TAMPA — Bill Gomez has this message for FDA officials considering a ban on prescription painkillers containing acetaminophen: Spend a day in my body.
Still suffering from the impact of a head-on auto wreck more than two decades ago, Gomez, 61, said he lives on a couch with a heating pad on his back. He's taken Percocet and Vicodin, both of which combine a narcotic with acetaminophen. The theory is that the combination is more powerful than just the opiate, either oxycodone or hydrocodone, alone. Gomez said that's true for him.
"I take oxycodone when the pain's not really bad, but truthfully, the Percocet works better," he said. "I'm tired of the government thinking it knows what's best for me."
A Food and Drug Administration advisory committee recommended Tuesday that the agency take steps to protect the public from overdoses of acetaminophen, the leading cause of liver failure in the United States. In addition to being present in a number of popular prescription medications, acetaminophen is found in dozens of widely used over-the-counter medications, including Tylenol, Excedrin and some forms of Robitussin and Vicks.
The committee recommended lowering the maximum single and daily doses of over-the-counter acetaminophen products. It also narrowly voted to call for pulling prescription drugs like Percocet and Vicodin from the market, or, alternately, put a black-box warning on the labels. The FDA gave no indication of when it might make a decision on its advisers' recommendations, which it often, but not always, follows.
Dr. Lynne Columbus of Palm Harbor, an anesthesiologist who specializes in pain management, said she'd have no problem with combination painkillers like Vicodin and Percocet being pulled from the market except for one thing:
The opiate in Vicodin — hydrocodone — is not widely available. And oxycodone, the narcotic in Percocet, has also been in short supply locally.
"We know what pharmacies are carrying plain oxycodone," she said. "For others who haven't been writing these prescriptions, this is going to be a blow. Especially primary care doctors who are not that comfortable writing non-combination painkiller prescriptions."
Combination painkillers are widely prescribed for patients with acute, post-surgical pain, like after having wisdom teeth removed, Columbus said. Long-term use, or the combination of the prescription pill with over-the-counter sources of acetaminophen, increases the chances of liver damage.
"And the problem with liver dysfunction is you don't know there's a problem until it's too late," she said.
Dr. David Baras, a physical medicine and rehabilitation doctor in Pinellas Park, received a box of patient handouts from the makers of Tylenol on Wednesday morning, listing 23 well-known remedies, from Actifed to Vanquish, that contain the ingredient.
"Acetaminophen is used pretty much for pain and headaches, but if you're looking for something for a runny nose, or sore throat, it's all mixed up with acetaminophen, too," he said. "I always tell patients it's easy to surpass the FDA's current recommended daily dose of 4,000 mg."
With that in mind, Baras switched a patient on Wednesday from Percocet to oxycodone. "My biggest concern is that there will be some patients who benefited from the combination, who say a straight opiate won't give the same relief," he said.
That's the case with Loretta Reno, a 91-year-old Tampa resident who has taken Vicodin for four years to alleviate arthritis pain.
"Oxycodone was too strong, and she's allergic to morphine," said her daughter, L.A. Reno. "Vicodin is the only thing she hasn't had a reaction to. With it, she's able to walk and do simple tasks."
A licensed practical nurse, Reno's daughter said she carefully monitors her mother's medications and watches over-the-counter drugs.
Angry that the FDA may take away the drug that keeps her aging mother mobile, Reno said, "We're becoming a nanny state. We're supposed to be adults, not children."
Kris Hundley can be reached at firstname.lastname@example.org or (727)892-2996.