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

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 - June 20, 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 - June 20, 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 - June 20, 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 - June 20, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: podcasts

FDA Drug Safety Podcast: SFDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering
On April 9, 2019 FDA announced we have received reports of serious harm in patients who are physically dependent on opioid pain medicines suddenly having these medicines discontinued or the dose rapidly decreased. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - April 17, 2019 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

FDA Drug Safety Podcast: 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
On February 25, 2019 FDA alerted the public that a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of tofacitinib (brand names Xeljanz, Xeljanz XR) was used in patients with rheumatoid arthritis (or RA). (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - March 5, 2019 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

FDA Drug Safety Podcast: FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat)
On February 21, 2019 FDA concluded there is an increased risk of death with Uloric (active ingredient febuxostat) compared to another gout medicine, allopurinol. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - February 27, 2019 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

FDA Drug Safety Podcast: FDA warns that symptoms of a serious condition affecting the blood cells are not being recognized with the leukemia medicine Idhifa (enasidenib)
On November 29, 2018 FDA is warning that signs and symptoms of a life-threatening side effect called differentiation syndrome are not being recognized in patients receiving the acute myeloid leukemia medicine Idhifa, active ingredient enasidenib. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - December 6, 2018 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

FDA Drug Safety Podcast: FDA warns about rare but serious risks of stroke and blood vessel wall tears with multiple sclerosis drug Lemtrada (alemtuzumab)
On November 29, 2018 FDA is warning that rare but serious cases of stroke and tears in the lining of arteries in the head and neck have occurred in patients with multiple sclerosis or MS shortly after they received Lemtrada, active ingredient alemtuzumab. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - December 4, 2018 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

FDA Drug Safety Podcast: FDA warns about severe worsening of multiple sclerosis after stopping the medicine Gilenya (fingolimod)
On November 20, 2018 FDA warned that when the multiple sclerosis (MS) medicine Gilenya (active ingredient fingolimod) is stopped, the disease can become much worse than before the medicine was started or while it was being taken. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - November 26, 2018 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research 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
On August 29, 2018, FDA warned that cases of a rare but serious infection of the genitals and area around the genitals have been reported with the class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (or SGLT2) inhibitors. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - September 5, 2018 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research 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
On August 3, 2018 FDA warned that the antibiotic azithromycin (brand name Zithromax, Zmax) should not be given long-term to prevent a certain inflammatory lung condition in patients with cancers of the blood or lymph nodes who undergo a donor stem cell transplant. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - August 6, 2018 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research 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
On July 10, 2018, FDA announced it is strengthening the current warnings in the prescribing information that fluoroquinolone antibiotics may cause significant decreases in blood sugar and certain mental health side effects. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - July 11, 2018 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research 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
On May 23, 2018, FDA warned that over-the-counter (or OTC) oral drug products containing benzocaine should not be used to treat infants and children younger than 2 years. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - May 31, 2018 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

FDA Drug Safety Podcast: FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq)
On May 18, 2018, FDA alerted the public that serious cases of neural tube birth defects involving the brain, spine, and spinal cord have been reported in babies born to women treated with dolutegravir used to treat human immunodeficiency virus (or HIV). (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - May 24, 2018 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

FDA Drug Safety Podcast: FDA warns of serious immune system reaction with seizure and mental health medicine lamotrigine (Lamictal)
On April 25, 2018, FDA warned that the medicine lamotrigine (brand name Lamictal) for seizures and bipolar disorder can cause a rare but very serious reaction that excessively activates the body ’s infection-fighting immune system. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - April 30, 2018 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research 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
On February 22, 2018, FDA advised caution before prescribing the antibiotic clarithromycin (brand name Biaxin) to patients with heart disease because of a potential increased risk of heart problems or death that can occur years later. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - February 26, 2018 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research 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
On February 1, 2018 FDA is warning that the medicine Ocaliva (active ingredient obeticholic acid) has been incorrectly dosed daily instead of weekly in patients with moderate to severe primary biliary cholangitis (or PBC), a rare chronic liver disease, increasing the risk of serious liver injury. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - February 7, 2018 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

FDA Drug Safety Podcast: FDA limits packaging for anti-diarrhea medicine Loperamide (Imodium) to encourage safe use
On January 30, 2018, to foster safe use of the over-the counter (or OTC) anti-diarrhea drug loperamide, 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 - February 6, 2018 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research 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
On January 11, 2018, FDA announced that it is 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 - January 16, 2018 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research 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)
On December 20, 2017, an Food and Drug Administration (FDA) review of four large clinical safety trials shows that treating asthma with long-acting beta agonists (LABAs) in combination with inhaled corticosteroids (ICS) does not result in significantly more serious asthma-related side effects than treatment with ICS alone. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - December 26, 2017 Category: Drugs & Pharmacology Authors: 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)
On November 15, 2017, FDA alerted the public that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (brand name Uloric) compared to another gout medicine called allopurinol. We required the Uloric drug manufacturer, Takeda Pharmaceuticals, to conduct this safety study when we approved the medicine in 2009. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - November 20, 2017 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

FDA Drug Safety Podcast: FDA warns about serious liver injury with Ocaliva (obeticholic acid) for rare chronic liver disease
On September 21, 2017, FDA warned that the liver disease medicine Ocaliva (active ingredient obeticholic acid) is being incorrectly dosed in some patients with moderate to severe decreases in liver function, resulting in an increased risk of serious liver injury and death. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - October 4, 2017 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

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
Based on our additional review, the U.S. Food and Drug Administration (FDA) is advising that the opioid addiction medications buprenorphine and methadone should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system (CNS). (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - October 2, 2017 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

FDA Drug Safety Podcast: FDA recommends separating dosing of potassium-lowering drug sodium polystyrene sulfonate (Kayexalate) from all other oral drugs
On September 6, 2017 FDA recommended that patients avoid taking the potassium-lowering drug sodium polystyrene sulfonate (brand name Kayexalate) at the same time as any other medicines taken by mouth. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - September 14, 2017 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

FFDA Drug Safety Podcast: FDA recommends separating dosing of potassium-lowering drug sodium polystyrene sulfonate (Kayexalate) from all other oral drugs
On September 6, 2017 FDA recommended that patients avoid taking the potassium-lowering drug sodium polystyrene sulfonate (brand name Kayexalate) at the same time as any other medicines taken by mouth. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - September 14, 2017 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

FDA Drug Safety Podcast: FDA identifies no harmful effects to date with brain retention of gadolinium-based contrast agents for MRIs; review to continue
On May 22, 2017, FDA announced that to date a review has not identified adverse health effects from gadolinium retained in the brain after the use of gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI). (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - May 25, 2017 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

FDA Drug Safety Podcast: FDA confirms increased risk of leg and foot amputations with the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR)
On May 16, 2017, based on new data from two large clinical trials, the FDA concluded that the type 2 diabetes medicine canagliflozin (brand names Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - May 25, 2017 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

FDA Drug Safety Podcast: FDA approves label changes for use of general anesthetic and sedation drugs in young children
On April 27, 2017 FDA notified the public that we have approved previously announced label changes regarding the use of general anesthetic and sedation medicines in children younger than 3 years. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - May 1, 2017 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts