Accutane and iPLEDGE

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The last ditch treatment for severe acne is a drug called Accutane (isotrenetoin). The problem is that Accutane is teratogenic (the risk of some birth defect is on the order of 35%). Because so many acne sufferers are of child bearing age, the FDA requires that Accutane be prescribed under a program called iPLEDGE which requires, well, let them tell you:
As part of the ongoing risk management of isotretinoin products, it is crucial that a female of childbearing potential selects and commits to use two forms of effective contraception simultaneously for one month before, during, and for one month after isotretinoin therapy. She must have 2 negative urine or blood (serum) pregnancy tests with a sensitivity of at least 25 mIU/ml before receiving the initial isotretinoin prescription. The first pregnancy test is a screening test and can be conducted in the prescriber's office. The second pregnancy test must be done in a CLIA-certified laboratory according to the package insert. Each month of therapy, the patient must have a negative result from a urine or blood (serum) pregnancy test conducted by a CLIA-certified laboratory prior to receiving each prescription.

Each month, the prescriber must enter the female patient's pregnancy results and the 2 forms of contraception she has been using in the iPLEDGE system. The iPLEDGE system verifies that all criteria have been met by the prescriber, patient, and pharmacy prior to granting the pharmacy authorization to fill and dispense isotretinoin. The pharmacist must obtain authorization from the iPLEDGE system via the program web site or phone system prior to dispensing each isotretinoin prescription for both male and female patients.

Unsurprisingly, doctors and patients are finding all this rather onerous:

Dr. Kathleen Carney-Godley, a dermatologist from East Greenwich, R.I., said that she tried to enter her patients into the system from home one Sunday but could not because she did not have her patients' Social Security numbers.

Her partner tried to enter a patient into the system, failed, called for help, was put on hold and had time enough to excise a cancerous skin lesion in another patient before being able to talk to an operator, Dr. Carney-Godley said.

Other doctors complained of nonsensical instructions from the system — like requiring pregnancy tests for male patients — and long waits on the phone.

According to Public Citizen (who want to see Accutane taken off the market) the total number of Accutane-related birth defects in the period 1982-2002 was 162 and that in the first year of the S.M.A.R.T. program that preceded iPledge they estimate that there were 16 births with birth defects and 31 with retardation (it's not clear if these numbers match up). This is out of about 160,000 women taking Accutane a year. So, the risk of having an affected child if you are taking Accutane under the old program was about .03%. (Note that the pregnancy rate is substantially higher but a lot of women opted for abortions.)

For comparison, the risk of fetal alcohol syndrome in the population at large is about 1.25 per 1000 live births (order 4000 infants a year). Ignoring the jurisdictional issue (FDA doesn't regulate alcohol) why doesn't this motivate some controls on drinking for women of childbearing age? Public Citizen calls Accutane "one of the two worst epidemics of preventable serious birth defects ever seen in the U.S.", but this is nonsense. As I've indicated, FAS is far more common than Accutane-related birth defects, as are Neural Tube Defects, about half of which could be prevented with folic acid supplementation. Even if this were true, the comparison is absurd, spanning, as it does, two orders of magnitude.

7 Comments

Accutane IS nasty-ass shit. Beyond its Class X Human Tetrogen status (it really IS that bad, and you need to be that hardass on teenagers to subscribe it right), it also really interacts badly with alcohol (Cooks liver faster than Vodka with a Tylenol chaser).

But also really useful: For a couple of years, my GF had to take it because of a genetic skin disorder. It was the ONYL thing that helped.

Also, .03% is already bad enough with people howling for its removal. The beurocratic thinking is that if the more onerous system (and that's not MUCH more onerous, even 3 years ago it was the monthly blood test, 2 forms of birth control etc, this just seems to be paperwork enforcement so you know it gets done) reduces that by just 1-2, thats enough to justify it.

Especially if its a choice between "Bastard system" and "market withdrawl": there really IS no substitute for accutane at this time for some really F@)##$ severe dermatologicla problems.

"The beurocratic thinking is that if the more onerous system reduces that by just 1-2, thats enough to justify it."

No, that's the public's thinking, which itself is flawed because it's based on personal fears and an absence of altruism and a sheer failure to examine the facts. No, the bureaucratic thinking is "I need to get re-elected."

The problem isn't actually the percentage rate of birth defects. The problem is in lawsuits. No one will sue themselves for drinking it up or forgetting to supplement with folic acid, but get a baby affected by this and there's no limit to the damages awarded in the resulting lawsuit. That's why.

As you point out, it's silly when you start comparing real percentages, but the actual issue is that this is a prescription medication. I honestly don't know what could be an alternative way of handling this. All the disclosure and waiver forms in the world won't mean squat when you show the baby to a jury.

Also, if it wasn't the only thing that wolud work in these severe dermatological cases, it would have been pulled from the market years ago.

Seems like we're missing some data. We have that .03% of women taking Accutane had a child with problems, per year. We also have that FAS affects .125% of live births. The missing figure is, what percent of live births to women taking Accutane have problems? Without knowing how many women taking Accutane give birth, the first figure doesn't tell us that.

Are you suggesting that alcohol is a worse teratogen than Accutane?

Public Citizen have been getting a number of comments over at Making Light about Cylert

Hal,

IIRC about a third of live births to women taking accutane have defects. It's a horrible teratogen. Alcohol is a far less serious teratogen in some relative sense but in terms of absolute numbers it's far worse and even in terms of end-to-end teratogenicity it's not that far off.

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