Life Without Vicodin Will Be OK, Doctors Say

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."
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FDA Scrutinizes Acetaminophen's Liver Risk

Acetaminophen is the most commonly used painkiller in the country and the U.S. Food and Drug Administration will scrutinize its safety record today in the shadow of concerns that people taking too much of it are damaging their livers.

Research has shown that hundreds of Americans each year experience acute liver failure as a result of taking acetaminophen -- widely known under the brand name Tylenol -- and about 100 people die annually from overdosing on the painkiller, either intentionally or unintentionally.

Although researchers have found that the drug is safe if taken at recommended levels, its prevalence in a variety of pain relievers, fever reducers and cough medicines as a somewhat hidden ingredient means patients don't realize they are taking several drugs that all contain acetaminophen.

Moreover, combining the medication with alcoholic beverages increases the risk of liver damage.

These concerns and more will be the subject of discussion today and Tuesday at the Center for Drug Evaluation and Research Joint Meeting of the Drug Safety and Risk Management Advisory Committee, the FDA's Nonprescription Drugs Advisory Committee, and the Anesthetic and Life Support Drugs Advisory Committee.

No matter the outcome of the meeting, however, consumers will still be able to get acetaminophen. Twenty-nine billion extended units (tablets/capsules/milliliters) of prescription and over-the-counter, acetaminophen-containing products were sold through retail and non-retail pharmacies in 2005, according to the FDA.

"It's important to say that they're not considering taking acetaminophen off the shelves," ABC News Medical Contributor Dr. Marie Savard said on "Good Morning America" this morning. "When taken in the proper dosage, this is a safe drug that's been used for more than a half century. The problem is that people often take more than the maximum dosage and that can cause serious liver damage and sometimes even death."

One of the items on the FDA's agenda, Savard said, is looking into eliminating combination drugs that contain acetaminophen to curb the incidence of accidental overdose. The agency will also be exploring the possibility of better labeling of these drugs -- including strong warnings about the risks of liver damage -- and it's considering reducing the maximum daily dosage levels for over-the-counter acetaminophen to no more than 3,250 milligrams from the current max of 4,000 milligrams per day.

Is Acetaminophen Safe?

The FDA has struggled with the issue of acetaminophen's safety since at least 1977, when an agency committee suggested that labels for pain relievers contain a warning that they can damage a patient's liver.

McNeil Consumer Healthcare, a Johnson & Johnson subsidiary and the manufacturer of Tylenol, said in a statement last month that they fear recommendations made by the FDA could have the effect of steering consumers away from an appropriate and safe drug.

"While we share the FDA's mutual goal of preventing and decreasing the misuse and overdose of acetaminophen, we have concerns that some of the FDA recommendations could discourage appropriate use and are not necessary to addressing the root causes of acetaminophen overdose," the statement read.

And the Consumer Healthcare Products Association, a not-for-profit association representing the makers of over-the-counter medicines and nutritional supplements, cited FDA data showing that more than 80 percent of fatalities associated with over-the-counter and prescription acetaminophen products involve intentional overdoses -- in other words, suicide attempts.

Savard agreed that, in most cases, acetaminophen is safe.

"The truth is that acetaminophen is the safest choice for pain and fever," she said. "The alternatives -- inflammation blockers, like aspirin and ibuprofen -- have even more safety concerns. They can cause ulcers and bleeding, high blood pressure, and kidney disease. With acetaminophen, if you stick to the right dose and don't take too much, it's generally very safe."

Still, the hazards of acetaminophen overdose have worried many poeple for years. In 2002, Dr. Peter Lurie of the consumer advocacy group Public Citizen appeared before the FDA's Nonprescription Drugs Advisory Committee to relay concerns about unintentional overdoses associated with acetaminophen. In November 2005, a study in the journal Hepatology found that the majority of acute liver failure cases in the United States were due to acetaminophen poisoning. And more recent research has suggested that these cases may be on the rise.

Keeping Yourself Safe From Acetaminophen Overdose

Fortunately, Savard said, consumers can go a long way in terms of protecting themselves if they simply monitor the drugs they are taking and, especially, if they are aware of the ingredients in the products they take to ease their pain.

"More than 200 products have acetaminophen in them," Savard said. "Everything you put in your mouth counts -- and that includes prescription drugs too, which can also contain acetaminophen."

Savard's advice to consumers? Read every label carefully and keep track of how many doses of acetaminophen you take per day. She added that consumers must also become more savvy to clues on labels that point to acetaminophen.

"When you're checking prescription drugs like these, look for the letters 'APAP,' which designate that the medication contains acetaminophen," she said. "Drugs like codeine and oxycodone often come with acetaminophen but, as I said, it's labeled as 'APAP.'"
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