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Post-Marketing AE Reports of Topical Calcineurin Inhibitors Pediatric Advisory Subcommittee of the Anti-Infective Drugs Advisory Committee Marilyn R. Pitts,

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Presentation on theme: "Post-Marketing AE Reports of Topical Calcineurin Inhibitors Pediatric Advisory Subcommittee of the Anti-Infective Drugs Advisory Committee Marilyn R. Pitts,"— Presentation transcript:

1 Post-Marketing AE Reports of Topical Calcineurin Inhibitors Pediatric Advisory Subcommittee of the Anti-Infective Drugs Advisory Committee Marilyn R. Pitts, Pharm.D., Safety Evaluator, Office of Drug Safety October 30, 2003 Pediatric Advisory Subcommittee of the Anti-Infective Drugs Advisory Committee Marilyn R. Pitts, Pharm.D., Safety Evaluator, Office of Drug Safety October 30, 2003 Center for Drug Evaluation and Research

2 2 Outline Background Drug Use Methods AERS Adverse Event Profile –Pediatric subgroup –Death/Hospitalized cases –Malignant and non-malignant cases –Infection cases Summary Background Drug Use Methods AERS Adverse Event Profile –Pediatric subgroup –Death/Hospitalized cases –Malignant and non-malignant cases –Infection cases Summary

3 3 Topical Calcineurin Inhibitors Pimecrolimus 1% Tacrolimus 0.03% & 0.1% Approved:12/13/200112/08/2000 2nd Line Tx:Yes Indication:Mild to mod. atopic dermatitis… Mod. To Severe atopic dermatitis… Approved for children < 2 No

4 4 # Prescriptions & Appearances IMS Health National Prescription Audit Plus TM, IMS National Disease & Therapeutic Index Audit TM Since Approval Pimecrolimus 1% Topical Tacrolimus 0.03%, 0.1% Total Rx3,230,0002,004,000 Appearances 0 to 2 yrs17%8% Appearances 3 to 16 yrs36%29%

5 5 Some Common Elements in Product Labeling Pimecrolimus 1% Topical Tacrolimus 0.03% + 0.1% Varicella zosterYes Herpes SimplexYes Eczema herpeticumYes LymphadenopathyYes Local Skin rxnYes Systemic AbsorptionYes

6 6 AERS Electronic Database –Adverse Event Reporting System 1969 – SRS 1997 – replaced by AERS ~ 3 million AE reports for drugs –Medwatch forms –Adverse Event Reporting System 1969 – SRS 1997 – replaced by AERS ~ 3 million AE reports for drugs –Medwatch forms

7 7 Methods Separate search of AERS database: –All reports with pimecrolimus as suspect agent –All reports with tacrolimus administered topically as suspect agent Separate search of AERS database: –All reports with pimecrolimus as suspect agent –All reports with tacrolimus administered topically as suspect agent

8 Pimecrolimus 1% Cream Approved 12/13/2001

9 9 Pimecrolimus – Overall Findings (Adult and Pediatric, n = 79) Location:US (64), Foreign (15) Gender:Female (53), Males (23), NR (3) Age:< 2 years (14) 2 to 16 years (17) Adverse Events: 60% - labeled 90% - involved the skin Cases of Interest: Hospitalization (7) Tumor growth (2) Pediatric (32)

10 10 Demographics of Pimecrolimus Pediatric Cases (32) Indications:Atopic or allergic dermatitis (25) Location:US (23), Foreign (9) Gender:Male (16), Female (16) Age:2 months – 15 years, median = 2 years (n = 30) < 2 years (14) AEsSkin reactions predominate Non-malignant tumor (2) Infections (7)

11 11 Hospitalized Pimecrolimus Pediatric Cases (n = 4) Ages:4 months, 6 months, 9 months and 18 months 18 month oldStaph aureus + axillary adenitis. Hosp for drainage, irrigation and IV Abx. 9 month oldOsteomyelitis, osteitis & soft tissue infection 20 days after starting pimecrolimus.

