WASHINGTON –Congressman Chris Smith (R-NJ) praised the Food and Drug Administration’s (FDA’s) for creating a strengthened distribution program for Isotretinoin (Accutane) – called IPLEDGE.  The program is aimed to prevent the use of the drug during pregnancy because of the significant risk of birth defects, abortions and miscarriages when taken by the mother.   The FDA estimates that each year, there are more than 2,000 pregnancy exposures to this drug.

Accutane is used to treat the most severe forms of acne, though it has been widely prescribed for lesser skin problems since its debut in 1982.  A woman who becomes pregnant while taking the drug can unknowingly expose her baby to severe defects, mental retardation and death.  These risks persist for mothers up to 30 days after stopping the drug. 

“I am pleased that the FDA has taken strong action to begin to protect mothers and their babies from the dangers of Accutane,” said Smith.  “It is my hope that the FDA take further action that addresses and tracks the psychiatric effects that Accutane can cause.” 

In a May letter to acting FDA Commissioner Lester Crawford, Smith along with Congressman Bart Stupak (D-MI) and Congressman Dr. Dave Weldon (R-FL) asked the FDA to assess the link between the psychiatric effects and Accutane.  The drug has been linked to 194 suicides in the U.S., according to the FDA, let alone unreported suicides.   In December, 2004, Roche, the maker of Accutane, estimated that the depression rate is 1.5 times higher among Accutane users. Earlier this year, a study by Emory University found Accutane affects the area of the brain associated with depression. 

The FDA announcement today will require all Accutane users to enroll in a national registry by December 31, 2005.  Doctors prescribing Accutane and drug stores that sell it also must enroll.  Women will be required to get multiple negative pregnancy tests when they are prescribed the drug and show proof of another negative pregnancy test with each monthly refill.  

“It is important that people become aware of the potential dangers of this drug, so they can protect themselves and their families from its side effects,” concluded Smith.