Heedless Consequences; Curing Acne ... Birth Defects

"Poor adherence with the Canadian prevention guidelines means that Canada, inadvertently, is using pregnancy termination rather than pregnancy prevention to manage fetal risk from isotretinoin."
"First of all it [Accutane] works. There is nothing quite as effective as it. [Doctors] are aware that when they've used it, patients have been really pleased with the results."
"Acne can be quite nasty and scarring [and can have psychological effects on young people]. It can deeply affect their psyche and cause depression."
"It might be a young man using it and someone comments at a party, 'Your acne is really clearing up'. And he says, 'I'm on this new treatment, I've got it with me, do you want to try it?' And he gives a few to a female friend, who unbeknownst is pregnant, or becomes pregnant."
"It just needs one dose at a vulnerable period."
"This information [birth defects caused by Accutane] is widely available and widely known and doctors and pharmacists are taught that this drug is highly teratogenic."
"We know that it does [cause birth defects]; we were looking at the safety of the system, looking at how many became pregnant while on it."
Dr. David Henry, senior scientist, Institute for Clinical Evaluative Sciences, Toronto

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Researchers estimate that between four and six women of every thousand prescribed isotretinoin will conceive during the time frame they are taking a three-month course of the powerful drug meant to clear up their acne. Of all drug formulations, this is the one that has the highest success rate by far. Which means it will be the first choice by doctors since its use comes with such a high degree of success. Most unfortunately, use of the drug also comes with a high potential for disaster for pregnant women.

Fetuses exposed to isotretinoin within the first trimester of a pregnancy have a high potential to physical abnormalities, from elongated or conical skulls, wide-set eyes, low-set ears, cleft palates, or life-threatening heart problems. Those babies born with all of these symptoms of a drug having disrupted normal development of a fetus for a healthy baby to be born, present as a dire warning to both women and their physicians.

The problem appears to be that doctors knowing full well the potential of the drug's developmental interference of a fetus do not appear to exercise due caution. And women are not fully aware of what they can be gambling with when during pregnancy they use the acne medication. A new study involving some 60,000 women for whom the drug was prescribed in British Columbia, Saskatchewan, Manitoba and Ontario indicates that reducing fetal exposure to Accutane through a pregnancy-avoidance program has had minimal effect.

Sun Media Archive   Despite grave risks, many Canadian women are still becoming pregnant while taking the drug

Of the 1,473 pregnancies that were recorded over the 15-year life of the study, of which Dr. Henry was the lead author, 1,041 resulted in medically induced abortions while 290 were "spontaneous losses"; miscarriages in other words. Of the 118 live births eleven cases, representing 9.3 percent, resulted in congenital malformations, according to the research team that reported on the study outcome, in the Canadian Medical Association Journal.

The active ingredient in Accutane, isotretinoin, as well as in the genetic versions of the product is simply one of the most toxic of drugs in its effect on a developing fetus. In theory women are meant to have two negative pregnancy tests before they begin using isotretinoin. They are meant to sign a consent form indicating they are fully knowledgeable of the risk of birth defects. And they are supposed to use two forms of birth control while treatment is ongoing, and for a month after the use of the drug is completed.

The use of Accutane has rapidly grown in popularity, with greater numbers of doctors prescribing it for even mild acne cases. Approved in 1983 as a drug of last-resort in response to scarring cystic acne failing to respond positively to less powerful treatments, the marketing of generic versions appears to have boosted its popularity. Half of all prescriptions for Accutane are written for female patients with the average age of 24.

A Roche Holding AG's Accutane acne pill package.  (TANNEN MAURY/BLOOMBERG NEWS)

Based on their interpretation of the search of records of use in the demographic of girls and women aged 12 to 48 in all four provinces during 1996 to 2001, of pregnancies occurring during treatment, the researchers estimate that one or two children are born with congenital anomalies each year in Canada through exposure to isotretinoin in the womb.

While doctors are meant to recommend less-restricted, safe drugs before "graduating" to Accutane or a generic formulation, only 45 to 72 percent of isotretinoin users, it was found, had received a prescription for a less-potent medication before being prescribed Accutane.

The researchers conclude that pregnancy is entirely preventable, and mores strenuous efforts should be made to ensure that while patients are on the isotretinoin protocol they avoid becoming pregnant for obvious enough reasons. "We've got the means to do it. Really doctors and pharmacists need to step up to the plate on this one and do a lot more than they have done", insists Dr. Henry; warning women of the risks, persuading them to take the required precautions.

And obviously enough women themselves need to be more informed and certainly more responsible.