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

Study 301: Vyxeos in Patients with Newly-Diagnosed Therapy-Related AML
The U.S. Food and Drug Administration (FDA) has approved VyxeosTM (daunorubicin and cytarabine) liposome for injection for the treatment of adults with two types of Acute Myeloid Leukemia (AML), a rap... Author: Cancer-News Added: 08/04/2017 (Source: Oncology Tube)
Source: Oncology Tube - August 4, 2017 Category: Cancer & Oncology 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 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 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

FDA Drug Safety Podcast: FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women
On April 20, 2017, FDA announced it is restricting the use of codeine and tramadol medicines in children. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - April 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 warns about increased risk of serious pancreatitis with irritable bowel drug Viberzi (eluxadoline) in patients without a gallbladder
On March 15, 2017, FDA announced it is warning that Viberzi (active ingredient eluxadoline), a medicine used to treat irritable bowel syndrome with diarrhea (IBS-D), should not be used in patients who do not have a gallbladder. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - March 22, 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 rare but serious allergic reactions with the skin antiseptic chlorhexidine gluconate
On February 2, 2017, the FDA announced it is warning that rare but serious allergic reactions have been reported with the widely used skin antiseptic products containing chlorhexidine gluconate. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - March 9, 2017 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts