But Accutane maker Hoffmann-La Roche Inc. reported that 183 women took the drug while pregnant during its strict tracking program, compared with 150 in the year before. Three generic manufacturers reported 19 more cases since December 2002 while using identical tracking programs.
FDA officials warned that many more women have probably become pregnant while on the drug but have not reported it.
"We believe these ... cases represent a fraction of what occurs," says Marilyn Pitts, PharmD, a safety evaluator with the FDA's office of drug safety.
The majority of the pregnancies ended in spontaneous or elective abortions, and regulators have received a handful of reports of birth defects.
Data show that women usually became pregnant while already taking isotretinoin, suggesting that they did not stick to warnings to use two forms of contraception while on treatment.
Patients are displaying "a pattern of failure to comply with the educational messages they receive," says Martin H. Huber, MD, vice president and global head of drug safety at Hoffmann-La Roche.
Stricter Tracking Standards
The company and three generic manufacturers will start stricter company-run tracking standards for women taking isotretinoin, including the distribution of unique identification numbers for all patients.
The numbers would be used in a single, centralized database including qualified doctors, pharmacists, and their patients. Doctors would have negative pregnancy tests confirmed and patients would be required to hear repeated educational messages before they could receive 30-day refills.
"If they don't access the system properly, they cannot get the product," Huber says.
Other groups called on the FDA to take stricter action, citing continued pregnancies while women take isotretinoin. The consumer group Public Citizen called on regulators to take the drug out of regular distribution and make it available only under very tightly regulated conditions.
The tracking programs are "clearly a failure," says Sydney M. Wolfe, director of Public Citizen's health research group. He called on regulators to stop "needless use of a drug that each year causes the need for hundreds of abortions" and birth defects.
The March of Dimes called on the FDA to mandate stricter tracking programs for the drug. The group released a statement warning that it would call for a ban on oral forms of isotretinoin if the FDA does not mandate stricter tracking standards for women.