The Food and Drug Administration (FDA) met a few years ago in Adelphi, Maryland to discuss the concern of two powerful medications used for pain control. The two painkillers are Percocet and Vicodin.
A panel was put together to vote on these medications and possibly determine if they should be pulled from the market.
The real concern is the drug Acetaminophen [Tylenol] which is found in high doses in both Vicodin and Percocet. Both medications fall under the category of Opioids.
Tylenol is a widely used medication and under normal doses it rarely may cause serious concern. But when this medication is taken in high doses – severe liver damage and acute liver failure could be the result.
According to the FDA more than 200 million drugs combined with Tylenol were prescribe last year alone.
The panel voted 20 – 17 that medications such as painkillers that are combined with acetaminophen should be taken of the market. This panel was to help determine the outcome of the medications in concern, but no absolute decision has been made.
Many panelists were concerned about an outright removal from the market and a separate vote took place regarding a black box warning placed on the medications combine with acetaminophen.
This vote took in the assumption that these medications will be allowed to stay on the market. A 36 – 1 vote in affirmation for a black box warning.
Several additional issues regarding acetaminophen were discussed including:
1.) Lower the maximum daily dose of acetaminophen
- It is currently at 4 grams per day
- 4 grams = 8 x 500mg extra strength Tylenol
- Another recommendation amount was not discussed
2.) 1,000 mg tablets should only be available by prescription
3.) Maximum single dose to be 650mg
4.) Tylenol cough and cold will not be pulled from the market
***An important final note is that the FDA organized the group of panelists but that the decision to pull medications combined with acetaminophen has not yet been finalized. More often than not the FDA will agree with its panel for the changes in Acetaminophen overall.
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