Push for delay in isotretinoin registry

A system is set up to reduce the number of pregnancies affected by this drug, but users see glitches.

By Victoria Stagg Elliott — Posted March 13, 2006

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Physicians are urging the Food and Drug Administration to hold off on making mandatory the strengthened risk management program, iPledge, designed to reduce the number of women who become pregnant while taking the acne drug, isotretinoin.

Developed by the drug's manufacturers, Hoffman-LaRoche, Genpharm, Ranbaxy Pharmaceuticals and Barr Laboratories, iPledge is an online system that registers anyone -- patients, physicians and pharmacists -- involved in the prescribing or use of isotretinoin. It is designed to link prescriptions to regular pregnancy testing and contraceptive use.

Doctors have had access for several months to iPledge as an option for managing their patients who are on this drug and say so far it has been unwieldy and is not ready to be made mandatory. Passwords for patients take too long to come in and may arrive after the prescription has expired. Also, the call center set up to respond to questions has been slow.

"The system is just not ready to go," said Diane Thiboutot, MD, who testified on this issue at a FDA hearing in February on behalf of the American Academy of Dermatology.

The full implementation of the program already has been delayed once. Initially the required use was supposed to kick in as of Dec. 31, 2005. The FDA since has taken action in response to complaints and does not foresee another delay. According to an agency statement, iPledge call center staff will be increased, and the process that replaces lost passwords has been improved.

"[We] are actively working with all the stakeholders to address these issues," said Laurene Isip, spokeswoman for Covance, the Princeton, N.J.-based company administering the iPledge system. "We believe that the iPledge program will be effective in furthering the public health goal to eliminate fetal exposure to isotretinoin."

AMA policy opposes mandatory registration of physicians and patients who use this drug but encourages voluntary educational programs on its use.

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External links

Food and Drug Administration on isotretinoin (link)

iPLEDGE, a program to help patients plan treatment and prevent pregnancy during the course of isotretinoin therapy (link)

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