FDA Drug Safety Podcasts
By U.S. Food and Drug Administration, Center for Drug Evaluation and Research
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Episodes: 77
Description
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
| Episode | Date |
|---|---|
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FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab)
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Feb 06, 2024 |
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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
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Jan 26, 2024 |
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FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan)
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Dec 08, 2023 |
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FDA updating warnings to improve safe use of prescription stimulants used to treat ADHD and other conditions
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May 31, 2023 |
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FDA updates prescribing information for all opioid pain medicines to provide additional guidance for safe use
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May 10, 2023 |
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FDA investigating risk of severe hypocalcemia in patients on dialysis receiving osteoporosis medicine Prolia (denosumab)
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Dec 16, 2022 |
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FDA warns about possible increased risk of death and serious side effects with cancer drug Copiktra (duvelisib)
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Jul 27, 2022 |
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FDA withdrew its approval for the cancer medicine Ukoniq (umbralisib) due to safety concerns
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Jul 07, 2022 |
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FDA recommends thyroid monitoring in babies and young children who receive injections of iodine-containing contrast media for medical imaging
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Apr 13, 2022 |
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FDA investigating possible increased risk of death with lymphoma medicine Ukoniq (umbralisib)
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Feb 09, 2022 |
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FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain
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Jan 24, 2022 |
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FDA warns that getting alcohol-based hand sanitizer in the eyes can cause serious injury
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Nov 09, 2021 |
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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
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Sep 08, 2021 |
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FDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancy; still advises most pregnant patients should stop taking statins
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Jul 22, 2021 |
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FDA warns that vapors from alcohol-based hand sanitizers can have side effects
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Jun 21, 2021 |
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Due to risk of serious liver injury, FDA restricts use of obeticholic acid (Ocaliva) in primary biliary cholangitis (PBC) patients with advanced cirrhosis
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Jun 03, 2021 |
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Studies show increased risk of heart rhythm problems with seizure and mental health medicine lamotrigine (Lamictal) in patients with heart disease
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Apr 02, 2021 |
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FDA warns that abuse and misuse of the OTC nasal decongestant propylhexedrine can lead to serious harm
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Mar 29, 2021 |
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Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib)
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Feb 08, 2021 |
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FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid
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Oct 22, 2020 |
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FDA warns about serious problems with high doses of the allergy medicine diphenhydramine (Benadryl)
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Sep 29, 2020 |
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FDA requiring Boxed Warning updated to improve safe use of benzodiazepine drug class
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Sep 29, 2020 |
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FDA removes Boxed Warning about risk of leg and foot amputations for the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR)
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Sep 01, 2020 |
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FDA recommends health care professionals discuss naloxone with all patients when prescribing opioid pain relievers or medicines to treat opioid use disorder
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Jul 29, 2020 |
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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
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Apr 24, 2020 |
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FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market
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Feb 19, 2020 |
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FDA strengthens warning that untreated constipation caused by schizophrenia medicine clozapine (Clozaril) can lead to serious bowel problems
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Feb 10, 2020 |
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Safety clinical trial shows possible increased risk of cancer with weight-loss medicine Belviq, Belviq XR (lorcaserin)
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Jan 23, 2020 |
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FDA warns about serious breathing problems with seizure and nerve pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR)
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Jan 02, 2020 |
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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
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Sep 11, 2019 |
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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)
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Aug 05, 2019 |
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FDA adds Boxed Warning for risk of serious injuries caused by sleepwalking with certain prescription insomnia medicines
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May 10, 2019 |
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FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering
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Apr 17, 2019 |
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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
|
Mar 05, 2019 |
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FDA warns that symptoms of a serious condition affecting the blood cells are not being recognized with the leukemia medicine Idhifa (enasidenib)
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Mar 05, 2019 |
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FDA warns about rare but serious risks of stroke and blood vessel wall tears with multiple sclerosis drug Lemtrada (alemtuzumab)
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Mar 05, 2019 |
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FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat)
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Mar 05, 2019 |
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FDA Drug Safety Podcast: FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes
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Sep 05, 2018 |
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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
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Aug 06, 2018 |
