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FDA:ODE I:DCRDP:JCP:9/20/02:OTC NSAIDs: 1 OTC NSAIDs AND NEPHROTOXICITY Juan Carlos Pelayo, M.D. On Behalf Of The Division Of Cardio-Renal Drug Products.

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Presentation on theme: "FDA:ODE I:DCRDP:JCP:9/20/02:OTC NSAIDs: 1 OTC NSAIDs AND NEPHROTOXICITY Juan Carlos Pelayo, M.D. On Behalf Of The Division Of Cardio-Renal Drug Products."— Presentation transcript:

1 FDA:ODE I:DCRDP:JCP:9/20/02:OTC NSAIDs: 1 OTC NSAIDs AND NEPHROTOXICITY Juan Carlos Pelayo, M.D. On Behalf Of The Division Of Cardio-Renal Drug Products FDA OTC Advisory Committee - September 20, 2002

2 FDA:ODE I:DCRDP:JCP:9/20/02:OTC NSAIDs: 2 QUESTIONS TO ADDRESS: ARE NON-PRESCRIPTION DOSES OF OTC NSAIDs NEPHROTOXIC? IF SO, WHAT IS THE OUTCOME OF A RISK- BENEFIT ANALYSIS?

3 FDA:ODE I:DCRDP:JCP:9/20/02:OTC NSAIDs: 3 NSAID-INDUCED NEPHROTOXICITY (PRESCRIPTION DOSES) EDEMA HYPERKALEMIA  BLOOD PRESSURE  SERUM CREATININE / ARF PROTEINURIA / NS / INTERSTITIAL NEPHRITIS ACUTE PAPILLARY NECROSIS CRF

4 FDA:ODE I:DCRDP:JCP:9/20/02:OTC NSAIDs: 4 AT RISK POPULATIONS VOLUME DEPLETION UNDERLYING KIDNEY DISEASE HEART FAILURE LIVER DYSFUNCTION WITH ASCITES ELDERLY PREGNANCY

5 FDA:ODE I:DCRDP:JCP:9/20/02:OTC NSAIDs: 5 NSAID-INDUCED NEPHROTOXICITY (PRESCRIPTION DOSES) WHAT ARE THE RATES OF OCCURRENCE OF NSAID-RELATED KIDNEY ADVERSE EVENTS FOR PRESCRIPTION DOSES?

6 FDA:ODE I:DCRDP:JCP:9/20/02:OTC NSAIDs: 6 NSAID-INDUCED NEPHROTOXICITY (PRESCRIPTION DOSES) STUDY DESIGN – PROSPECTIVE, RANDOMIZED, PLACEBO- CONTROLLED, PARALLEL GROUP DESIGN – TREATMENT DURATION 18 WEEKS – 361 HEALTHY SUBJECTS WITH OSTEOARTHRITIS WERE EVALUATED PER GROUP – RENAL ADVERSE EVENTS AS REPORTED BY THE INVESTIGATORS – IBUPROFEN 2400 mg/DAILY vs.. PLACEBO

7 FDA:ODE I:DCRDP:JCP:9/20/02:OTC NSAIDs: 7 EDEMA 18 Weeks

8 FDA:ODE I:DCRDP:JCP:9/20/02:OTC NSAIDs: 8 HYPERKALEMIA 18 Weeks

9 FDA:ODE I:DCRDP:JCP:9/20/02:OTC NSAIDs: 9 HYPERTENSION 18 Weeks

10 FDA:ODE I:DCRDP:JCP:9/20/02:OTC NSAIDs: 10  SERUM CREATININE 18 Weeks

11 FDA:ODE I:DCRDP:JCP:9/20/02:OTC NSAIDs: 11 PROTEINURIA 18 Weeks

12 FDA:ODE I:DCRDP:JCP:9/20/02:OTC NSAIDs: 12 NSAID-INDUCED NEPHROTOXICITY (PRESCRIPTION DOSES) ACUTE RENAL FAILURE 0% INTERSTITIAL NEPHRITIS 0% ACUTE PAPILLARY NECROSIS 0%

13 FDA:ODE I:DCRDP:JCP:9/20/02:OTC NSAIDs: 13 OTC NSAIDs IBUPROFEN (1984) – Max. Dose 1200 mg/Daily (40% Prescription Dose) NAPROXEN (1994) – Max. Dose 600 mg/Daily (40% Prescription Dose) KETOPROFEN (1995) – Max. Dose 75 mg/Daily (25% Prescription Dose)

14 FDA:ODE I:DCRDP:JCP:9/20/02:OTC NSAIDs: 14 NSAID-INDUCED NEPHROTOXICITY GRACIAS

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