Food and Drug Administration (FDA) Podcasts This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

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

Incorporating Relevant and Meaningful Patient-Reported Outcomes in RCC Clinical Trials
Bellinda King-Kallimanis, PhD of U.S. Food and Drug Administration, Maryland (FDA ) discusses Incorporating Relevant and Meaningful Patient-Reported Outcomes in RCC Clinical Trials at the Seventeen... Author: kidneycancer Added: 11/08/2018 (Source: Oncology Tube)
Source: Oncology Tube - November 8, 2018 Category: Cancer & Oncology 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