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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
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Jul 12, 2018 |
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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
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Jun 01, 2018 |
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FDA Drug Safety Podcast: FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq)
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May 24, 2018 |
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FDA Drug Safety Podcast: FDA warns of serious immune system reaction with seizure and mental health medicine lamotrigine (Lamictal)
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Apr 30, 2018 |
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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
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Feb 27, 2018 |
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FDA Drug Safety Podcast: FDA adds Boxed Warning to highlight correct dosing of Ocaliva (obeticholic acid) for patients with a rare chronic liver disease
|
Feb 07, 2018 |
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FDA Drug Safety Podcast: FDA limits packaging for anti-diarrhea medicine Loperamide (Imodium) to encourage safe use
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Feb 06, 2018 |
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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
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Jan 16, 2018 |
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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)
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Jan 02, 2018 |
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FDA Drug Safety Podcast: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings
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Dec 21, 2017 |
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FDA Drug Safety Podcast: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric)
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Nov 20, 2017 |
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FDA Drug Safety Podcast: FDA warns about serious liver injury with Ocaliva (obeticholic acid) for rare chronic liver disease
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Oct 04, 2017 |
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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
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Oct 02, 2017 |
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FDA Drug Safety Podcast: FDA recommends separating dosing of potassium-lowering drug sodium polystyrene sulfonate (Kayexalate) from all other oral drugs
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Sep 14, 2017 |
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FDA Drug Safety Podcast: FDA identifies no harmful effects to date with brain retention of gadolinium-based contrast agents for MRIs; review to continue
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May 26, 2017 |
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FDA Drug Safety Podcast: FDA confirms increased risk of leg and foot amputations with the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR)
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May 25, 2017 |
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FDA Drug Safety Podcast: FDA approves label changes for use of general anesthetic and sedation drugs in young children
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May 01, 2017 |
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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
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Apr 27, 2017 |
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FDA Drug Safety Podcast: FDA warns about increased risk of serious pancreatitis with irritable bowel drug Viberzi (eluxadoline) in patients without a gallbladder
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Mar 22, 2017 |
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FDA Drug Safety Podcast: FDA warns about rare but serious allergic reactions with the skin antiseptic chlorhexidine gluconate
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Feb 08, 2017 |
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FDA Drug Safety Podcast: Updated FDA review concludes that use of pioglitazone may be linked to an increased risk of bladder cancer
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Dec 28, 2016 |
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FDA Drug Safety Podcast: FDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C
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Oct 07, 2016 |
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FDA Drug Safety Podcast: FDA warns about serious risks and death when combining opioid pain or cough medicines with benzodiazepines; requires its strongest warning
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Sep 07, 2016 |
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FDA Drug Safety Podcast: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects
|
Aug 02, 2016 |
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Update: FDA evaluating the risk of burns and scars with Zecuity (sumatriptan) migraine patch
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Jun 21, 2016 |
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FDA Drug Safety Podcast: FDA warns about serious heart problems with high doses of the antidiarrheal medicine loperamide (Imodium), including from abuse and misuse
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Jun 16, 2016 |
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FDA Drug Safety Podcast: FDA evaluating the risk of burns and scars with Zecuity (sumatriptan) migraine patch
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Jun 08, 2016 |
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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
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Jun 03, 2016 |
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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
|
May 26, 2016 |
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FDA Drug Safety Podcast: FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together
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May 25, 2016 |
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FDA Drug Safety Podcast: FDA warns about rare but serious skin reactions with mental health drug olanzapine (Zyprexa, Zyprexa Zydis, Zyprexa Relprevv, and Symbyax)
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May 17, 2016 |
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FDA Drug Safety Podcast: FDA warns about new impulse-control problems associated with mental health drug aripiprazole (Abilify, Abilify Maintena, Aristada)
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May 06, 2016 |
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FDA Drug Safety Podcast: FDA approves brand name change for antidepressant drug Brintellix (vortioxetine) to avoid confusion with antiplatelet drug Brilinta (ticagrelor)
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May 06, 2016 |
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FDA Drug Safety Podcast: FDA to review study examining use of oral fluconazole (Diflucan) in pregnancy
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May 03, 2016 |
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FDA announced that a safety review has found type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure
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Apr 27, 2016 |
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FDA Drug Safety Podcast: FDA revises warnings regarding use of the diabetes medicine metformin in certain patients with reduced kidney function
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Apr 14, 2016 |
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FDA Drug Safety Podcast: FDA warns about several safety issues with opioid pain medicines; requires label changes
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Mar 31, 2016 |
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FDA Drug Safety Podcast: FDA cautions about dosing errors when switching between different oral formulations of antifungal Noxafil (posaconazole); label changes approved
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Jan 12, 2016 |