Experiences From Specific Focused Pediatric Postmarketing Review

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Chapter: Pharmacovigilance: Pharmacovigilance in Pediatrics

To fulfill its Congressionally mandated requirement that all adverse events reported during the year after a product has received pediatric exclusivity be referred to the Office of Pediatric Therapeutics at the FDA.


Experiences From Specific Focused Pediatric Postmarketing Review

To fulfill its Congressionally mandated requirement that all adverse events reported during the year after a product has received pediatric exclusivity be referred to the Office of Pediatric Therapeutics at the FDA, and a review of the safety reports be publicly presented to the Pediatric Advisory Committee, the FDA has developed a thorough approach for the review and report of pediatric adverse events.

The methods for the specific pediatric post-exclusivity review include an analysis of all adverse events reported to FDA’s Adverse Event Reporting System (AERS) during the one year after exclusivity was granted to the product. It is important to under-stand the timing with respect to approval of products for a new pediatric indication, and the new labelling and marketing for the pediatric use. BPCA requires a pediatric-exclusivity determination within the 3 months after submission of the studies. The review of the data to make a decision about efficacy, safety and dosing in the pediatric population takes 6 months (exception, time frame is 10 months if the pediatric data are submitted as part of an NDA). Thus, the action (e.g., approval or non-approval) occurs at least 3 to 4 months after exclusivity is determined. As a consequence, a product may have been on the market for its approved pediatric indication only a few months when its 1-year post-exclusivity anniversary occurs. There maybe limited reporting of pediatric adverse events to the AERS system in the 1-year post-exclusivity because of this situation. FDA may also look at all pediatric AEs reported since marketing of the product when there are limited pediatric data in the AERS system for the 1-year post-exclusivity period. An assessment is also made of how much the drug is used in the pediatric population. In addition, published literature, the summaries of the clinical, pharmacology and toxicology reviews, the trials conducted for exclusivity and the product’s labelling are reviewed to prepare a safety analysis for the Pediatric Advisory Committee. There have been situations where the above process has led to more questions. Additional studies of the product which have been submitted to the agency are then reviewed and other known studies which have been conducted but not submitted to the Agency may also be requested for submission and review.

 Between June of 2003 and November 2005, there have been eight Pediatric Advisory Committee meet-ings to review the safety analysis of 50 products which have been granted pediatric exclusivity. Twelve ther-apeutic categories of products have been involved (see Figure 40.1). The reviews for 39 products raised no new concerns that were not already adequately labelled. In four reviews, the committee expressed a desire that additional monitoring occur and an updated analysis be presented to the committee in another 1 to 2 years. This has usually occurred when there were very few reports and the committee thought additional time might provide a better assessment or limited reports had some concerning aspect. For seven products, the committee expressed concerns warrant-ing further study, better labelling and/or further review, and/or reporting.


These products can be cate-gorized into four areas as follows:

Opioid Transdermal Systems associated with misuse and deaths or serious adverse outcomes.

Selective Serotonin Reuptake Inhibitors (SSRIs) associated with neonatal withdrawal syndrome following prenatal exposure.

Antidepressants and an association with suicidality reports which were only confirmed by the reanaly-sis of the controlled pediatric clinical trials submit-ted to the FDA for pediatric exclusivity.

Stimulants used to treat Attention Deficit Hyperac-tivity Disorder (ADHD) and postmarketing reports of psychiatric and cardiovascular adverse events.


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