An FDA review panel today called for safety restrictions on the popular over-the-counter pain reliever Tylenol, including reducing its maximum dose. Concerns over cases of liver damage and failure prompted expert review. The panel recommended lowering the maximum dose of over-the-counter Tylenol from 4 grams, or eight pills of a medication such as Extra Strength Tylenol. They did not specify how much it should be lowered. The panel also endorsed limiting the maximum single dose of the drug to 650 milligrams. That would be down from the 1,000-milligram dose, or two tablets of Extra Strength Tylenol.
The experts also ruled that prescription drugs that combine acetaminophen with other painkilling ingredients (such as Vicodin and Percocet) should be eliminated. They cited FDA data indicating that 60 percent of Tylenol-related deaths are related to prescription products. If the combination products are eliminated, the acetaminophen and the other ingredients could be prescribed separately. In effect, patients would take two pills instead of one, and be more aware of the acetaminophen they are consuming.
These panel recommendations have impact on plastic surgery as Percocet and Vicodin are the most common postoperative pain medications that we prescribe. Many of my patients have concerns about the doses of Tylenol to which they may be exposed. For this reason, I have been using when possible ActiPatch technology for its pain management and anti-inflammatory effects which reduces patients needs for these drugs.
ActiPatch is a topically applied battery-operated device that elicits pulsed electromagnetic fields that is proven to be capable of modulating inflammation and edema in local tissues. It is easily applied and removed and is inexpensive. I have used it in my Indianapolis plastic surgery practice over the past two years and have found it effective for postoperative relief of pain and swelling after breast augmentation, liposuction, tummy tucks and certain types of facial surgeries. I have patients apply it for up to 48 hours after surgery. While it may not completely eliminate the need for some prescription medication, the overall doses and duration of need certainly appear reduced.
The timing of these Tylenol (acetaminophen) recommendations further validates my use of the ActiPatch devices for my patients. They provide a natural and drug-free adjunct to conventional pharmacologic therapies that have no risk of any adverse reactions. Unlike drugs, they do not induce prolonged use or dependency and more quickly help patients get back to an unmedicated lifestyle after surgery.
Dr. Barry Eppley
Indianapolis, Indiana