Due to risk of serious liver injury, FDA restricts use of obeticholic acid (Ocaliva) in primary biliary cholangitis (PBC) patients with advanced cirrhosis

Episodes

FDA adds warning about rare occurrence of serious liver injury with use of Veozah (fezolinetant) for hot flashes due to menopause
20 Sep· FDA Drug Safety Podcasts
Listen to an audio podcast of the September 12th, 2024 FDA Drug Safety Communication on rare occurrence of serious liver injury with use of Veozah (fezolinetant) for hot flashes due to menopause.
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FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab)
6 Feb· FDA Drug Safety Podcasts
Listen to FDA Drug Safety Podcast titled, FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab).
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Update on FDA’s ongoing evaluation of reports of suicidal thoughts or actions in patients taking a certain type of medicines approved for type 2 diabetes and obesity
26 Jan· FDA Drug Safety Podcasts
Listen to FDA Drug Safety Podcast, FDA's preliminary evaluation has not found evidence that use of GLP-1 RAs causes suicidal thoughts/actions.
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FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan)
8 Dec 2023· FDA Drug Safety Podcasts
Listen to an audio podcast of the November 28, 2023, FDA Drug Safety Communication, FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan).
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FDA updating warnings to improve safe use of prescription stimulants used to treat ADHD and other conditions
31 May 2023· FDA Drug Safety Podcasts
Listen to an audio podcast of the May 11, 2023, FDA Drug Safety Communication on warnings to improve safe use of prescription stimulants used to treat ADHD and other conditions
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FDA updates prescribing information for all opioid pain medicines to provide additional guidance for safe use
10 May 2023· FDA Drug Safety Podcasts
Listen to an audio podcast of the April 13, 2023, FDA Drug Safety Communication, FDA updates prescribing information for all opioid pain medicines to provide additional guidance for safe use.
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FDA investigating risk of severe hypocalcemia in patients on dialysis receiving osteoporosis medicine Prolia (denosumab)
16 Dec 2022· FDA Drug Safety Podcasts
FDA investigating risk of severe hypocalcemia in patients on dialysis receiving osteoporosis medicine Prolia (denosumab)
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FDA warns about possible increased risk of death and serious side effects with cancer drug Copiktra (duvelisib)
27 Jul 2022· FDA Drug Safety Podcasts
Listen to an audio podcast of the June 30, 2022, FDA Drug Safety Communication. Results from a clinical trial show a possible increased risk of death with Copiktra (active ingredient duvelisib) compared to another medicine to treat leukemia and lymphoma.
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FDA withdrew its approval for the cancer medicine Ukoniq (umbralisib) due to safety concerns
7 Jul 2022· FDA Drug Safety Podcasts
Listen to an audio podcast of the 6/1/22 for Ukoniq . FDA withdrew its approval for the cancer medicine Ukoniq (active ingredient umbralisib) due to safety concerns. Ukoniq was approved to treat two specific types of lymphoma: marginal zone lymphoma (MZL) and follicular lymphoma (FL)
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FDA recommends thyroid monitoring in babies and young children who receive injections of iodine-containing contrast media for medical imaging
13 Apr 2022· FDA Drug Safety Podcasts
Listen to an audio podcast of the March 30, 2022 FDA Drug Safety Communication Iodinated Contrast Media
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FDA investigating possible increased risk of death with lymphoma medicine Ukoniq (umbralisib)
9 Feb 2022· FDA Drug Safety Podcasts
Listen to an audio podcast of the February 3, 2022, FDA Drug Safety Communication, FDA is investigating a possible increased risk of death with the cancer medicine Ukoniq (umbralisib). We are re-evaluating this risk against the benefits of Ukoniq for its approved uses.
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FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain
24 Jan 2022· FDA Drug Safety Podcasts
Listen to an audio podcast of the January 12, 2022, FDA Drug Safety Communication warning that dental problems have been reported with medicines containing buprenorphine that are dissolved in the mouth.
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FDA warns that getting alcohol-based hand sanitizer in the eyes can cause serious injury
9 Nov 2021· FDA Drug Safety Podcasts
“Listen to FDA Drug Podcast, FDA warns that getting alcohol-based hand sanitizer in the eyes can cause serious injury
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FDA requires warnings about increased risk of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions
8 Sep 2021· FDA Drug Safety Podcasts
Listen to an audio podcast of the September 1, 2021 FDA Drug Safety Communication on requiring revisions to the Boxed Warning for Xeljanz/Xeljanz XR, Olumiant, and Rinvoq to include information about the risks of serious heart-related events, cancer, blood clots, and death.
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FDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancy; still advises most pregnant patients should stop taking statins
22 Jul 2021· FDA Drug Safety Podcasts
Listen to an audio podcast of the July 20, 2021 FDA Drug Safety Communication, FDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancy; still advises most pregnant patients should stop taking statins
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FDA warns that vapors from alcohol-based hand sanitizers can have side effects
21 Jun 2021· FDA Drug Safety Podcasts
Listen to an audio podcast of the June 16, 2021 Drug Safety Communication "FDA warns that vapors from alcohol-based hand sanitizers can cause symptoms such as headache, nausea, and dizziness after applying to the skin"
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Due to risk of serious liver injury, FDA restricts use of obeticholic acid (Ocaliva) in primary biliary cholangitis (PBC) patients with advanced cirrhosis
3 Jun 2021· FDA Drug Safety Podcasts
Listen to FDA Drug Safety Podcast on due to risk of serious liver injury, FDA restricts use of Ocaliva in primary biliary cholangitis (PBC) patients with advanced cirrhosis
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Studies show increased risk of heart rhythm problems with seizure and mental health medicine lamotrigine (Lamictal) in patients with heart disease
2 Apr 2021· FDA Drug Safety Podcasts
Listen to an audio podcast of the March 31, 2021 FDA Drug Safety Communication that FDA review of studies show a potential increased risk of heart rhythm problems, in patients with heart disease taking lamotrigine (Lamictal). FDA requiring studies to evaluate heart risk across the drug class.
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FDA warns that abuse and misuse of the OTC nasal decongestant propylhexedrine can lead to serious harm
29 Mar 2021· FDA Drug Safety Podcasts
Listen to an audio podcast of the March 25, 2021 FDA Drug Safety Communication warning that abuse and misuse of the over the counter (OTC) nasal decongestant propylhexedrine (brand name Benzedrex) can lead to serious harm such as heart and mental health problems.
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Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib)
8 Feb 2021· FDA Drug Safety Podcasts
Listen to FDA Drug Safety Podcast on Drug Safety Communication titled "Initial safety trial results find increased risk of serious heart-related problems and cancer with tofacitinib (Xeljanz, Xeljanz XR)
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Episodes

