At the heart of the FDA's new scrutiny of prescription painkillers is a chemical called acetaminophen (aka. paracetamol). The key component in Tylenol and other popular painkillers, it has caused many injuries to the liver, as the suggested maximum daily dose is just below the dosage levels that could cause serious organ damage.  (Source: Wikimedia Commons)

Acetaminophen toxicity in the liver proceeds via the red path (other common non-toxic metabolic pathways shown in blue).  (Source: Wikimedia Commons)

The FDA is considering removing from the market Nyquil and other drug cocktails which combine acetaminophen with other medications.  (Source: Procter & Gamble)
Many household names may seem serious changes

The U.S. Food and Drug Administration is considering serious changes that may impact the sales of prescription and over-the-counter painkillers. According to the FDA, there are over 56,000 acetaminophen overdoses per year in the U.S. alone. 

Acetaminophen is a leading painkiller found in Tylenol, Procter & Gamble's NyQuil, and Novartis' Theraflu among others.  The cyclic hydrocarbon derivative is also frequently combined with opiates or other pain relievers in medications such as Percocet (oxycotin+acetaminophen).  Overdoses can cause severe liver damage and even death.

The FDA began a two-day meeting starting today, polling 35 experts about what the best approach is to reduce the dangers of acetaminophen-related liver damage.  At issue are the current 4 gram-per-day maximum dose listings featured on many of the drugs, a dose just below levels which can cause potentially fatal liver injury.  The FDA says that by emphasizing safety, drug makers like Tylenol essentially mislead consumers into the belief that the drugs are "extremely safe and not likely to lead to serious injury."

Among the suggestions are to add "black box" warnings to certain drugs, pull others off the market, and to reduce the dosage in still others.  Such restrictions would be major blow to the pharmaceuticals industry, potentially costing it millions. 

Nyquil and Theraflu are among the combination drugs that some experts are suggesting get pulled off the market.  The FDA is concerned about consumers not realizing that these drug cocktails contain acetaminophen and taking Tylenol in addition, elevating their dosage to dangerous levels.

Still, the provisions may only go so far -- only five of the 72 deaths reported with acetaminophen in 2005 were from combination drugs.  Of the remaining, 40 deaths were caused by prescription acetaminophen drugs and 27 involved single-ingredient over-the-counter acetaminophen products, such as Tylenol.

A reported 28 billion doses of such products were sold in 2005.  The pharmaceutical industry is already pleading with the FDA to avoid making changes.  States the Consumer Healthcare Products Association, "These products provide consumers with effective pain relief and are safe and effective when used according to labeled direction."

"I modded down, down, down, and the flames went higher." -- Sven Olsen

Most Popular Articles

Copyright 2018 DailyTech LLC. - RSS Feed | Advertise | About Us | Ethics | FAQ | Terms, Conditions & Privacy Information | Kristopher Kubicki