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Food and Drug Administration Drug Safety Podcast

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Location:

United States

Description:

The FDA Drug Safety Podcasts provide emerging safety information about drugs in conjunction with the release of Public Health Advisories.

Language:

English


Episodes

FDA Drug Safety Podcast: FDA confirms increased risk of leg and foot amputations with the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR)

5/25/2017
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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.

Duration: 00:02:59


FDA Drug Safety Podcast: FDA approves label changes for use of general anesthetic and sedation drugs in young children

5/1/2017
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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.

Duration: 00:02:59


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

4/26/2017
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On April 20, 2017, FDA announced it is restricting the use of codeine and tramadol medicines in children.

Duration: 00:02:59


FDA Drug Safety Podcast: FDA warns about increased risk of serious pancreatitis with irritable bowel drug Viberzi (eluxadoline) in patients without a gallbladder

3/22/2017
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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.

Duration: 00:02:59


FDA Drug Safety Podcast: Updated FDA review concludes that use of pioglitazone may be linked to an increased risk of bladder cancer

3/9/2017
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On December 12, 2016, FDA announced as a result of an updated review, that it has concluded that use of the type 2 diabetes medicine pioglitazone (brand names Actos, Actoplus Met, Actoplus Met XR, Duetact, Oseni) may be linked to an increased risk of bladder cancer.

Duration: 00:02:59


FDA Drug Safety Podcast: FDA revises description of mental health side effects of stop-smoking medicines Chantix and Zyban to reflect clinical trial findings

3/9/2017
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On December 16, 2016, the FDA announced that based on our review of a large clinical trial that we required the drug companies to conduct, we have determined the risk of serious side effects on mood, behavior, or thinking with the stop-smoking medicines Chantix (active ingredient varenicline) and Zyban (active ingredient bupropion) is lower than previously suspected.

Duration: 00:03:00


FDA Drug Safety Podcast: FDA warns about rare but serious allergic reactions with the skin antiseptic chlorhexidine gluconate

3/9/2017
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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.

Duration: 00:02:59


FDA Drug Safety Podcast: FDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C

10/7/2016
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On October 4, 2016, FDA announced it is warning about the risk of hepatitis B virus (HBV) becoming an active infection again in any patient who has a current or previous infection with HBV and is treated with certain direct-acting antiviral (DAA) medicines for hepatitis C virus.

Duration: 00:03:00


FDA Drug Safety Podcast: FDA warns about serious risks and death when combining opioid pain or cough medicines with benzodiazepines; requires its strongest warning

9/7/2016
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On August 31, 2016, FDA announced that a review has found that the growing use of combining opioid medicines with benzodiazepines and other drugs that depress the central nervous system (CNS) has resulted in serious side effects, including slowed or difficult breathing and deaths.

Duration: 00:02:59


FDA Drug Safety Podcast: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects

8/2/2016
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On July 26, 2016, FDA approved changes to the labels of fluoroquinolone antibacterial drugs for systemic use (i.e., taken by mouth or by injection).

Duration: 00:02:59


FDA Drug Safety Podcast: Update: FDA evaluating the risk of burns and scars with Zecuity (sumatriptan) migraine patch

6/21/2016
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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.

Duration: 00:04:32


FDA Drug Safety Podcast: FDA evaluating the risk of burns and scars with Zecuity (sumatriptan) migraine patch

6/8/2016
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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.

Duration: 00:01:50


FDA Drug Safety Podcast: FDA warns about serious bleeding risk with over-the-counter antacid products containing aspirin

6/8/2016
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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.

Duration: 00:02:59


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

6/3/2016
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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.

Duration: 00:03:00


FDA Drug Safety Podcast: FDA warns about rare but serious skin reactions with mental health drug olanzapine (Zyprexa, Zyprexa Zydis, Zyprexa Relprevv, and Symbyax)

5/18/2016
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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.

Duration: 00:02:59


FDA Drug Safety Podcast: FDA warns about new impulse-control problems associated with mental health drug aripiprazole (Abilify, Abilify Maintena, Aristada)

5/6/2016
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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).

Duration: 00:03:20


FDA Drug Safety Podcast: FDA approves brand name change for antidepressant drug Brintellix (vortioxetine) to avoid confusion with antiplatelet drug Brilinta (ticagrelor)

5/6/2016
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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).

Duration: 00:02:59


FDA Drug Safety Podcast: FDA warns about several safety issues with opioid pain medicines; requires label changes

3/30/2016
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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.

Duration: 00:03:00