Will Vicodin and Lortab be Taken off the Market?

The FDA has finally decided to address the problem of unintentional overdoses of acetaminophen (aka Tylenol). While most bloggers have recently been up in arms about this, saying thing such as, “I find it somewhat odd that so much attention is focused on acetaminophen, since it’s one of the safer drugs out there,” acetaminophen is actually quite dangerous. It’s the most common cause of acute liver failure. Furthermore, most people don’t realize that the toxic dose of acetaminophen isn’t much higher than a therapeutic dose. For example, the maximum recommended daily dose of acetaminophen is 4,000mg per day, but as little as 6,000mg (just twelve 500mg tablets) per day for two days is capable of causing liver toxicity.

Last week an FDA advisory committee met to determine which steps should be taken to limit unintentional overdoses of acetaminophen. The panel produced several recommendations:

• Removing 500mg tablets of acetaminophen from the nonprescription market
• Lowering the maximum adult single dose of acetaminophen to 650mg
• Decreasing the 4,000mg maximum adult daily dose of acetaminophen (probably to 3250mg)

While I fully support each of these recommendations (because they make sense), the panel also recommended a course of action that I certainly hope the FDA DOES NOT implement. In a 20 to 17 vote, the committee voted to eliminate all prescription-only drugs that contain acetaminophen.

While the FDA isn’t required to follow the recommendations of such an advisory panel, they usually do so. And if the FDA forces all prescription drugs containing acetaminophen off the market, this will have terrible consequences. Let’s take a look at just a few of the drugs that will be affected:

• Hydrocodone/acetaminophen (generic Lortab, Vicodin, and Norco): This medication was the most highly prescribed drug in America last year, with more than 121 million prescriptions filled.
• Oxycodone/acetaminophen (generic Percocet): This drug accounted for 29 million prescriptions (26 million generic prescriptions and 3 million prescriptions for the branded generic Endocet) in 2008.
• Propoxyphene/acetaminophen (generic Darvocet): Over 20 million prescriptions were filled in 2008 for this drug.
• Codeine/acetaminophen (generic Tylenol #3): More than 13 million prescriptions were filled in 2008 for this drug.

Just these four fast-acting pain medications added up to more than 180 million prescriptions last year. Remember, if these medications go away, these prescriptions will still need to be filled . . . just with other drugs. So, what drugs will be left on the market to replace these 180 million prescriptions?

• Hydrocodone/ibuprofen (generic Vicoprofen): This combination drug could be counted on to replace the acetaminophen combinations, but this drug is actually seldom used. With just 2.2 million prescriptions filled last year, an entire year’s supply of generic Vicoprofen would be able to replace about a week’s worth of hydrocodone/acetaminophen prescriptions.
• Codeine: Codeine is also available as single-ingredient preparation; however, this drug is a Schedule II controlled substance. So, unlike codeine/acetaminophen combinations, this medication requires a written prescription with each fill. Also, this medication isn’t manufactured in quantities large enough to compensate for the loss of the products that contain acetaminophen.
• Oxycodone: Oxycodone tablets and capsules are already prescribed fairly frequently. However, with just 7.8 million prescriptions filled last year, this drug still won’t put a dent in the huge shortage that will be caused by the withdrawal of drugs that contain acetaminophen. In addition, there’s actually already an oxycodone shortage that the FDA has made much worse.
• Morphine: The FDA has also forced all but one manufacturer of immediate-release morphine tablets off the market, and created a shortage with this drug as well.
• Tramadol: While this drug is readily available, its 21 million prescriptions per year still won’t come close to filling the void of these other products. Also, tramadol is a very weak pain medication. When compared to most of these other drugs, it’s practically useless in my opinion.
• Propoxyphene: This medication is also a fairly weak pain medication. In addition, propoxyphene has problems of its own (such as heart toxicity, even at low doses) which make it a bad choice to replace these products.

Let’s hope that the people at the FDA use their brains on this one, and actually think of the devastating consequences of their potential actions. Perhaps people would benefit if these drugs were removed from the market, but this process has to be carried out in the right away to minimize any shortages of pain medications.