For Your Protection

I’ve written about some pharmacology topics before, and usually they’re coherent, but this one is being written when I am rather, well, pissed off.

There’s a group of drugs called opioids, which, simply put, are drugs that behave like morphine. A lot of the general public may have taken these drugs are one point or another, such as after dental surgery. Common examples are Tylenol #3, Vicodin, Lortab, and Percocet. These drugs are all controlled under the Controlled Substances Act. There are different levels of control status, called “schedules.” Schedule I are the most tightly controlled, and Schedule V are the least controlled. What schedule a drug is placed on depends on

  1. How medically beneficial it is;
  2. How likely it is to be abused;
  3. How likely it is to cause physical dependence;
  4. How likely it is to cause psychological dependence, or addiction.

(For more information on this topic, see my rather technical piece here)

Drugs that are Schedule I are completely illegal. They’re not recognized as having any medical purpose, and they’re very likely to cause abuse, dependence, and addiction. Examples are heroin, marijuana, etc. Schedule II drugs are very tightly controlled, but can be prescribed. These drugs include highly potent opioids like morphine, methadone, oxycodone, and hydrocodone (unless combined with a non-opioid); amphetamines (used for ADD drugs), and others. Surprisingly, some drugs like methamphetamine and cocaine are Schedule II, because they have some recognized medical use. However, they’re rarely used or prescribed. Schedule III drugs are where drugs like Tylenol #3 and Vicodin fall (Percocet is still Schedule II even though it has a non-opioid). They contain a Schedule II substance, but they’re combined with a non-opioid, usually acetaminophen/APAP (Tylenol) or aspirin. Schedule III drugs are a lot easier for doctors to prescribe, because they’re not as controlled. Schedule II drugs are required by law to be locked in a separate drawer in pharmacies that stock them, and are hand delivered and tracked heavily to reduce diversion to the black market.

These Schedule III opioids like Vicodin are only Schedule III because of the combined ingredient. Well, why does that matter? Drug companies claim the acetaminophen (APAP) enhances the effects of the opioid, and so makes it so you require a lower dose of the narcotic. This has never really been proven clinically, but it is possible. But, if APAP made the opioid stronger, why is it in a schedule that has fewer controls? The real reason these drugs are combined is to deter abuse. Acetaminophen is highly toxic to the liver in overdose. So, if someone pops a dozen Vicodin to get high, the APAP that’s in those pills is going to make them really sick, by causing permanent liver damage. If someone takes a WHOLE lot, it will destroy their liver, and they will die, very, very painfully.

The thing is, people abusing these medications don’t care. They’re going to take them to get high even if it makes them sick, because they just don’t care. So now people are turning up with liver failure from abusing drugs like Vicodin. Now the FDA is considering banning all prescription drugs containing acetaminophen. Their official reasoning is that people are dumb, and they come home from the dentist with some Vicodin and pop those and then think “hey I’ll take some extra strength Tylenol too!” and that exceeds the maximum safe APAP dosage. The FDA max APAP dose per day is 4,000mg. In Europe, it’s 6,000mg. It’s never been proven what’s safe and what isn’t. It also depends on the specific users metabolism. My doctor insists I don’t take more than 2,000mg per day, which is half the legal maximum.

The thing that really gets me is that the FDA put APAP into these drugs specifically to prevent abuse by damaging the liver. Now that it’s working, they’ve decided they should ban these drugs. Who is running this shit? They’re mad at themselves. So if they ban these drugs, how will people that depend on them continue to have pain relief? For example, if a chronic pain patient taking something like Vicodin suddenly can’t get Vicodin because it’s now illegal, what are they to do? They can’t get JUST the hydrocodone component because that’s illegal in the United States. They can’t get Percocet because it would have been banned too. Their only options are to move to morphine, oxycodone, or any number of Schedule II drugs which are a lot harder to get doctors to give you (it’s hard enough to get them to give you Schedule IIIs). An interesting exception is Percodan, which is oxycodone + aspirin instead of APAP. Aspirin has its own overdose risks, including total loss of hearing.

So in summary, the FDA demanded drug companies put APAP into drugs to avoid abuse, and now they’re scolding them for causing liver failure. They’re blaming everyone else for their mistakes, including the patients. Sure, your average person that gets Vicodin three times their entire life isn’t going to lose out on this so much, but what about chronic pain patients that depend on these types of medication in order to lead a normal life. People like me.

Acetaminophen is over-the-counter. Anyone can grab a bottle and overdose, but we need to worry about the APAP content in controlled drugs?

The mind boggles.