FDA Drug Safety Podcast: Interim clinical trial results find increased risk of leg and foot amputations, mostly affecting the toes, with the diabetes medicine canagliflozin (Invokana, Invokamet); FDA to investigate
On May 18, 2016, FDA is alerting the public about interim safety results from an ongoing clinical trial that found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with the diabetes medicine canagliflozin (brand names Invokana, Invokamet). (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - May 26, 2016 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

FDA Drug Safety Podcast: FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together
On May 12, 2016 FDA is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - May 17, 2016 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 skin reactions with mental health drug olanzapine (Zyprexa, Zyprexa Zydis, Zyprexa Relprevv, and Symbyax)
On May 10, 2016, the U.S. Food and Drug Administration (FDA) announced it is warning that the antipsychotic medicine olanzapine can cause a rare but serious skin reaction that can progress to affect other parts of the body. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - May 17, 2016 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 new impulse-control problems associated with mental health drug aripiprazole (Abilify, Abilify Maintena, Aristada)
On May 3, 2016, FDA warned that compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with the use of the antipsychotic drug aripiprazole (Abilify, Abilify Maintena, Aristada, and generics). (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - May 6, 2016 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 brand name change for antidepressant drug Brintellix (vortioxetine) to avoid confusion with antiplatelet drug Brilinta (ticagrelor)
On May 2, 2016, FDA announced it has approved a brand name change for the antidepressant Brintellix (active ingredient vortioxetine) to decrease the risk of prescribing and dispensing errors resulting from name confusion with the blood-thinning medicine Brilinta (active ingredient ticagrelor). (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - May 6, 2016 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 review study examining use of oral fluconazole (Diflucan) in pregnancy
On April 26, 2016 FDA announced that it is evaluating the results of a Danish study that conclude there is a possible increased risk of miscarriage with the use of oral fluconazole (brand name Diflucan) for yeast infections. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - May 3, 2016 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

FDA Drug Safety Podcast: FDA announced that a safety review has found type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure
FDA announced that a safety review has found type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - April 27, 2016 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

FDA Drug Safety Podcast: FDA revises warnings regarding use of the diabetes medicine metformin in certain patients with reduced kidney function
On April 8, 2016 FDA announced it is requiring labeling changes regarding the recommendations for metformin-containing medicines for diabetes to expand metformin’s use in certain patients with reduced kidney function. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - April 14, 2016 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

Breaking News: Expert Perspective on Venclexta (venetoclax) Approval
The U.S. Food and Drug Administration (FDA) has approved a new drug Venclexta (venetoclax) for use in CLL patients with the 17p deletion. Andrew Schorr interviewed CLL expert Dr. Thomas Kipps to get h... Author: patientpower Added: 04/13/2016 (Source: Oncology Tube)
Source: Oncology Tube - April 14, 2016 Category: Cancer & Oncology Source Type: podcasts

FDA Drug Safety Podcast: FDA cautions about dosing errors when switching between different oral formulations of antifungal Noxafil (posaconazole); label changes approved
On January 4, 2016 FDA cautioned that differences in dosing regimens between the two oral formulations of the antifungal Noxafil (active ingredient posaconazole) have resulted in dosing errors. To help prevent additional medication errors, the drug labels were revised to indicate that the two oral formulations cannot be directly substituted for each other but require a change in dose. Direct milligram for milligram substitution of the two formulations can result in drug levels that are lower or higher than needed to effectively treat certain fungal infections. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - March 30, 2016 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

FDA Drug Safety Podcast: FDA revises labels of SGLT2 inhibitors for diabetes to include warnings about too much acid in the blood and serious urinary tract infections
On December 4, 2015, FDA announced a safety review has resulted in adding warnings to the labels of a specific class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors about the risks of ketoacidosis and of serious urinary tract infections (UTIs). Both conditions can result in hospitalization. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - March 30, 2016 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

FDA Drug Safety Podcast: FDA eliminates the Risk Evaluation and Mitigation Strategy (REMS) for rosiglitazone-containing diabetes medicines
On December 16, 2015, the FDA announced it is eliminating the Risk Evaluation and Mitigation Strategy (REMS) for rosiglitazone-containing type 2 diabetes medicines, which are approved as Avandia, Avandamet, Avandaryl, and generics. The REMS is no longer necessary to ensure that the benefits of rosiglitazone medicines outweigh their risks. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - March 30, 2016 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 several safety issues with opioid pain medicines; requires label changes
On March 22, 2016, FDA announced warnings about several safety issues with the entire class of opioid pain medicines. These safety risks are potentially harmful interactions with numerous other medications, problems with the adrenal glands, and decreased sex hormone levels. We are requiring changes to the labels of all opioid drugs to warn about these risks. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - March 30, 2016 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts

Flibanserin for Hypoactive Sexual Desire Disorder in Women (JAMA Internal Medicine)
Interview with Ellen T. M. Laan, PhD, author of Efficacy and Safety of Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Women: A Systematic Review and Meta-Analysis, and Steven Woloshin, MD, MS, author of US Food and Drug Administration Approval of Flibanserin: Even the Score Does Not Add Up (Source: JAMA Specialty Journals Author Interviews)
Source: JAMA Specialty Journals Author Interviews - February 29, 2016 Category: Journals (General) Authors: The JAMA Network Source Type: podcasts