response from FDA, 2/8/10

Office of Pediatric Therapeutics


February 8, 2010

Dear Dr. Feder,

I wanted you to know we have received, via the postal service, your letter dated February 3, 2010. In this letter you and a number of your colleagues express concern about the “off-label use of dexamethasone on pregnant women with the purpose of preventing genital virilization in fetuses who might be 46,XX fetuses affected by 21-hydroxylase deficiency, a form of Congenital Adrenal Hyperplasia (CAH.”

We are in the process of involving Dr. Robert Nelson, the agency’s pediatric ethicist and others in reviewing your concerns and providing a response. Over the next couple of weeks someone from this office may email or call you, if there are clarifications that we may request in order to better inform our response.

Thank you for your letter.


Dianne Murphy, MD, FAAP