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Food and Drug Administration Drug Safety Podcast

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

The FDA Drug Safety Podcasts provide emerging safety information about drugs in conjunction with the release of Public Health Advisories.
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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 warns about increased risk of cancer relapse with long-term use of azithromycin (Zithromax, Zmax) antibiotic after donor stem cell transplant

8/6/2018
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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.

Duration:00:02:59

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

7/11/2018
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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.

Duration:00:02:59

FDA Drug Safety Podcast: FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq)

5/24/2018
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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).

Duration:00:03:29

FDA Drug Safety Podcast: FDA warns of serious immune system reaction with seizure and mental health medicine lamotrigine (Lamictal)

4/30/2018
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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.

Duration:00:02:59

FDA Drug Safety Podcast: FDA adds Boxed Warning to highlight correct dosing of Ocaliva (obeticholic acid) for patients with a rare chronic liver disease

2/7/2018
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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.

Duration:00:02:59

FDA Drug Safety Podcast: FDA limits packaging for anti-diarrhea medicine Loperamide (Imodium) to encourage safe use

2/6/2018
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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.

FDA Drug Safety Podcast: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric)

11/20/2017
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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.

Duration:00:02:59

FDA Drug Safety Podcast: FDA warns about serious liver injury with Ocaliva (obeticholic acid) for rare chronic liver disease

10/4/2017
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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.

Duration:00:02:59

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

10/2/2017
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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).

Duration:00:03:29

FFDA Drug Safety Podcast: FDA recommends separating dosing of potassium-lowering drug sodium polystyrene sulfonate (Kayexalate) from all other oral drugs

9/14/2017
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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.

Duration:00:02:59