FDA refuses to delay March 1 debut of Accutane registry
Thursday, February 23rd 2006, 12:38 pm
By: News On 6
WASHINGTON (AP) _ A registry program intended to prevent use of the acne drug Accutane by pregnant women will begin next week as planned following an earlier delay, federal regulators said Thursday.
The iPledge system will start Wednesday, the Food and Drug Administration said. The program, originally scheduled to debut Nov. 1, 2005, requires physicians, pharmacies and patients to register if they are to prescribe, sell or take the drug.
The American Academy of Dermatology had urged the FDA to postpone the start of iPledge, saying problems with the program could keep the drug from patients who need it for severe acne. The drug, known formally as isotretinoin, is best known as Accutane but also is sold generically as Amnesteem, Claravis and Sotret.
The complaints about the registry's logistics that sparked the call for a delay, including problems would-be registrants had reaching the call center or receiving replacement passwords, are being addressed, the FDA said.
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.