By: Jean Johnson for Wounds1In 2001 after realizing that the acne drug Accutane made by Roche Holding causes miscarriage, abortion and birth defects, the Federal Drug Administration (FDA) imposed a voluntary system of control. A recent mid-August announcement on tough new regulations, though, signifies the FDA’s lack of faith in physicians’ ability or willingness to abide by initial guidelines.
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Beginning August 22, the FDA’s national registry known as iPLEDGE will be collecting data on all Accutane prescriptions. To get the drug, patients must first sign a document informing them of Accutane’s risks. Then their physician must register the patient in the database, along with the results of two pregnancy tests performed by a laboratory. A woman must get her prescription filled within seven days of the pregnancy tests and physician registration. She must also self-register on iPLEDGE confirming her pregnancy tests and agreeing to use two forms of birth control. Finally, before actually filling the prescription, pharmacists must check the database for physician and patient compliance. If the program sounds drastic, it’s because since Accutane reached the market in 1982, the FDA has counted more than 160 babies born with birth defects and upwards of 2,000 pregnancies, most of which ended abortion or miscarriage. Although animal studies suggested Accutane caused birth defects, the agency allowed the drug onto the market imposing only warning-labels restrictions after the first birth defect was reported in 1983. As concern grew throughout the next two decades, increasing labeling measures were imposed culminating in 2001 when Roche and the FDA working cooperatively, asked physicians to ensure that patients signed consent forms, underwent two pregnancy tests, and promised to use two forms of birth control.
The problem arose when the voluntary system didn’t work. Women taking Accutane kept winding up pregnant – 325 alone that the FDA found out about in the intervening years. Consequently, this year’s stringent moves – the iPLEDGE registry.
“We are very happy that this has happened and wish it had been done years ago,” said Nancy Green, M.D., medical director of the March of Dimes. “If this doesn’t work, we will call for the FDA to take this drug off the market.”
Off the market? Those suffering from the kind of severe, scarring acne for which Accutane has provided miraculous relief, dearly hope that doesn’t happen. In 2002, the last year before generic versions of Accutane became available, physicians wrote 170,000 prescriptions for the drug, half of them to women.
Experts are hopeful that the national registry will enable those who need Accutane and are willing to comply with prudent behavior, to continue to enjoy the drug’s benefits.
“This is a system that has been long in the works, and many would say is long overdue,” FDA’s deputy drug chief, Sandra Kweder, M.D., said. “The responsibility for ensuring that fetuses are not exposed to this medicine is enormous and is shared by everyone.”
Nonetheless, an Oklahoma dermatologist, Mark Naylor, M.D., thinks that the FDA has overstepped its bounds even though it is unfortunate that some physicians did not follow the earlier voluntary guidelines. “It’s up to physicians and patients to decide how the drug gets used,” said Naylor. “Not the FDA.” The dermatologist added that he feared many physicians would stop prescribing Accutane because of the new restrictions are cumbersome and intrusive.
Sidney Wolfe, M.C., director of the Public Citizen’s Health Research Group, a consumer advocacy group, acknowledged that some physicians and pharmacists have been irresponsible, but he put the greater blame on drug companies’ aggressive marketing plans that in theory predispose physicians to prescribing excessive drugs.
What the FDA thinks on this score is beside the point. But with its recent moves on Accutane, the drug agency has gone on record as having little faith that adequate percentages of physicians across the country will self-regulate.
That is perhaps the most significant outcome of the national database for Accutane. The idea that as of 2005, the nation’s agency that controls the use of drugs in the country has issued a clear vote of no confidence to the medical community.
