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Accutane Access Now Easier With Changes to iPledge

Dec 6, 2007 | Parker Waichman LLP

Accutane prescriptions might now be a little easier for women to fill.  The government announced some changes Wednesday designed to ease access to the drug.  A program entitled iPledge-a risk management program designed to reduce the risk of fetal exposure to isotetinoin (Accutane) prescribed for the treatment of severe recalcitrant nodular acne-was amended to ensure that every user of Accutane (or its generic substitutes), every doctor who prescribes it, and every pharmacy that sells it follow strict rules ensure sure women do not become pregnant while on the drug.  Among those rules are month-by-month prescriptions based on monthly pregnancy tests.

But last summer, the Food and Drug Administration (FDA) heard evidence that iPledge has not ended the problem.  There were 122 pregnancies in the program's first year and another 37 in the four months since.  Another 19 pregnancies occurred in women who managed to get the drug despite never enrolling in iPledge.  Despite this, in October, the FDA agreed to a few changes, announcing Wednesday that iPledge is now implementing these changes.  Women of childbearing age who do not fill a prescription within seven days of a pregnancy test will be allowed to get another test and then fill the prescription, with the exception of the initial prescription.  Until now, those who didn't act within seven days were frozen out of the program for the next 23 days.  Those women will have to fill the prescription within seven days of a pregnancy test rather than within seven days of first seeing their doctor.

Accutane is considered the biggest breakthrough in acne drug therapy in the past two decades and is the only drug with the potential to clear acne permanently after once course of treatment, which is usually five months.  Accutane should be reserved for cases of severe recalcitrant nodular acne, the type of acne resistant to standard acne treatment, including oral antibiotics, and is characterized by many nodules or cysts-inflammatory lesions filled with pus and lodged deep within the skin. The lesions can cause pain, permanent scarring, and negative psychological effects.

Since the FDA approved Accutane in 1982, nearly 5 million people in the U.S. and 12 million worldwide have been treated with it.  Half the patients taking the are females, most of childbearing age.  Accutane is known to be teratogenic, or able to cause birth defects, and is designated Category X, meaning it must be avoided under all circumstances during pregnancy.  Nursing mothers also should not use Accutane.  Birth defect risk among pregnant women is extremely high-25 to 35 percent-and include hydrocephaly (enlargement of the brain's fluid-filled spaces) and microcephaly (small head), heart defects, facial deformities such as cleft lip and missing ears, and mental retardation.  This does not account for other defects not detectable at birth, such as learning disabilities. The drug is also notorious for severe Accutane side effects, which range from light to even life-threatening: patients may develop serious problems affecting organs such as the liver, intestines, eyes, ears, and skeletal system.  Some patients have developed serious psychiatric problems, including depression; some have developed suicidal behavior and others have succeeded in their suicide attempts. Sufferers and their relatives who believe they became victims of the defective drug ponder over initiating lawsuits against Roche.


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