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Food and Drug Administration Drug Safety Podcast

42 Episodes

3 minutes | a month ago
Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib)
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)
3 minutes | a month ago
FDA Drug Safety Podcast: FDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C
FDA Drug Safety Podcast: FDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C
3 minutes | 4 months ago
FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid
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)."
3 minutes | 5 months ago
FDA warns about serious problems with high doses of the allergy medicine diphenhydramine (Benadryl)
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).
3 minutes | 5 months ago
FDA requiring Boxed Warning updated to improve safe use of benzodiazepine drug class
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.
3 minutes | 6 months ago
FDA removes Boxed Warning about risk of leg and foot amputations for the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR)
FDA removes Boxed Warning about risk of leg and foot amputations for the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR)
4 minutes | 10 months ago
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
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
3 minutes | a year ago
FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market
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.
3 minutes | a year ago
FDA strengthens warning that untreated constipation caused by schizophrenia medicine clozapine (Clozaril) can lead to serious bowel problems
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.
2 minutes | a year ago
Safety clinical trial shows possible increased risk of cancer with weight-loss medicine Belviq, Belviq XR (lorcaserin)
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).
3 minutes | a year ago
FDA warns about serious breathing problems with seizure and nerve pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR)
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.
3 minutes | 2 years ago
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 warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes
3 minutes | 2 years ago
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
FDA Drug Safety podcast on azithromycin (Zithromax, Zmax) antibiotic
3 minutes | 2 years ago
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
3 minutes | 2 years ago
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
4 minutes | 2 years ago
FDA Drug Safety Podcast: FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq)
FDA Drug Safety Communication: FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq)
3 minutes | 2 years ago
FDA Drug Safety Podcast: FDA warns of serious immune system reaction with seizure and mental health medicine lamotrigine (Lamictal)
2 minutes | 2 years ago
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
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
3 minutes | 2 years ago
FDA Drug Safety Podcast: FDA adds Boxed Warning to highlight correct dosing of Ocaliva (obeticholic acid) for patients with a rare chronic liver disease
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.
3 minutes | 2 years ago
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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