FDA Alerts
FDA Safety Communication: Chantix
The U.S. Food and Drug Administration (FDA) has reviewed the results from two FDA-sponsored epidemiological studies that evaluated the risk of neuropsychiatric adverse events associated with the smoking cessation drug Chantix ( varenicline ).
FDA Drug Safety Communication: Xigris
The U.S. Food and Drug Administration (FDA) is informing healthcare professionals and the public that on October 25, 2011, Eli Lilly and Company announced a worldwide voluntary market withdrawal of Xigris [ drotrecogin alfa (activated)].
FDA approves Ferriprox
The U.S. Food and Drug Administration today approved Ferriprox ( deferiprone ) to treat patients with iron overload due to blood transfusions in patients with thalassemia , a genetic blood disorder that causes anemia, who had an inadequate response to prior chelation therapy.
FDA Approves First Generic Olanzapine
The U.S. Food and Drug Administration today approved the first generic versions of Zyprexa ( olanzapine tablets) and Zyprexa Zydus ( olanzapine orally disintegrating tablets) to treat schizophrenia and bipolar disorder.
FDA approves Onfi to treat severe type of seizures
On Oct. 21, the U.S. Food and Drug Administration approved Onfi tablets ( clobazam ) for use as an adjunctive (add-on) treatment for seizures associated with Lennox-Gastaut syndrome in adults and children 2 years of age and older.
FDA Approves Soliris For Rare Pediatric Blood Disorder
The U.S. Food and Drug Administration today approved Soliris ( eculizumab ) to treat patients with atypical hemolytic uremic syndrome ( aHUS ), a rare and chronic blood disease that can lead to kidney (renal) failure and is also associated with increased risk of death and stroke.
FDA Approves Prolia for osteoporosis
On September 16, 2011, the U.S. Food and Drug Administration granted approval for denosumab ( Prolia , Amgen Inc.) as a treatment to increase bone mass in patients at high risk for fracture receiving androgen deprivation therapy (ADT) for nonmetastatic prostate cancer or adjuvant aromatase inhibitor (AI) therapy for breast cancer. In men with nonmetastatic prostate cancer, denosumab also reduced the incidence of vertebral fracture.
FDA Drug Safety Communication: Saphris
The U.S. Food and Drug Administration (FDA) is warning the public that serious allergic reactions have been reported with the use of the antipsychotic medication Saphris ( asenapine maleate ).
FDA Drug Safety Communication: Reclast
The U.S. Food and Drug Administration (FDA) has approved an update to the drug label for Reclast ( zoledronic acid) to better inform healthcare professionals and patients of the risk of kidney (renal) failure.
FDA Alerts: Avastin
The U.S. Food and Drug Administration (FDA) is alerting health care professionals that repackaged intravitreal injections of Avastin ( bevacizumab ) have caused a cluster of serious eye infections in the Miami, Florida area.