title: Safety of gadoxetate disodium: Results from the clinical phase II-III development program and postmarketing surveillance.
abstract: OBJECTIVE
  To summarize the safety data of gadoxetate disodium, reported in 12 Phase II and III clinical development studies and in the postmarketing surveillance database.
  
  
  METHODS
  Patients with liver lesions received gadoxetate disodium-enhanced liver magnetic resonance imaging (MRI). Adverse events (AEs) were recorded and evaluated with regard to a potential drug relationship. Subgroup analyses were run on patients with special medical history. Worldwide spontaneous AEs and adverse drug reactions (ADRs) from postmarketing safety surveillance were analyzed.
  
  
  RESULTS
  A total of 1989 patients were included in the clinical development program. A total of 1581/1989 (79.5%) patients received the finally approved dose of 0.025 mmol/kg body weight. 10.1% of patients reported AEs, 4.1% were classified as related AEs. Nausea and headache were the most frequently reported related AEs, with 1.1% each. Age, history of contrast media allergy, liver cirrhosis, or impaired liver or renal function did not significantly impact the frequency and type of AEs. The postmarketing safety surveillance database encompassed more than 2.2 million patients. Nausea was the most frequent ADR, with a reporting rate of 0.00652%; all other symptoms were below 0.004%.
  
  
  CONCLUSIONS
  Gadoxetate disodium for liver MRI has an excellent safety profile.
authors: Bayer HealthCare Pharmaceuticals, Medical Care, Global Medical and Clinical Affairs, Radiology & Interventional, Berlin, Germany.|Department of Gynecology, Obstetrics and Reproductive Medicine, University Medical School of Saarland, Homburg/Saar, Germany.
authors: Jan S
authors: JS
authors: Endrikat
authors: Bayer HealthCare Pharmaceuticals, Global Pharmacovigilance and Risk Management, Whippany, New Jersey, USA.
authors: Susan
authors: S
authors: Dohanish
authors: Bayer HealthCare Pharmaceuticals, Medical Care, Medical and Clinical Affairs, Radiology & Interventional, Whippany, New Jersey, USA.
authors: Thomas
authors: T
authors: Balzer
authors: Bayer HealthCare Pharmaceuticals, Medical Care, Global Medical and Clinical Affairs, Radiology & Interventional, Berlin, Germany.
authors: Josy A M
authors: JA
authors: Breuer
mesh_terms: D000293:Adolescent; D000328:Adult; D000369:Aged, 80 and over; D001835:Body Weight; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D003287:Contrast Media / Q000009:adverse effects* / Q000627:therapeutic use; D005260:Female; D019786:Gadolinium DTPA / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D008099:Liver / Q000187:drug effects* / Q000473:pathology*; D008107:Liver Diseases / Q000473:pathology*; D008113:Liver Neoplasms / Q000473:pathology*; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D061214:Patient Safety; D011358:Product Surveillance, Postmarketing; D055815:Young Adult
chemical_list: D003287:Contrast Media; C073590:gadolinium ethoxybenzyl DTPA; D019786:Gadolinium DTPA
keywords: gadoxetate disodium; liver MR imaging; safety