeticholic acid) for patients with a rare chronic liver disease

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA Drug Safety Podcast: FDA limits packaging for anti-diarrhea medicine Loperamide (Imodium) to encourage safe use

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA Drug Safety Podcast: FDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and older

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

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)

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA Drug Safety Podcast: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA Drug Safety Podcast: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric)

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA Drug Safety Podcast: FDA warns about serious liver injury with Ocaliva (obeticholic acid) for rare chronic liver disease

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA Drug Safety Podcast: FDA urges caution about withholding opioid addiction medications from patients taking benzodiazepines or CNS depressants: careful medication management can reduce risks

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA Drug Safety Podcast: FDA recommends separating dosing of potassium-lowering drug sodium polystyrene sulfonate (Kayexalate) from all other oral drugs

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA Drug Safety Podcast: FDA identifies no harmful effects to date with brain retention of gadolinium-based contrast agents for MRIs; review to continue

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA Drug Safety Podcast: FDA confirms increased risk of leg and foot amputations with the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR)

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA Drug Safety Podcast: FDA approves label changes for use of general anesthetic and sedation drugs in young children

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA Drug Safety Podcast: FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA Drug Safety Podcast: FDA warns about increased risk of serious pancreatitis with irritable bowel drug Viberzi (eluxadoline) in patients without a gallbladder

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA Drug Safety Podcast: FDA warns about rare but serious allergic reactions with the skin antiseptic chlorhexidine gluconate

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA Drug Safety Podcast: FDA review results in new warnings about using general anesthetics and sedation drugs in young children and pregnant women

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA Drug Safety Podcast: Updated FDA review concludes that use of pioglitazone may be linked to an increased risk of bladder cancer

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA Drug Safety Podcast: FDA revises description of mental health side effects of stop-smoking medicines Chantix and Zyban to reflect clinical trial findings

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA Drug Safety Podcast: FDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA Drug Safety Podcast: FDA warns about serious risks and death when combining opioid pain or cough medicines with benzodiazepines; requires its strongest warning

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA Drug Safety Podcast: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

Update: FDA evaluating the risk of burns and scars with Zecuity (sumatriptan) migraine patch

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA strengthens kidney warnings for diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR)

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

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

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA Drug Safety Podcast: FDA evaluating the risk of burns and scars with Zecuity (sumatriptan) migraine patch

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA Drug Safety Podcast: FDA warns about serious bleeding risk with over-the-counter antacid products containing aspirin

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

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

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

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

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA Drug Safety Podcast: FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA Drug Safety Podcast: FDA warns about rare but serious skin reactions with mental health drug olanzapine (Zyprexa, Zyprexa Zydis, Zyprexa Relprevv, and Symbyax)

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA Drug Safety Podcast: FDA warns about new impulse-control problems associated with mental health drug aripiprazole (Abilify, Abilify Maintena, Aristada)

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA Drug Safety Podcast: FDA approves brand name change for antidepressant drug Brintellix (vortioxetine) to avoid confusion with antiplatelet drug Brilinta (ticagrelor)

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA Drug Safety Podcast: FDA to review study examining use of oral fluconazole (Diflucan) in pregnancy

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA announced that a safety review has found type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA Drug Safety Podcast: FDA revises warnings regarding use of the diabetes medicine metformin in certain patients with reduced kidney function

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA Drug Safety Podcast: FDA warns about several safety issues with opioid pain medicines; requires label changes

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

FDA Drug Safety Podcast: FDA cautions about dosing errors when switching between different oral formulations of antifungal Noxafil (posaconazole); label changes approved

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

Drug Infomation