FDA panel calls for Percocet, Vicodin ban
The group recommended limits on daily doses of acetaminophen.
Sep. 01, 2009
A government advisory panel recommended this summer that the Food and Drug Administration ban two widely prescribed medications and increase regulation of over-the-counter products to limit amounts of a certain painkiller associated with liver damage.
The FDA's Drug Safety and Risk Management Advisory Committee said in a July report the agency should ban two prescription painkillers, Percocet and Vicodin, due to their high levels of acetaminophen and the ease with which patients can become addicted to them.
Bernard Abrams, president of the Missouri Pain Intiative, an advocacy group for people who suffer chronic pain, said his group does not think acetaminophen-opiate combination drugs should be banned, but rather available with a maximum of 325 mg of acetaminophen per pill.
"The consensus is that drugs like Percocet and Vicodin should be available combined with lower doses of acetaminophen," Abrams said. "We certainly don't think they should be eliminated."
The FDA panel also voted 36-1 that if the drugs are not banned from the market, they should be given a black box warning, the FDA's most severe warning label.
American State Pain Initiatives Director June Dahl said her group, a national coalition of state pain advocacy groups, favors this approach rather than banning the drugs outright.
"A far better solution would be to increase warning labels or increase education about the risk of liver toxicity through public service announcements," she said.
Jeffrey Phillips, MU director of applied research and associate professor of medicine, said many patients do not know these painkillers contain acetaminophen and are often told to supplement those painkillers with Tylenol, increasing the possibility of liver toxicity.
"This might be throwing the baby out with the bathwater, but people tend not to know that there's acetaminophen in there," Phillips said. "No one tells them."
The panel voted 20-17 to ban medications with acetaminophen and opiates. An earlier FDA report had shown liver damage and even death was linked to heavy consumption of acetaminophen, which is easier on the stomach than aspirin and ibuprofen.
"Generally, we've been taught that this is pretty safe stuff," Phillips said. "But some patients use it chronically and it's not uncommon for them to develop liver toxicity."
The panel also said a single dose should only contain 650 mg of acetaminophen; some medications contain as much as 1,000 mg per dose. The panel said drugs with concentrations that high should only be available by prescription.
The FDA is not required to adopt the panel's recommendations, but usually does so. The Office for New Drugs at the FDA's Center for Drug Evaluation and Research will consider the suggestions.
DeAnna DuBose, spokeswoman for Abbott Laboratories, which makes Vicodin, said the combination of acetaminophen and hydrocodone has been available for more than 30 years and said some patients rely on it as part of their recovery.
"It is important to balance the need for patient safety and treatment options," DuBose said.
DuBose said there have been precedents of the refusing advice the panel gives and said the company would react to the final decision when one is reached.
"At this point it is too early to speculate on next steps until receiving the Agency's guidance," she said.