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FDA Drug Safety Podcast

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

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FDA Drug Safety Podcast
FDA Drug Safety Podcast

FDA Drug Safety Podcast

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

3
Followers
0
Plays
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About Us

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

Latest Episodes

FDA Drug Safety Podcast: SFDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering

On April 9, 2019 FDA announced we have received reports of serious harm in patients who are physically dependent on opioid pain medicines suddenly having these medicines discontinued or the dose rapidly decreased.

-1 sAPR 17
Comments
FDA Drug Safety Podcast: SFDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering

FDA Drug Safety Podcast: Safety trial finds risk of blood clots in the lungs and death with higher dose of tofacitinib (Xeljanz, Xeljanz XR) in rheumatoid arthritis patients; FDA to investigate

On February 25, 2019 FDA alerted the public that a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of tofacitinib (brand names Xeljanz, Xeljanz XR) was used in patients with rheumatoid arthritis (or RA).

-1 sMAR 5
Comments
FDA Drug Safety Podcast: Safety trial finds risk of blood clots in the lungs and death with higher dose of tofacitinib (Xeljanz, Xeljanz XR) in rheumatoid arthritis patients; FDA to investigate

FDA Drug Safety Podcast: FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat)

On February 21, 2019 FDA concluded there is an increased risk of death with Uloric (active ingredient febuxostat) compared to another gout medicine, allopurinol.

-1 sFEB 27
Comments
FDA Drug Safety Podcast: FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat)

FDA Drug Safety Podcast: FDA warns that symptoms of a serious condition affecting the blood cells are not being recognized with the leukemia medicine Idhifa (enasidenib)

On November 29, 2018 FDA is warning that signs and symptoms of a life-threatening side effect called differentiation syndrome are not being recognized in patients receiving the acute myeloid leukemia medicine Idhifa, active ingredient enasidenib.

-1 s2018 DEC 6
Comments
FDA Drug Safety Podcast: FDA warns that symptoms of a serious condition affecting the blood cells are not being recognized with the leukemia medicine Idhifa (enasidenib)

FDA Drug Safety Podcast: FDA warns about rare but serious risks of stroke and blood vessel wall tears with multiple sclerosis drug Lemtrada (alemtuzumab)

On November 29, 2018 FDA is warning that rare but serious cases of stroke and tears in the lining of arteries in the head and neck have occurred in patients with multiple sclerosis or MS shortly after they received Lemtrada, active ingredient alemtuzumab.

-1 s2018 DEC 4
Comments
FDA Drug Safety Podcast: FDA warns about rare but serious risks of stroke and blood vessel wall tears with multiple sclerosis drug Lemtrada (alemtuzumab)

FDA Drug Safety Podcast: FDA warns about severe worsening of multiple sclerosis after stopping the medicine Gilenya (fingolimod)

On November 20, 2018 FDA warned that when the multiple sclerosis (MS) medicine Gilenya (active ingredient fingolimod) is stopped, the disease can become much worse than before the medicine was started or while it was being taken.

-1 s2018 NOV 26
Comments
FDA Drug Safety Podcast: FDA warns about severe worsening of multiple sclerosis after stopping the medicine Gilenya (fingolimod)

FDA Drug Safety Podcast: FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes

On August 29, 2018, FDA warned that cases of a rare but serious infection of the genitals and area around the genitals have been reported with the class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (or SGLT2) inhibitors.

-1 s2018 SEP 5
Comments
FDA Drug Safety Podcast: FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes

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

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.

-1 s2018 AUG 6
Comments
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

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

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.

-1 s2018 JUL 11
Comments
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

FDA Drug Safety Podcast: Risk of serious and potentially fatal blood disorder prompts FDA action on oral over-the-counter benzocaine products used for teething and mouth pain and prescription local anesthetics

On May 23, 2018, FDA warned that over-the-counter (or OTC) oral drug products containing benzocaine should not be used to treat infants and children younger than 2 years.

