1 One Year Post Exclusivity Adverse Event Review Update: Orlistat Pediatric Advisory Committee Meeting April 11, 2007 Hari Cheryl Sachs, MD, FAAP Medical.

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Presentation transcript:

1 One Year Post Exclusivity Adverse Event Review Update: Orlistat Pediatric Advisory Committee Meeting April 11, 2007 Hari Cheryl Sachs, MD, FAAP Medical Officer Pediatric and Maternal Health Staff Office of New Drugs Food and Drug Administration

2 PAC Meeting February 2005 Conclusions: Orlistat Minimal use in pediatric patients Insufficient events to draw any conclusions Reports of cholelithiasis during trial and post-marketing surveillance (relationship to therapy vs. underlying obesity and rapid weight loss unclear) FDA recommended continued monitoring of AEs, particularly for the risk of cholelithiasis, for this drug in all populations.

3 Background Drug Information Drug: Xenical ® (orlistat) Therapeutic Category: lipase inhibitor Sponsor: Roche Original Market Approval: April 23, 1999 Pediatric Exclusivity Granted: September 12, 2003 OTC switch (adults only): February 7, 2007 Mechanism of action: inhibits absorption of dietary fats

4 Background Drug Information Orlistat Rx (Xenical) –Indication (> 12 years of age): Obesity management in conjunction with weight loss Body Mass Index (BMI) > 30 mg/m 2 or 27 mg/m 2 with risk factors (hypertension, diabetes, dyslipidemia) –Dosage: 120 mg TID Orlistat OTC (Alli) –Indication: (> 18 years of age) Weight loss in adults when used with reduced calorie and low-fat diet –Dosage: 60 mg TID with meals containing fat

5 Outpatient Drug Use Trends: Orlistat Dispensed prescriptions for all age groups have continued to decrease: from ~1.6 million (Oct Sept 2002) to 547,000 (Oct Sept 2006). 1 Orlistat is prescribed mainly in adults. 2 Pediatric patients (ages 1-16) account for <1 % of prescriptions annually. 2 1 Verispan, LLC, Vector One® National (VONA) Data extracted Verispan, Total Patient Tracker, data extracted

6 Cholelithiasis: Orlistat Adverse Events: cholelithiasis/acute cholecystitis (April 1999 through Dec 2006) Domestic cases (all ages): 37 Pediatric cases: one, previously described No additional pediatric cases since Feb 2005 Conclusion: Some concern re: possible association between cholelithiasis and orlistat use in all populations No safety concern specific to pediatrics

7 Labeling Change: Orlistat Jan 2007 Precautions: General Substantial weight loss can increase risk of cholelithiasis Clinical trial of type 2 Diabetes prevention: orlistat: 47/1649 (2.9%) placebo: 30/1655 (1.8%) Incidence of cholelithiasis similar at similar amounts of weight loss Postmarketing reports: pancreatitis

8 PAC Meeting April 2007 Summary: Orlistat Minimal use in pediatric patients Additional cases of cholelithiasis identified in adults Labeling reflects an increased risk of gallstone formation with substantial weight loss. FDA recommends routine monitoring of AEs for this drug in all populations. AE reporting for nonprescription products will be required in the near future. Does the Advisory Committee concur?

9 Acknowledgements OSE Mark Avigan Vicky Borders- Hemphill Solomon Iyasu Rosemary Johann- Liang Joslyn Swann OPT Dianne Murphy Barbara Gould DMEDP Eric Colman Oluchi Elekwachi Theresa Kehoe Bruce Stadel DNCE Bindi Nikhar Joel Schiffenbauer Steven Osborne PMHS Lisa Mathis Jean Temeck Kristin Phucas