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Drug Safety Podcast

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The FDA Drug Safety Podcasts are produced by FDA's Center for Drug Evaluation and Research (CDER). They provide emerging safety information about drugs in conjunction with the release of Drug Safety Communications. Here you'll find the latest US Food and Drug Administration news and information.

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

Drug Safety Podcast

by U.S. Food and Drug Administration, Center for Drug Evaluation and Research

2M ago

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 ..read more

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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

Drug Safety Podcast

by U.S. Food and Drug Administration, Center for Drug Evaluation and Research

3M ago

Listen to FDA Drug Safety Podcast, FDA's preliminary evaluation has not found evidence that use of GLP-1 RAs causes suicidal thoughts/actions ..read more

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

Drug Safety Podcast

by U.S. Food and Drug Administration, Center for Drug Evaluation and Research

11M ago

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 ..read more

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

Drug Safety Podcast

by U.S. Food and Drug Administration, Center for Drug Evaluation and Research

1y ago

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 ..read more

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

Drug Safety Podcast

by U.S. Food and Drug Administration, Center for Drug Evaluation and Research

1y ago

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

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

Drug Safety Podcast

by U.S. Food and Drug Administration, Center for Drug Evaluation and Research

1y ago

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 ..read more

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

Drug Safety Podcast

by U.S. Food and Drug Administration, Center for Drug Evaluation and Research

1y ago

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 ..read more

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

Drug Safety Podcast

by U.S. Food and Drug Administration, Center for Drug Evaluation and Research

2y ago

Listen to an audio podcast of the March 30, 2022 FDA Drug Safety Communication Iodinated Contrast Media ..read more

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

Drug Safety Podcast

by U.S. Food and Drug Administration, Center for Drug Evaluation and Research

2y ago

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 ..read more

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

Drug Safety Podcast

by U.S. Food and Drug Administration, Center for Drug Evaluation and Research

2y ago

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 ..read more

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