The acne drug isotretinoin has long posed an agonizing dilemma for doctors and patients.
Isotretinoin, sold as Accutane and other brand names, can clear up severe acne and prevent scarring when other treatments fail. But it also can cause miscarriages, premature births and birth defects such as mental retardation and cleft lip.
Despite patient education efforts, at least 2,000 isotretinoin users have gotten pregnant over the years, "and this may be the tip of the iceberg," according to March of Dimes.
So this year, the Food and Drug Administration began requiring patients to enroll in a stringent pregnancy- prevention program called iPledge.
Female patients must have pregnancy tests before, during and after taking isotretinoin, take two forms of birth control and answer questions on a Web site. Prescriptions last only 30 days, and must be filled within seven days of an office visit.
But critics say that iPledge, though well-intentioned, is cumbersome and poorly administered. Callers to the iPledge hotline have waited more than an hour to get through. Many patients have been unable to access their mandatory iPledge accounts. And even men and women who can't get pregnant are required to enroll in iPledge, although their requirements are less stringent.
In a recent letter to the U.S. Food and Drug Administration, Sen. Dick Durbin (D-Ill.) and seven other senators wrote: "Our offices continue to receive numerous complaints from doctors, patients and pharmacists about the inflexible and confusing requirements that have denied access to the drug to thousands of qualified patients."
'Confusion' acknowledged
Among those patients is Nicole Marconi, a middle school teacher in Downstate Alton. Marconi said she fulfilled all iPledge requirements. But the system did not authorize her pharmacy to fill the prescription. Marconi called iPledge, but got busy signals or was put on hold. Her doctor's office tried to help, but "they were just as frustrated as I was."
After seven days, Marconi's prescription expired, forcing her to wait a mandatory 23 days to get a new prescription, which she was able to fill.
About 165,000 patients have registered with iPledge, which is jointly administered by companies that sell the drug as generic isotretinoin or under the brand names Accutane, Amnesteem, Claravis and Sotret.
The companies acknowledge "confusion and delays" when iPledge began last March, but say they have "worked diligently to rectify the situation." Staffing has been increased, call waiting times have "significantly declined" and 86 percent of calls have been answered. The firms say they also have made the Web site more user friendly.
For Marconi, at least, isotretinoin has been worth the hassle. Her skin, once pockmarked by deep, painful sores, has cleared up completely. "It's a heavy duty drug, but it does the job."
Isotretinoin can cause dry skin, chapped lips, dry eyes, nosebleeds and high cholesterol. Rare but serious side effects include depression and other mental problems; damage to the liver, intestines and esophagus; vision and hearing problems, and joint and muscle pain.