FDA adds warning about rare occurrence of serious liver injury with use of Veozah (fezolinetant) for hot flashes due to menopause

FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab)

Update on FDA’s ongoing evaluation of reports of suicidal thoughts or actions in patients taking a certain type of medicines approved for type 2 diabetes and obesity

FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan)

FDA updating warnings to improve safe use of prescription stimulants used to treat ADHD and other conditions

FDA updates prescribing information for all opioid pain medicines to provide additional guidance for safe use

FDA investigating risk of severe hypocalcemia in patients on dialysis receiving osteoporosis medicine Prolia (denosumab)

FDA warns about possible increased risk of death and serious side effects with cancer drug Copiktra (duvelisib)

FDA withdrew its approval for the cancer medicine Ukoniq (umbralisib) due to safety concerns

FDA recommends thyroid monitoring in babies and young children who receive injections of iodine-containing contrast media for medical imaging

FDA investigating possible increased risk of death with lymphoma medicine Ukoniq (umbralisib)

FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain

FDA warns that getting alcohol-based hand sanitizer in the eyes can cause serious injury

FDA requires warnings about increased risk of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions

FDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancy; still advises most pregnant patients should stop taking statins

FDA warns that vapors from alcohol-based hand sanitizers can have side effects

Studies show increased risk of heart rhythm problems with seizure and mental health medicine lamotrigine (Lamictal) in patients with heart disease

FDA warns that abuse and misuse of the OTC nasal decongestant propylhexedrine can lead to serious harm

Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib)