Medication Warnings

The past week has been busy for the FDA. Last week they held a two-day meeting discussing Tylenol acetaminophen) overdose and what can be done to improve patient safety. Acetaminophen is a popular pain reliever that is often used alone, but is in a lot of combination products, notably over-the-counter cold remedies and prescription pain killers such as Percocet and Vicodin. One of the problems, according to many experts, is that patients are unaware of how much acetaminophen is in each of these medications so they are taking more than the maximum daily dose, which is 4000 mg for most adults. Michael Ashburn, director of pain medicine and palliative care at the University of Pennsylvania Health System, says that since the components of Percocet (oxycodone and acetaminophen) are available separately, maybe they should be prescribed independently as well. This would be one way to ensure patients are aware of their dosages.

Just yesterday the FDA issued a press release about Darvocet, another acetaminophen-containing product. It has been linked to fatal overdoses, especially in the elderly, so the FDA will soon require that it carry a "black box" warning, emphasizing the potential for overdose.

Since so many headache sufferers are on these pain relievers it will be interesting and important to watch and follow where we are headed. Pulling these drugs off the market is one potential outcome, and should it come to that, there will be a lot of patients looking for alternatives.

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