The most important side effect is birth defects, which a little bit of accutane at the wrong time has a good chance of causing. Fortunately most patients should be male. Although it's tempting to completely exclude females from the drug Congress would never accept that and there are some women who really do need the drug. Accutane is NOT stored in the bodies of men or women and is probably all out of the system within a couple weeks rather than the months suggested upthread. That poster may have worked for Roche on accutane, but her memory is factually incorrect on this point. Pregnancy is permitted one month after the last dose without any drug related risks. Accutane is NOT a mutagen, that is it does NOT damage DNA or chromosomes. It IS a potent teratogen; that is to say it damages developing organs while they are growing. Accutane doesn't damage sperm and having the father on accutane doesn't damage the fetus; presumably not enough accutane is transferred via sperm to the mom to cause any problems in her.
The challenge in preventing birth defects is to avoid pregnancy for 6-7 months, the standard course and one month either side of it. The drug companies have excellent plans for avoiding that if doctors and patients would just follow them. If they can't follow the plans they (doctor or patient) shouldn't use the drug. Adequate and properly timed pregnancy testing avoid starting accutane on someone already pregnant. Monthly pregnancy testing thereafter won't directly prevent pregnancy, but it should remind them of the need to avoid it. I checked my literature today and hysterectomy IS acceptable as sufficient contraception. Lesser sterilization (tubals or vasectomies) are not sufficient contraception. I'm not sure if being proven post-menopausal is sufficient, but realistically post-menopausal women won't need accutane. Absolute abstinence is deemed sufficient contraception and of course it always works when it is really done. The trouble for Dermatologists, just as for parents, is how well can you believe the girls on this subject. I send all my female accutane patients to the Gynecologist for contraceptive counselling, for which Roche will pay, hoping they can recognize those girls lying to their parents and me both. Another risk with trusting abstinence alone is these girls may not have been able to get dates because of their acne, but may start dating and sex as they improve. Other than absolute abstinence or hysterectomy the acceptable contraception options require at least two forms of primary or secondary choices with at least one being from the primary list. Primary choices: Combination oral contraceptives, Norplant, injectable hormonal contraceptives, IUD, surgical sterilization (male or female partner), hormonal vaginal contraceptive ring. Secondary choices: condoms+spermacide, diaphragm+spermacide, cervical cap. I've not had any accutane pregnancies so the above seems to be working for me. The biggest advantage the new SMART plan added was requiring doctors to register for it before they could prescribe the drug. That should stop many doctors who rarely prescribed it and who were ignorant of when and how to use it from causing problems. They'll refer the patient rather than deal with the extra paperwork. Alas there will always be some bad apples in medicine as in all other fields. Even if the FDA banned accutane there would be problems as a black market in accutane would soon develop.
The most common side effects result from accutane shrinking sebaceous glands to almost nothing. Dry skin is usual and chapped lips is universal. Dry eyes and dry nasal mucosa is also common. This generally reverses completely after stopping treatment. Those whose acne never recurs still go back to being as greasy as they were before accutane within a year after stopping treatment. About 20% have various musculoskeletal aches and pains, which generally resolve a week after stopping therapy. In my experience athletes are more apt to complain of such, but I warn all patients of the possibility. Some may wish to schedule their course outside of their main sport's season, but most seem to tolerate this as a price for clearing their faces. Blood tests are followed for potential blood, liver and lipid problems, but other than raised triglycerides such problems are rare. I've only had one patient who had to stop treatment because of lab tests. There is a long list of miscellaneous side effects that are rarely significant problems. Realistically if their acne was severe enough most kids will tolerate the dryness and aches and otherwise tolerate accutane well.
Depression, potentially leading to suicide, is the other "side effect" the media, lawyers and politicians talk up. Whether or not it is a true association is questionable and I caution my fellow freepers to process claims of accutane depression the same way they process many other claims from such sources. Depression is extremely common in teens and suicide is the number three cause of death in teens (after accidents and homicide) so a fair number of cases could still be chance associations. It is likely that many accutane patients would be depressed by their bad faces before treatment ever started. In my experience for most patients accutane is the best "happy pill" available, they are uniformly delighted by the change in their skin. Multiple retrospective studies show significantly less depression in accutane treated patients than in acne patients in general. IIRC the number of suicides reported to Roche over the history of the drug is about one tenth that would be expected by chance. Perhaps it has been under reported, but I doubt teen suicides have been under reported that much. Also accutane works through the vitamin A pathway; its effects and side effects generally parallel those of vitamin A overdoses. Depression is not known to be a vitamin A side effect and no one has suggested any other way accutane could cause depression. To be up front I have had three patients who became depressed while on accutane, one of whom spent one night in the psych unit. All three elected to finish their accutane and did well on all counts. As I have loads of depressed patients they may well be chance associations. Depression "from" accutane became politicized after Congressman Stupak's (D-MI) son committed suicide IIRC one month after finishing accutane. His parents have seized on accutane as the cause to the exclusion of all else and realistically aren't going to change their minds no matter what evidence is supplied to the contrary. Having lost a cousin to suicide I can understand their grief even though I question their conclusions. Unfortunately Stupak is on the subcommittee overseeing the FDA so his concerns can have real effects on the availability of the drug. The other case that pushed the media's concern over depression was the kid who flew a plane into a Tampa building. They have sued Roche, but almost certainly he hadn't taken a single pill of accutane yet. The only depressing thing about his case is that a lawyer would take it.
The article talks about potentially increasing the restrictions on accutane to match those placed on thalidomide. That would be a terrible change. Although thalidomide is useful for many skin diseases that are otherwise difficult to treat, I'll never be able to prescribe it. My one doctor, one nurse office just doesn't have time to deal with the hours of paperwork required. Many pharmacies wouldn't be able to deal with the required paperwork at their end either. If accutane were similarly regulated I'd have to stop offering it and send all my patients requiring it an hour away to the University of Iowa. They are probably the only Dermatologists in the state in a group big enough to deal with such paperwork. Many other rural states would have similar problems. The current restrictions are workable and are fairly reasonable.