This article requires a subscription to view the full text. If you have a subscription you may use the login form below to view the article. Access to this article can also be purchased.
Approximately 40 years ago, in the wake of thalidomide-induced phocomelia, Dr. Harry Shirkey1 labeled children as therapeutic orphans, raising awareness of the paucity of medication safety and efficacy data in children. In the interim, there have been some gains for children as the result of workshops focusing on pediatric drug development,2,3 programs such as the Pediatric Pharmacology Research Unit Network, and laws such as the Best Pharmaceuticals for Children Act (BPCA) of 2002 that grants an additional 6 months of marketing exclusivity for new medications in which pediatric studies are performed and provides for mechanisms that fund the study of off-patent medications used in children. Since the legislation’s implementation, >100 products have been granted exclusivity, including gabapentin, lamotrigine (LTG), oxcarbazepine, and levetiracetam. Of note, approximately a third of the products studied required relabeling because of important differences in dosage, safety, or efficacy in children.4,5
Despite advances, the picture has only minimally improved for children <2 years of age. Although they represent a significant proportion of patients with new onset epilepsy, none of the antiepileptic medications approved since 1993, including those granted …
AAN Members
We have changed the login procedure to improve access between AAN.com and the Neurology journals. If you are experiencing issues, please log out of AAN.com and clear history and cookies. (For instructions by browser, please click the instruction pages below). After clearing, choose preferred Journal and select login for AAN Members. You will be redirected to a login page where you can log in with your AAN ID number and password. When you are returned to the Journal, your name should appear at the top right of the page.
AAN Non-Member Subscribers
Purchase access
Letters: Rapid online correspondence
REQUIREMENTS
You must ensure that your Disclosures have been updated within the previous six months. Please go to our Submission Site to add or update your Disclosure information.
Your co-authors must send a completed Publishing Agreement Form to Neurology Staff (not necessary for the lead/corresponding author as the form below will suffice) before you upload your comment.
If you are responding to a comment that was written about an article you originally authored:
You (and co-authors) do not need to fill out forms or check disclosures as author forms are still valid
and apply to letter.
Submission specifications:
- Submissions must be < 200 words with < 5 references. Reference 1 must be the article on which you are commenting.
- Submissions should not have more than 5 authors. (Exception: original author replies can include all original authors of the article)
- Submit only on articles published within 6 months of issue date.
- Do not be redundant. Read any comments already posted on the article prior to submission.
- Submitted comments are subject to editing and editor review prior to posting.
You May Also be Interested in
Topics Discussed
Alert Me
Recommended articles
Adjunctive lamotrigine for partial seizures in patients aged 1 to 24 months
Efficacy of antiepileptic drugs in adults predicts efficacy in children
Risk and association of HLA with oxcarbazepine-induced cutaneous adverse reactions in Asians
Practice advisory: The use of felbamate in the treatment of patients with intractable epilepsy