The acne put drugs into isotretinoin has long posed an agonizing dilemma for doctors and patients.

Isotretinoin, sold as Accutane and other brand names, can clear up unadorned acne and prevent scarring when other treatments fail. on the contrary it also can cause miscarriages, premature births and birth foibles such as mental retardation and chasm lip.

Despite patient education efforts, at least 2000 isotretinoin users have gotten pregnant from one side of to the other the years, "and this may be the tip of the iceberg," according to March of Dimes.

with equal reason this year, the Food and put drugs into Administration began requiring patients to enlist in a stringent pregnancy-prevention program called iPledge.

Female patients must have pregnancy ordeals before, during and after taking isotretinoin, take pair forms of birth control and answer questions onward a Web site. Prescriptions last no other than 30 days, and must be filled within seven days of an office visit.

unless critics say that iPledge, nevertheless well-intentioned, is cumbersome and poorly administered. Callers to the iPledge hotline have waited more than an hour to master through. Many patients have been unable to access their mandatory iPledge accounts. And on the same level men and women who can't gain pregnant are required to enlist in iPledge, although their requirements are les stringent.

In a modern letter to the U.S. bread 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 remedy to thousands of qualified patients."

'CONFUSION' ACKNOWLEDGED

Among those patients is Nicole Marconi, a middle sect teacher in Downstate Alton. Marconi said she fulfilled all iPledge requirements. on the other hand the system did not authorize her pharmacy to fill the prescription. Marconi called iPledge, if it were not that got busy signals or was impose on hold. Her doctor's office tried to help, nevertheless "they were just as frustrated as I was."

After seven days, Marconi's prescription expired, forcing her to wait a mandatory 23 days to acquire a new prescription, which she was able to fill.

About 165000 patients have registered with iPledge, which is jointly administered on companies that sell the medicine as generic isotretinoin or beneath the brand names Accutane, Amnesteem, Claravis and Sotret

The companies acknowledge "confusion and delays" when iPledge began last March, nevertheless 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, one time pockmarked by deep, painful sores, has cleared up completely "It's a heavy service drug, but it does the job"

Isotretinoin can cause arid skin, chapped lips, dry vigilances nosebleeds and high cholesterol. Rare further serious side effects include depression and other mental problems; damage to the liver, intestines and esophagus; vision and hearing vexed questions and joint and muscle pain.

jritter@suntimes.com

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