FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab) |
Yes |
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 |
Yes |
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) |
Yes |
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 |
Yes |
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 |
Yes |
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) |
No |
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) |
No |
June 30, 2022 |
Listen Run Time: 00:4:00
|
Transcript |
FDA withdrew its approval for the cancer medicine Ukoniq (umbralisib) due to safety concerns |
No |
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 |
No |
March 30, 2022 |
Listen Run Time: 00:4:30 |
Transcript |
FDA investigating possible increased risk of death with lymphoma medicine Ukoniq (umbralisib) |
No |
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 |
No |
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 |
No |
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 |
No |
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 |
No |
July 20, 2021 |
Listen Run Time: 00:3:00 |
Transcript |
FDA warns that vapors from alcohol-based hand sanitizers can have side effects |
No |
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 |
No |
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 |
No |
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 |
No |
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) |
No |
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 |
No |
October 15, 2020 |
Listen Run Time: 00:3:00 |
Transcript |
FDA warns about serious problems with high doses of the allergy medicine diphenhydramine (Benadryl) |
No |
September 24, 2020 |
Listen Run Time: 00:3:00 |
Transcript |
FDA requiring Boxed Warning updated to improve safe use of benzodiazepine drug class |
No |
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) |
No |
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 |
No |
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 |
No |
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 |
No |
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 |
No |
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 |
No |
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) |
No |
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) |
No |
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 |
No |
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 |
No |
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) |
No |
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) |
No |
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 |
No |
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 |
No |
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 |
No |
February 25, 2019 |
Listen Run Time: 00:3:00 |
Transcript |
FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat) |
No |
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) |
No |
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) |
No |
November 29, 2018 |
Listen Run Time: 00:3:00 |
Transcript |
FDA warns about severe worsening of multiple sclerosis after stopping the medicine Gilenya (fingolimod) |
No |
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 |
No |
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 |
No |
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 |
No |
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 |
No |
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) |
No |
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) |
No |
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 |
No |
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 |
No |
February 1, 2018 |
Listen Run Time: 00:3:00 |
Transcript |
FDA limits packaging for anti-diarrhea medicine Loperamide (Imodium) to encourage safe use |
No |
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 |
No |
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) |
No |
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 |
No |
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) |
No |
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 |
No |
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 |
No |
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 |
No |
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 |
No |
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) |
No |
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 |
No |
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 |
No |
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 |
No |
March 15, 2017 |
Listen Run Time: 00:3:00 |
Transcript |
FDA warns about rare but serious allergic reactions with the skin antiseptic chlorhexidine gluconate |
No |
February 2, 2017 |
Listen Run Time: 00:3:00 |
Transcript |
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