On September 1, 2011, the Food and Drug Administration issued a Drug Safety Communication warning the public that serious allergic reactions have been reported with the use of the antipsychotic medication Saphris, active ingredient asenapine maleate.
Category Archives: Drug Safety Information Podcasts
FDA Drug Safety Podcast for Healthcare Professionals: Drug labels for the Tumor Necrosis Factor-alpha (TNFa) blockers now include warnings about infection with Legionella and Listeria bacteria
On September 7, 2011, the Food and Drug Administration issued a Drug Safety Communication informing healthcare professionals that the Boxed Warning for the entire class of Tumor Necrosis Factor-alpha, or TNFa, blockers has been updated to include the risk of infection from two bacterial pathogens, Legionella and Listeria.
FDA Drug Safety Podcast for Healthcare Professionals: New contraindication and updated warning on kidney impairment for Reclast (zoledronic acid)
On September 1, 2011, the Food and Drug Administration issued a Drug Safety Communication informing the public that FDA has approved an update to the drug label for Reclast, active ingredient zoledronic acid, to better inform healthcare professionals and patients of the risk of renal failure.
FDA Drug Safety Podcast: Long-term, high dosage use of Diflucan during pregnancy may lead to rare birth defects
On August 3, 2011 the Food and Drug Administration issued a Drug Safety Communication that explains how long-term, high dosage use of diflucan during pregnancy may be associated with rare birth defects.
FDA Drug Safety Podcast for Healthcare Professionals: Updated drug labels for pioglitazone-containing medicines
On August 4, 2011, the Food and Drug Administration issued a Drug Safety Communication informing the public that the Agency has approved updated drug labels for the pioglitazone-containing medicines to include safety information that the use of pioglitazone for more than one year may be associated with an increased risk of bladder cancer.
FDA Drug Safety Podcast for Healthcare Professionals: FDA alerts healthcare professionals to stop performing heart scans with CardioGen-82 due to potential for increased radiation exposure in patients
On July 26, 2011, the Food and Drug Administration issued a Drug Safety Communication alerting healthcare professionals to stop using CardioGen-82 for cardiac positron emission tomography, or PET, scans. The manufacturer, Bracco Diagnostics, Inc. has decided to voluntarily recall CardioGen-82.
FDA Drug Safety Podcast for Healthcare Professionals: Chantix (varenicline) drug label now contains updated efficacy and safety information
On July 22, 2011, the Food and Drug Administration issued a Drug Safety Communication informing that public that FDA has approved an updated drug label for the smoking cessation aid Chantix, active ingredient varenicline, to include information about the efficacy and safety of the drug in two patient populations who may benefit greatly from giving up smoking — those with cardiovascular disease and those with chronic obstructive pulmonary disease, or COPD.
FDA Drug Safety Podcast for Healthcare Professionals: Safety review update of Recombinant Human Growth Hormone (somatropin) and possible increased risk of death
On August 4, 2011, the Food and Drug Administration issued a Drug Safety Communication updating the public about its ongoing safety review of recombinant human growth hormone, or somatropin, and possible increased risk of death.
FDA Drug Safety Podcast for Healthcare Professionals: Use of long-term, high-dose Diflucan (fluconazole) during pregnancy may be associated with birth defects in infants
On August 3, 2011, the Food and Drug Administration issued a Drug Safety Communication informing the public that chronic, high doses (400-800 mg/day) of the antifungal drug Diflucan, active ingredient fluconazole, may be associated with a rare and distinct set of birth defects in infants whose mothers were treated with the drug during the first trimester of pregnancy.
FDA Drug Safety Podcast for Healthcare Professionals: FDA Drug Safety Podcast for Healthcare Professionals: Serious CNS reactions possible when linezolid (Zyvox.) is given to patients taking certain psychiatric medications
On July 26, 2011, the Food and Drug Administration issued a Drug Safety Communication informing the public of reports of serious central nervous system reactions when the drug methylene blue is given to patients taking serotonergic psychiatric medications.