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iPLEDGE update: Latest changes are good news for patients, prescribers


An FDA advisory committee, which met in August pregnancies during the first year of iPLEDGE and voted unanimously to approve several positive changes to the program. Distorted media reports on adverse effects of isotretinoin continue to raise concern among patients. 2007, reviewed data on patient

Key Points

National report - Recently approved modifications to iPLEDGE will make treatment with isotretinoin easier for dermatologists and their patients, says Hilary E. Baldwin, M.D., associate professor of clinical dermatology, State University of New York, Brooklyn.

"For those of you who have stopped prescribing isotretinoin because of iPLEDGE, this program should not be considered an obstacle anymore," Dr. Baldwin says.

Statistics document that isotretinoin prescribing was dramatically impacted by iPLEDGE. While the number of prescriptions being written for the oral retinoid reached its peak at about 2 million in 2002, the number fell over the next two years, partially in response to the launch of the SMART (System to Manage Accutane Related Teratogenicity) program. Thereafter, prescribing began to increase, but there was an immediate 40 percent drop in the number of prescriptions written per month, from 100,000 to about 62,000, when iPLEDGE was initiated.

There have been several changes to iPLEDGE since the program was launched. The most recent changes were introduced last month and reflect the decisions of a Food and Drug Administration (FDA) advisory committee that met in August 2007. The recent modifications include elimination of the 30-day lockout for females of childbearing potential who miss the seven-day window for filling their prescription. However, these individuals will still need to return to the office to receive another pregnancy test.

In addition, after the initial visit, follow-up seven-day windows will start from the date of the pregnancy test rather than the date of the office visit.

"This means that pregnancy tests can, once again, be done several days prior to the office visit," Dr. Baldwin says.


Data on patient pregnancies provided the foundation for the iPLEDGE revisions. In 2006, a total of 305,000 patients were registered to use isotretinoin, including 137,415 females of childbearing potential. During the first year of iPLEDGE, there were 122 pregnancies, of which 72 percent occurred in women who said they were on birth control pills and using condoms, and 18 percent were in women who said they were using abstinence. Ten pregnancies occurred in women before they started the drug.

"This latter number is the crucial figure the FDA is looking at to see if we are doing our job. No one should be starting isotretinoin while pregnant," Dr. Baldwin says.

Of the 10 pregnancies, seven were in women who had a false negative pregnancy test, two involved women with falsified records, and the other involved a mother who used her daughter's medication.

"This means that in seven of the 10 pregnancies, prescribers were not at fault. False-negatives are common in early pregnancy. The cases of falsified records involved a physician and a physician's assistant; they were both kicked out of the system and surely will face legal action. The situation with the mother and daughter reinforces that, at the confirmation screen, we need to be telling our patients not to share the drug," Dr. Baldwin says.

Reported outcomes for the 122 pregnancies included therapeutic abortion being chosen by 54 women and spontaneous abortion occurring in 21 women. Twenty women were still pregnant with no issues thus far, one woman delivered a healthy full-term baby, and the remainder were lost to follow-up.

"Since iPLEDGE removes the possibility of the large reporting error that occurred with pregnancies during SMART, these 122 pregnancies represent a sizable decrease in pregnancy rate.

Therefore, even though iPLEDGE may increase the hassle factor, it is working, and "If it prevents one isotretinoin baby from entering the world, it is well worth the effort," Dr. Baldwin says.


While the efficacy of isotretinoin in treating severe acne is unquestioned, controversy continues to surround its risks. Hype about depression induced by isotretinoin is blatant in the lay press, Dr. Baldwin says, but she says the results of all well-designed studies that have been conducted to examine that association fail to support any causal relationship.

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