On March 1, the FDA begins the iPLEDGE program. Women of childbearing age who wish to receive Accutane must register with the program, as do physicians who wish to prescribe it. The goal is to minimize devastating birth defects that can occur, should women get pregnant on Accutane:
The FDA has spent more than 20 years attempting to eliminate the use of isotretinoin by pregnant women since it can cause birth defects. Still, since Accutane sales began in 1982, the FDA has received reports of more than 2,000 pregnancies among users. Most ended in abortion or miscarriage, but the FDA counts more than 160 babies born with drug-caused defects.
Accutane is intended for severe acne only, but is widely acknowledged to be prescribed for more minor cases. The registry may work to curb much of that abuse.
…The FDA previously estimated that 100,000 isotretinoin prescriptions are filled each month. As of Monday, just 27,713 patients had registered with iPledge, FDA spokeswoman Susan Cruzan said.
We recall that Ralph Nader used to campaign against Accutane, saying that corporate interests and patient vanity had led to dozens of birth defects and countless abortions. We were always disappointed that the patient-responsibility approach (making female patients sign documents acknowledging the risks) was not 100% effective. The iPLEDGE system may be the lumbering bureaucratic solution that Nader, patients, and corporations can all agree on.
If it works, iPLEDGE may serve as a model to limit side effects (and liability) for other controversial drugs.
More from the FDA’s iPledge program and the registration site.