slide1 n.
Download
Skip this Video
Loading SlideShow in 5 Seconds..
Update to Post Exclusivity Pediatric Adverse Event Review: Atorvastatin Pediatric Advisory Committee Meeting November PowerPoint Presentation
Download Presentation
Update to Post Exclusivity Pediatric Adverse Event Review: Atorvastatin Pediatric Advisory Committee Meeting November

Loading in 2 Seconds...

play fullscreen
1 / 14

Update to Post Exclusivity Pediatric Adverse Event Review: Atorvastatin Pediatric Advisory Committee Meeting November - PowerPoint PPT Presentation


  • 164 Views
  • Uploaded on

Update to Post Exclusivity Pediatric Adverse Event Review: Atorvastatin Pediatric Advisory Committee Meeting November 16, 2006. Jean Temeck, MD, Acting Medical Team Leader Pediatric and Maternal Health Staff Office of New Drugs Center for Drug Evaluation and Research

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'Update to Post Exclusivity Pediatric Adverse Event Review: Atorvastatin Pediatric Advisory Committee Meeting November' - griselda


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
slide1
Update to Post Exclusivity Pediatric Adverse Event Review:Atorvastatin Pediatric Advisory Committee Meeting November 16, 2006

Jean Temeck, MD, Acting Medical Team Leader

Pediatric and Maternal Health Staff

Office of New Drugs

Center for Drug Evaluation and Research

Food and Drug Administration

background drug information
Background Drug Information
  • Drug: Lipitor® (atorvastatin)
  • Therapeutic Category: lipid-lowering agent
  • Sponsor: Pfizer
  • Original Market Approval: December 17, 1996
  • Pediatric Exclusivity Granted: February 22, 2002
  • Mechanism of action: inhibitor of HMG-CoA reductase
background drug information1
Background Drug Information
  • Pediatric Indication: adjunct to diet to reduce total-C, LDL-C, and apo B levels in boys and post-menarchal girls, 10 to 17 years of age with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present
    • LDL-C remains >190 mg/dl or
    • LDL-C remains >160 mg/dl and there is a positive family history of premature CVD or >2 CVD risk factors are present
  • Pediatric Dosage:
    • initial dose 10 mg daily with maximum 20 mg daily
background drug information2
Background Drug Information
  • Pediatric Indication: to reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable.
  • Dosage: 10-80 mg daily
atorvastatin pediatric labeling changes
Atorvastatin: Pediatric Labeling Changes
  • Patient Package Insert approved May, 2004; updated June, 2006
    • Indicated for children over 10 years whose cholesterol does not come down enough with exercise and low fat diet alone
    • Keep out of reach of children
atorvastatin pediatric drug use trends 1
Atorvastatin: Pediatric Drug Use Trends1
  • Pediatric use is small (<0.1% of total number of prescriptions dispensed in retail pharmacies)
  • # of pediatric prescriptions dispensed by year:
    • in 2002: 36,668 prescriptions
    • in 2003: 36,894
    • in 2004: 37,101
    • in 2005: 32,381

1Verispan, Vector One®: National (VONA), data extracted Aug 2006

atorvastatin pediatric adverse events
Atorvastatin: Pediatric Adverse Events
  • None during the one year post exclusivity (2/22/02-3/22/03)
  • 12 (0.15% of total reports for all ages) during the subsequent three year period (3/22/03-8/22/06)
    • All serious, including one death
    • 9 post-natal reports in children 2-16 years (3 accidental ingestions; 6 other reports)
    • 3 in utero exposures (included 1 stillbirth); pregnancy category X
atorvastatin pediatric other post natal adverse events
Atorvastatin: Pediatric Other Post-Natal Adverse Events
  • 6 other reports in patients aged 4-16 years
    • iron-deficiency anemia (16 year old female; anemia labeled)
    • pancreatitis (labeled)
    • muscle stiffness, chest pain and elevated CPK level (labeled)
    • bone marrow suppression (no details provided; unlabeled)
    • bronchospasm (positive rechallenge; unlabeled)
    • hemoptysis (diffuse pulmonary alveolar hemorrhage; unlabeled)
bronchospasm case report
Bronchospasm Case Report
  • Foreign report
  • 4 year old male
  • Diagnosis: myocardial ischemia
  • Medications:
    • simvastatin since 3/04; duration unknown
    • atorvastatin since 4/04; duration unknown
    • clopidogrel and aspirin
  • Bronchospasm (reversible): noted 3/04; positive rechallenge x3 (no details provided); intervention not reported but resolved 5/04
hemoptysis case report
Hemoptysis Case Report
  • Foreign report
  • 16 year old male
  • Diagnosis: familial hypercholesterolemia
  • Medications:
    • atorvastatin: 6/04-1/05
    • nicotinic acid: 6/04-12/04
  • Hemoptysis 12/04; bronchoscopy: diffuse pulmonary alveolar hemorrhage; echocardiogram: cardiomegaly; diagnosed with moderate heart failure
atorvastatin pediatric other post natal adverse events1
Atorvastatin: Pediatric Other Post-Natal Adverse Events
  • Above adverse events that are unlabeled are confounded by underlying illness, concomitant medications and/or insufficient information.
atorvastatin in utero exposures
Atorvastatin: In Utero Exposures
  • Congenital blindness; atorvastatin during first 8 weeks of pregnancy.
  • Congenital hepatomegaly, single functional kidney and stillbirth at 33 weeks gestational age; maternal diabetes mellitus; insulin, gliclazide, metformin and atorvastatin: unknown start date but last 3 drugs discontinued 2.5 months prior to delivery.
  • “Born with myopathy”; paternal exposure to atorvastatin 2-3 months prior to conception.
summary atorvastatin
Summary: Atorvastatin
  • Pediatric unlabeled post-natal adverse events: no new safety signal identified: few reports, single cases, confounded or insufficient information
  • In utero exposures: Pregnancy category X
  • The FDA recommends routine monitoring of atorvastatin for AEs in all populations
  • Does the Advisory Committee concur?
acknowledgements
OSE

Jennie Chang

David Moeny

Jo Wyeth

Rosemary Johann-Liang

PMHS

Lisa Mathis

Kristin Phucas

DMEP

Eric Colman

Eileen Craig

Acknowledgements