This article looks at the possibility of a Vicodin ban. Periodically, already approved medications are reevaluated to see if they still meet the standards of the Food and Drug Administration. One key element of this reassessment is if a drug product is “safe and effective.” These are relative terms. The “safe” part doesn’t mean it can’t cause harm, but that the harm is less than the benefits patients get from the medication.
When an FDA review panel recommended a Vicodin ban and similar products (Lorcet, Percocet) be withdrawn from the market, they focused on the acetaminophen (Tylenol) that such products contain. The worry is that having the acetaminophen in the formulation was causing liver damage in patients with chronic pain.
There’s a few insider secrets that the public isn’t aware of when it comes to combo-products like Vicodin and considering a Vicodin ban. The first is that the labels call only for short term use in pain relief. Despite the manufacturers knowing that doctors will prescribe the drugs for long term, chronic pain, the drugs aren’t approved for that use. Arguably, the manufacturer can’t be sued if the drug is used long term and causes harm.
Another “secret” is that the acetaminophen in the mixed products (hydrocodone and acetaminophen) probably doesn’t do much, if anything, for pain relief. In a sense, you are combining a very strong narcotic (hydrocodone) with an over-the-counter analgesic (Tylenol). So why is the ineffective ingredient in there? It’s there to prevent illegal injection of the “real” pain reliever – the narcotic. Hydrocodone could be extracted from Vicodin and injected by addicts. The acetaminophen makes this much harder to do.
So what’s the problem? The problem is that long-term, or high dose acetaminophen damages the liver. This has recently been demonstrated to be the case, even at levels we thought were safe. This isn’t true for the narcotic. Patients who need higher levels of pain relief will tolerate higher doses. But because the pills are mixed, increasing the amount you take of one ingredient means you get more than you should of the other.
In effect, we are putting some legitimate patients at risk for no other reason that preventing misuse by addicts.
The Vicodin ban might be a good idea in the end, as long as doctors have an option to prescribe other pain meds for patients who need relief.