-1 s2018 MAY 31
Comments
FDA Drug Safety Podcast: Risk of serious and potentially fatal blood disorder prompts FDA action on oral over-the-counter benzocaine products used for teething and mouth pain and prescription local anesthetics

Latest Episodes

FDA Drug Safety Podcast: SFDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering

On April 9, 2019 FDA announced we have received reports of serious harm in patients who are physically dependent on opioid pain medicines suddenly having these medicines discontinued or the dose rapidly decreased.

-1 sAPR 17
Comments
FDA Drug Safety Podcast: SFDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering

FDA Drug Safety Podcast: Safety trial finds risk of blood clots in the lungs and death with higher dose of tofacitinib (Xeljanz, Xeljanz XR) in rheumatoid arthritis patients; FDA to investigate

On February 25, 2019 FDA alerted the public that a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of tofacitinib (brand names Xeljanz, Xeljanz XR) was used in patients with rheumatoid arthritis (or RA).

-1 sMAR 5
Comments
FDA Drug Safety Podcast: Safety trial finds risk of blood clots in the lungs and death with higher dose of tofacitinib (Xeljanz, Xeljanz XR) in rheumatoid arthritis patients; FDA to investigate

FDA Drug Safety Podcast: FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat)

On February 21, 2019 FDA concluded there is an increased risk of death with Uloric (active ingredient febuxostat) compared to another gout medicine, allopurinol.

-1 sFEB 27
Comments
FDA Drug Safety Podcast: FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat)

FDA Drug Safety Podcast: FDA warns that symptoms of a serious condition affecting the blood cells are not being recognized with the leukemia medicine Idhifa (enasidenib)

On November 29, 2018 FDA is warning that signs and symptoms of a life-threatening side effect called differentiation syndrome are not being recognized in patients receiving the acute myeloid leukemia medicine Idhifa, active ingredient enasidenib.

-1 s2018 DEC 6
Comments
FDA Drug Safety Podcast: FDA warns that symptoms of a serious condition affecting the blood cells are not being recognized with the leukemia medicine Idhifa (enasidenib)

FDA Drug Safety Podcast: FDA warns about rare but serious risks of stroke and blood vessel wall tears with multiple sclerosis drug Lemtrada (alemtuzumab)

On November 29, 2018 FDA is warning that rare but serious cases of stroke and tears in the lining of arteries in the head and neck have occurred in patients with multiple sclerosis or MS shortly after they received Lemtrada, active ingredient alemtuzumab.

-1 s2018 DEC 4
Comments
FDA Drug Safety Podcast: FDA warns about rare but serious risks of stroke and blood vessel wall tears with multiple sclerosis drug Lemtrada (alemtuzumab)

FDA Drug Safety Podcast: FDA warns about severe worsening of multiple sclerosis after stopping the medicine Gilenya (fingolimod)

On November 20, 2018 FDA warned that when the multiple sclerosis (MS) medicine Gilenya (active ingredient fingolimod) is stopped, the disease can become much worse than before the medicine was started or while it was being taken.

-1 s2018 NOV 26
Comments
FDA Drug Safety Podcast: FDA warns about severe worsening of multiple sclerosis after stopping the medicine Gilenya (fingolimod)

FDA Drug Safety Podcast: FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes

On August 29, 2018, FDA warned that cases of a rare but serious infection of the genitals and area around the genitals have been reported with the class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (or SGLT2) inhibitors.

-1 s2018 SEP 5
Comments
FDA Drug Safety Podcast: FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes

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

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.

-1 s2018 AUG 6
Comments
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

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

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.

-1 s2018 JUL 11
Comments
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

FDA Drug Safety Podcast: Risk of serious and potentially fatal blood disorder prompts FDA action on oral over-the-counter benzocaine products used for teething and mouth pain and prescription local anesthetics

On May 23, 2018, FDA warned that over-the-counter (or OTC) oral drug products containing benzocaine should not be used to treat infants and children younger than 2 years.

-1 s2018 MAY 31
Comments
FDA Drug Safety Podcast: Risk of serious and potentially fatal blood disorder prompts FDA action on oral over-the-counter benzocaine products used for teething and mouth pain and prescription local anesthetics
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