Module II -  New FDA Actions

Saturday August 15, 1998 - Question 1

Which of the following statements concerning the calcium channel blocker mibefradil (Posicor) is correct?

A) In June of 1998, the FDA imposed a mandatory withdrawal of mibefradil from the market.
 
B) Mibefradil was withdrawn from the market because it was ineffective in treating hypertension and chronic angina pectoris.
 
C) Mibefradil was withdrawn from the market because of serious and potentially life-threatening drug interactions.
 
D) Data from a three-year long-term study of mibefradil in CHF patients demonstrated superior efficacy over placebo when added to standard therapy for CHF.
 
E) Mibefradil showed promise because it offered unique benefits over existing agents.
 
 

Discussion