Accutane (also known as Isotretinoin) is a potent medication used to treat moderate to severe acne, and has proven to be remarkably effective in improving even the worst breakouts (take my word for it- I have seen it perform miracles). However, because of its host of prohibitive side effects, dermatologists tend to only prescribe it as a drug of last resort.

On the milder end of the side effects spectrum, a person beginning a course of Accutane can expect to experience a nasty acne flare-up (coupled with EXTREME dryness of the skin, hair, lips and mucous membranes) in the first 1-3 months that they are taking the drug. Having witnessed this acne flare-up/dryness combo firsthand, I will put it bluntly: Accutane will (temporarily) make you look like you have a horrendous flesh-eating disease. However, once you have suffered this trial by fire, your skin will positively glow with radiance- it is truly astonishing to behold.

On the serious side, Accutane is a teratogen and is highly likely to cause birth defects if taken during pregnancy. A few of the more common birth defects that this drug has caused include: hearing and visual impairment; missing or malformed earlobes; facial dysmorphism; cleft palates; and mental retardation. In the U.S. more than 2,000 women have become pregnant while taking the drug between 1982 and 2003, with most pregnancies ending in abortion or miscarriage. However, about 160 babies with birth defects were born.

Consequently, the mandatory iPLEDGE program was enacted in 2005, the largest and arguably most complex risk-management program ever undertaken by the FDA in an attempt to ensure that female patients do not become pregnant while taking Accutane. As of March 2006, only prescribers registered and activated in iPLEDGE are able to prescribe it, and only patients registered and qualified in iPLEDGE will be able to have the drug dispensed to them. Inexplicably, men must also register for the iPLEDGE program. Well, at least they aren’t required to take a pregnancy test….

In addition, female patients cannot obtain or fill their first prescription unless they undergo an initial screening and two negative blood or urine pregnancy tests with documented results verified by the prescriber and entered into the iPLEDGE password-protected system. Female patients also must pledge to use two forms of contraception for one month before, during, and after completing Accutane therapy. Each month thereafter, the patient must have a negative pregnancy test result, and this result as well as verification of the two methods of contraception being used must entered by the prescriber into the iPLEDGE system.

Unsurprisingly, dermatologists are not iPLEDGE’s biggest fans. Most complain that it is inordinately onerous, structurally flawed and poorly organized. The net effect, say dermatologists, is a bottleneck in office operations, delays in patient care, and, ultimately, barriers to delivery of a drug that has proved the only effective therapy for many patients with severe, recalcitrant acne.

Only time will tell whether the iPLEDGE campaign will successfully deter pregnancy amongst Accutane users. However, the FDA cannot be accused of not giving it the old college try….

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