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FDA Drug Safety Podcast: FDA warns of serious immune system reaction with...

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...

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FDA Drug Safety Podcast: FDA to evaluate potential risk of neural tube birth...

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...

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FDA Drug Safety Podcast: Risk of serious and potentially fatal blood disorder...

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.

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FDA Drug Safety Podcast: FDA reinforces safety information about serious low...

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...

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FDA Drug Safety Podcast: FDA warns about increased risk of cancer relapse...

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...

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FDA Drug Safety Podcast: FDA warns about rare occurrences of a serious...

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...

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FDA Drug Safety Podcast: FDA warns about severe worsening of multiple...

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...

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FDA Drug Safety Podcast: FDA warns about rare but serious risks of stroke and...

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...

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FDA Drug Safety Podcast: FDA warns that symptoms of a serious condition...

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...

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FDA Drug Safety Podcast: FDA adds Boxed Warning for increased risk of death...

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

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FDA Drug Safety Podcast: Safety trial finds risk of blood clots in the lungs...

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,...

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FDA Drug Safety Podcast: SFDA identifies harm reported from sudden...

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...

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FDA Drug Safety Podcast: FDA approves Boxed Warning about increased risk of...

On July 26, 2019, FDA approved new warnings about an increased risk of blood clots and death with the 10 mg twice daily dose of tofacitinib (brand names Xeljanz, Xeljanz XR), used in patients with...

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