July 2, 2009 -- For 22-year-old Jacob Rosenberg, life without his daily dose of Vicodin wouldn't be much of a life at all.
"Before I began taking narcotics two years ago, I would spend my days in bed," said Rosenberg, who has suffered from fibromyalgia and rheumatoid arthritis for five years, and chronic pain for 10. "I was in college and I wasn't capable of doing anything – go to classes or go out."
"But since I've been on Vicodin my pain is 80 percent diminished," said Rosenberg. "It gives me the ability to be a normal person."
Rosenberg is one of millions of Americans who fill prescriptions each year for an acetaminophen-based narcotic – or combination drugs – such as Vicodin or Percocet, the two most popularly prescribed drugs in the country.
But patients like Rosenberg are worried that the solution to their pain may soon be unavailable to them after an expert advisory panel for the U.S. Food and Drug Administration voted earlier this week to ban combination drugs.
The panel's vote came after days of deliberation over ways to reduce the liver damage risk associated with acetaminophens. The panel also voted to keep over-the-counter combination pills containing acetaminophen on the shelves and lower the maximum dosage of these pills.
The panel voted 36 to 1 to recommend a "black box" warning for prescription medications that combine acetaminophen with another drug.
"It's completely unfair to take these drugs away from us," said Rosenberg. "Without them you can't act like a normal person."
Experts Say Hope Is Not Lost Without Combination Drugs
But medical professionals disagree, and say that those suffering from chronic pain will not be left without medication should the FDA decide to heed the advice of the panel.
"There are a lot more drugs out there than are being used," said Dr. Charles Kim, a pain management specialist at Mount Sinai School of Medicine in New York.
"I would tell patients who are panicking over [this vote] to relax, it doesn't mean they're going to take pain medication off the market completely but just that they're thinking about changing certain prescribing patterns to increase safety," said Kim.
More FDA regulation on prescription combination agents as well as more labeling of over-the-counter acetaminophens could help reduce the number of unintended overdoses, according to Dr. Eugene Viscusi, the director of pain management at Thomas Jefferson University in Philadelphia.
Because nearly 42,000 people visit emergency departments each year with acetaminophen overdoses, half of which are accidental, eliminating drugs that aren't clearly labeled to have acetaminophen in them could decrease this number significantly, said Viscusi.
"The problem is not just with prescription narcotics," said Viscusi, "It's their use in combination with over-the-counter drugs."
Eliminating combination drugs would result in patients being able to treat their pain with two different pills, rather than just one. While some may see this as an inconvenience, Viscusi said he's hopeful it might lead to increased awareness about what patients are actually ingesting.
"This would be the best thing," said Viscusi. "If you're taking the acetaminophen separately from your opioid then you know exactly what you're taking."
And as for patients who say nothing else will ease their pain but the acetaminophen-based narcotics, Viscusi says there are other drugs that can help them.
"There will be other drugs, it just may require a little adjustment in thinking for those doctors who consistently prescribe Vicodin and Percocet," said Viscusi.
Other Drug Alternatives
Percocet, for example, could be given to patients by prescribing them Oxycodone – which does not include acetaminophen – and then instructing the consumer to take Tylenol as well.
Still, Viscusi is advocating for better labeling on over-the-counter drugs in addition the ban of combination agents as well as more education for consumers and medical professionals alike.
Kim agrees with Viscusi and said that with more training and education, doctors will realize the Vicodin and Percocet are not the only options for pain management.
"Many doctors don't readily have the experience or knowledge of prescribing other agents that either reduce the amount of acetaminophen or take it out completely, such as Norco, Roxicodone, OxyIR, OxyFast or hydromorphone," said Kim.
"These can be safely and effectively used on patients with quality of life-dependent needs who many not be candidates for the acetaminophen, yet need the adequate pain relief to function in their daily lives," he added.
But those who would likely be directly affected by an FDA ban on combination drugs – patients of chronic pain – are still worried.
"This will hurt a huge amount of people who look to those medications to help manage the pain so they can be a productive part of society," said Penney Cowan, the executive director of The American Chronic Pain Association, who has been suffering from chronic pain herself for more than 30 years.
"It will narrow the field even more when it comes to treatment for pain," said Cowan. "There is going to be a point where there just won't be any other options."
"The problem with pain is that we don't see it, and we can't measure it," said Cowan. "People don't understand just how much pain we are in."