Risk of birth defects spurs drug registry
WASHINGTON – It’s about to get tougher to buy the acne drug Accutane, as the government imposes a last-ditch effort to prevent birth defects caused by the skin-clearing pills.
Starting at year’s end, thousands of Accutane users – plus doctors who prescribe it and stores that sell it – must enroll in a national registry that ensures they understand all the drug’s risks, and take special steps to avoid the most notorious one, Accutane-damaged pregnancies.
Critics see it as the drug’s last chance after two decades of safety warnings and other restrictions failed.
“We are very happy that this has happened and wish it had been done years ago,” said Dr. Nancy Green, medical director of the March of Dimes, which long pushed for the change.
The group will closely monitor whether the unprecedented sales curbs are enough to protect babies. If not, “we may very well call for it to be taken off the market,” Green said.
The Food and Drug Administration announced the new iPLEDGE program Friday, more than a year after its own scientific advisers urged the move.
“This is a system that has been long in the works and many would say is long overdue,” said Dr. Sandra Kweder, the FDA’s deputy drug chief. “The responsibility for ensuring that fetuses are not exposed to this medicine is enormous and is shared by everyone” who takes, prescribes or sells it.
If a woman becomes pregnant while taking the acne drug, her baby can suffer severe brain and heart defects, mental retardation and other abnormalities, even if the mother took only a small dose for a short period. There’s a risk for 30 days after stopping the drug, too.
The drug also may trigger or worsen depression or suicidal thoughts.
Under iPLEDGE, every patient – man or woman – must enroll in a computerized registry starting Dec. 31 to receive Accutane or generic versions of the drug isotretinoin. Doctors must register, too, if they wish to continue prescribing the pills. Drugstores and wholesalers must register for the pills’ manufacturers to ship them supplies.
While the FDA has imposed patient registries in an effort to control side effects from other troublesome drugs, this is the largest and most complex ever tried.
All patients seeking a prescription must sign a document informing them of all of Accutane’s side effects, agree to monthly doctor visits for refills and agree not to share the pills with anyone. Then the doctor registers each patient into the iPLEDGE database, giving him or her an identifying code number, and writes the prescription.
Women of childbearing age also must undergo two pregnancy tests before the initial prescription and monthly pregnancy testing before each refill. They also must agree to use two forms of birth control while using Accutane.