FDA Drug Safety Podcast: FDA strengthens kidney warnings for diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR)
On June 14, 2016, FDA strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (brand names Invokana, Invokamet) and dapagliflozin (brand names Farxiga, Xigduo XR). (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - June 21, 2016 Category: Drugs & Pharmacology Authors: U.S. Food and Drug Administration, Center for Drug Evaluation and Research Source Type: podcasts
FDA Drug Safety Podcast: Update: FDA evaluating the risk of burns and scars with Zecuity (sumatriptan) migraine patch
On June 10, 2016, Zecuity manufacturer, Teva Pharmaceuticals, announced it has decided to temporarily suspend sales, marketing, and distribution to investigate the cause of burns and scars associated with the Zecuity patch. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - June 21, 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 serious heart problems with high doses of the antidiarrheal medicine loperamide (Imodium), including from abuse and misuse
On June 7, 2016, FDA is warning that taking higher than recommended doses of the common over-the-counter (OTC) and prescription diarrhea medicine loperamide (brand name Imodium), including through abuse or misuse of the product, can cause serious heart problems that can lead to death. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - June 15, 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 serious bleeding risk with over-the-counter antacid products containing aspirin
On June 6, 2016, FDA warned consumers about the risk of serious bleeding when using nonprescription, also known as over-the-counter or OTC, aspirin-containing antacid products to treat heartburn, sour stomach, acid indigestion, or upset stomach. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - June 8, 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 evaluating the risk of burns and scars with Zecuity (sumatriptan) migraine patch
On June 2, 2016, FDA announced it is investigating the risk of serious burns and potential permanent scarring with the use of Zecuity (sumatriptan iontophoretic transdermal system) patch for migraine headaches. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - June 8, 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 that prescribing of Nizoral (ketoconazole) oral tablets for unapproved uses including skin and nail infections continues; linked to patient death
On May 19, 2016, FDA announced it is warning health care professionals to avoid prescribing the antifungal medicine ketoconazole oral tablets to treat skin and nail fungal infections. (Source: FDA Drug Safety Podcasts)
Source: FDA Drug Safety Podcasts - June 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: 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 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 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
