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 (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - April 24, 2020 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

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. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - February 19, 2020 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

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. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - February 10, 2020 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

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). (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - January 23, 2020 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

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. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - January 2, 2020 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

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
Listen to an audio podcast of the August 28, 2019 FDA Drug Safety Communication: FDA warns about rare occurrence of serious liver injury with use of hepatitis C medicines Mavyret, Zepatier, and Vosevi with advanced liver disease. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - September 11, 2019 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

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)
Listen to an audio podcast of the July 26, 2019 FDA Drug Safety Communication on FDA approval of Boxed Warning about increased risk of blood clots and death with higher dose of arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR). (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - August 5, 2019 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering
(Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - July 17, 2019 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

FDA Drug Safety Podcast: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric)
(Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - July 12, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: podcasts

FDA Drug Safety Podcast: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings
Listen to an audio podcast of the December 19, 2017 FDA Drug Safety Communication "FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings". This is an update to the FDA Drug Safety Communication: FDA identifies no harmful effects to date with brain retention of gadolinium-based contrast agents for MRIs; review to continue, issued May 22, 2017. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - July 12, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: podcasts

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)
(Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - July 12, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: podcasts

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
Listen to an audio podcast of the January 11, 2018 FDA Drug Safety Communication requiring safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone to limit the use of these products to adults 18 years and older because the risks of these medicines outweigh their benefits in children younger than 18. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - July 12, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: podcasts

FDA Drug Safety Podcast: FDA limits packaging for anti-diarrhea medicine Loperamide (Imodium) to encourage safe use
Listen to an audio podcast of the January 30, 2018 FDA Drug Safety Communication detailing serious heart problems with high doses of the antidiarrheal medicine loperamide, including from abuse and misuse. FDA announced it is working with manufacturers to use blister packs or other single dose packaging and to limit the number of doses in a package. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - July 12, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: podcasts

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. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - July 12, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: podcasts

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 (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - July 12, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: podcasts

FDA Drug Safety Podcast: FDA warns of serious immune system reaction with seizure and mental health medicine lamotrigine (Lamictal)
(Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - July 12, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: podcasts

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) (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - July 12, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: podcasts

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
(Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - July 12, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: podcasts

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
(Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - July 12, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: podcasts

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 (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - July 12, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: podcasts

FDA Drug Safety Podcast: FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes
(Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - July 12, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: podcasts

FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat)
(Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - July 12, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: podcasts

FDA warns about rare but serious risks of stroke and blood vessel wall tears with multiple sclerosis drug Lemtrada (alemtuzumab)
(Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - July 12, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: podcasts

FDA warns that symptoms of a serious condition affecting the blood cells are not being recognized with the leukemia medicine Idhifa (enasidenib)
(Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - July 12, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: podcasts

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
(Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - July 12, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: podcasts

FDA Drug Safety Podcast: FDA warns about serious bleeding risk with over-the-counter antacid products containing aspirin
(Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - July 12, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: podcasts

FDA adds Boxed Warning for risk of serious injuries caused by sleepwalking with certain prescription insomnia medicines
(Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - July 12, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: podcasts

FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering
(Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - July 12, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: podcasts

FDA Drug Safety Podcast: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric)
(Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - June 20, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: podcasts

FDA Drug Safety Podcast: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings
Listen to an audio podcast of the December 19, 2017 FDA Drug Safety Communication "FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings". This is an update to the FDA Drug Safety Communication: FDA identifies no harmful effects to date with brain retention of gadolinium-based contrast agents for MRIs; review to continue, issued May 22, 2017. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - June 20, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: podcasts

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)
(Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - June 20, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: podcasts

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
Listen to an audio podcast of the January 11, 2018 FDA Drug Safety Communication requiring safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone to limit the use of these products to adults 18 years and older because the risks of these medicines outweigh their benefits in children younger than 18. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - June 20, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: podcasts

FDA Drug Safety Podcast: FDA limits packaging for anti-diarrhea medicine Loperamide (Imodium) to encourage safe use
Listen to an audio podcast of the January 30, 2018 FDA Drug Safety Communication detailing serious heart problems with high doses of the antidiarrheal medicine loperamide, including from abuse and misuse. FDA announced it is working with manufacturers to use blister packs or other single dose packaging and to limit the number of doses in a package. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - June 20, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: podcasts

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. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - June 20, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: podcasts

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 (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - June 20, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: podcasts

FDA Drug Safety Podcast: FDA warns of serious immune system reaction with seizure and mental health medicine lamotrigine (Lamictal)
(Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - June 20, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: podcasts

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) (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - June 20, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: podcasts

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
(Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - June 20, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: podcasts

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
(Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - June 20, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: podcasts

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 (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - June 20, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: podcasts

FDA Drug Safety Podcast: FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes
(Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - June 20, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: podcasts

FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat)
(Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - June 20, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: podcasts

FDA warns about rare but serious risks of stroke and blood vessel wall tears with multiple sclerosis drug Lemtrada (alemtuzumab)
(Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - June 20, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: podcasts

FDA warns that symptoms of a serious condition affecting the blood cells are not being recognized with the leukemia medicine Idhifa (enasidenib)
(Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - June 20, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: podcasts