FDA warns against high-dose acetaminophen

JONESBORO, AR (KAIT) - A warning from the Food and Drug Administration against high dose prescriptions of acetaminophen has recently affected pharmacy shelves.

That's not necessarily a bad thing, though according to a pharmacist Region 8 News spoke with.

"Tylenol in and of itself is a very safe drug when it's taken in correct amounts," Pharmacist Tracy Mooneyham with Soo's West End Pharmacy said.

According to the FDA, they've recommended health care providers prescribe drug products that contain 325 milligrams or less of acetaminophen.

"The difficulty becomes when people begin to receive prescriptions for combination pain products whether it be oxycodone, hydrocodone," Mooneyham explained.

Mooneyham said that is where it can become an issue, as those doses often have higher amounts of acetaminophen, or Tylenol, than the recommended level. Mooneyham explained that as pain killers like hydrocodone, oxycodone and the like can run a dependency issue, it can create problems down the road.

"Those people have the potential obviously to ingest more Tylenol than what's recommended and of course, that's detrimental to the liver."

According to the FDA, overdoses from acetaminophen send 56,000 people to emergency room every year and kill 500.

"The goal, again, with the new combination products is to provide a product that the patient can use the narcotic portion of the pain medication a certain number of times a day an amount of Tylenol that was above the recommended dose."

Mooneyham said this is something pharmacies were expecting for awhile as the FDA made the recommendation to remove high-dose acetaminophen from the market back in 2011.

Mooneyham said that for the past six months or so, they've been working to use up their current supply of the high-dose pills they have in stock for two reasons.

"To let those supplies dwindle out so when the change occurred we wouldn't have an excessive amount of inventory that couldn't be returned but also to begin to transition patients that were on high dose combination products to a product that could be dispensed."

The FDA said there's nothing that indicates the benefits of taking more than 325 milligrams of acetaminophen outweighs the risk for liver injury. Mooneyham urged as with any prescription, consult with your doctor or pharmacist.

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