Local pharmacists and doctors had mixed reactions to a federal recommendation that would ban certain prescription drugs that contain acetaminophen, the active chemical ingredient in Tylenol, and lower the daily maximum of over-the-counter medicines that contain the drug.

The recommendation, made by a panel of 37 experts assembled by the Food and Drug Administration to address reducing deadly overdoses with acetaminophen, would ban prescriptions for Vicodin and Percocet, two of the leading prescription pain medications in the U.S. It also would lower the maximum daily dose of over-the-counter acetaminophen from 4 grams, or eight pills of a medication such as Extra Strength Tylenol. The panel did not specify how much it should be lowered.

The FDA 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. A majority of panelists also said the 1,000-milligram dose should be available only by prescription.

The FDA is not required to follow the advice of its panels, though it usually does. The agency gave no indication when it would act on the recommendations.

Jeff Willerford, a pharmacist at Lynn’s La Vega Pharmacy, said while prescriptions of Percocet have declined in recent years, Vicodin, a brand of the narcotic hydrocodone, is a staple in treatment for chronic pain, cancer, and medical and dental surgery.

“I’d say we fill 30 to 40 prescriptions of Vicodin a day,” Willerford said. “I think if you were to take away people’s Vicodin, there would be a very public and immediate outcry.”

But Dr. Charles Stern, a family physician at Scott & White Clinic in Waco, said the FDA recommendation likely would force doctors to begin prescribing hydrocodone and Percocet that contain lower doses of acetaminophen instead of banning the drugs outright. Both medicines contain acetaminophen combined with narcotics to relieve pain.

“There are some hydrocodone preparations out there that, instead of having 500 milligrams of acetaminophen in them, they have 325 milligrams of it, and Percocet has some of the various strengths of acetaminophen as well,” Stern said. “There are some people who have had liver disease that we’ve had to use lower doses of Tylenol when they require pain medicine.”

Stern estimated that the average primary care physician may write up to five prescriptions in a given day for Vicodin. He said though switching to painkillers with lower doses of acetaminophen would mean some adjustments for physicians, they still will be effective in treating patients.

“I’ve begun prescribing painkillers with the lower doses of acetaminophen for the past five years or so on my own, and I haven’t within my practice really noticed a significant difference,” Stern said. “It’s not something that’s going to compromise a general primary care physician or any other physician prescribing pain medication; we’re just going to have to be more aware of what to prescribe. Our goal is still going to be to try to take care of patients’ pain needs.”

Willerford said doctors should be allowed to make the call on how much acetaminophen is appropriate for their patients. He added that while narcotic-based pain relievers like Vicodin are subject to abuse, doctors have a duty to properly treat patients who are suffering from severe pain.

“I trust the doctors to make an adequate diagnosis and to prescribe correctly, and probably 99 percent of the time they do,” Willerford said. “And pharmacies monitor the usage. If a patient comes in gets a month’s supply of a narcotic and they want it every 15 days, well, a red flag is raised, and we will notify the doctors.”

Overdose risks

The panel’s recommendations are aimed at reducing accidental acetaminophen overdoses when consumers take the maximum daily allowances of Tylenol and also take another over-the-counter medicine that also contains acetaminophen, such as Sudafed, TheraFlu or NyQuil.

Willerford said he also disagrees with the recommendation to reduce the maximum amounts of acetaminophen available over the counter. As long as people follow the guidelines written on the label, the medicine is safe to use as it is currently manufactured, he said.

“The label directions for over-the-counter use of Tylenol are appropriate, but when you sell something over the counter, people can take it however they want to, unfortunately,” Willerford said. “You really can’t legislate morality, ethics or intelligence. If people are going to abide by the rules written on the bottle — that’s fine. If they go overboard, that’s their own conscious decision.”

Acetaminophen is the leading cause of liver failure in the U.S. and sends 56,000 people to the emergency room annually. About 200 die each year.

Willerford said that although Tylenol can lead to liver complications, it is still the best over-the-counter medicine to treat fever and inflammation. While there are other substitutes that can be used, such as ibuprofen-based medicines like Advil, Motrin or Aleve, those medicines also can cause adverse health problems.

“They don’t affect the liver as much, but they can affect the kidneys, they can affect people’s blood pressure, and in high dosages to susceptible individuals, they can cause ulcers,” Willerford said. “(If) you do away with one and everybody switches to the others, we’ll have problems with that, too.”

Stern said more than anything, the FDA recommendations should reinforce to consumers the importance of looking at the labels of medicines they purchase over the counter to reduce the chances for accidental acetaminophen overdoses.

“The biggest point the FDA is trying to make is that people who may take something for your cold and fever, make sure you’re not taking too much acetaminophen, and realize that some of the products that you buy over the counter may contain acetaminophen, but you may not be aware of it,” Stern said.

The Associated Press contributed to this story.

rdennis@wacotrib.com

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