Category Archives: FDA Drug Safety Podcasts

FDA Drug Safety Podcast: FDA eliminates the Risk Evaluation and Mitigation Strategy (REMS) for rosiglitazone-containing diabetes medicines

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On December 16, 2015, the FDA announced it is eliminating the Risk Evaluation and Mitigation Strategy (REMS) for rosiglitazone-containing type 2 diabetes medicines, which are approved as Avandia, Avandamet, Avandaryl, and generics. The REMS is no longer necessary to ensure that the benefits of rosiglitazone medicines outweigh their risks.
Source: FDA Drug Safety Podcasts

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

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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.
Source: FDA Drug Safety Podcasts

FDA Drug Safety Podcast: FDA cautions about dosing errors when switching between different oral formulations of antifungal Noxafil (posaconazole); label changes approved

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On January 4, 2016 FDA cautioned that differences in dosing regimens between the two oral formulations of the antifungal Noxafil (active ingredient posaconazole) have resulted in dosing errors. To help prevent additional medication errors, the drug labels were revised to indicate that the two oral formulations cannot be directly substituted for each other but require a change in dose. Direct milligram for milligram substitution of the two formulations can result in drug levels that are lower or higher than needed to effectively treat certain fungal infections.
Source: FDA Drug Safety Podcasts

FDA Drug Safety Podcast: FDA revises labels of SGLT2 inhibitors for diabetes to include warnings about too much acid in the blood and serious urinary tract infections

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On December 4, 2015, FDA announced a safety review has resulted in adding warnings to the labels of a specific class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors about the risks of ketoacidosis and of serious urinary tract infections (UTIs). Both conditions can result in hospitalization.
Source: FDA Drug Safety Podcasts

FDA Drug Safety Podcast: FDA advises of rare cases of underactive thyroid in infants given iodine-containing contrast agents for medical imaging

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On November 17, 2015, FDA announced it is advising that rare cases of underactive thyroid have been reported in infants following the use of contrast media containing iodine, also called “contrast dye,” for X-rays and other medical imaging procedures.
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FDA Drug Safety Podcast: FDA review finds long-term treatment with blood-thinning medicine Plavix (clopidogrel) does not change risk of death

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On November 6, 2015 FDA announced that a review has determined that long-term use of the blood-thinning drug Plavix (active ingredient clopidogrel) does not increase or decrease overall risk of death in patients with, or at risk for, heart disease.
Source: FDA Drug Safety Podcasts

FDA Drug Safety Podcast: FDA requires drug interaction studies with potassium-lowering drug Kayexalate (sodium polystyrene sulfonate)

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On October 22, 2015, the FDA announced it is requiring the Kayexalate manufacturer to conduct studies to investigate Kayexalate’s potential to bind to other medications administered by mouth – drug interactions that could affect how well the other medications work.
Source: FDA Drug Safety Podcasts