How much is too much - FDA concerned with Vicodin & Percocet

Most employers will see that prescription narcotics will be among their top 10 highly utilized medications for an employer sponsored health plan. Employee safety is of greater concern when individuals are using and abusing narcotic pain medication. Many of these medications are easily accessible and rather cheap; however, recent news about the dangers of some of these medications may quickly have the most popular varieties taken off the market.

On June 30, 2009 an advisory committee to the U.S. Food and Drug Administration recommended that the FDA restrict the use of acetaminophen, one of the most widely-used pain medications. Some of the more popular medications containing acetaminophen are over the counter drugs such as Tylenol, Excedrin and NyQuil as well as other prescription brand-name medications such as Vicodin, Percocet, Lortab, and Tylenol w/codeine.

If taken in the recommended doses, acetaminophen is a safe and effective fever reducing and pain medication, however, it is widely overused. The average healthy adult has the recommended maximum dose of acetaminophen over a 24 hour period of 4000 mg. Each extra-strength Tylenol pill currently contains 500 mg, and each regular strength pill contains 325 mg. Overdoses occur when individuals multi-medicate to treat various symptoms not knowing that acetaminophen is a common ingredient in each of the medications being taken. A common mistake occurs because it is often difficult to identify products containing acetaminophen as it is often labeled as APAP on pharmacy containers. Another common overuse of acetaminophen is the PM version of Tylenol. Many individuals take Tylenol PM on a regular basis to medicate for sleep deprivation or insomnia. This combined with daily pain medications often result in accidental overdose.

Acetaminophen overdose causes severe liver damage and have been linked to 56,000 emergency room visits, 26,000 hospitalizations, and 458 deaths during the 1990’s according to the FDA. The agency cited another study, a 2007 Centers for Disease Control and Prevention population-based report, that estimated acetaminophen was the likely cause of most of the estimated 1,600 acute liver failures each year.

The FDA isn’t trying to eliminate the use of acetaminophen, but has suggested restrictions on its use that will reduce the recommended dosages and eliminate some popular prescription products that contain acetaminophen such as Vicodin and Percocet.

We recommend that you become familiar with the manufacturers dosage recommendations and adhere to all warning labels and guidelines in order to avoid accidental acetaminophen overdose.
References: FDA, “Joint Meeting of the Drug and Safety and Risk Management Advisory Committee with the Anesthetic and Life Support Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee Meeting Announcement,” June 29-30, 2009. Source.

– Stephanie O’Dell