12 12 Pimecrolimus Associated Pediatric Infection Cases (7) Location:US (4), foreign (3) Age Range:9 months to 15 years, median = 18 months (n = 7) Outcome:Hospitalization (2) Other (2) Infections Seen: Abscess, Bronchitis, Eczema herpeticum + infected eyes, Scarlatina, Soft tissue infection, Staph aureus + adenitis, Strep throat

13 13 Non-Malignant Tumor Growth Pimecrolimus Pediatric Cases (2) OnsetType 5 year old49 daysGranulomatous lymphadenitis w/ reactive hyperplasia Unknown ageNRFacial tumor

14 Topical Tacrolimus Ointment 0.03%, 0.1% Approved 12/08/2000

15 15 Topical Tacrolimus – Overall Findings (Adult and Pediatric, n = 183) Location:US (164), Foreign (19) Gender:Female (103), Male (74), NR (6) Age:< 2 years (7) 2 to 16 years (29) Adverse Events: 95% - labeled 50% - involved the skin Cases of Interest: Death (3), Hosp (18) Pediatric (36) Malignancy (5) Acute Renal Failure (4)

16 16 Topical Tacrolimus Death Cases (3) OnsetAdverse Event 28 year old 1 monthsKaposi’s sarcoma 54 year old 3 monthsNon-Hodgkin’s lymphoma 3 year old9 monthsStreptococcal pneumonia, sepsis

17 17 Demographics of Topical Tacrolimus Pediatric Cases (36) Indication:Atopic dermatitis Location:US (35), Foreign (1) Gender:Male (18), Female (13), NR (5) Age:< 2 yrs (7) 2 to 16 (29) Product:0.03% (21), 0.1% (10), NR (5) AEsSkin and application site rxn predominated Infections (10) Serum levels (2)

18 18 Topical Tacrolimus Associated Pediatric Infection Cases (10) Location:US (9), foreign (1) Age Range:13 months to 16 years, median = 4 years (n = 10) Outcome:Death (1), Hospitalization (3) Other (6) Infections Seen: Pneumonia/sepsis, eczema herpeticum, staph aureus sepsis, chickenpox, warts, strep sepsis, herpes zoster, herpes simplex keratitis, erythema infectiosum

19 19 Malignancies Associated with Topical Tacrolimus (5) Location:US (4), foreign (1) Age Range:28 to 56 years, median = 52 years (n = 5) Outcome:Death (2) Other (3) Onset:1 month to 6 months (median = 3.5) Malignancies Seen: Anaplastic large cell lymphoma w/mets, B cell lymphoma, Kaposi's sarcoma, non-Hodgkin's lymphoma

20 20 Overall Summary Pimecrolimus & Topical Tacrolimus AERS Post-Marketing AE Reports –Serious Outcomes –Malignancies –Infections –Pediatric AE Reports off label use in children < 2 years old (pimecrolimus, topical tacrolimus) adult topical tacrolimus product use in children AERS Post-Marketing AE Reports –Serious Outcomes –Malignancies –Infections –Pediatric AE Reports off label use in children < 2 years old (pimecrolimus, topical tacrolimus) adult topical tacrolimus product use in children

21 21 Acknowledgements Mark Avigan, M.D., C.M., Acting Director, DDRE, Office of Drug Safety Renan Bonnel, Pharm.D., M.Ph., Safety Evaluator, DDRE, Office of Drug Safety Claudia B. Karwoski, Pharm.D., Team Leader, DDRE, Office of Drug Safety Division of Dermatological and Dental Drug Products Office of Counter-Terrorism and Pediatric Drug Development Mark Avigan, M.D., C.M., Acting Director, DDRE, Office of Drug Safety Renan Bonnel, Pharm.D., M.Ph., Safety Evaluator, DDRE, Office of Drug Safety Claudia B. Karwoski, Pharm.D., Team Leader, DDRE, Office of Drug Safety Division of Dermatological and Dental Drug Products Office of Counter-Terrorism and Pediatric Drug Development

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