One that won't make me nervous

I'd been meaning to get rid of some comment-spam on this blog, from dubious web hucksters selling percocet and vicodin... but an FDA advisory panel may have solved my problem in a different way, today recommending to ban painkillers that contain acetaminophen (this was part of a series of decisions to limit overdoses of tylenol, in the hopes of preventing what is now the #1 cause of liver failure in the US).

The panel's decision let to my first front page post on Metafilter which recapped some of tylenol's history and its popularity (because of their rigid self-link rules, I couldn't highlight my Medgadget post on Tylenol at 50).

The Metafilter discussion was intelligent as usual, though unfortunately I couldn't stick around to address some misconceptions that arose. Some highlights for those who don't want to sift through 100+ comments:

Meehawl wrote:
you could just mandate that all paracetemol be combined with a sufficient dose of methionine to replenish the liver's glutathione levels and so lower the probability of a runaway toxic fulmination. This would of course make the pills more expensive to manufacture so that's not really going to happen. The argument against it, using the high NNT of 999 people who would be pre-treated with methionine so that the 1 overdoser can benefit seems lacking given the severity of the outcome, the cost of the post-exposure treatment, and the lack of side effects of the pre-treatment.


homonculus wrote:
Also, it is important for pain patients to be heard by the FDA about this: if they are thinking of pulling something like getting rid of Vicodin and Percoset *without* offering replacements without the acetaminophen that are the same level controlled substances, it would be very bad for pain patients.

There does appear to be a hydrocodone (Vicodin) which is schedule III and an oxycodone (percocet) with ibruprofen instead, which is schedule II, which would be existing options but schedule II's are more of a pain in the butt.


I just read a bit about that. From MedPageToday:

In a far less decisive vote, the committee voted 20 to 17 in favor of a more extreme recommendation to pull all prescription products containing acetaminophen from the market.

Because the split was so close, it is unclear whether the FDA will adopt the recommendation, but if it did, some options would be eliminated for pain patients. For instance, patients taking Vicodin would not have an acetaminophen-free option because there is no hydrocodone-only formula.

In addition, removing the acetaminophen from the Vicodin would move the drug into the more-strictly regulated "class II" schedule of narcotics from its current classification as a class III drug, creating additional barriers for physicians prescribing the drug to patients.


That makes me think it's unlikely the FDA will ban them. The outcry would be too great.


stopgap looked up the other drug use mortality data and compared it to tylenol's 56,000 OD presentations and 1000-1600 liver failures:

For the others, the following stats are from 2005. I saw some reports that suggest MDMA might be around 50, and I also saw marijuana as 0.

Heroin: 2,011
Cocaine: 6,228
Ecstasy/MDMA: no data
Marijuana (Cannabis poisoning): 112
Cars: 45,343

Clearly, we need to reduce the standard dosage of motor vehicle use.


But the most spot-on comment may have been the first one, by inigo2:
Sweeeet - my medicine cabinet's gonna be worth a ton in a few months.

Thanks to our collective number crunching, we now have a handle on the problem -- 56,000 acetaminophen overdoses, with 1600 progressing to liver failure. It sounds unacceptable until you realize there were 124 million prescriptions of tylenol combined with opiates, and untold numbers of OTC Tylenols taken as well. Suddenly the number of complications looks manageable, compared to the amount of patients that rely on these drugs. That, plus the UK's mixed results in managing this problem, suggests to me that banning percocet and vicodin is not the solution.

I'm looking forward to reading more from medical bloggers in the days to come about this practice-changing recommendation. But for now I just want to reflect on a rite of passage: tomorrow, graduated medical students become interns and start ordering and prescribing their first drugs. I remember receiving advice about this transition, hearing that 'in July, when you're first adapting to responsibility for patients, you'll think twice before even ordering Tylenol for a fever.' Well, with a likely black box warning to come and increased scrutiny on dosing, tomorrow's interns will be anxious about ordering Tylenol long past July.