The FDA Amendments Act (FDAAA) was passed in 2007 to address ...

[sam.t96]

The FDA Amendments Act (FDAAA) was passed in 2007 to address which aspect of drug safety?
 
  a. Allowing pharmaceutical companies to identify off-label uses of medications ap-proved for other uses
  b. Evaluating drug safety information that emerges after a drug has been approved and is in use
  c. Expediting the approval process of the U.S. Food and Drug Administration (FDA) so that needed drugs can get to market more quickly
  d. Requiring manufacturers to notify patients before removing a drug from the market

Question 2

A patient receives an epidural anesthetic during labor and delivery. The nurse caring for the newborn in the immediate postpartum period will observe the infant for:
 
  a. bradycardia.
  b. hypoglycemia.
  c. jitteriness.
  d. tachypnea.

[softEldritch]

Answer to Question 1

B
The FDAAA was passed to enable the Food and Drug Administration to continue oversight of a drug after granting it approval so that changes in labeling could be made as necessary and post-marketing risks could be tracked and identified. A provision of the FDA Modernization Act (FDAMA), passed in 1997, allows drug companies to promote their products for off-label uses as long as they promise to conduct studies to support their claims. Regulations to permit accelerated approval of drugs for life-threatening diseases were adopted in 1992 by the FDA. The require-ment that drug companies notify patients 6 months before removing a drug from the market is a provision of the FDAMA.

Answer to Question 2

A
Local anesthetics can cross the placenta, causing bradycardia and central nervous system (CNS) depression in the infant. They do not affect blood glucose. Jitteriness is a sign of CNS excitation. Increased respirations are not an adverse effect in the newborn.

[sam.t96]

TYSM

[bassamabas]

Excellent